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Table of Contents March 2011 • Volume 14, No. 2, Part 1 of 2

36 Antioxidants: High Expectations for a High Quality of Life

In a market filled with so many options for consumers, only the best will rise to the top—and stay there.

Cover design by: Jessica Carlin

46 Antioxidant Science:

50

From Antioxidants to ‘AntiAGEnts’ Antioxidants are entering a new era of product performance.

50 Is Vitality the New Energy? Vitality is becoming an attractive health proposition for consumers and a good business opportunity for companies.

58 Functional Confectionery: Finding the Sweet Spot

Is there a place for healthiness in the indulgent world of candy, chocolate and gum?

64 How Should ‘Bioactives’ Be Studied? The conversation among researchers in the scientific community about studying bioactives has started, and industry needs to be part of those discussions.

ALSO IN THIS ISSUE: 11th Annual Nutraceuticals World & Contract Pharma Supplement, starting on page 67 Columns 28 • Word From Wall Street by Adam Ismail

32 • Healthcare Practitioner Corner by Erik Goldman

30 • Inside China by Jeff Crowther

34 • From the Corners of the World by Paul Altaffer & Grant Washington-Smith

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March 2011

Table of Contents

14

102

104

Departments 8 • Top Of The News • Dannon settles yogurt ads case for $21 million; more supplement regulation on the way 10 • Editorial • a word from the editor 12 • Nutraceuticals World In Print & Online • line-up of expanded coverage @ nutraceuticalsworld.com 14 • Industry News • Dietary guidelines overlook benefits of EPA/DHA; NCL files Vitaminwater complaint 99 • Nutraceuticals Research • a recap of the latest clinical trials 102 • Supply Source • profiles on Ecuadorian Rainforest and Indena 104 • New Products • recent nutraceutical product introductions 108 • Suppliers Corner • new developments from industry suppliers 111 • People In The News • who’s who and who’s moving where 112 • Calendar • upcoming industry events 112 • Classified Section • classified advertising section 113 • Advertisers Index • cross reference of advertisers in this issue 114 • The Nutraceuticals Multiverse • a quirky look at nutraceuticals in a parallel universe NUTRACEUTICALS WORLD’S circulation is audited by BPA International. Authorization to photocopy items in NUTRACEUTICALS WORLD for internal or personal use, or internal or personal use of specific clients, is granted by Rodman Publishing, provided a base fee of U.S. $1 per page is paid directly to: Copyright Clearance Center, 27 Salem St., Salem, MA 01970 USA. NUTRACEUTICALS WORLD (ISSN 1531 0671) is published 10 times a year (Jan/Feb; March; April; May; June; July/August; September; October; November, December), in addition to a Company Capabilities supplement and Beauty I&O supplement, by Rodman Publishing Corporation, 70 Hilltop Road, Ramsey, NJ 07446 USA. Phone: 201-825-2552. Fax: 201-825-0553. Periodical postage paid at Ramsey, NJ 07446 and additional mailing offices. Publications Mail Agreement No: 40028970: Return Undeliverable Canadian Addresses to Circulation Dept. or PO Box 1051, Fort Erie, ON L2A 6C7; [email protected]. POSTMASTER: Send address changes to NUTRACEUTICALS WORLD, 70 Hilltop Road, Ramsey, NJ 07446 USA. Printed in USA. Free subscriptions to NUTRACEUTICALS WORLD are available to qualified individuals. Others are as follows: U.S. one year subscription $95.00, Mexico/Canada one year subscription $120.00 (5% GST required on Canadian orders. GST #134451756). Foreign Airmail one year subscription $195.00. Back issues available: $12/issue. Payment must be made in U.S. dollars via U.S. bank or by Visa or Mastercard. The publisher reserves the right to determine qualification of free subscriptions. Missing Issues: Claims for missing issues must be made within three months of the date of the issue. Also publishers of HOUSEHOLD AND PERSONAL PRODUCTS INDUSTRY (HAPPI), BEAUTY PACKAGING, NONWOVENS INDUSTRY, INK WORLD, LABEL & NARROW WEB INDUSTRY, COATINGS WORLD, CONTRACT PHARMA, MEDICAL PRODUCT OUTSOURCING AND ORTHOPEDIC DESIGN & TECHNOLOGY. Printed in the U.S.A.

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“Growing market sizes, heightened attention to product safety and the continuing harmo-

Top Of The News

nization of food supplement regulations show a global trend toward more regulation.” —IADSA

Dannon Settles Yogurt Ads Case for $21 Million

Facing charges of deceptive advertising for its Activia yogurt and DanActive dairy drink, the Dannon Company has reached a settlement with FTC. As a result, the company will stop claiming that one daily serving of Activia relieves irregularity and that DanActive helps people avoid catching colds or the flu. Dannon has also agreed to pay $21 million to resolve investigations into its advertising from 39 state attorneys general. However, Dannon said it does not admit any wrongdoing. As part of its ongoing efforts to make sure that marketers do not overstate the health benefits of their products, the FTC charged that Dannon’s ads were deceptive because the company did not have substantiation for its claims. “These types of misleading claims are enough to give consumers indigestion,” said FTC chairman Jon Leibowitz.“Consumers want, and are entitled to, accurate information when it comes to their health. Companies like Dannon shouldn’t exaggerate the strength of scientific support for their products.” Under the settlement, Dannon is prohibited from claiming that any yogurt, dairy drink or probiotic food or drink reduces the likelihood of getting a cold or the flu, unless the claim is approved by FDA. Although companies usually do not need FDA approval of their health claims to comply with the FTC Act, the FTC determined in this case that requiring FDA approval will give Dannon clearer guidance going forward, and help ensure that it complies with the settlement order. Dannon may not claim that Activia yogurt will relieve temporary irregularity or help with slow intestinal transit time, unless the claim is not misleading and the ad conveys that three servings of Activia yogurt must be eaten each day to obtain these benefits. Dannon may claim that eating fewer than three servings a day provides these benefits only if the company is relying on two well-designed human clinical studies substantiating the claim.

More Regulation on the Way For Global Supplement Market

Growing market sizes, heightened attention to product safety and the continuing harmonization of food supplement regulations show a global trend toward more regulation, according to the International Alliance of Dietary/Food Supplement Associations (IADSA). While food supplement harmonization is already underway in the European Union, decisions are expected this year on key aspects of the Association of South East Asian Nations’ (ASEAN) similar harmonization process toward a regional legislation. “Many countries are in the process of developing new regulatory frameworks, and regulators are increasingly monitoring the successes and challenges of similar initiatives across the globe,” said Peter Zambetti, IADSA chairman. At the national level, IADSA’s plans this year include working in China, Eastern Europe and Russia with regulators and academia to discuss regulatory issues related to food supplements. Regionally, IADSA will continue its focus on Latin America. At the global level, IADSA’s focus will remain on food additives, as the Codex Committee on Food Additives (CCFA) meets to consider adoption of key draft provisions for food additives used in sup-

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Top Of The News

plements worldwide. IADSA has also identified technical changes in relation to the Codex review of Nutrient Reference Values (NRVs) for vitamins and minerals, and some other initiatives such as the proposal to develop a standard for marine oils. Speaking of marine oils, the Global Organization for EPA and DHA Omega-3 (GOED), Salt Lake City, UT, has finalized its position on the development of a Codex Standard, supporting the principle of establishing a uniform global standard for quality and definition of various types of marine oils containing EPA and DHA omega 3s. According to GOED, while the standard should include EPA and DHA concentrates derived from fish oils, the standard should exclude oils derived from plant, vegetable and algal sources since the marine environment is not involved at any stage in the production of these oils. GOED also said a viable standard should be established in a manner that will promote international trade and protect human health. Current approaches to identify oils based on fatty acid profiles are not thought to be commercially feasible. GOED’s support for a marine oil standard is conditional upon the ability to adopt a standard that is flexible enough to allow for rapid innovation and natural variations in product composition due to environmental factors. Without such consideration, restriction, rather than promotion, of free trade may be the end result, the organization said. This position was forwarded to the U.S. Delegate to the Codex Committee on Fats and Oils (CCFO) of the Codex Alimentarius Commission (Codex) for consideration. The position paper will also be forwarded to other Codex delegates and industry groups focused on the issue.

DSM Buys Martek for $1 Billion

March 2011

Netherlands-based Royal DSM N.V. has acquired Martek Biosciences Corporation, Columbia, MD, for more than $1 billion. Martek will provide DSM with new opportunities in the infant nutrition segment as well as food and beverage and dietary supplements and create a strong platform for DSM to enter the growing omega 3 and omega 6 market through Martek’s microbial DHA (docosahexaenoic acid) and ARA (arachidonic acid) products. DSM will be able to channel and accelerate the growth of these products into other regions, applications and market segments beyond Martek’s current U.S.based position in infant formula ingredients and growing position in food and beverage and dietary supplement applications. The two companies already have a longstanding relationship, as DSM supplies Martek with the key base material for its ARA product. DSM has complementary intellectual property to the broad range of patents and intellectual property Martek owns, which will further extend the competitiveness of the combined company’s proprietary products. DSM will also benefit from Martek’s recent acquisition of Amerifit, a consumer business for branded dietary supplements with specific health benefits. The acquisition is expected to realize material revenue synergies through expanded distribution, marketing and product development as well as other operational efficiencies, and will accelerate DSM’s revenue growth. www.nutraceuticalsworld.com

Nutraceuticals World • 9

From The Editor

Great Expectations We all want to live long, but more important we want to live well. And consumers today—of all ages—have their own expectations for what constitutes a healthy lifestyle. While the health and wellness category and its cousin LOHAS (Lifestyles of Health and Sustainability) remain attractive opportunities in the business world due to the billions of consumers these markets could potentially serve, they are equally challenging for the same reason—their broad appeal. As guest author Julian Mellentin of New Nutrition Business explains in this month’s article “Is Vitality the New Energy?” which starts on page 50, vitality, much like health and wellness (and LOHAS), seems to be something everyone wants but doesn’t necessarily know how to get. And translating those wants into products is another story. Are vitality products supposed to cater to those left out of the energy drinks movement? Is it just Baby Boomers who are looking for vitality products? The answers to these questions are a bit more complicated than you would expect. “Because vitality is a relatively amorphous concept, no one is sure exactly what it means,” Mr. Mellentin said. “That’s why vitality positioning represents both an attractive and yet open opportunity for marketers scratching for growth in a betterfor-you arena where few untested propositions remain.” Since there is no consensus regarding a definition for vitality, the term takes on a life of its own depending on who’s defining it—and thus making the products. In this vein, as Mr. Mellentin points out, the vagueness of the term is its biggest strength yet biggest weakness. In the end, using an ambiguous term like vitality may lure people in but it may eventually create distrust. According to a recent survey conducted by Siegel & Gale, U.S. consumers are willing to pay a 4-6% premium for brands they believe offer a greater degree of simplicity compared to their competitors. That could translate into billions more dollars in categories—like health—where confusion reigns supreme! If the struggles facing the vitality market sound familiar, that’s probably because you’ve read similar articles about the antioxidant market in these pages for more than a decade. While antioxidants are in huge demand across a broad range of demographics—just like vitality—they are increasingly being linked to more specific health issues (e.g., joint health, cardiovascular health) as a means of survival, beyond their function as an antioxidant. (See this issue’s two articles on antioxidants, which start on pages 36 and 46, respectively, to learn more about the other developments in this market.) Eventually the focus will narrow for vitality too, as consumers look for more benefit-oriented products—and trade in their great expectations for more realistic ones.

Editor: Rebecca Wright ([email protected]) Associate Editor: Sean Moloughney ([email protected]) Online Editor: Joanna Cosgrove ([email protected]) Vice President/Editorial Director: Tom Branna ([email protected]) Art & Technical Manager: Michael Del Purgatorio ([email protected]) Designer: Jessica Carlin ([email protected]) President: Rodman J. Zilenziger, Jr. ([email protected]) Executive Vice President/Publisher: Matthew Montgomery ([email protected]) Associate Publisher: Stephen E. Lipscomb ([email protected]) Advertising: Dayle Verrengia ([email protected]) Production Manager: Pat Hilla ([email protected]) Circulation Manager: Joe DiMaulo ([email protected]) Online Director: Paul Simansky ([email protected]) 70 Hilltop Road, Ramsey, NJ 07446 USA Tel: 201-825-2552; Fax: 201-825-0553 E-mail: [email protected] Website: www.nutraceuticalsworld.com Subscription Information: To renew/subscribe/update subscription information, please visit www.nutraceuticalsworld.com and click on “subscription services” or contact [email protected]; 201-825-2552 x356

Columnists Anthony Almada MSc GENr8, Inc.

Paul Altaffer RFI Ingredients, Inc.

Paula Brown British Columbia Institute of Technology

Jeff Crowther The Natural Products Association (NPA), China

Erik Goldman Holistic Primary Care

Joerg Gruenwald analyze & realize AG

Todd Harrison Venable LLP

Adam Ismail Global Organization for EPA & DHA (GOED)

Doug Kalman Miami Research Associates

Dr. A. Elizabeth Sloan Sloan Trends, Inc.

Grant Washington-Smith Alticor, Inc.

Editorial Advisory Board Steve Allen Nutrition Capital Network

Nancy Childs, PhD Saint Joseph’s University

Steven Dentali, PhD American Herbal Products Association (AHPA)

Loren Israelsen United Natural Products Alliance (UNPA)

Alex Merolli Nutri+Food Business Consultants

Editor’s Note: I would like to take this opportunity to welcome Ellen Schutt, former editor of Nutraceuticals World, and Scott Steinford of ZMC USA to our editorial advisory board. Both are good friends of the magazine who want to help keep us moving in the right direction. We look forward to working with them!

Paul Paslaski BioVittoria Limited

Ellen Schutt LaunchNatural

Scott Steinford ZMC USA

Gregory Stephens, RD (Business Insights Columnist) Windrose Partners

Rhonda Witwer National Starch Food Innovation

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March 2011

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The New NutraceuticalsWorld.com Nutraceuticals World launched a redesigned website last year, featuring expanded content, enhanced navigational tools and additional resources that streamline access to our comprehensive archive of market information.

Knowledge Center In an effort to help you access more than 10,000 articles from the past 10 years of Nutraceuticals World’s coverage, we have created a “Knowledge Center,” which contains a growing base of information designed to offer you the most relevant news and articles associated with specific categories in the nutraceuticals industry. We have divided the Knowledge Center into two sub-categories—Nutraceuticals Markets and Health Conditions, which are divided further into nearly 50 unique sections, such as Antioxidants, Baby Boomers, Contract Manufacturing, Herbs & Botanicals, Cardiovascular Health, Immune Function, Sports Nutrition and Women’s Health.

TrendSense Industry expert Liz Sloan is flexing her marketing muscles, offering analysis on different segments each month using Sloan Trends’TrendSense models. You can find her analysis, complete with downloadable TrendSense Data Charts, under the “Research” tab of our website.

Top Online Stories @ nutraceuticalsworld.com New Discovery for Fatty Acids UCLA research team engineers a novel technique that could lead to new, more effective nutritional supplements.

Taking Stock of Label Claims IFIC webcast panel spoke about rules and regs plus consumer food culture.

Dairy Research Trends DRI cites diabetes, heart health and diet qualities as key focus areas.

‘Naturally Filtered’ Blog Does the children’s health market need to grow up? Look for associate editor Sean Moloughney’s blog under the “Opinions” tab of our website.

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March 2011

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“Even though low seafood intakes were called out specifically, EPA and DHA did not make the list of concerns despite documented estimates that more

Industry News

people die from low omega 3 intakes than from low fruit and vegetable consumption in the U.S.” —GOED, in response to the release of the 2010 Dietary Guidelines for Americans

Dietary Guidelines Overlook Benefits of EPA/DHA The Department of Health and Human Services (HHS) and the Department of Agriculture (USDA) have released the 2010 Dietary Guidelines for Americans, the federal government’s evidence-based nutritional guidance to promote health, reduce the risk of chronic diseases and reduce the prevalence of overweight and obesity through improved nutrition and physical activity. The guidelines focus on balancing calories with physical activity, and encourage Americans to consume more healthy foods like vegetables, fruits, whole grains, fat-free and low-fat dairy products and seafood, and to consume less sodium, saturated and trans fats, added sugars and refined grains. According to the Global Organization for EPA and DHA Omega-3 (GOED), Salt

Lake City, UT, the guidelines fail to account for low intake of omega 3s EPA and DHA. Consistent with prior Dietary Guidelines revisions, increased seafood consumption was recommended for the general population, in part for its EPA and DHA content. In contrast to the available scientific evidence, there was no recommendation for pregnant or lactating women to increase consumption of seafood (i.e., DHA) above and beyond what is recommended for the general population, GOED noted. Also, low intakes of specific nutrients were cited as posing public health concerns for the first time, but EPA and DHA were not included on this list. USDA and HHS note that low intake of fruits, vegetables, whole grains, milk and seafood has led to low enough intakes of potassium, dietary fiber, calcium and vitamin D to create public health concerns. Even though low seafood

intakes were called out specifically, EPA and DHA did not make the list of concerns despite documented estimates that more people die from low omega 3 intakes than from low fruit and vegetable consumption in the U.S., GOED said.

NCL Files Complaint with FTC Against Vitaminwater Ads In a formal complaint filed with FTC, the National Consumers League (NCL), Washington, D.C., has called advertising and labeling claims made by Vitaminwater “dangerously misleading” and urged the commission to halt “deceptive statements.” NCL pointed to print and television advertisements that suggest Vitaminwater can replace flu shots and prevent illness. “These advertising claims are not only untrue, they constitute a public health menace,”said Sally Greenberg, executive director of NCL.“Stop-

The Children Are Our Future

sugar; more than half (53%) were low in fiber; more than half (53%) of products did not contain any fruits or vegetables (of the The long-term health of children hangs in the balance as fruits and vegetables found, half came from just two ingredients: parents learn to navigate tricky nutrition labels and the tomatoes and corn); 24% of prepared foods were high in satuenergy beverage market. rated fats; and more than one-third (36%) of prepared foods and meals were high in sodium. Parents shouldn’t look to labels on the “We did the study because we want front of food packages for guidance on to be sure that what parents see is picking the healthiest products for their what they get,” said study author and kids, according to a new Prevention Innutritionist, Juliet Sims. “The results stitute study, which found 84% of prodshocked us. More often than not, comucts examined didn’t meet basic panies are telling parents food is nutritional standards. The study looked healthy when it’s not.” at the front-of-package labeling on 58 To answer calls for more and better “Better-for-You” children’s products— nutrition information, U.S. food and bevthose that manufacturers tout as their erage manufacturers and retailers have most nutritious. launched Nutrition Keys, a voluntary The nutritional content was compared front-of-pack nutrition labeling system Parents need to be more careful than ever when it comes to what their kids eat—and drink. against nutritional criteria derived from designed to help consumers make inthe U.S. Dietary Guidelines and the Naformed choices. The Nutrition Keys protional Academies of Science. In spite of the claims on the labels, gram will change the look of the vast majority of the country’s study findings reveal: more than half (57%) of the study products most popular food and beverage products by placing important qualified as high sugar, and 95% of products contained added nutrition information (calories, saturated fat, sodium and total

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Industry News

ping these Vitaminwater claims, which contradict information by the Centers for Disease Control and other public health authorities, should be a top FTC priority.” The complaint also urged FTC to pull a poster ad for Vitaminwater that states: “flu shots are so last year” and pictures three varieties of Vitaminwater under the banners “more vitamin c, more immunity…”; and a TV ad for Vitaminwater Power-C that depicts a woman who has so many unused sick days at work that she can take them to stay home and watch movies with her boyfriend. The ad states: “One of my secrets? Vitaminwater power-c. It’s got vitamin C and zinc to help support a healthy immune system. So I can stay home with my boyfriend—who’s also playing hooky.” The NCL complaint also asked FTC to halt deceptive label statements for Vitaminwater that describe the product as a “nutrient enhanced water beverage” and that claim “vitamins + water = all you need.”According to NCL, the statements are deceptive because the products on which they appear are not simply made from vitamins and water, but are made with crystalline fructose or other forms of sugar, and contain 125 calories per bottle.

Industry Trade Organizations to Help FDA The dietary supplement industry’s leading trade associations have joined forces with FDA to support heightened efforts aimed at addressing significant public health problems posed by products that are illegally marketed as dietary supplements but contain the same active ingredients as FDA-approved drugs or other ingredients that do not qualify as dietary ingredients. The American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA) and the United Natural Products Alliance (UNPA) pledged support to help FDA rid the market of illegal products that pose a danger to consumers and tarnish the reputation of the legitimate supplement industry. The industry coalition also endorsed FDA’s actions to use its regulatory muscle to hold accountable those who violate the law and jeopardize public health, using tough criminal sanctions when appropriate. In addition, by being transparent and engaging in ongoing dialogue with the supplement industry, the agency is ac-

sugars content) on the front of packages. To appeal to busy consumers, the information will be presented in a fact-based, simple and easy-to-use format. The icon will inform consumers about how the key nutrients in each product fit into a balanced and healthy diet as part of the federal government’s daily dietary advice. In addition, the Nutrition Keys icon on some products will display information about “nutrients to encourage” that are important for a healthy diet, but are generally under-consumed. Nutrients to encourage that may appear on some products as part of the Nutrition Keys icon include: vitamins A, C and D, potassium, fiber, calcium, iron and protein. Companies will begin to place the icon on their products in 2011, according to seasonality and production schedules. In other health news, a new review of energy drink consumption among children, adolescents and young adults has been published in the journal Pediatrics. The review concluded that long-term research should aim to understand the effects in atrisk populations and better regulate energy drink sales. In the short-term, the authors wrote, pediatricians need to be aware of the possible effects of energy drinks in vulnerable populations and screen for consumption to educate families. According to self-report surveys, energy drinks are consumed by 30% to 50% of adolescents and young adults. Frequently containing high and

March 2011

knowledging its understanding of the vital role that the associations can play in helping to ensure that consumers have access to safe, high quality products. FDA’s concerns focus on three categories of products particularly susceptible to spiking with undisclosed ingredients: weight loss, sexual enhancement and body building, categories in which consumers may be looking for immediate or dramatic results.

Pfizer Strengthens Supplement Business In an effort to strengthen its supplement portfolio, Pfizer Inc., New York, NY, has entered an agreement to purchase Ferrosan’s consumer healthcare business, based in Copenhagen, Denmark, from Altor 2003 Fund GP Limited. Ferrosan is a consumer healthcare company established in the Nordic region with a portfolio of leading brands. Since 1920, Ferrosan has grown to serve a broader market including Russia, the Ukraine, Poland, Turkey and many countries throughout Central and Eastern Europe. “Ferrosan is an excellent strategic fit that strengthens our presence in dietary supplements with a new set of compelling brands and product pipeline,” said Paul

unregulated amounts of caffeine, these drinks have been reported in association with serious adverse effects, especially in children, adolescents and young adults with seizures, diabetes, cardiac abnormalities or mood and behavioral disorders, or those who take certain medications. Of the 5448 U.S. caffeine overdoses reported in 2007, 46% occurred in those younger than 19 years of age. Several countries and states have debated or restricted their sales and advertising. At the same time, energy shots continue to grow in popularity as companies exploit still untapped opportunities, according to “10 Key Trends in Food, Nutrition & Health 2011,” written by Julian Mellentin of New Nutrition Business who says 2011 promises to be another “year of the energy shot.” Rapid success of energy shots, a market that has grown to more than $1 billion in retail sales, reflects the extent to which there are huge areas of untapped opportunities in products for energy, he said. “There are opportunities to create new brands, new segments and new categories through strategies focusing on groups of consumers who aren’t served by the energy drink brands currently available.” Other opportunities, he pointed out, include new ingredients with a higher “natural and healthy” score, as well as new carriers—other than caffeinated beverages—with better health credentials, such as dairy and fruit juices.

www.nutraceuticalsworld.com

Nutraceuticals World • 15

Industry News

Sturman, president, Pfizer Consumer Healthcare. “The transaction will mark an important step towards expanding Ferrosan’s brands through Pfizer’s global foot-

print.” Ferrosan’s portfolio includes Multitabs, a multivitamin brand, Bifiform, a probiotic, Fri Flyt/Active Omega and IMEDEEN premium oral skincare brands.

NCCAM Includes Favorable Mention of Omega 3s in Strategic Plan The National Center for Complementary

looked for by the 65% of consumers who read nutritional labels, reports IFIC’s “2010 Food & Health Survey.” Low sodium ranked 3rd behind whole grain and high fiber as the most sought after health claim on food packages—overtaking low fat—according to FMI’s “2010 U.S. Grocery Shopper Trends.” More than half (53%) of consumers are extremely (18%) or somewhat (35%) concerned about sodium per IFIC. Most important, concern over sodium is bringing with it a new series of potential market opportunities. Are Americans getting enough potassium? Should magnesium play a greater role in heart health? What about the increased incidence of hypertension in children and the growing incidence of stroke in younger

Getting Ahead of the Curve: Sodium By Dr. A. Elizabeth Sloan

adults, as stoke cases decline in those age 65+? The 2010 U.S. Dietary Guidelines Committee report, mandatory menu labeling for restaurants, and a new American Stroke Association at the American Heart Association are among the new forces fueling the lower sodium movement. And, with pediatricians now checking blood pressure as early as age 3, one in three U.S. adults suffering from hypertension and 79 million prehypertension, the negative climate will grow stronger still. Sales of foods/beverages carrying a lower/reduced/no sodium claim reached nearly $15 billion in mass channels, excluding Wal-Mart for the year ended 12/27/09, according to the Nielsen Co. The number of products touting a sodium claim grew 10%. One-third (34%) of food shoppers bought more lower-in-sodium items in 2010 compared to the previous year [Food Marketing Institute (FMI), “2010 Shopping for Health”]. Sodium now ranks 2nd only to calories as the ingredient most

Market Potential According to Sloan Trends’ TrendSense model, sodium is an enormous Level 3 mass market opportunity, which has accelerated steadily during the past decade. A major jump in research/medical activity and funding around 2006-07 shot consumer activity and the marketability of low sodium products into the limelight. Despite an apparent leveling off of the Medical trend line, because the activity level is so large—around 90,000 new studies worldwide per year—even a small change in Medical Counts represents an enormous amount of new data and fresh opportunities for news/messages in the marketplace. In a gigantic category, e.g., sodium, a flattening in Medical Counts is unlikely to slow the movement down.

* Although there are many factors that go into determining consumer trends, measuring how medical/nutrition activity levels have risen over the past decade, as well as some of the key milestones that have occurred and how these issues have been understood and embraced by the public are essential in predicting the sustainability of the Consumer trend line.

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Industry News

and Alternative Medicine (NCCAM) has released its third strategic plan (20112015), presenting a series of goals and objectives to help determine priorities for

future research. Within the plan document, omega 3s received favorable mention three different times, according to the Global Organization for EPA and DHA

Growth Opportunities • > 4 in 5 consumers believe that low sodium (85%) and low-salt (84%) foods are healthier (Technomic, “The Healthy Eating Consumer Trend Report, 2010”). • 60% regularly purchased reduced/lower sodium foods in 2010 (IFIC, 2010). • 63% of Boomers, 57% of Gen Xers and 46% of Gen Yers are deliberately trying to avoid salt/sodium in their diet (The Hartman Group, “2010 Reimagining Health & Nutrition”). • 59% are interested in learning the amount of sodium they should consume; 53% which foods/beverages are high/low in sodium; 55% how sodium impacts their health; 48% who should be concerned about sodium (IFIC, 2010). • Heart health is now the 2nd most frequent positioning for new functional foods/drinks in the U.S. market (Innova Market Insights, 2010). • More than 90% of Americans will develop hypertension in their lifetime (AHA, 2010). • Nearly 50% of U.S. households have someone with HBP; 87% of those with HBP use Rx meds, but nearly 50% also rely on a healthy diet (IRISymphony, 2010). • Consumer concern over HBP is skewing younger: 40% Gen Yers are very concerned, 48% Gen Xers and 66% of Boomers (The Hartman Group, 2010). • Of the 42% of grocery shoppers who have hypertension or perceive they are at risk, 65% have changed their purchasing habits (FMI, “U.S. Grocery Shopper Trends,” 2009). • HBP has tripled in the past decade in U.S. children (NIH/CDC). • The low income market is expected to bring in $115 billion in incremental CPG sales in the next 10 years; 46% of those in households with incomes <$25K and 54% with incomes $26K-$50K want more low salt/sodium foods (IRI “Low Income Report,” 2010). • Only 28% of diners say they look for low sodium when ordering at a restaurant vs. 56% in grocery stores. In restaurants, 35% would be willing to pay up to 10% more for low sodium menu options (Technomic, 2010). • Healthy options for kids ranked as the 2nd hottest trend for 2010 among quickservice restaurant operators. Am. Culinary Federation chefs ranked kids nutrition 6th, and nutrition/health 15th as the hottest overall restaurant trends for 2011 (Nat’l Restaurant Assn. “What’s Hot?” 2009, 2010).

Omega-3 (GOED), Salt Lake City, UT. A growing body of evidence suggests fish oil/omega 3 products may help prevent complications of cardiovascular disease

important snack attribute, ranking right behind, no trans, low fat, low sugar and low calorie—and equal to whole grains (IRI SnaxPo, 2010). Dollar sales of snacks carrying a low sodium claim grew 7% in mass channels and convenience stores in 2009. With swapping for a healthier version of the same product being the most common way shoppers choose to improve the healthfulness of their family’s diet, offering low sodium alternatives to favorite foods will become commonplace (FMI, “Shopping for Health,” 2010). With 49% of all meal preparers cooking more from “scratch” compared to 2009, low sodium versions of basic cooking ingredients and healthier, lower sodium sauces, spice mixtures and condiments will find a welcome market. References furnished upon request. About the author: Dr. A. Elizabeth Sloan is president of Sloan Trends, Inc., Escondido, CA, which is a consulting firm that offers trend-tracking and predictions, strategic counsel and businessbuilding ideas for food, supplement and pharmaceutical marketers. Each month she will provide analysis and discuss opportunities of a particular market being covered in a given issue.

SLOAN TRENDS’ TRENDSENSE is a 15-year-old trend tracking system, which identifies and quantifies trends as well as predicts the optimal timing, sustainability and life-cycle stage of ingredients, terms, product opportunities and related market issues. The model displays medical and consumer “activity levels” based on a comprehensive analysis of five critical sources of information— consumer, trade and competitive, legal and regulatory and media coverage. The resulting charts give insight into the market’s changing health issues and concerns, the ingredients that are up-and-coming and those that have just about run their course, as well as what health claims, marketing messages and products will bring your company the most success. • Emerging Phase = Trends begin to appear on the radar screen. Companies should begin to collect literature and market details for those that exhibit continual growth and that might be of interest. • Popularization Phase = Medical/Nutrition crossover to consumer media and marketplace; opportunity for niche or specialty markets. Marketers/manufacturers should begin a detailed evaluation of the supporting marketing and scientific data and determine if this term/trend offers a good strategic fit and is appropriate to pursue. Ap-

Functional Foods & Beverages More than half (52%) of consumers are looking for functional foods/drinks that help lower blood pressure (Mintel, “Functional Foods-US,” 2009). Among those who have purchased lower/reduced sodium foods, 58% bought canned soup, 48% snacks and 41% canned vegetables. Four (43%) in 10 say low sodium is an

March 2011

propriate product development procedures should be undertaken. • Commercialization Phase = Mass-market ready. Mainstream consumers have a significant degree of familiarity with the term/trend and there is opportunity for competitive advantage by getting out ahead of the competition or by providing a unique and highly innovative product positioning for success.

www.nutraceuticalsworld.com

Nutraceuticals World • 17

Industry News

and other significant health problems. Two independent lines of evidence— data from the National Health Interview Survey (NHIS) regarding use of dietary supplements and industry sales data— suggest that results of CAM research influence consumers’ decisions regarding CAM use. The publication of “negative” results from clinical trials preceded declines in both the frequency of use and the sales of several non-vitamin/non-mineral dietary supplements. Similarly, publication of evidence pointing toward the potential value of omega 3 fatty acids/fish oil preceded increased use and sales.

Fish Oil Tops Most Popular Supplements—Again Among people who use dietary supplements, the most popular products at the end of 2010 were fish oil, multivitamins, vitamin D, calcium and CoQ10, according to a survey conducted by ConsumerLab.com, White Plains, NY. Use of vitamin D surged in 2010 to 56% of those

surveyed, up from 48% in 2009 and 37% in 2008—a 52% increase over the twoyear period. Fish oil continued its rise in popularity, used by 75% of those surveyed, up from 74% in 2009. Meanwhile, multivitamin use declined to 70% last year from 72% in 2009 and 74% in 2008.

Glanbia Acquires BSN for $144 Million Ireland-based Glanbia plc has acquired Boca Raton, FL-based Bio-Engineered Supplements and Nutrition (BSN) for $144 million. The business was acquired on a debt-free basis and is expected to be earnings enhancing in 2011. The acquisition was funded through Glanbia’s existing banking facilities. BSN is a developer, provider and distributor of nutritional products designed for health, training, physique development and performance. Glanbia believes the acquisition enhances the group’s performance nutrition portfolio and delivers further growth opportunities in this area.

The Highs and Lows of the Herbal Supplement Market Although growing steadily worldwide, European legislation poses obstacles to the food and beverage market. The global herbal supplements and remedies market exhibited robust growth over the past decade, with no significant decline on account of the worldwide recession, and could exceed $93 billion by 2015, according to a new report from Global Industry Analysts, Inc. In fact, the world market exhibited steady growth for the crisisridden period of 2008-2009 and beyond. The importance of a healthy diet and lifestyle was not dampened by the financial meltdown witnessed in almost every other product segment worldwide. The recession may have actually increased a preference for dietary supplements, the report stated. Escalating prices, tighter budgets and high healthcare costs have actually driven consumers toward the more economical, healthier and safer option of alternative medicine and dietary supplements for relief from physical and mental disorders. In the U.S. alone, the sales of vitamins and supplements at the retail level recorded a significant increase of more than 10% in 2008, as compared to the previous year. While demand for healthy foods and drinks has created a significant opportunity for botanicals to act as functional ingredients, the adoption of new health claims legislation in Europe

18 • Nutraceuticals World

Pharmavite Claims Upheld in NAD Review The National Advertising Division (NAD) of the Council of Better Business Bureaus has determined that Pharmavite, LLC, Mission Hills, CA, can support challenged advertising claims for the company’s Nature Made GreatMind dietary supplement. According to Pharmavite, the product is a cognitive health supplement based on a formulation developed and studied by Dr. Thomas Shea, PhD, and his colleagues at the University of Massachusetts, Lowell. The formulation has been studied by Dr. Shea and his colleagues in subjects with early, moderate and late-stage Alzheimer’s disease. Those subjects showed improvement on certain cognitive and dementia rating scales, and the formulation was then later studied in healthy subjects using cognitive scales to evaluate the effects. Pharmavite stated that GreatMind contains vitamin E, folic acid, vitamin B12, N-acetyl-L-cysteine (NAC), acetyl-

has forced manufacturers to reevaluate their approach to new product development, according to a new report from Business Insights titled “Targeted Botanical and Herbal Food and Drinks in Europe.” Among various claims made on new product launches through August 2010, 49% were targeted at the metabolic/endocrinology therapeutic area, with weight management being the main area of focus. Other than Most claims related to herbs and probiotics, botanibotanicals have been rejected by EFSA. cals and herbs have been least successful in securing positive approvals from the European Food Safety Authority (EFSA). Of the 67 opinions published pertaining to botanicals and herbs in the first two batches, 66 have been rejected. In fact, botanicals have temporarily been removed from EFSA’s assessment process creating uncertainty over the future regulatory environment. However, with the European Commission contemplating the adoption of an alternative assessment procedure, it could still be possible for previously rejected health claims to successfully reach the market via an updated evaluation process.

www.nutraceuticalsworld.com

March 2011

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Industry News

L-carnitine hydrochloride (ALCAR) and S-adenosylmethionine (SAM-e), in the same formulation as the ingredients used in the studies conducted by Dr. Shea and his colleagues, although the amount of vitamin B12 in GreatMind was increased to 12 mcg from 6 mcg. Following its review of the evidence in the record, NAD concluded that the results of the Shea Studies, which found statistically significant improvement in various measures of cognitive ability in those participants taking GreatMind, provided a reasonable basis for the specific claims about the supplement’s ability to improve and maintain memory and cognitive ability.

Atrium Innovations Acquires Seroyal for $110 Million Looking to reinforce its position in developing dietary supplements for the health and nutrition industry, Atrium Innovations, Quebec City, Canada, has acquired Ontario, Canada-based Seroyal International for $110 million. Seroyal commercializes premium dietary supplement brands primarily targeting the healthcare practitioner (HCP) channels in Canada and in the U.S. with annualized consolidated revenues of approximately $40 million. Seroyal’s product portfolio consists of three main brands: Genestra, Unda and Pharmax. These brands are well known among HCP chan-

nels and account for close to 90% of total revenues, with Genestra being the core of these HCP brands. Another brand, CoreLab, owned in a joint venture, is a Health Food Store brand currently sold in the U.S. In addition, the company is the exclusive distributor for the Canadian and U.S. markets of Unda, a European homeopathic brand. Revenues derived from the Canadian and U.S. markets account, respectively, for approximately 65% and 35% of total sales.

Bakery Products Market Going Healthy The global baking industry is currently fac-

How Do Dietary Supplements and Food Components Fit Into the Investigational New Drug Process?

Recognized As Safe (GRAS) status for a given use, even when the research is conducted on a healthy population. This is true even when the investigator has no involvement or interest in the commercial aspects of a product. For example, an investigator CRN believes FDA should provide a broader list of IND interested in evaluating a yogurt product from the grocery store exemptions for dietary supplements and food components. that contains beneficial bacteria for its ability to prevent constipation in a healthy population would be required to file an IND. CRN In January, the Council for Responsible Nutrition (CRN), Washbelieves this is incongruent with the intent of the IND. ington, D.C. submitted comments to FDA regarding InvestigaUnlike pharmaceutical research, the majority of dietary suppletional New Drug (IND) applications, with an emphasis on ment and ingredient research is not driven by industry. For a variproviding further clarification on dietary supplements and food ety of reasons, including limited intellectual property protection, components and drugs, as well as acknowledging the inherent the majority of supplement research is supported by government differences between all of these products. grants and performed by academic researchers that are indeAccording to CRN, the Draft Guidance does provide clarity pendent of industry. Because FDA guidance is aimed at industry in some areas, including the important disand not academia, CRN is concerned that tinction that the clinical investigation of a the Draft Guidance will go unnoticed by the dietary supplement for a structure/function academic nutrition and complementary and endpoint does not require an IND applicaalternative medicine (CAM) research comtion. However, CRN has identified several munities that are focused on expanding sciareas where the Draft Guidance leaves imentific knowledge and pay little attention to portant questions unanswered for industry the complex linguistic nuances encomand the research community. passed within regulatory definitions. FurtherAs the organization points out, the IND apmore, they may not understand the plication process is specifically designed to regulatory distinctions between drugs, supsupport companies that have screened a plements and their intended use, and thus novel molecule for pharmacological activity may be unable to appropriately design a and acute toxicity potential in animals and study protocol to accurately reflect the inwish to test its diagnostic or therapeutic potent of the investigation. IND reviewers must understand the inherent differences between dietary tential in humans. While this framework is If all companies and independent investisupplements/food components and drugs. applicable to the drug development process, gators conducting clinical research on diCRN says it may not be a suitable framework etary supplements with the intent of for research on dietary supplements and food components that studying them as drugs followed the Draft Guidance, FDA would are already safely consumed by millions of Americans. likely not have the resources to review and process the massive According to the Draft Guidance, an IND may be required to number of IND applications that would be submitted. Some of study a dietary supplement that is currently safely consumed by this research is conducted by independent investigators who are millions of Americans or a food ingredient that has Generally unaware of a product’s regulatory category and therefore design

20 • Nutraceuticals World

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March 2011

Industry News

ing opportunities as well as challenges created by the economic crisis, according to Global Industry Analysts, Inc. The still volatile financial scenario is changing the way bakers approach their businesses. For instance, there has been a noticeable shift toward natural and healthy bakery products consisting of vitamins, whole grains and fibers. Bakers have introduced organic baked goods, breakfast cereals, breads and biscuits enriched with nutritional and natural ingredients in single-serve and portable packaging. Several companies eliminated preservatives and artificial flavors in their products in a bid toward image changeover as makers of healthier

and natural bakery products. About 35% of global cereal product launches in 2009 claimed to be functional cereals with health benefits.

LSRO Reviews Diet’s Effect on Mental Energy The Life Sciences Research Organization, Inc. (LSRO), Bethesda, MD, has undertaken a review of the scientific evidence for more than 35 food ingredients, dietary supplements, dietary constituents and dietary factors and any measure of mental energy that could support related claims. The review, titled“Do Specific Constituents and Supplements Affect Mental Energy?”

studies that are appropriate to their research questions. FDA should provide additional clarification related to IND requirements for clinical studies designed to assess “disease risk reduction” versus “prevention.” Currently, CRN asserts, there are no validated biomarkers as surrogate endpoints for “health promotion,” “wellness,” or “supporting normal structure and function” and therefore investigators by default will choose to assess effects such as lowering of blood pressure or serum cholesterol levels, or similar effects on other established surrogates, many of which may also be viewed as therapeutic effects. This, in turn, would necessitate an IND. CRN is aware that the Center for Drug Evaluation and Research (CDER) has available an investigator-initiated IND that may alleviate some of these concerns. However, it is the organization’s understanding that the Center for Biologics Evaluation and Research (CBER) does not have such a program available and the Center for Food Safety and Applied Nutrition (CFSAN) has no IND process whatsoever. CRN recommends that FDA develop a consistent IND process across all the relevant regulatory categories and consider how academic researchers will be made aware of and comply with the provisions in the Draft Guidance. Another issue that may negatively impact dietary supplements and food components is that naturally occurring materials have inherent variability that may not fit the IND model. For example, CRN said, there can be challenges in obtaining an IND for a fish body oil product that has a two-year shelf life intended for use in a five-year clinical trial. If a second lot of fish oil is introduced during the second year of the trial there may be small (but unavoidable) differences in fatty acid composition and ratios in the replacement lot. This is due to natural seasonal variability in the fatty acid composition of fish used to produce fish oil. Historically, IND application reviewers, presumably without dietary supplement expertise, have struggled to understand these practical differences between dietary supplements/food components and drugs. To account for physical and biochemical differences between

March 2011

was published in the December 2010 issue of Nutrition Reviews. Mental energy was defined as consisting of mood (transient feelings about the presence of fatigue or energy), motivation (determination and enthusiasm) and cognition (sustained attention and vigilance). The review article focused on four dietary constituents/supplements: Ginkgo biloba, ginseng, glucose and omega 3 polyunsaturated fatty acids (PUFA) to illustrate the current state of the peer-reviewed scientific literature on dietary constituents and mental energy. The strongest evidence, other than that for caffeine, suggests effects of Ginkgo biloba on

drugs and dietary supplements/food components, dietary supplement INDs, when required, should be reviewed by individuals with expertise in dietary supplements and food components, nutrition research and/or the application of CAM therapies. DSHEA defines a dietary supplement, in part, as a “product that does not contain an article authorized for investigation as a new drug, antibiotic or biological for which substantial clinical investigations have been instituted and for which existence of such investigations has been made public.” When a company is collecting data to submit a New Dietary Ingredient (NDI) notification to FDA and studies are conducted under IND Draft Guidance and the study results are published before the product is marketed as a food or dietary supplement, then it can no longer be marketed as a food or dietary supplement. As a result, CRN explained, a product would then require FDA drug approval before being legally marketed. In this example the company may impose a particular study design or use of therapeutic endpoints in a clinical study involving a healthy population to explore the possibility of obtaining data for a health claim petition (disease risk reduction) or marketing the product as a medical food with no intentions of marketing the product as a drug. CRN believes that the above mentioned scenario is a significant disincentive to conducting NDI-related clinical research under IND Draft Guidance and creates an additional legal grey area as well as an obstacle to ingredient innovation for the dietary supplement industry Given these issues, CRN believes FDA should provide a broader list of IND exemptions for dietary supplements and food components. Greater consideration should be given to allow for exemption of products that have a history of safe use, or are currently safely consumed as a food by millions of Americans (e.g., broccoli sprouts, yogurt, etc.). Furthermore, the organization said, the final guidance should provide clarification on IND requirements for studies conducted on a dietary supplement for targeted endpoints associated with an approved health claim or a qualified heath claim.

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Industry News

certain aspects of mood and attention in healthy subjects, as well as associations between omega 3 PUFA and reduced risk of age-related cognitive decline. Until recently, mental energy has been only loosely defined and methods to assess it were not clearly described. For most ingredients and dietary factors, fewer than five scientific studies addressed mental energy.

Omega Protein Acquires Cyvex Nutrition Omega Protein Corporation, Houston, TX, producer of omega 3 fish oil and specialty fish meal products, has acquired Cyvex Nutrition, Inc., Irvine, CA. Matthew Phillips, Cyvex’s president and COO, will continue with Cyvex as its new CEO. Gilbert Gluck, founder and former owner of Cyvex, will continue to assist Cyvex as a consultant. “The acquisition of Cyvex provides Omega

Protein with a strong line of non-marine based products and a stronger omega 3 distribution network for OmegaPure, our proprietary refined menhaden fish oil,”said Joe von Rosenberg, Omega Protein’s Chairman of the Board, president and CEO. In other news, Cyvex has renewed and expanded its distribution agreement with CK Nutritional Ingredients, Toronto, Ontario, Canada. Effective through 2013, C.K. Foods will continue to market and sell Cyvex’s complete library of antioxidant and nutraceutical ingredients in Canada.

ConsumerLab.com Reviews Seed Oils According to ConsumerLab.com, White Plains, NY, only 11 of 17 omega 3 and omega 6 fatty acid supplements made from seed oils met quality criteria for freshness and labeling. Among the six products that

Reports Available Rising consumer interest in health and naturalness is strongly reflected in new product activity in the global soft drinks market. According to Innova Market Insights, 60% of soft drink launches recorded globally in 2010 had a health positioning of some sort. This was primarily in terms of “passive health” [food minus], although more than 20% of products were launched with an active health [food plus] message of some kind. For further information: www.innovadatabase.com Consumer thriftiness and health-consciousness will continue to influence the food and beverage ingredient and flavor trends that emerge in 2011, according to “Food Flavors and Ingredients Outlook 2011” from Packaged Facts. The market researcher predicts there will be greater use of natural, organic, local and antibiotic and hormone-free ingredients at quick serve restaurants (QSRs), fast casual restaurants and at retail. In a separate report, Packaged Facts says gluten-free foods and beverages, once regarded as niche products only of interest to people who couldn’t tolerate wheat, have transformed into mainstream sensations embraced by consumers both out of necessity and as a personal choice toward achieving a healthier way to live. In 2010, the U.S. gluten-free foods and beverages market reached an estimated $2.6 billion in retail sales, according to “Gluten-Free Foods and Beverages in the U.S., 3rd Edition.” The market enjoyed a compound annual growth rate (CAGR) of 30% over the 2006-2010 period. Another Packaged Facts reports indicates that sales of pet supplements and nutraceutical treats felt the impact of the recession, due primarily to a downturn on the equine side of the

22 • Nutraceuticals World

failed testing, two were marketed for pets. This particular review focused on supplements claiming to contain alpha-linoleic acid (ALA) or gamma-linolenic acid (GLA). Two products were found to be spoiled, as indicated by peroxide values above 10 meq/kg. One was a flaxseed oil supplement found to have a peroxide value of 68 meq/kg. The other was a pet product with flax and fish oil that had a peroxide value of 18 meq/kg and contained approximately 75% of its listed amounts of the omega 3 fatty acids EPA and DHA. A second pet product contained far more (573.5%) of its claimed amount of oleic acid—a monounsaturated omega 9 fatty acid. Two borage oil supplements contained less than their listed amounts of GLA or oleic acid. Some products did not properly label the type of oil from which they were made, which is an FDA requirement.

market, but the market now appears set to track back up. Many positive factors are at play, including Americans’ receptiveness to supplements in general, the expanding health needs of an aging pet population, greater availability and exposure at retail and the relative affordability of nutraceutical treats. As a result, even though formal regulatory status continues to evade pet supplements, sales are expected to reach $1.6 billion by 2015, a 27% increase from 2010. For further information: www.packagedfacts.com The global market for soy foods is forecast to exceed $42 billion by the year 2015, according to a new report from Global Industry Analysts Inc. Increasing health consciousness, growing demand for nutritious diets and rising consumer awareness about the health benefits of soy foods are the key factors fueling growth in the global soy foods market. Other market drivers include an aging population, growing popularity of organic soy foods and introduction of innovative new products. For further information: www.strategyr.com Concerns regarding product safety, efficacy and deceptive advertising practices of vitamins and dietary supplements are causing regulatory agencies to take a deeper look, and to revise the regulations for such products, according to a new report from Euromonitor International. Adequate and reliable consumer education on the benefits and risks of supplements is required as an aging population is expected to support future sales, the report states. This report—“Vitamins and Dietary Supplements Regulation Update”—examines the size, growth trends and potential opportunities in the vitamins and dietary supplements market. For further information: www.euromonitor.com

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March 2011

Industry News

NAD Review Supports Some i-flex Claims, Recommends Changes The National Advertising Division (NAD) of the Council of Better Business Bureaus has recommended that Parsippany, NJbased DSM Nutritional Products discontinue certain advertising claims for its “i-flex”dietary supplement, including performance claims, comparative claims and “green” claims. NAD requested that DSM provide substantiation for advertising claims made in print and Internet advertising and on product labels for i-flex, a dietary supplement made from rose hips and advertised for joint health benefits. Following its review, NAD found that existing research on rose hip powder was sufficiently reliable to support general claims that i-flex provides “a joint health benefit.”However, NAD recommended the advertiser discontinue claims that “i-flex from Patented Danish Rosehips Gives Rapid Joint Relief and Comfort to 4 out of Every 5 People”and“The longer term effect is also impressive.” In the absence of research that compares the relative efficacy of glucosamine and rose hip powder, NAD said the advertiser could not support the comparative performance claims at issue. Further, NAD recommended the advertiser discontinue claims that suggest i-flex is made of a “green and sustainable”ingredient and that the formula “has been used by thousands all over Europe with fantastic results…”

ONC & Wilmar Align Ocean Nutrition Canada Limited (ONC), Dartmouth, Nova Scotia, has entered an exclusive, long-term agreement with Singapore-based Wilmar International Limited (Wilmar), Asia’s leading agribusiness, and a global leader in omega 3 foods. The collaboration between these two market giants has resulted in the launch of Wilmar’s new Arawana 3A+ premium cooking oil, which contains ONC’s MEG-3 fish oil. According to a national survey conducted by the Ministry of Health of the People’s Republic of China, the average daily intake of EPA/DHA of Chinese residents is only 37.6 mg/day. This daily intake is less than 25% of the EPA/DHA level accepted by the U.S. Institute of Medicine (IOM), and less than 10% 24 • Nutraceuticals World

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of the intake recommended by the International Society for the Study of Fatty Acids and Lipids (ISSFAL). Due to this deficiency in the Chinese diet, Wilmar, in association with the Chinese Nutrition Society (CNS), is launching Arawana blended oil enriched with MEG-3 fish oil, which will be available at supermarkets and traditional markets throughout China.

ICV Partners Acquires Stauber Performance Ingredients ICV Partners (ICV), a private investment firm, has acquired Stauber Performance Ingredients, Fullerton, CA, a distributor of nutraceutical ingredients to the dietary supplement industry, from J. H. Whitney & Co. Dan Stauber, CEO, and select members of the management team, will continue to have a meaningful ownership interest in the company. Established more than 40 years ago, Stauber distributes vitamins, minerals, herbs, fruits, vegetables and amino acids to the food, pharmaceutical, cosmetic and health food industries.

Stratum Acquires Stake in ESM Technologies Stratum Nutrition, St. Louis, MO, has acquired a significant interest in ESM Technologies, LLC, Carthage, MO. ESM now becomes a joint venture between its previous owners and Stratum’s parent, Novus International. Current management will continue to run ESM. Previously, Stratum Nutrition and ESM had been working together under a strategic alliance termed a “Technology Partnership.” The companies will continue to work collaboratively to advance the science behind ESM’s ingredients.

ChromaDex to Provide Vitamin K2 Services Supplying analytical reference standards, quality control methods and related analytical testing services for vitamin K2, menaquinone-7 (MK-7) in raw materials and finished goods, ChromaDex Corporation, Irvine, CA, has entered a global agreement with Kappa Bioscience AS, Oslo, Norway. Vitamin K2 is shown to have significant importance for optimal utilization of calcium in the body related to bone and cardiovascular health. March 2011

Industry News

Fuji Signs Deal with Sanat Fuji Health Science, Burlington, NJ, has concluded a marketing agreement with Sanat Products Ltd, India, involving the strategic placement of spirulina products within the North American market. Both companies are involved in the cultivation of microalgae for natural human health benefits. Fuji is a leader in the production of natural astaxanthin from the single cell microalgae, Haematococcus pluvialis, and Sanat is a major producer of organic spirulina.

P.L. Thomas to Represent Burgundy Extracts Burgundy Botanical Extracts, Reyssouze, France, and P.L. Thomas (PLT), Morristown, NJ, have formed an agreement through which PLT will market and sell Burgundy’s botanical extracts for food and dietary supplements in the U.S. and Canada. Burgundy’s botanical extracts line includes cost-effective generic extracts as well as unique branded ingredients, such as UTIRose hibiscus extract, EyesBerry blend of berries and IridoForce Devil’s Claw.

Beijing Gingko Group Partners with Premium Ingredients Beijing Gingko Group (BGG) has appointed Premium Ingredients International Europe (PII) as the exclusive distributor of its range of licorice extracts and derivatives for the food, beverage and cosmetic industries across Europe. Products falling within the agreement include: licorice powders and block, monoammonium glycyrrhizinate, glycyrrhizic acid and 18-β-glycyrrhetinic acid.

etary supplement and natural health products market, CK Nutritional Ingredients, Toronto, Ontario, Canada, and Hughson, CA-based Nut-trition, Inc. have entered a strategic partnership. Under the terms of the agreement, CK Nutritional Ingredients has been granted exclusive responsibility in Canada for sales, marketing and distribution of Nut-trition’s Almond Bran ingredient. Using proprietary technology, Nut-trition has successfully converted dried almond skins—recovered from the almond blanching process—into a highvalue food ingredient that can be incorporated into bakery products, nutrition bars, cereals, fermented dairy products, nutritional products and more. Almond bran is a natural prebiotic that provides bioactive and bioavailable antioxidants. It is also an “excellent source”of dietary fiber, essential minerals and natural almond sterols, and contributes a distinctive flavor and color to food products.

Biothera Names Xsto Eastern U.S. Distributor Biothera, Eagan, MN, has named Xsto Solutions, Morristown, NJ, its eastern U.S. distributor of Wellmune WGP and the company’s other immune-enhancing ingredients for foods, beverages and supplements. Wellmune WGP is a natural ingredient clinically proven to enhance key immune cells. The E.T. Horn Company distributes Biothera’s ingredients in the western U.S.

WILD Flavors, Sterling Technology Form Partnership

UAS Laboratories, Inc., Eden Prairie, MN, has acquired all outstanding shares of APN Labs, Inc., Wausau, WI, to become the sole owner. APN Labs manufacturers nutraceuticals for companies seeking to develop or maintain name brand products. The company also has its own condition-specific probiotic blends as well as other ingredients.

Adding to its Health Ingredient Technology & Solutions (H.I.T.S.) line-up, WILD Flavors, Erlanger, KY, has established a partnership with Sterling Technology, Brookings, SD, making WILD the exclusive provider of Immunel and Tegricel bioactive milk peptide products. The new partnership will combine Sterling’s scientific research expertise in bioactive milk peptides with WILD’s product development and flavor expertise.

CK Nutritional Ingredients Partners with Nut-trition, Inc.

BioGaia Signs Product Development Agreement

Covering the Canadian food, beverage, di-

Sweden-based BioGaia and SCA have

UAS Acquires Contract Manufacturer

26 • Nutraceuticals World

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signed a long-term collaboration agreement for the purpose of developing new health products through BioGaia’s probiotic bacteria and application technologies combined with SCA’s competence in the field of hygiene products. BioGaia’s task will be to match different patented strains with different indications, test these in clinical trials, and create formulations that are specially adapted to the indication. SCA will offer patented technologies in the area of hygiene and an extensive distribution network where probiotics can be marketed and sold. The areas of interest include intimate hygiene products and products for the elderly.

Herbamed Teams Up With DVA America Israel-based Herbamed Ltd. has named DVA America, Princeton, NJ, its exclusive agent for Ultrasome CoQ10 in the eastern U.S. and Canada. Ultrasome is Herbamed’s liposomal-like formulation of CoQ10. The patent-protected formulation improves the bioavailability of the CoQ10 by combining ubiquinone with a dual layer of phospholipids to create a small droplet (liposome). This liposome protects the CoQ10 and delivers it to the GI tract.

BioScreen Hosts Chinese FDA Delegation BioScreen Testing Services, Los Angeles, CA, recently hosted a delegation of 25 officials from the Chinese Food and Drug Administration of Chongqing City P.R. China. Over a three-week period, the officials traveled throughout the U.S. to gain a better understanding of the current practices of food and drug safety. China is looking to improve its regulatory oversight and standards. During the visit, BioScreen conducted a presentation on how the U.S. FDA inspects and regulates laboratories and industries, and also conducted a comprehensive tour of the BioScreen Laboratories. In addition to educating officials on U.S. general practices, BioScreen management also learned a great deal regarding the regulation of drugs and cosmetics in China and gained insight into China’s current and future regulatory goals. March 2011

Word From Wall Street

Vitacost.com went public in October 2009. This transaction was particularly notable because many analysts considered it a sign that the financial crisis had passed. The last time Vitacost.com issued earnings guidance was July 2010, when the company said it expected to have annualized sales around $220 million. This guidance was lower than expectations, but the company’s outlook was still fairly

The Vitacost.com Bankruptcy What does it mean for the future of the industry?

By Adam Ismail

Adam Ismail is the executive director of the Global Organization for EPA and DHA Omega-3s (GOED), Salt Lake City, UT. He previously worked in business development, mergers and acquisitions, and business strategy at Cargill Health & Food Technologies, Health Strategy Consulting and Health Business Partners. He can be reached at [email protected]. 28 • Nutraceuticals World

rosy. The real news was still to come... In August, Vitacost.com’s CEO left the company in what was described as a “mutual separation.”Then in October its CFO left without explanation. In December, the company sent a letter to the Securities & Exchange Commission (SEC) saying its financial statements could not be relied upon to provide an accurate picture of the company’s financial health, dating all the way back to 1994. Its shares were trading at $5.70 at the time, but trading was halted in the stock and has yet to resume as of the writing of this column. Then in January reports emerged that the company was considering a pre-packaged bankruptcy, leaving most of the financial community somewhat perplexed. Vitacost.com is as large as Internet retailers of supplements go, holding about a 20% share of sales, according to Nutrition Business Journal market data. That being the case, the impact of this crisis on the nutrition industry should be limited. Most of the recent revelations about the company’s financial health have come under the helm of its new management, which appears to be focused on sorting out the problems with the company. In www.nutraceuticalsworld.com

fact, they claim business is continuing as usual at the company. The company depends on having access to a wide variety of brands and products, so if it goes into pre-packaged bankruptcy, its suppliers will likely already have worked out deals. Why Bankruptcy? So why is Vitacost.com considering bankruptcy in the first place? Typically, a company only files for bankruptcy if its debt payments are larger than it can afford. But Vitacost.com had $37 million in debt, and almost $40 million in cash and securities in the bank. Now, the company did say that its financial statements could not be relied upon, but it had indicated in filings with the SEC that its problems stemmed from defects in its corporate organizational and formation documents, as well as stock splits and share issuances prior to its IPO. So if Vitacost.com’s problems are related to its equity position instead of its debts, why would it consider bankruptcy filings? Any answers are just speculation, but it is important to know that when the company disclosed it was considering a pre-packaged bankruptcy, it also said it was considering a lawsuit. There are several clues in the statements that have been released. First, the company said its financial statements could not be relied upon dating back to 1994, which is when the company was founded. Since the company has implied that its problems lie in the Articles of Incorporation, it may be a matter of the company only having a certain number of authorized shares, and that shares or options it issued exceeded the allowed amount. Also, the company is incorporated in Delaware, which typically only requires a company’s name, address, registered agent and the number of shares authorized in its Articles of Incorporation. There are of course other issues that could create a problem, including different share March 2011

Word From Wall Street

“If Vitacost.com’s problems are related to its equity position instead

insight, including a hearing with NASDAQ, in which the company will appeal the recent de-listing of its stock. The company has maintained that it should continue to be publicly traded in the stock markets and specifically on NASDAQ, but the recent issues have caused the company to be out of compliance with the exchange’s requirements.

While the company’s operations may be unaffected due to its low debt load, there is no doubt its stock price will be affected once trading is resumed. Hopefully Vitacost.com can emerge from all of its problems with a new sense of transparency and strength, because after all it has been one of this sector’s biggest sucNW cess stories.

of its debts, why would it consider bankruptcy filings?” classes with various voting rights and powers, restrictions on authorization of shares, etc. However, most of these issues could cause the financial statements to be misrepresented because it is difficult to tell how much of the company’s earnings are represented by each share. None of these answer the bankruptcy question fully, however litigation might. It is possible that clauses in the company’s early corporate documents have created a significant liability for the company, but had one of these issues come to light it would have likely triggered a special filing with the SEC. Important Hearings May Determine Vitacost.com’s Future At this point, every potential explanation is still just speculation. However, there are some significant dates coming for Vitacost.com that could provide more

Want more financial news? Log on to nutraceuticalsworld.com and click on the “Opinions” section to read past “Word from Wall Street” columns.

March 2011

www.nutraceuticalsworld.com

Nutraceuticals World • 29

Inside China

The Wall Street Journal recently published an article, titled“Selling Health Food to China.”The article highlighted ongoing inroads multinationals like Nestle, PepsiCo and Coca-Cola are making in China’s developing health food market and presented a picture of growth and profits for all involved. Although true for some multinationals, everyone should remember that these larger companies are using in-coun-

New Opportunities in China Companies must be prepared when entering one of the most difficult but potentially most profitable markets in the world.

By Jeff Crowther

Jeff Crowther began his career in the natural health products industry in 1993. During his career he has worked with two of America’s largest dietary supplement companies, GNC and NBTY. Since 2005, he has been living in Beijing and working on both business development and industry regulatory issues. Currently, he is the CEO and Executive Director of the U.S.-China Health Products Association. The association is working to promote the further development of China’s natural health products industry and is committed to increasing the trade and availability of such products, which will benefit the health and well-being of both industry and consumers alike. He can be reached at [email protected]. 30 • Nutraceuticals World

try facilities to produce their products, which drastically reduces manufacturing costs and logistic expenses. This also eliminates import taxes and other related fees. Furthermore, by manufacturing in China these companies can also enjoy preferential treatment to some degree for creating Chinese jobs. For those small to medium-sized enterprises (SMEs) looking to export to China it is important to keep these tales of huge sales and successes in perspective. In order to tap into China’s huge consumer base, price is certainly a top concern. Products must be competitively priced regardless of where they originate. For instance, nutrition bars and energy drinks produced by domestic companies retail for the equivalent of $1 or less and in the dietary supplement range local products generally sell for around $15. Another factor that affects all involved is China’s current regulatory scheme for dietary supplements. China’s State Food and Drug Administration is in charge of policing the industry and has some of the most restrictive rules of any market. Unfortunately, regulatory barriers are causing many U.S. and other foreign SMEs to shy away from the market. But it is not all doom and gloom for comwww.nutraceuticalsworld.com

panies looking to export. In fact, an imported product has some distinct advantages. For example, these products enjoy a higher level of consumer confidence. Chinese consumers normally view imported products from the U.S. as being of higher quality and safety. Over the years, ongoing food safety issues have called into question the quality and safety of domestically produced products. And this point was really driven home when China’s dairy industry was crippled by widespread melamine adulteration. Parents were scrambling to buy baby formula from New Zealand, Singapore and the U.S.—basically anywhere but China. At this point, many local companies are not just marketing to keep their customers or gain new ones, they are in fact trying to convince the masses that their brand is safe. It’s routine to see companies using foreigners in their ad campaigns wearing white lab coats to associate their products with safety and quality. Another plus for imports is China’s fastpaced economic growth, which is fueling an expanding upper middle class armed with disposable income. Moreover, the appreciating Chinese currency against the U.S. dollar is marginally reducing the costs of imported products. But remember, just because you can import a product doesn’t mean it’s going to sell. Developing a sales channel that targets wealthy Chinese consumers as well expats who are willing to pay for higher ticketed imported brands is crucial. Wine is a good example. Throughout first-tier cities such as Beijing and Shanghai there are numerous specialty wine shops selling an array of global brands. Also, many high-end supermarkets have a section dedicated to imported wine, so for this industry there is a well-established channel to enter. Conversely, imported dietary supplements still have a way to go toward establishing a well-developed channel. Of course, every supermarket and pharmacy across China carries dietary supplements, March 2011

Inside China

but they are mostly domestically produced local and multi-national brands that fit the price range of the average Chinese consumer. There are also a variety of other brands claiming to be made in the U.S. or other western countries. However, you won’t recognize any of these brands because they are specifically made for the China market and typically contract manufactured in the U.S. Some of these are legit and some are not. Many lack the proper registrations and sometimes it is difficult to discern where in fact the product originated. Higher priced imported products traditionally do not fare well in these channels; moreover, profit margins on imports aren’t typically high enough to allow for the layers of distributors needed to truly penetrate the market. Too many U.S. dietary supplement companies enter the China market and soon after fail because their local partner put their products in poorly suited channels. NBTY entered the China market with its Nature’s Bounty and Met-Rx lines and quickly realized its mistake. So the company created its own sales channel from scratch by establishing kiosks in upscale shopping centers, directly targeting its consumer base. The lack of well established sales channels coupled with increasing high-end consumer demand have piqued the interests of a variety of entrepreneurs, companies and firms to develop a specialty health food store channel. This channel is now in development and World Health Store (WHS) is leading the way. WHS like NBTY learned early on that it had to control its own destiny in China and invest in creating a channel. Its channel consists of brick and mortars, store-in-store concepts, an e-commerce platform and an importing arm of the company. By having all this in place, the company can control its business, from manufacturer to market. Its importing business, not only supplies its retail and e-commerce business, but it also supplies a growing number of health product kiosks, gyms and store-in-store wholesale accounts

throughout China. To further strengthen the confidence in the industry’s development, 2010 saw a variety of large investment firms seeking opportunities in China’s growing natural health products industry, including the high profile potential buyout of GNC by Chinese food giant Guang Ming. In fact, by the end of 2010, I was contacted by three different investment firms looking for opportunities in China’s growing natural health product industry. Previous years haven’t seen this level of interest in developing sales channels or market investment. The development of a specialty health food store channel is a strong indicator

of long-standing relationships with U.S. and Chinese government agencies, organizations and industry. Because a large percentage of ingredients used by U.S. manufacturers are sourced from China, the association sees its mission of protecting the supply chain of utmost importance. NSF, one of the association’s founding members, is an integral part of accomplishing this mission. NSF has positioned itself in China as a market leader in issuing third party GMP certifications to those suppliers who pass the organization’s rigorous audit and adhere to producing safe, high quality products. NSF has a fully staffed office in Shanghai with trained auditors and support staff, and has thus far certified more than 25 Chinese suppliers. In 2011, NSF will expand its operations in China by opening a testing facility, which will focus on Certificate of Analysis (C of A) verification and screening for contaminants such as pesticides, heavy metals and melamine. NSF’s membership with the U.S.-China Health Products Association creates a strategic package that offers unparalleled services for companies looking to find quality ingredient suppliers as well as those looking to enter the market. Another important aspect of the association’s work is to offer its members business services, including trademark and product registration as well as partner matching and strategic guidance. China is already the most important global player for ingredients and it is slated to become a leading destination for finished products in the years ahead. As 2011 moves along, we as an industry should be looking forward to a prosperous new year and should work together to fully develop the opportunities NW in China.

“The development of a specialty health food store channel is a strong indicator that China’s natural health product

industry is moving in the right direction.”

March 2011

that China’s natural health product industry is moving in the right direction. The expansion of this channel is creating greater opportunities for U.S. manufacturers and marketers of natural health products and is a welcome commercial force that will assist in leveraging regulatory change. Another force for change and development that arrived in 2010 was that of the U.S.-China Health Products Association. A New Trade Association Although opportunities are growing in China, there still remains a lot of work to be done in moving the industry toward a more transparent and open system, which is best accomplished through a non-profit trade association working in conjunction with both industry and government. U.S.-China Health Products Association’s main objectives are to work on regulatory advocacy measures, increase U.S. exports, provide market intelligence, encourage tradeshows and trade missions as well as promote quality assurance along the supply chain. These initiatives are made possible by the association’s network www.nutraceuticalsworld.com

Editor’s Note: For more information on the China market and how to become a member of the U.S.-China Health Products Association, contact the association at [email protected]. Nutraceuticals World • 31

Healthcare Practitioner Corner

As I mentioned in my previous column (December 2010), my company (Holistic Primary Care-News for Health & Healing) recently conducted a survey of roughly 2000 primary care doctors nationwide to learn more about how practitioners—especially mainstream MDs—interface with the supplement and natural products industries. The 52-question study told us a lot about what’s going on in the trenches of clinical

Change We’d Better Believe In Regardless of politics, the healthcare situation will continue to spiral out of control—and most doctors want out.

By Erik Goldman

Erik Goldman is the co-founder and editor of Holistic Primary Care-News for Health & Healing, a quarterly medical news publication reaching 80,000 primary care MDs, NDs and DOs, and covering the wide spectrum of natural healthcare. Before launching Holistic Primary Care in October 2000, he was the New York Bureau Chief for International Medical News Group, a well-established medical publishing company that produces clinical news publications for various medical specialties. He has been writing for medical audiences about clinical practice and socioeconomic trends in medicine for 20 years. He can be reached at 212-406-8957; Fax: 212-4068959; E-mail: [email protected]; Website: www.holisticprimarycare.net. 32 • Nutraceuticals World

practice these days. Suffice it to say, there are a lot of unhappy doctors out there, and they’re looking for help—in improving their patient care, and in surviving the economic forces conspiring against them. If you still harbor the belief that an MD degree is a ticket to easy street, and that doctors are exploiting the American public, you’d better open your eyes—and read something else besides insurance company media blitzes. What our survey respondents—the vast majority of whom are conventionally trained MDs—are telling us is that they’re having a rough go of it. But as the ancient Chinese sages stated, in crisis is found opportunity. I believe the crisis today’s doctors are facing spells great opportunity for natural products companies that can bring forward real, trustworthy, meaningful solutions. Nearly 20% of our respondents—that’s 1 in 5 of a representative sample of American primary care doctors—is contemplating making a major change in his/her practice situation in the next year or two. That’s HUGE! Many are considering a shift out of insurance and into direct-pay non-insurance practice or a “membership” or “concierge”practice model (i.e., the MDVIP approach). Others are thinking about openwww.nutraceuticalsworld.com

ing up medical spas or fitness centers, to try and serve the growing demand for truly health-focused healthcare. But some of them are thinking about bailing out of medicine altogether, selling their practices to large hospital networks, or taking corporate jobs as salaried physician-employees. It’s a situation akin to what happens in the retail space when small Mom & Pop stores, unable to compete with the giants, are forced to sell or fold. Interestingly, it’s the same dynamic that’s happened down on the farm, where small farm families feel tremendous economic pressure to either farm for “Big Ag” or sell off their land and move someplace warm—if they can afford to. Welcome to corporate feudalism! But I digress. Doctors who do want to stay in the doctoring game are eagerly looking for new sources of revenue. More than 40% of our respondents said they are looking to incorporate products, services or procedures that would generate new cash streams. Hear that, people? Forty percent of primary care doctors are looking for new ways to make money, and the sale of supplements and natural products is a prime option for fulfilling that need. Interestingly, physician interest in supplement sales was robust among doctors who plan to stay in insurance-based medicine as well as those who are thinking about jumping off the insurance treadmill. With continued downward pressure on insurance reimbursement, it seems that many insurance-based docs are having trouble making ends meet. Office-based dispensing is looking a lot more attractive to a lot more doctors. That said, there are numerous stumbling blocks that make physicians wary, and companies that can address these obstacles have the best shot at winning a strong segment of the coveted practitioner dispensing market. March 2011

Healthcare Practitioner Corner

Want to learn more about the practitioner channel? Get the details! Holistic Primary Care’s new report, “Primary Care Physicians & Holistic Medicine: Transition, Transformation, Opportunity—An Executive Report from Holistic Primary Care’s 2010 Physicians’ Survey,” provides comprehensive analysis of physician attitudes, practice patterns and personal experience with holistic nutrition-based medicine, nutraceuticals and natural products. It is the first survey of its kind to assess a large and representative sampling of conventionally trained Medical Doctors across the U.S. The full report, complete with charts, graphs and a detailed analysis, is available for purchase at www.holisticprimarycare.net, or contact Erik Goldman at 212406-8957 or [email protected].

March 2011

www.nutraceuticalsworld.com

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Bottom line is that if you want practitioners to support your brands—whether as direct points of sale or as consumer influencers—you need to be able to guarantee the safety and quality of your products and the validity of your claims. Healthcare in this country is at a unique, troubling and exciting break-point, and not just because of healthcare reform. Obama-care or no Obama-care, the dynamics that are driving doctors to seek change are going to continue. The healthcare reform plan could even intensify their desire for new practice models and new revenue streams. Doctors are already working at capacity under current insurance plans. How are they going to handle 40 million more patients? But even if the Republicans and the Tea Partiers have their way and somehow manage to kill off the reform plan, the basic facts remain that insurance plans add tremendous overhead costs to primary care without adding to the quality of the care or the patient-physician interaction. They also create tremendous hassle-factors for doctors. Keep in mind that physician unrest didn’t begin in 2008 when Obama was elected. The shift toward holistic medicine and the emergence of direct-pay and concierge-care models were both in full swing 10 years ago, while Bush & Co were running things in Washington. This is not about politics, it’s about how to create better health. The real creative solutions are going to come from patients, doctors and the ethical businesses that derive value from fostering the therapeutic relationship. Now, that’s change I can believe in. I NW hope you will agree!

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Respondents told us that beyond ethical and quality concerns, one of the biggest obstacles is logistics. Most physicians do not understand the dynamics of “retailing,” and after all, office-based dispensing is really a form of retailing. Many of them are unsure of how to go about bringing product lines into their offices and how to engage patients in an ethical and unobtrusive manner. Anything you can do to streamline the process and provide physicians with turnkey tools for implementation of a dispensing strategy will improve your ability to win new practitioner customers. The survey showed a clear overlap between the types of supplements that doctors take for their own health—and the good news is that most doctors are taking basic nutraceuticals—and the sort of products they will recommend to their patients. This was true even among doctors who do not sell supplements and have no interest in doing so. The message here is that if you can make physicians personally aware of the health value of your company’s products, if they have direct experience with the products, they are more likely to be comfortable recommending them to patients. In this sense, doctors are no different than the rest of us; we all like to tell others about things we like and products that have helped us feel better. Be aware, however, that in order to engage physicians you need to have a strong trust proposition, not just a value proposition. Reservations about product quality and efficacy, while not a primary deterrent to office-based dispensing, was certainly a concern among the survey respondents.

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From the Corners of the World

As U.S. manufacturers continue to look to better their business performance and seek improved revenues in 2011, one commonly accepted method is to examine new markets. As part of a new series of articles,“From the Corners of the World”will address some of the unique market and business opportunities presented by the countries of Southeast Asia.

Singapore 2011: The Gateway to Southeast Asia Singapore is an attractive option for companies interested in entering the Asian market.

By Paul Altaffer & Grant Washington-Smith

Paul Altaffer is on the product and business development team at RFI Ingredients, Blauvelt, NY, a manufacturer of innovative natural ingredients and custom formulations for the functional food and dietary supplement industries. He was previously the founder and president of Nat-Trop, an ingredient company now operated by RFI that develops and trades primarily in South American products. He can be reached at 510-3370300; E-mail: [email protected]. Grant Washington-Smith has over 17 years of experience across a variety of businesses in the natural products industry. He previously worked in business development and brand management for Alticor Inc. Prior to arriving in the U.S., Grant was involved in marketing and business development throughout New Zealand, Australia and the Asia/Pacific region. His focus has been on the commercial development of the novel and the innovative. He can be reached at [email protected]. 34 • Nutraceuticals World

Southeast Asia is home to some of the fastest growing economies in the world. The countries that make up this economic zone, which is often referred to as the ASEAN bloc, include Burma, Cambodia, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand and Vietnam. Lately, when companies undertake their market analysis of the broader Asian market, the focus often falls on China, Japan, Korea and Taiwan. However, the growth of the ASEAN bloc countries is expected to be second only to China in market growth in the coming years. Oh Singapore! Singapore represents a very attractive option for companies interested in entering the Asian market, but also looking to avoid some of the major complications associated with entering very large and culturally diverse regions. While Singapore is one of the smallest Asian countries, with a population of 5 million, it is among the most affluent— with a per capita GDP (PPP) of $57,238. It is also the most “Westernized” of all the Asian markets. And, more than 60% of Singapore’s population is classified as middle income or upper income. At the same time, the Singaporean Government continues to stimulate population growth through inward migration and enwww.nutraceuticalsworld.com

couraging more local births. The latest government projections indicate that the population could grow to between 6 million and 6.5 million during the next 20 years. Accordingly, it is forecasted that by 2030 19% of Singapore’s population will be over the age of 65, compared to the current 7%. The effects of aging are going to strain health resources, which is why current governmentsponsored awareness efforts are directed at general health and wellness. The Health Concerns of Singaporeans Swiss-born Adrian Jacklowsky is the managing director of Singapore-based ORAC Life Sciences International, LLP. Prior to establishing his own company, he was director of marketing, Asia Pacific, at DSM Nutritional Products. He has been working in Asia since the Asian crisis in early 1998, building businesses for Roche and DSM in the areas of nutrition, personal care and supplement ingredients. Mr. Jacklowsky now consults to the global nutraceuticals industry on market development in Southeast Asia. He was kind enough to provide some of his insights on Singapore’s nutraceutical market for this column. Rising awareness of health concerns and increasingly health-conscious consumers are driving growth in the Singaporean market, according to Mr. Jacklowsky. “Even in the recession of 2009, nutritional supplements managed to sustain positive growth, with consumers wanting to remain healthy,” he said.“It was believed that this was driven by employees such as office-workers, fearing for their jobs and not wanting to apply for leave when ill.” Mr. Jacklowsky believes that combination supplements (as opposed to single ingredient products) continue to capture the largest proportion of the market, at 60% share. Marketed mostly as condition-specific products, consumers value combination formulas because they address a condition with a single dose, rather than having to buy separate March 2011

From the Corners of the World

bottles of individual ingredient products. One ingredient that has bucked the trend of combination formulas is glucosamine. As a retail product, glucosamine has been demonstrating rapid growth and capturing significant market share. This is due to the rising awareness from Singapore’s aging population—a market within which the number of consumers suffering from joint pain has been increasing. In addition, the culture of Singapore consumers is that prevention is better than cure, so many aging consumers have started taking glucosamine as a preventative measure. While concerns over the H1N1 flu virus have declined during the past year, Mr. Jacklowsky believes that this global pandemic left a lasting impression because it increased the interest in immune-boosting supplements among consumers. Moreover, he suggested that this increase has boosted awareness of the overall benefits of consuming nutritional supplements.

Bayer (Southeast Asia) Pte Ltd has had great success with Nature’s Way Einstein Junior, which launched in August 2009. This product contains fish oil to aid a child’s brain development. The company ran numerous television advertisements to inform consumers of its launch—and the efforts have paid off. Prospects for Singapore’s Nutraceuticals Market Awareness and education will continue to fuel the interest in and consumption of condition-specific products such as joint, bone and heart health formulas. Consumers will also look for products that can address more than one condition. One example is CoQ10, which is typically taken to support normal cardiac function, but might also be used for increased energy or healthy gums and skin. While the outlook across condition-specific supplements looks good, nutritional supplements that are expected to experience slower growth during the next five years

(compared to the past five years) include the mature product categories and single ingredient formula products, such as echinacea, garlic and mineral supplements. Growth opportunities during the next five years all appear to be driven by specific health concerns associated with aging. Mr. Jacklowsky also sees plenty of room for the growth of superfruit products, both as supplements and functional beverages, and cites General Nutrition Centers Inc’s Resveratrox as one example of a market success. This product has been met with consumer acceptance and strong sales. In fact, antioxidant benefits boosting overall health and wellness seem to have resonated very well with retail consumers. Stay Tuned! The next column in this series will focus on the regulatory requirements for companies seeking to export to Singapore. We will also examine the retail channel and distribution considerations in this market. NW

Beauty, Child Development & Other Trends Another category growing nicely in Singapore is beauty supplements, including those either containing collagen for improved skin tone and elasticity or formulas specifically for skin lightening. Mr. Jacklowsky believes the unique blending of Eastern and Western culture in Singapore is a major reason behind the success of these products, especially because consumers think they can become more beautiful from the inside out. Tonics and bottled nutritive drinks grew by 6% in value in 2009 compared to 2008, largely as a result of the growing popularity of collagen drinks from companies such as Nature’s Farm Pte Ltd. Eu Yan Sang (S) Pte Ltd also launched Floral Tea Bird’s Nest with rose or chamomile extract, which is also supposed to aid consumers’ mental health and provide beauty benefits. Learning and education is a huge cultural focus in Singapore, which is a major reason why child-specific nutritional supplements containing ingredients such as DHA are important to parents. Singapore is known for having a competitive education system, prompting parents to do whatever it takes to improve the academic performance of their children. In order to tap into this growing trend, March 2011

www.nutraceuticalsworld.com

Nutraceuticals World • 35

Antioxidants: High Expectations for a High Quality of Life

In a market filled with so many options for consumers, only the best will rise to the top—and stay there.

By Mark Crawford Contributing Editor

A

lmost everyone knows the basics—free radicals damage cell membranes and DNA through a process known as oxidative stress, which may lead to future health problems and the early onset of disease or aging. The good news, of course, is that antioxidants “fight” these dangerous compounds and help preserve health and longevity. Average consumers are far more interested in wellness and health than they used to be, especially Baby Boomers. Boomers, who will be living longer and staying more active than generations before them, are already refusing to accept the natural signs of aging. “Consumers continue to seek the prover36 • Nutraceuticals World

bial ‘fountain of youth’ and are willing to spend their hard-earned dollars on natural anti-aging moisturizers and supplements that may erase those fine lines that crop up over time,”said Steve Holtby, president and CEO of Soft-Gel Technologies, Los Angeles, CA.“Generation-X/30-something consumers are also striving to maintain their youthful looks. They are spending thousands of dollars on cosmetic products and procedures to help reverse, or at least suspend, the aging process.” As a result, antioxidants are in huge demand across a broad range of demographics. The market is already packed with a variety of ingredients considered to have antioxidant capabilities. Researchers and ingrediwww.nutraceuticalsworld.com

ent suppliers continue to scour the globe, including rainforests and other remote locations, hoping to discover the next new group of antioxidants more powerful than the last. Right now consumers are especially interested in superfruits, both long-time standards such as cranberries and blueberries

This article in a nutshell: • Top-shelf reputations • Up-and-comers • Emerging contenders • Key challenges • Condition-specific antioxidants • Standing out in the crowd

March 2011

Antioxidants

and less familiar, more exotic entries.“Superfruits such as acai, mangosteen, goji and pomegranate are flying off both brick-andmortar and Internet shelves,” indicated Sherry Torkos, a holistic pharmacist and nutritional and research consultant for Pharmachem Laboratories, Kearny, NJ. Also increasingly popular are green-food products, which are typically presented as high-dose, powdered beverage mixes that contain nutrient greens and fruits to supplement the vegetables and fruits that aren’t being consumed in most people’s diets. Some green-food and red-food manufacturers, such as Blauvelt, NY-based RFI Ingredients, are developing highly concentrated liquid antioxidant extracts from these foods, which can be labeled as“fresh brewed”if they are extracted with water. “These extracts contain much higher levels of polyphenols and antioxidants than single-strength products do, and can be added to beverages to boost the polyphenol and flavonoid content and enhance flavor,” explained Jeff Wuagneux, CEO and president of RFI Ingredients.

Top-Shelf Reputations Famous, long-standing antioxidants—vitamin C, vitamin E, selenium, beta-carotene, blueberries, cranberries, alpha lipoic acid (ALA) and coenzyme Q10 (CoQ10), to mention a handful—continue to be in high demand. Even though they have been well-studied, researchers continue to find new ways to increase their efficacy. For example, both ALA and CoQ10 are supported by high-quality research demonstrating consistent health benefits, especially regarding heart health, diabetes/blood sugar management, gum/oral health and overall anti-aging. One way scientists are improving the function of these ingredients is by developing enhanced delivery systems, such as Pharmachem Laboratories’ patented pre-chelation technology, which boosts the digestion and absorption of CoQ10, selenium and other nutrients. Polyphenols—antioxidants found in tea and dark chocolate, among other dietary sources—have also long been known to benefit overall health. Now they are being studied for possible effects on vascular health (including blood pressure) and on the body’s ability to use insulin.“Laboratory studies suggest that EGCG, a polyphenol found in green tea, may protect against cardiovascular disease and have a beneficial effect on insulin activity and glucose control,” said Soft Gel’s Mr. Holtby. Blueberries have always been a consumer favorite—not just for their antioxidants but also because they are an easy-to-formulate, flavorful ingredient for a variety of products. Tom Payne, industry specialist for the U.S. Highbush Blueberry Council, cited animal studies by the USDA Human Nutrition Research Center (HNRC) that demonstrate the health benefits of blueberries, especially regarding motor skills and brain function. “Blueberry-fed mice performed better than their control group counterparts in motor behavioral learning and memory,” said Mr. Payne.“Researchers also found a marked decrease in oxidative stress in two regions of the brain and better retention of signal-transmitting neurons compared with the control mice. The compound that appears responsible for this neuron protection—anthocyanin— 38 • Nutraceuticals World

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Antioxidants

gives blueberries their color and may be the key to their antioxidant and anti-inflammatory properties.” In other developments, research continues to demonstrate the health benefits of glutathione, which is found in every cell of the body and is another major player in the antioxidant market. “According to researchers at Emory University, levels of glutathione vary during a 24-hour period, spiking about six hours after each meal and hitting their lowest point in the morning hours,”said Karen Todd, director of marketing for Kyowa Hakko New York, NY. “Because glutathione levels can only be increased through food intake or dietary supplementation, unless people get up during the night and eat their glutathione levels will be lowest in the morning.” Antioxidants can also work together synergistically to create enhanced health benefits. Some of these antioxidants may not have relevant biological activity individually, or work through the same biochemical mechanisms; yet together they can

create an interlinked defense system that protects against disease associated with oxidative stress. Most antioxidants lose their protective power once they have quenched a single free radical.“Five antioxidants—alpha lipoic acid, the complete vitamin E complex (tocopherols and tocotrienols), vitamin C (in both fat-soluble and water-soluble forms), glutathione and CoQ10—are unique in their synergistic ability to ‘recycle’ one another into their active antioxidant forms,” explained Mr. Holtby.“Selenium (an essential cofactor of the enzyme thioredoxin reductase) and flavonoids are also proven antioxidants in the body’s defense system against oxidation.”

Up-and-Comers More “exotic” high-antioxidant ingredients are being heavily marketed to consumers in the form of functional foods and beverages.“Some of these include the maqui berry (highest ORAC value of the known

superfruits), acai, goji and other berries,”said Steve Siegel, vice president of Ecuadorian Rainforest, LLC, Belleville, NJ. Other superfruits include dragonfruit, cupuaçu, rambutan, camu camu and yuzu. European black currant and lingonberry, as well as various types of teas beyond the usual green and black varieties, such as Tulsi tea, are also rising in popularity. Super C-3-G has significant potential and antioxidant content. The extract is obtained from black rice (Oryza sativa L. indica) grown in Korea and has the same dark pigment found in other types of antioxidantrich foods, such as berries. “However, unlike berries, black rice extract has greater than 25% anthocyanin content,” said Matt Phillips, president and CEO of Cyvex Nutrition, Irvine, CA. “The anthocyanins are composed of 90% cyanidin-3glucoside (C-3-G). This is important because the amount of C-3-G appears to be directly proportional to the amount of antioxidant activity. Not only does black rice extract have the highest ORAC compared to other berry

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Antioxidants

anthocyanin extracts, it also contains other valuable antioxidants such as vitamin E, tocotrienol and carotene. With such high ORAC levels there are quite a few studies being conducted on its benefits for eye health and other conditions.” Natural lutein esters, another rising star in the antioxidant market, are becoming popular for eye health and maintaining a youthful appearance. “These compounds play crucial roles in the macula, the part of the eye responsible for detailed vision,” noted Laura Troha, marketing manager for La Grange, IL-based Cognis Nutrition & Health, now part of BASF. “Compelling evidence shows natural lutein esters can increase macular pigment density, which has been associated with a lower risk of age-related macular degeneration. As for skin health, natural lutein esters improve skin hydration and elasticity. Research shows it also protects against damage from UV light.”

quercetin, kaemferol and myrecetin). “In fact, the ORAC value of chia seed is comparable to that of fresh blueberries,”said Pharmachem’s Ms. Torkos.“It is very unique for a seed to have this level of antioxidants. A wealth of new research findings continue to support the potential of resveratrol, a powerful antioxidant that has been shown to significantly impact the aging process, regulate cardiovascular function and fight cancer. It achieved “superstar” status, partly due to promotion by Dr. Mehmet Oz on Oprah. “Preliminary evidence suggests that trans-resveratrol has antioxidant activity and also causes blood vessel dilation,” said Mr. Holtby. “It scavenges free radicals and other oxidants and inhibits low density

Emerging Contenders In vitro studies have demonstrated that cinnamon has antioxidant, anti-inflammatory, immunomodulatory and antimicrobial properties. This common spice contains some of the most varied and potent antioxidants of all plants, making it an important food in the control of oxidative stress and thereby the wide range of chronic diseases that are associated with oxidative damage. “In a comprehensive global analysis of more than 3100 different foods published in the January 2010 edition of the Nutrition Journal, cinnamon was found to have one of the highest antioxidant contents of all the foods studied,”Soft Gel’s Mr. Holtby pointed out. Turmeric’s principle constituent, curcumin, has been extensively studied by western researchers and scientists for its potent antioxidant activity. Turmeric is thought to reduce inflammation by lowering histamine levels and may also stimulate the adrenal glands to increase production of a hormone that reduces inflammation. It is often used to ease joint pain and inflammation associated with arthritis and other disorders. A big surprise for many consumers is that chia seed provides a significant amount of antioxidants (caffeic acid, chlorogenic acid, 42 • Nutraceuticals World

Resveratrol has been found to exert a number of potentially cardioprotective effects in vitro.

lipoprotein (LDL) oxidation. Resveratrol has been found to exert a number of potentially cardioprotective effects in vitro, including the inhibition of platelet aggregation, promotion of vasodilation by enhancing the production of nitric oxide and inhibition of inflammatory enzymes.” “Some fundamental aspects of resveratrol’s action need to be understood before it can be developed into a clinically viable anti-cancer drug,”added Lakshmi Prakash, vice president of innovation and business development for Sabinsa Corporation in East Windsor, NJ.“These pertain to the key mechanism(s) by which resveratrol potentiates its effects. Current research suggests www.nutraceuticalsworld.com

these might be through novel pathways requiring an understanding of cellular uptake, sentinel targets and in vivo biological networks. The metabolism of resveratrol and its bioavailability also warrant further consideration in light of recent in vitro and in vivo studies.”

Key Challenges Antioxidants have broad appeal because they have been linked to good health and disease prevention. Educating consumers about antioxidants with solid, easy-tounderstand science can be a challenge— many marketers simply tout that antioxidants help protect the body against oxidative damage caused by free radicals. “Properly promoting these key nutrients, however, requires taking scientific evidence and presenting it to the consumer in a simple, understandable manner,” stressed Soft Gel’s Mr. Holtby. With the recent upsurge in FDA/FTC warning letters pertaining to inaccurate or excessive antioxidant claims in food products (Lipton, POM Wonderful are some recent examples), companies are likely to be more careful with their messaging in 2011. “This fear of antioxidant claims may cause a slowdown in the market trend for antioxidants in foods as companies choose to be more careful about what they say,”RFI’s Mr. Wuagneux stated. But doing scientific studies won’t necessarily allow companies to make claims Mr. Wuagneux said. “POM Wonderful had studies and they were called on it by FTC; in fact POM is filing suit against them. Instead of using the word ‘antioxidant’ companies can make content claims with words like ‘polyphenols’or‘flavonoids.’These words are almost mainstream and are fairly wellknown to be antioxidant compounds. It may also be possible to discuss ‘free radical scavenging’ instead of ‘antioxidants.’” Mr. Wuagneux further noted that the way manufacturers respond to this issue would depend considerably on the resolution of the dispute between POM and FTC. The ORAC (oxygen radical absorbance capacity) assay continues to be a challenge. This testing method places an antioxidant “value” on both foods and supplements by measuring the degree to which a sample inMarch 2011

Antioxidants

hibits the action of an oxidizing agent and how long it takes. ORAC testing has made a significant impact on the industry’s ability to quantify antioxidant performance. “The ORAC assay measures the fluorescence of a target attacked by free radicals, Sabinsa’s Dr. Prakash explained.“It typically uses a single concentration of antioxidant or extract, should be conducted at a range of concentrations and the reaction conditions should be carefully controlled.” For example, she said some test substances are sensitive to light and temperature, so samples stored in brown bottles under refrigeration give different results than those left on the bench top in clear glass. Another problem with ORAC is the interaction of the sample with the fluorescein reagent used in the test. Some phenols bind to it, probably through hydrogen bonding or pi interactions, preventing decay of fluorescein fluorescence.“When this happens,” Dr. Prakash said,“the test overestimates antioxidant activity, giving extraordinarily high ORAC values that are unrelated to actual radical scavenging activity.” Test tube ORAC values also don’t tell the full tale of the“power”of an antioxidant. “The more aggressively the test tube ORAC value is used for marketing a product, the more obvious it becomes that nothing else was ever tested on the product,” commented Frank Schonlau, director of scientific communications for Natural Health Science in Chicago, IL. “Key issues that come into play are ingredient specifications, safety data, bioavailability, stability testing and clinical research. Test tube ORAC values can mislead consumers to believe a product is validated.” In fact, the ORAC value of the blood of human subjects can be investigated before and after consumption of antioxidants to evaluate their efficacy. Such experiments have been repeatedly carried out with Pycnogenol and are published in peer-reviewed medical journals (i.e., Devaraj et al., Lipids, 2002). “Such ORAC investigations in humans in controlled clinical trials will require a budget of $100,000 compared to $100 for a test tube ORAC assay, ”Mr. Schonlau added. “Yet such clinical studies are much more compelling because they prove the antioxidant is bioavailable and indicate the dosage required to exert an effect in the body.” 44 • Nutraceuticals World

Condition-Specific Antioxidants Consumers are increasingly looking for antioxidants that can help them manage specific health conditions. An antioxidant such as lutein is fairly well known for its benefits for eye health, just as cranberries are generally recognized for their ability to treat urinary tract infections. As antioxidants continue to grow in popularity and the list of antioxidants gets longer, consumers are eager to find condition-specific antioxidant products. “A lot of the trends in the industry right now are specifically related to aging and disease conditions,” said Kyowa Hakko’s Ms. Todd. “Therefore companies are looking at solutions to increase mobility and improve digestion because these are key issues for people as they age. Although glutathione has several health benefits, at Kyowa Hakko we are keeping our message simple right now and focusing on its antioxidant/anti-aging applications.“ “Beauty from within”is a relatively new product category of ingestibles, sometimes referred to as cosmeceuticals and nutricosmetics. These antioxidants are being positioned as “beauty enhancing” ingredients. “New niche opportunities exist for pairing shelf-stable beauty food concepts with cosmetic brands in department stores where food is not traditionally sold,” said the U.S. Highbush Blueberry Council’s Mr. Payne. Antioxidant research is also shifting its focus from oxidative stress to inflammation. Oxidative stress and inflammation are interrelated—inflammatory cells generate reactive oxygen species, while oxidative stress may participate in the initiation of inflammation, a process often associated with aging. A consumer suffering from arthritis would rather turn to a product with proven efficacy for reducing joint problems than, say, an antioxidant only boasting high ORAC values. “High sensitivity C-reactive protein is a major marker in the bloodstream indicative of inflammatory processes in the body,” said Natural Health Science’s Mr. Schonlau.“Taking an antioxidant may help to lower these inflammatory processes and consequently this marker will decrease in the blood.” www.nutraceuticalsworld.com

Standing Out in the Crowd Key factors making a product successful in today’s crowded antioxidant market include a sound, scientific understanding of its health benefits, delivery systems that are favored by consumers, acceptable price points and science-based marketing/outreach that strives to educate consumers, allowing them to make informed decisions. Consumers are more informed than ever before and have a myriad of choices at their fingertips—a company can have the best science in the world, but if consumers don’t know about the benefits of the product, or understand them, they will move on to the next one. For today’s consumer, antioxidant products must meet both the nutritional/health standards and lifestyle demands for every key demographic—especially teen, parent, adult and senior. They will buy items that best fit their activity levels and interest patterns. The products must be easy to consume and be available in a preferred delivery form (i.e., food, supplement, energy bar, gummies, beverages). The source and quality of the ingredients and manufacturing processes are also being considered more seriously by customers. “Product quality is center stage with more focus on the supply chain and a specific brand’s reputation,” said Cognis’ Ms. Troha. “Consumers are looking more closely at where a product is derived, how it’s produced and whether it’s sustainable.” At RFI, researchers are also conducting more clinical studies with selected antioxidants. “These types of studies, which actually show some quantitative effect of antioxidant supplementation over time, will ultimately make products stand out, both on the ingredient and finished product level,” Mr. Wuagneux said. “This is the NW future of the industry.”

About the author: Mark Crawford is a freelance writer based in Madison, WI. Armed with a science background, he writes about a variety of subjects, from manufacturing to discovery to commercialization to testing/verification to market performance. Personally, natural health is one of his favorite fields. He can be reached at [email protected]. March 2011

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Antioxidant Science: From Antioxidants to ‘AntiAGEnts’

Antioxidants are entering a new era of product performance. By Ronald Prior, PhD, USDA & Boxin Ou, PhD, David Bell, MBA, Qiuyan Zhao, MD, MBA, & HuiLin Wei, MD, PhD, Brunswick Laboratories Antioxidants are growing up. They have emerged from their adolescence into the prime of maturity. In doing so, they have proven themselves to be versatile performers. In fact, these natural product compounds traditionally referred to as “antioxidants” may deserve a new name—”antiAGEnts.” In the past decade, antioxidants have captured the consumer imagination—for the most part, for the better. They have become a part of the consumer vocabulary and have helped shape the landscape of nutrition products, from conventional supplements to specialty foods to cosmetics. During this time, antioxidant research has been robust. Central to the findings are: (1) that phyto-compounds traditionally called “antioxidants” demonstrate diverse characteristics; and (2) that “antioxidants” are implicated in a complex array of interconnected mechanisms in vivo. The diversification of antioxidants’ role has important implications for natural products and the varied forms they take in the anti-aging marketplace. 46 • Nutraceuticals World

The New Science of Antioxidants There is continued interest in and questions regarding the antioxidant capacity of the diet and in vivo antioxidant status and effects on health outcomes. There is increasing evidence that the postprandial (after meal) state is an important contributing factor to chronic disease. A decrease in plasma antioxidant capacity has been observed following a meal containing macronutrients but no sources of antioxidants. The role of fruit and vegetable phenolic compounds to protect health and lower disease risk through their actions in mitigating fed-state metabolic and oxidative stressors is of interest. Berries such as blueberries, grapes and strawberries have been shown to reduce postprandial oxidative stress. More research is needed in this area, but data from several studies summarized by Dr. Burton-Freeman suggest that consuming phenolic-rich fruits increases the antioxidant capacity of the blood. And when they are consumed with high fat and carbohydrate “pro-oxidant and pro-inflammatory” meals, they may counterbalance their negative effects. Given the content and www.nutraceuticalsworld.com

availability of fat and carbohydrates in the Western diet, regular consumption of phenolic-rich foods, particularly in conjunction with meals, appears to be a prudent strategy to maintain oxidative balance and health. It is becoming increasingly apparent that phenolic-rich foods may impact health outcomes through other mechanisms in addition to strictly antioxidant effects. Studies suggest that oxidative stress and systemic inflammation are involved in the pathogenesis of ischemic stroke and consuming a diet with a high total antioxidant capacity has been related to reduced inflammation, along with increased circulating antioxidants. In a cross-sectional and randomized intervention study of 41,620 men and women, a diet rich in total antioxidant capacity was associ-

This article in a nutshell: • The new science of antioxidants • The ORAC method today • A new measure of performance: ‘cardinal wellness factors’ • Cell-based assays

March 2011

Antioxidant Science

ated with a reduction in incidence of ischemic stroke and to a lesser extent in all types of stroke. In another study, positive associations were observed between dietary antioxidant capacity and adiponectin concentration and a negative relationship with inflammatory markers. As a result, an adiponectin-mediated route through which antioxidant-rich foods exert beneficial effects against inflammation and cardiovascular diseases can be hypothesized. Consumption of a Mediterranean diet, especially rich in virgin olive oil, has also been associated with higher levels of plasma antioxidant capacity. In addition, plasma total antioxidant capacity may lead to a reduction in body weight after three years of intervention in a high cardiovascular risk population. In another study, a group of patients with Type 2 diabetes was given a polyphenol-rich antioxidant supplement, and a decrease in LDL and an increase in HDL was observed. In addition, a byproduct of lipid peroxidation (plasma MDA) was decreased in the study group compared to the placebo group, and an increase in antioxidant defense was observed based upon increases in total plasma GSH and antioxidant capacity. These observations indicated that the polyphenol-rich antioxidant supplement may have been important in antagonizing effects on oxidative stress and lipid peroxidation in patients with Type 2 diabetes and might be beneficial in preventing cardiovascular complications. Based on positive associations observed for total fruit and vegetable intakes and what was termed total antioxidant performance, Talegawkar et. al. suggested that it might be prudent to focus on increasing consumption of fruit, vegetables, nuts and seeds to increase total antioxidant capacity. In this vein, accurately testing the antioxidant level in natural products and ex vivo samples remains an important task, which is why the Oxygen Radical Absorbance Ca-

pacity (ORAC) method remains relevant. And here’s why: (1) ORAC is an established standard that already plays a valuable role in the dietary supplement and functional food industries; (2) significant improvements have been made to the method; and (3) there appears to be a vital link between ORAC level and bioassay efficacy markers.

The ORAC Method Today Briefly, ORAC was developed as an analytical tool for estimating the antioxidant capacity of substances, with an obvious application to natural products. It was an important advancement in commercially available analysis and has become a de facto standard in the natural products industry. Let’s consider some important facts: • From the beginning, the ORAC method was considered a starting spot—not a definitive endpoint—for comprehensive antioxidant analysis. • The original ORAC method is not a universal standard—it favors certain antioxidant substances over others (e.g., anthocyanins over carotenoids) due to the use of only one free radical source (peroxyl radical), which was chosen initially because it is the most common radical source found in the human body. • There now exists a complementary suite of assays based on a unified ORAC chemistry that broadens the analytical scope of antioxidant testing. This evolution process has resulted in the Total ORAC suite (see Table 1). It expands the ORAC platform to measure antioxidant capacity against five primary reactive oxygen species (commonly referred to as radicals)— peroxyl, hydroxyl, peroxynitrite, superoxide anion and singlet oxygen. While Total ORAC is subject to some of the same limitations as the original ORAC method, it substantially improves broadspectrum antioxidant analysis. It also gives

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Table 1: Total ORAC of Select Benchmarks

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Antioxidant Science

evidence of the diverse antioxidant potential of natural products against radicals other than peroxyl. In some instances this potential may be specialized (e.g., carotenoids vs. singlet oxygen); in other cases, there is balanced antioxidant performance against multiple radicals. Compounds such as resveratrol and standardized ingredients such as green tea extract exhibit significant broad-spectrum antioxidant capacity.

The significance of Total ORAC is that while these primary radicals may all broadly contribute to the same outcomes—oxidative damage and corresponding disease states— they have unique characteristics that need to be addressed. Like position players on a sports team, antioxidant substances have different skill sets. And it is meaningful and valuable to know how antioxidants will perform against different opponents.

Natural Products: Do They Perform? Brunswick Laboratories puts natural products to the test using its cell-based assays. At Brunswick Labs, cell-based assays have been modified to make them applicable to a range of product formats and high-throughput. This represents a fundamental step forward in commercially viable cell-based methods in the natural products industry. A critical feature of the tests is that they address primary wellness factors. Each test uses a specific marker—a measureable biological parameter— to quantify performance. For this study, Brunswick researchers selected three cell-based assays: Cellular Antioxidant Assay (CAA), Cellular Anti-inflammation Assay (NF-kB) and Cellular UVA/UVB protection (UVA/UVB). A central objective of the cell-based testing program is to provide analytical tools for industry that are relevant for a range of products, from pure compounds to consumer products. Brunswick tested several standardized benchmarks with each of the Cardinal Wellness Factors. Samples were selected from each of these categories: reference compounds, extracts and concentrated foods. These included: • Pure compounds: naringenin • Food extracts: cocoa, grape seed • Complete foods: acai, camu camu Here is what Brunswick researchers found (see Table 1). Quercetin was used as positive control in cell-based assays. The quercetin equivalent (QE) was then calculated by reference to the curve established with pure quercetin in those assays. All results are expressed using the QE per gram sample (QE/g). This allows for useful comparison across different product types. Table 1: Cell-Based Assay Results

Note: Camu camu FD powder provided by Amazon Origins, LLC, Naples, FL.

48 • Nutraceuticals World

A New Measure of Performance: ‘Cardinal Wellness Factors’ There has been a steady and justified call for analytical tools that help establish the efficacy of natural products. Industry participants note the structural challenges of conducting full-scale clinical studies to validate product efficacy, which puts even greater impetus on finding reliable and cost

The NF-kB assay demonstrates the sample’s ability to inhibit NFkB, an important transcription factor that adjusts the gene expression for many inflammatory factors. As the results show, NF-kB activity is inhibited by all tested samples at different levels. The cocoa extract has the highest potentiality to inhibit inflammatory factors among these five samples. The CAA assay demonstrates the sample’s ability to reduce cellular free radical levels generated by AAPH (2,2’-azobis-2-methylpropanimidamide dihydrochloride), a water-soluble azo compound that is used extensively as a free radical generator. As shown in the table, all samples demonstrate significance, with the cocoa extract exhibiting the most powerful free radical scavenging activity, followed by grape seed extract and naringenin. The UVA/UVB assay demonstrates the sample’s ability to reduce UVA/UVB-induced free radicals in skin cells. In this assay, a human skin cell line was cultured to confluency, testing compounds, positive controls (antioxidants) and negative controls (vehicles alone) were added to the cells, and cells were then exposed to UVA/UVB light treatment. Free radicals generated upon UVA/UVB irradiation were measured. The decreased amount of free radical generation was calculated and expressed as free radical scavenging activity. Four of the five samples demonstrated significant free radical reduction. Going a step further, Brunswick researchers also saw interesting results when they converted to standard dosages. For example, a standard dose of grape seed extract might be 200 mg, while a standard dose of acai powder might be 5 grams. On a dose-equivalent basis, NF-kB performance then becomes 84 QE/g for grape seed extract and 115 QE/g for camu camu powder. The same “recommended dose” conversion can also be extended to the other assays as well. Conclusions The central message from this study is that natural products in a variety of standardized forms demonstrate significant efficacy against primary wellness factors. This is indicative of the multifaceted anti-aging effects of natural products—in particular, those with a complex matrix of active constituents. Another meaningful result of this study is the broad correlation between Total ORAC and cell-based outcomes. Although preliminary, these results support the view that Total ORAC is a useful tool for suggesting not only antioxidant, but also other important antiaging outcomes.

www.nutraceuticalsworld.com

References furnished upon request.

March 2011

Antioxidant Science

effective solutions. There are at least three valuable applications of commercial-grade efficacy methods. Quality control (QC). There has never been a greater proliferation of natural product ingredients, or a greater range of QC challenges. For example, grape seed extract comes from multiple geographic sources, varies widely in standardized specifications, and defies easy validation. Robust, efficient efficacy tests that address the performance characteristics of grape seed extract samples can provide a new tool to add to other foundational QC benchmarks for suppliers and manufacturers. Product formulation. Companies have built premium ingredients and products around ORAC for the better part of a decade, and have begun to do so with Total ORAC. With a reliable suite of outcome-based efficacy tests, they can begin to do the same thing with anti-aging formulations. Such tests would deliver valuable guidance in the development of condition-specific formulations—with performance results unique to the actual formulation. Consumer education. Consumers continue to seek better information about the natural products they purchase. Cell-based efficacy tests deliver valid pre-clinical test results for actual products that target primary wellness concerns. At present, most products rely upon scientific information that is generic to constituent ingredients. Product- and condition-specific validation benefits consumers and the companies that provide it.

Cell-Based Assays Cell-based assays have been developed to determine product potency, functionality and mode of action of nutraceutical and biopharmaceutical products Live human cell lines are grown in a laboratory environment. These cells are then exposed to certain harmful substances, such as free radicals, ultraviolet light irradiation and inflammatory agents. Other substances (such as antioxidant-containing natural products) are then introduced to see if they protect the cells from these harmful sources of damage. Cell-based assays are well suited to the current industry imperative because: (1) they are well established in research; (2) they are versatile; and (3) they represent a cost-effective pre-clinical alternative to in vivo animal or human testing. As with any assay short of in vivo testing, there are limitations. But if these limitations are recognized and kept in focus, cell-based assays bring companies one NW step closer to in vivo clinical testing. References furnished upon request.

About the authors: Ronald Prior, PhD, is an adjunct professor, Dept. Food Science, University of Arkansas, Fayettevile, AR, and science consultant for Brunswick Laboratories. Boxin Ou, PhD, is the chief science officer at Brunswick Laboratories, Inc. David Bell, MBA, is the president of Bell Advisory Services. Qiuyan Zhao, MD, MBA, is the director of Biology & Immunology at Brunswick Laboratories, Inc. HuiLin Wei, MD, PhD, is a chief scientist at Brunswick Laboratories, Inc. If you have any questions regarding the information or references in this article, contact Mr. Bell at 617-5759822 or [email protected]. March 2011

www.nutraceuticalsworld.com

Nutraceuticals World • 49

Vitality

Is the New Energy

?

Vitality is becoming an attractive health proposition for consumers and a good business opportunity for companies.

By Julian Mellentin Editor New Nutrition Business

The desire for “vitality” is one that commonly surfaces in consumer research. And with many benefit areas—heart, digestive, weight and others—seeming to be increasingly crowded competitive spaces, the “white space” opportunity of vitality appeals to the growing number of food, beverage and supplement companies worldwide, who are appropriating the term “vitality” and using it to position and market new products. “Vitality” has become a promise for several general-nutrition supplements, including one from Nu Skin called AgeLoc Vitality. The concept is also being attached to more food and beverage products. In perhaps the most notable appearance of this attribute in the mainstream market so far, Kraft’s Trident gum brand has just introduced a new line called Vitality that includes vitamin C, white tea and other ingredients.

The Psychology of Vitality Because vitality is a relatively amorphous concept, no one is sure exactly what it means. That’s why vitality positioning represents both an attractive and yet open op50 • Nutraceuticals World

portunity for marketers scratching for growth in a better-for-you arena where few untested propositions remain. “Vitality is a psychological key that says, ‘Live longer; live better,’” said Tom Pirko, president of Bevmark Consulting, a leading strategic, product and branding advisor to global beverage giants. “But we’re early on in this. Mainstream companies are still turning it over to their marketing departments to provide a clearer definition. We’re at the first stage.” In fact, in the case of“vitality,”checking a dictionary isn’t such a bad idea. “Capacity to live and develop” is how the MerriamWebster U.S. Dictionary defines the term. “Physical or mental vigor especially when highly developed.” Yet vitality as an operative concept for food, beverage and supplement businesses means something a little bit different to everyone who is invested in it, as it does to consumers. Here is a sampling of the various ways those in the industry have described vitality to us: “Vitality can mean whatever you want it to mean, which is why it’s a claim that the industry likes.” “Vitality is not an ingredient. It’s an exwww.nutraceuticalsworld.com

perience.” “Vitality is a little part of that puzzle of feeling better. It’s psychological as much as it is biochemical.” “Vitality isn’t the same thing as wellness. Wellness is defined by the lack of any health problems; it’s a broader term.” “Vitality certainly suggests health and wellness in its broadest sense. But more specifically, it suggests energy and, potentially longevity—that you’ll live a healthier lifestyle and less will go wrong if you can grasp vitality.” “Vitality lacks a regulatory definition. There is no measuring stick for it. It’s all based on the reported experiences of the consumer.” “Vitality is more of a marketing thing. And hand in hand, it’s synonymous with health and wellness.” “’Vitality’ is just a new term for ‘energy,’ I think. But the market will tell.”

This article in a nutshell: • The psychology of vitality • Product opportunities & demographics • Who’s already delivering vitality? • The challenges of pursuing vitality

March 2011

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The reasons for greater industry and consumer interest in vitality seem to be threefold. First, the attention to vitality positioning appears to be a reaction against the use of what used to be a synonymous term: “energy.” Many in the industry believe that the growth of the energy drink segment has narrowed the classic definition of energy so that consumers are only capable of thinking of it in the sense of Red Bull or Monster beverages, or 5 Hour Energy shots. And energy drinks are often associated with the “crash” that consumers experience once the stimulants—typically caffeine and taurine—and the sugar rush they provide wear off. “We have a whole rash of what I call energy loan-shark drinks, but people are starting to wise up,” said Dr. Jacob Teitelbaum, author of the book From Fatigued to Fantastic and medical director of the Fibromyalgia and Fatigue Centers, which focus on restoring vitality for chronic-fatigue patients. He also markets a line of vitality-oriented supplements, with profits going to charity. “People are recognizing that these drinks are nutritionally deficient. And they’re getting sicker and sicker and sicker with these drinks, and many are starting to understand that they want healthy energy—they want to feel vitality.” Shawn Talbott, a nutritional biochemist, said, “the challenge for marketers has been finding ways to describe ‘mental-physical energy’ outside of the caffeine-sugar rush of sports drinks and energy shots.” But the Salt Lake Citybased researcher and author prefers to use the term “vigor” to describe what others call “vitality.” “The use of ‘vitality’ in the market is mostly just a new-agey way of saying ‘energy’ and is not really hitting the sweet spot of vigor that is lacking in so many people,” said Mr. Talbott, who has written a book about the vigor concept. Second, the concept of vitality is increasingly important to Baby Boomers, whose leading edge is now beginning to reach the conventional retirement age of www.nutraceuticalsworld.com

65. As a generation, especially in the U.S., Baby Boomers have defined and redefined every cultural, medical and social institution as they have matured and aged. There is every reason to believe their quest for vitality—whether they define it that way or not—will shape much of the direction of the better-for-you market during the next several years.“If you’re a senior citizen, you think about vitality more than anything else,” quipped Mr. Pirko, himself a member of the leading edge of Baby Boomers.“If not, you’re dead.” But the desire for vitality isn’t restricted to those 45-and-older. “When people talked about vitality, it used to be imagining older people who were trying to get back their youth,” said Rachel Geller, chief strategic officer of Geppetto Group, a New York-based strategic-marketing agency. “But now, vitality also has been embraced by young people as a feeling of balance and that all four spheres of the individual—emotional, physical, intellectual and spiritual—are being helped from the inside out.” Third, there is a sense that vitality is a tonic for many Westerners of all ages who have been beaten down by the global recession and its aftermath. “Consumers are reacting to the combination of things affecting them right now,” Mr. Pirko explained.“In the pelting that they’re getting from these other things, they’re searching for ideas and concepts for feeling better, and vitality is one of them.”

Who’s Already Delivering Vitality? The supplement industry is experimenting with a wide range of ingredient combinations in a quest to deliver a credible vitality benefit. Provo, UT-based Nu Skin has embraced the vitality concept in a new supplement product called AgeLoc Vitality, which is geared toward improving what the company calls “the three dimensions of vitality: physical vigor, mental acuity and sexual health.” It’s meant to be the “uncola” by contrast with energy drinks, according to Kevin Fuller, vice president of global marketing for the multi-level marketing firm. March 2011

Vitality

According to Nu Skin, AgeLoc improves the function of the body’s mitochondria, which represent a key source of vitality.

Instead, AgeLoc Vitality battles “the low-energy, sluggish feeling” experienced by aging individuals by repairing what the company calls “youth gene clusters” that are related to the aging process. AgeLoc does so by improving the function of the body’s mitochondria, the “digestive system” of the cell that takes in nutrients, breaks them down and distributes them as energy. Nu Skin calls mitochondria “a key source of youthful vitality.” AgeLoc Vitality contains several key ingredients, including extracts of pomegranate and Asian ginseng as well as Cordyceps Cs-4 mushroom mycelia. Nu Skin says that initial findings from a survey found that 90% of consumers who tried AgeLoc Vitality “felt positive changes in fatigue levels while taking it or noticed an increase in fatigue after discontinuing use.” Research informed Nu Skin about each of the ways in which a new supplement could address consumer desires about restoration of vitality. “We found there was basically a disconnect between what people thought was available to them and what their needs actually were,”Mr. Fuller explained. “They’re familiar with stimulants to overcome simple fatigue. But what they’re experiencing is more than just simple fatigue, and so they were dissatisfied with the side effects of simple stimulants.” Individuals “don’t want to be spun up and agitated in the way that caffeine can make you feel,”Mr. Fuller added.“But they do aspire to have a baseline energy level that goes up, like a tide rises—instead of peaks and valleys.” Decline of mental acuity is “another strong fear that people have” as they age, Mr. Fuller pointed out.“Many of them are professionals who are concerned about 54 • Nutraceuticals World

performance in the workplace. And, third, consumers were interested in a product that conferred ‘sexual benefits’ such as increasing libido and desire—not necessarily functional benefits.” Interestingly, he offered, Nu Skin found a commonality in these desires among aging consumers in its markets worldwide; the company generates only 17% of its sales in the U.S. “The only significant difference in how consumers in various markets perceived the benefits,”Mr. Fuller noted, “is a greater focus in some Asian markets on sexual vitality. This tends to get more play in Asia, and they tend to be more comfortable talking about it.” Mr. Fuller said Nu Skin does produce drinks, such as a superfruit-based beverage, but that it chose a capsule form of delivery for AgeLoc Vitality.“Putting it in a ready-to-drink liquid would have pushed people to compare it with energy products, which we didn’t think would be advantageous to us.” Moreover, including efficacious amounts of the active ingredients required concentrations that would have prohibited a drink from tasting good, he says. And because the effects of AgeLoc Vitality take up to a month to manifest themselves in the body, Nu Skin wanted to contrast the product with the “immediate effects”expected from an energy drink. Nu Skin developed a mix-in powder variety for AgeLoc Vitality, he added,“but in the end, focus groups of consumers didn’t see the benefits of having a mix-in versus a capsule.” Another supplement brand, Genr8, is partially adopting vitality positioning for its Vitargo S2 supplement, a patented starch extract marketed by the Dana Point, CA-based performance-nutrition company. But Genr8 does so only in the limited context of “use for intensely training individuals,” explained Anthony Almada, president and CEO. Trident seems to be hedging its bets similarly with its own use of vitality positioning. It’s true that, with its new Vitality brand, Trident is stepping over a line that most confectionery brands have drawn between gum products and truly nutritionally functional ingredients. Most“better-for-you” gums at this point stick with www.nutraceuticalsworld.com

relatively conventional functionality, such as fighting the bacteria that cause bad breath, and don’t deliver ingredients that form the basis of true nutrition, such as vitamins or herbs. And Trident is touting Vitality as a “delicious piece of well-being,” boasting that one piece contains“10 percent of the daily value of vitamin C,” and includes one flavor, a Citrus-Strawberry blend called Vigorate. Other varieties include Rejuve, a blend of mint and white tea, as well as Awaken, with Peppermint flavor and “a dash of ginseng.” The pellet-sized pieces of gum also come in a box that “clicks” when opened or closed and is aimed at a slightly older demographic than most new gum products. “One thing we found is that, as people age, the gum flavors may be less relevant to their lifestyle,” said Kraft spokesman Basil Maglaris. “This is an opportunity that we saw [to be] relevant with consumers in the 25-to-34 age range.” Yet, while Kraft is attempting to appropriate the emotional meanings of vitality in the new Trident line and to leverage its unprecedented plunge into better-for-you ingredients, its vitality positioning really only lies on the surface and doesn’t appear as important to marketing the product as the line’s unconventional flavors. Vitality’s message will focus “more on the experience associated with the gum,” Mr. Maglaris said, in part because only one flavor has vitamin C. In fact, Trident’s real target with Vitality appears to be Wrigley’s new gum line called 5, which is sold in slick, black-colored packs in flavors such as React, Zing and Flare. And in its hesitance to go too far down the road of vitality positioning, Kraft may be learning from the challenges that other consumer goods companies have encountered. In 2006, Vindi Banga, the then-president of Unilever Foods, announced at a major corporate meeting in Barcelona, Spain that Unilever would be deploying a business platform called the Vitality Life Goals Model. “More than ever, people are looking for real solutions to achieve their goals in life,” he told the gathering. “Next to a healthy diet and good hygiene, we see that emoMarch 2011

Vitality

Vitality has been embraced by young people as a feeling of balance and that all four spheres of the individual—emotional, physical, intellectual and spiritual—are being helped from the inside out.

tional well-being is an important contributor to a long and healthier life. The Vitality Life Goals really tap into the fundamental requirements of people, and we can identify opportunities right across our portfolio of brands that truly deliver holistic vitality solutions helping people look good, feel good and get more out of life.” Fellow Unilever executive Ralph Kugler, president for home and personal care, said that Unilever would spend the majority of its $1 billion annual research budget on“vitality-driven innovation”and that 60% of the food innovations already in the Unilever pipeline at that time were “vitality-related.” Yet, these executives never really explained exactly what they meant by “vitality” nor connected it solidly to any practical vision of how the idea could become so central to the company’s activities. 56 • Nutraceuticals World

The Challenges of Pursuing Vitality Five years later, vitality has disappeared from Unilever’s strategy—and it’s difficult even to locate a historical discussion of vitality on Unilever’s website. It’s possible that Unilever simply experienced one of the obvious limits of vitality positioning that is on the flipside of one of its biggest advantages: its vagueness. “Look at the 2-oz. shot market and at the new products you’re seeing: condition-specific products for recovering, relaxing, sleeping—lots of conditions,” said Andy Dratt, executive vice president of Imbibe, a Wilmette, IL-based formulator of private-label, better-for-you beverages for major retailers. “So far we’re not seeing lots and lots of vitality-themed products primarily because the industry is trying to deliver products www.nutraceuticalsworld.com

that are benefit-oriented, and they do best when they’re well-defined—so that the consumer knows exactly what the product will deliver.” And if any food, beverage or supplement manufacturer should seek to get more precise about rendering vitality in some kind of nutritional formula, they would face different kinds of challenges. “It would be very difficult to do, to just put ‘vitality’ in a bottle,” said Ram Chaudhari, chief scientific officer and senior executive vice president of Fortitech, the Schenectady, NY-based firm that helps ingredient and food companies develop better-for-you products.“You’d have to have so many nutrients—proteins, carbohydrates, omega 3s, co-factors and bioactive compounds—in order to get maximum benefits. And then you’d have to get them all working optimally together.” Mr. Chaudhari continued: “Multivitamins are fine; they’re part of vitality—but only a subcategory. They don’t equate to vitality. “There are 60 to 70 bioactive compounds you need for overall vitality, and it would be impossible to put them into one [product]. Plus, then you have the issue of bioavailability, and you’d have so many interactions among all of these things that you can’t even imagine them.” Such difficulties, Mr. Chaudhari explained, are why few companies are beating down Fortitech’s door to come up with a single, comprehensive answer to the vitality challenge—and opportunity. And the comprehensiveness of the nutrients that are required for humans to feel completely vital is one big reason that“you have to have a variety of foods, not just one beverage or food,” Mr. Chaudhari pointed out. “You can’t change your whole health condition with just one thing. It isn’t going NW to happen.”

About the author: Julian Mellentin is an expert on the business of functional foods and has been involved in this area for more than 15 years. Mr. Mellentin is also the editor of New Nutrition Business, a long-established international journal on the global nutrition business. He can be reached at [email protected]; Website: www.new-nutrition.com. March 2011

Functional

Confectionery: Finding the Sweet Spot

Is there a place for healthiness in the indulgent world of candy, chocolate and gum? By Sean Moloughney Associate Editor

Consumers have a serious sweet tooth. Candy has practically become a staple of the U.S. diet, as candy and gum ranked fourth among 2009 food category sales in Food, Drug and Mass channels, behind carbonated beverages, milk and salty snacks—ahead of cereal—according to SymphonyIRI data. Per capita, the average U.S. consumer spent $93 on confectionery products in 2008, according to the U.S. Department of Commerce. The U.S. confectionery category as a whole generated about $29 billion in retail sales in 2009, representing nearly 4% growth over the previous year, according to the National Confectioners Association (NCA), Washington, D.C. Chocolate candy represented approximately 58% of total confectionery sales, or $17 billion, while gum accounted for $3 billion. NCA estimated the global confectionery market at about $150 billion. An obsession with sweets, alongside a seemingly antithetical focus on health and wellness, has led to the evolution of the functional confectionery category, which Euromonitor International segments into 58 • Nutraceuticals World

three markets: medicated confectionery, fortified/functional gum and fortified/functional chocolate. Globally, these three categories accounted for more than $11 billion in retail sales in 2010, growing 3% over the previous year, the market researcher claims. Functional/fortified gum represents 53% market share, while medicated confectionery comprises 45% and functional chocolate makes up the remaining 2%. “Between 2005 and 2009 the whole category increased by 19% and we expect it to grow by 16% through 2014,” said Ewa Hudson, head of health and wellness research at Euromonitor.“That is more or less similar growth to what has happened in the past.” Led by brands like Halls and Ricola, most medicated confectionery products are positioned as cough suppressants and are designed to deal with upper respiratory conditions and immune support. Ms. Hudson predicted the share of medicated confectionery would decrease slightly in favor of functional gum and chocolate. Asia-Pacific is the largest market overall with sales of more than $4 billion. This rewww.nutraceuticalsworld.com

gion also represents about half of the world’s functional chocolate sales. Western Europe ($4 billion) and North America ($1 billion) are the next largest functional confectionery markets. However, Ms. Hudson predicted Latin America and Eastern Europe would see the fastest growth (25%), followed by Asia (20%) alongside slower growth in Western Europe (10%) and North America (5%) through 2015.

Market Drivers Consumers no longer dismiss the notion that candy can offer health benefits, according to Tom Vierhile, director of Datamonitor’s Product Launch Analytics.“A lot of the credit for that should go to the chocolate category, where dark chocolate

This article in a nutshell: • Market drivers • Stick with gum • Chocolate’s recipe for success • ‘Super’ value added?

March 2011

Functional Confectionery

Sales of sugar-free gum grew more than credible energy boost for those who lead products (especially products with high cacao contents) have helped hammer 7% in 2009, according to NCA. “Examples active and exhausting lifestyles—from athhome this point the last few years,”he said. of fortified uses in gum include energy letes to rock stars.” According to Datamonitor’s Product “Press reports supporting the concept that boost, smoking cessation, breath freshendark chocolate can be ‘good for you’ have ing, tooth whitening and calcium fortifica- Launch Analytics, the percentage of new gum products launched in the U.S. that tion,” said NCA’s Ms. Ellek. also helped.” Recently, Kraft’s Cadbury North America claim to be “high” in a particular nutrient, Also propelling market growth, younger consumers are increasingly turning to quick subsidiary, Parsippany, NJ, launched Trident grew from less than 4% in 2009 to nearly and convenient functional foods as a Vitality, an energy-boosting gum available 12% in 2010.“The chewing gum category means of dealing with day-to-day issues in three varieties: Vigorate, Rejuve and is beginning to see an influx of new items, Awaken. Vigorate gum contains a“burst”of including high profile launches like Stride like stress and lack of energy, he added. “Affordable indulgence woven into a citrus and strawberry with 10% of the Daily Spark and Trident Vitality, introductions healthy treat—that’s the power of func- Value of vitamin C. Rejuve gum contains that take a Vitaminwater-like approach to tional confectionery products,” said Jenn mint and white tea, and Awaken contains introducing health benefits to the chewEllek, director of trade communications and peppermint and ginseng. Cadbury has also ing gum category,” said Datamonitor’s Mr. Vierhile. marketing, NCA. “As Moving forward with consumers become inits commitment to the creasingly health-conmedical and functional scious, the development foods market, in Februof better-for-you items ary, Nestle acquired has become an imporCM&D Pharma Limtant factor for manufacited, which makes Fosturers. They also realize trap, a chitosan-fortified that candy is a small chewing gum designed pleasure that consumers to treat hyperphoswill indulge in whether phatemia by binding to it is functional or not. At phosphorus in the the end of the day, they saliva, thus reducing the want something that total phosphate load in tastes good.” the gastrointestinal (GI) Ms. Ellek said new tract, according to the products continue to company. Fostrap chewdrive the confectionery ing gum does not recategory overall, noting lease either the that those released in chitosan, or the chithe last two years actosan-phosphorus comcount for 30% of sales. plex, into the GI tract “So when we’re thinkand thus does not intering of functional prodProducts launched in the last two years account for 30% of confectionery sales. fere with the absorption ucts, manufacturers know—despite the economy and proven introduced Stride Spark Sugarfree Gum, of other medications. Jennifer Jackson-Luth, senior manager, brands—they need to deliver new products which is now available to U.S. consumers to the consumers because that’s really what in two varieties: Kinetic Mint and Kinetic Marketing Communications, Wm. Wrigley drives this category.” Fruit. This gum contains B6 and B12 vita- Jr. Co., Chicago, IL, said Wrigley is continmins, while claiming to contain 30% fewer ually testing functional ingredients in its gums. “Our number one priority is ensurcalories than sugared gum. New Rockstar Sugar Free Energy Gum, ing great taste and a quality product. TechStick with Gum Growing in popularity among con- from Rockstar, Inc., has also hit stores in the nology is getting there, but we think there sumers and product manufacturers, func- U.S. and Canada. Iced Mint and Iced Or- are improvements to be made on taste and tional gums represent one of the most ange flavors contain 80 mg of caffeine per quality. We’re not interested in introducing promising product areas. Xylitol and bak- serving (two pieces). The label states: “Caf- a new product unless we are confident in ing soda are among the most common in- feine - B-vitamins - Taurine - One pack its ability to be sustainable.” According to Ms. Jackson-Luth, the gredients in these gums, which are equals 5, 8 oz. energy drinks.”Company litdesigned to offer oral health benefits, said erature also states,“Rockstar energy gum is company has supported clinical research scientifically formulated to provide an in- via the Wrigley Science Institute to back the Euromonitor’s Ms. Hudson. 60 • Nutraceuticals World

www.nutraceuticalsworld.com

March 2011

Functional Confectionery

oral health benefits of chewing sugar-free gum for more than 25 years. “Today Wrigley is furthering research about how gum can help manage weight, help reduce situational stress and increase focus, alertness and concentration.” Interest in functional gums has resulted in part from scientific evidence documenting the efficacy of chewing gum as a delivery system, according to Thomas Jahn, business development, Denmark-based Gumlink Nutraceuticals.“Various active ingredients (in gums) are backed by studies exhibiting an equal bioavailability to pills/capsules, and in some cases a faster one at that,” he said. Mr. Jahn also noted that functional confectionery products are typically positioned on specific health platforms. For example, gummies fortified with multivitamins are doing well in the children’s health market, chocolate is mainly formulated with antioxidants and gum is mostly used for energy or oral care applications.“At Gumlink, we have—with our dual-layered compressed gum—developed around 15 concepts targeting practically all major application areas, since we see chewing gum as a no-brainer for a lot of these categories. As soon as chewing gum becomes more and more accepted as a delivery system this category will start to lift off.” Concepts include immune defense, weight management, joint health, heart health and energy. According to the company,“Oral care will see an enhanced focus during 2011 as Gumlink, in collaboration with strong partners, will be able to market concepts with a pharmaceutical touch such as chlorhexidine, oral care probiotics, antacids and also a new concept that in terms of efficacy comes quite close to matching the good old toothbrush.” Ms. Hudson also noted the potential of probiotics in the oral care market, particularly in the U.S. and Asia. However, manufacturers in the EU have been hesitant to launch new products or make claims on existing ones due to an unfavorable regulatory environment.“I think a number of manufacturers are a little bit skeptical right now and would prefer to wait and see what happens before they make any claims on their products,” she said. Another barrier for probiotic products has been a higher price point. “The price doesn’t justify the cost of the ingredient alone,” said Ms. Hudson. Still, if probiotic gum and mints attain massmarket appeal it could significantly boost sales of the whole category, she added.

Chocolate’s Recipe for Success Delivering health benefits alongside exceptional taste has been a recipe for success in the functional foods market. Chocolate offers a unique opportunity to provide that profitable combination. Laura Bergan, marketing manager for the food manufacturing division of Barry Callebaut, Americas region, said the company has been “looking at ways to re-invent chocolate through innovative research and development initiatives designed to harness the healthy components of cocoa and preserve them in new chocolate products.” Chocolate is a natural vehicle for health due to its naturally occurring cocoa flavonols, she added.“Dark chocolate is growing at March 2011

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Nutraceuticals World • 61

Functional Confectionery

a higher rate than milk chocolate products because consumers have learned there are higher flavonol levels in dark than milk.” According to NCA, dark chocolate sales increased 9% in 2009 and will continue to grow, but at a slower pace than in previous years. According to Barry Callebaut, its Acticoa preserves a maximum amount of the cocoa flavonols that occur naturally in the cocoa bean. “These cocoa flavonols are powerful components and may have a positive effect on both the body and mind,” said Ms. Bergan. “Recent studies conducted in Europe have suggested that the dietary consumption of cocoa flavonols plays a potentially important role in supporting our health and well-being.” The company claims regular consumption of the cocoa flavonols found in Acticoa can help strengthen the body’s natural resistance to environmental stressors; maintain cardiovascular health, including helping to maintain blood pressure, blood circulation and cholesterol at healthy levels; help maintain skin health, including increased skin elasticity and hydration as well as protection from the harmful effects of ultraviolet (UV) radiation caused by regular exposure to the sun. Capitalizing on dark chocolate’s antioxidant benefits for skin health, Frutels LLC offers its signature confectionery product intended to fight acne. Originally designed as a gummy candy to offer clear skin from the inside out, the company has now blended its nutritional vitamin formula with dark chocolate. The Frutels formula contains vitamins C and E, a full-spectrum vitamin B complex, zinc, choline and inositol, biotin and folic acid. Companies are also adding protein and fiber to chocolate in order to satisfy consumer cravings for healthier products. For example, Mars’ Snickers brand launched its Marathon Protein Bar in October 2010. Caramel Nut Rush (20 grams of protein) and Chocolatey Nut Burst (21 grams of protein) are both an “excellent source” of fiber (10 grams) and are low glycemic (index is 26).

‘Super’ Value Added? Looking to add value to their confec62 • Nutraceuticals World

tionery products, many companies have started using real fruit or fruit juice ingredients as well as trendy superfruits. For example, Jelly Belly Superfruit Mix Jelly Beans feature Acai Berry, Barbados Cherry, Cranberry, Blueberry and Pomegranate flavors. According to the company, the products are “naturally sweetened” with evaporated cane juice and tapioca syrup and are an “excellent source” of vitamin C. The product is fat-free, gluten-free and each jellybean contains 4 calories. Wrigley’s Ms. Jackson-Luth said fruit flavors have been a key contributor to gum and candy growth. “Wrigley continues to introduce new flavors and innovations to leverage this trend and delight consumers.” The company also recently rolled out Extra Dessert Delights, which contain 5 calories per stick of gum and offer consumers a “simple tool to avoid snack cravings.” Some experts also view chocolate as an underappreciated superfruit. Recent research conducted by scientists at the Hershey Center for Health & Nutrition—published in the Chemistry Central Journal in February—concluded that cocoa powder and dark chocolate had equivalent or significantly greater ORAC, total polyphenol content (TP) and total flavonol content (TF) values compared to other fruit powders and juices tested, such as blueberry, cranberry and pomegranate. Various fruit powders and retail fruit products were obtained and analyzed for antioxidant capacity. Among the various powders that were tested, cocoa powder was the most concentrated source of ORAC and TF, according to researchers. Similarly, dark chocolate was a significantly more concentrated source of ORAC and TF than the fruit juices, the study concluded. While a high antioxidant content serves chocolate well, its high calorie and fat content has been an obstacle in the functional food market. As manufacturers look to minimize unhealthiness in their products, alternative plant-based sweeteners are gaining importance. According to Curtis Vreeland, principal of the confectionery market research firm Vreeland & Associates, agave nectar is a versatile sweetener with a low glycemic index and intense sweetness.“Agave can be www.nutraceuticalsworld.com

used in a broad spectrum of confectionery applications, including energy bars and endurance gels. It joins tapioca, rice syrup and barley syrup as popular plant-based sweeteners. Stevia has also become quite accepted as a plant-based sweetener.” In terms of functional ingredients, chia seeds are popping up in more confectionery applications, according to Mr. Vreeland.“Not only are chia seeds a better source of omega 3 fatty acids than flaxseed, a popular plant-based alternative, they can be stored longer without becoming rancid,” he said. Cleveland, OH-based Fantasy Candies incorporates chia into some of its SweetDreams72 bars. According to owner/chocolatier Joel Fink, “the addition of chia seeds, fruits, nuts and spices allows us to replace by 25% the amount of chocolate in our bars, thus reducing their sugar and saturated fat content.” “Over the years scientists have discovered that chocolate is naturally packed with many healthy properties,”said Mr. Vreeland. Xan Confections, Irvine, CA, has taken chocolate’s good-for-you benefits, fortified them, and categorized them into five functional platforms under the CocoXan brand: Coco Heart (with antioxidants), Coco Well (with Wellmune WGP), Coco Brain (with vitamins and DHA), Coco Preggers (with folic acid and DHA omega 3 for new and soon-to-be mothers) and Coco PMS (with antioxidants and anti-inflammatory ingredients, sold under the tagline “Un-Bitch Yourself”). As the functional confectionery market evolves further, Datamonitor’s Mr. Vierhile predicted more “healthy lifestyle-oriented launches”rather than those geared toward tackling specific and more complex medical issues like high cholesterol, heart disease and joint pain. Confectionery is, first and foremost, an indulgence, he added. “Consumers are not necessarily oriented toward seeking out products that aid chronic health issues in this market. A safer bet going forward would be softer attempts to communicate functional benefits to consumers without getting too medical or claim-oriented. I suspect this means more of a focus on issues like energy and relaxation, versus addressNW ing chronic disease symptoms.” March 2011

NEW DATE:

June 28-30, 2011 Jacob K. Javits Convention Center New York, NY www.hbaexpo.com

Where Beauty

Meets Business

To reserve your exhibit space, contact your sales representative today. Ellen Evers, SENIOR ACCOUNT EXECUTIVE [email protected] 201.788.0352 Kevin Roach, ACCOUNT EXECUTIVE [email protected] 609.759.7607 Emanuela Treneva, INTERNATIONAL SALES DIRECTOR [email protected] +33 (0) 1 73 28 14 76

How Should

‘Bioactives’ Be Studied?

By Andrew Shao, PhD Senior Vice President, Scientific & Regulatory Affairs The Council for Responsible Nutrition (CRN)

The conversation among researchers in the scientific community about studying bioactives has started, and industry needs to be part of those discussions. Editor’s Note: The following article was submitted on behalf of CRN. As of press time, Dr. Shao is no longer with CRN, and is currently employed by Herbalife Ltd. One of the roles of the public health scientist is to look forward, to identify gaps that need to be addressed in the scientific literature, and to question the scientific framework used to establish or inform policy decisions. As a scientist in the nutrition community, it is my job to seek approaches to establish the health benefits of bioactive food components, and investigate ways that industry can create products that provide value for consumers. There’s been a brewing dialogue in the nutrition science community during the past several years about whether the current framework applied to studying the effects of essential nutrients is the most appropriate. This dialogue needs to continue, but it’s time to add another layer to the conversation, one that both the dietary supplement and functional food industries must consider, both for their own growth and for the benefit of those who use these products.

Moving Beyond Evidence Based Medicine (EBM) Consider this: For nutrients such as vi64 • Nutraceuticals World

tamin D, vitamin C and calcium, standardsetting bodies and policymakers recognize their essentiality in the diet—and have established a systematic, but perhaps not necessarily the most appropriate, way of studying them and interpreting the evidence. This has allowed for a means to incorporate essential nutrients into a broad scientific framework for nutrition policy to inform policy decisions—from recommended intake levels, to Tolerable Upper Intake Levels (ULs), to their recognition in the official Dietary Guidelines for Americans. This systematic approach to studying nutrients is also the underpinning of FDA-approved health claims. The approach, most recently articulated in the Institute of Medicine’s (IOM) Dietary Reference Intake (DRI) report for calcium and vitamin D, relies almost exclusively on the randomized, controlled trial (RCT) as the scientific basis for informing nutrition policy decisions. While the appropriateness of this framework itself has generated substantial controversy in the nutrition science community, if we dare to peek beyond essential nutrients, there is an additional gaping hole, the Grand Canyon of nutrition, one which our industry must consider filling. As our understanding continues to evolve www.nutraceuticalsworld.com

about the role of nutrition in disease prevention and health promotion, we must look not just to essential nutrients, but also to non-essential nutrients, including bioactives such as isoflavones, flavonols, carotenoids and anthocyanidins. Unlike for past generations, whose public health and nutrition policymakers dealt with diseases and conditions of deficiency, our health challenges today center around conditions of excess—excess calories, excess sedentary lifestyle, excess stress, and so on. Thus, optimizing health is no longer solely about avoiding diseases of overt nutrient deficiency, such as rickets and scurvy. Bioactives are food components that are present in the diet and believed to provide health benefits, particularly for certain populations, but lack an established, widely recognized research framework that would enable scientific bodies like the IOM to establish recommended intakes. Would the DRI framework be the appropriate avenue for these nutrients? And if not, what other

This article in a nutshell: • Moving beyond evidence based medicine (EBM) • Serving the greater good

March 2011

Studying Bioactives

scientific approach should be applied to inform broad recommendations for bioactive intake levels? In other words, without DRIs and the accompanying accepted methods that legitimize essential nutrients, how can bioactives ever be taken seriously by policymakers and have the chance to impact consumers’ health? Let’s take a step back. Bioactives are not considered“essential”nutrients in the traditional sense, because they are not required for the body to function, (i.e., their absence does not produce disease); they are, however, sometimes referred to as“conditionally essential”—especially for specific populations under certain circumstances. For example, there are evidence-supporting benefits associated with lutein for eye health and isoflavones for bone health. However, while little is known about how certain bioactives behave in the body, it is also undoubtedly true that humans have been exposed to them through the diet for millennia, and that we have possibly evolved to a point where we are physiologically dependent on certain bioactive compounds in order to function optimally in our environment. Research suggests there is an inverse relationship between these and other bioactives and chronic disease risk. But if they are not essential nutrients, nor are they drugs, what scientific framework should be applied to help scientific policymakers to accurately and adequately incorporate them into broad-based policy recommendations? As with the essential nutrients, for bioactives the key to unlocking the policy door is research. The most appropriate way to study nutrients in humans is itself a topic of debate in the scientific community and the discussion is still in its infancy. But more and more nutrition scientists are agreeing that the traditional drug-like model—evidencebased medicine (EBM)—is not the most appropriate way to study nutrients. Since nutrients and drugs behave so differently, it is clear that we must shift the paradigm from an EBM to an evidence-based nutrition (EBN) framework that takes into account the unique homeostatic properties and nuances of essential nutrients and appropriately balances risk and benefit. While an EBM paradigm and its heavy reliance on RCTs is frequently applied to nutrients because an EBN framework has yet to be defined, this March 2011

approach does not take into account how essential nutrients behave in the body, the complex nutrient networks involved and their subtle effects over time, as opposed to how drugs work, usually in isolation and with acute and powerful action. The question for bioactives is, where do they fall in that equation? One important element of a hypothetical framework for studying bioactives is that RCT data should not be considered the only accepted form of evidence nor necessarily the gold standard, but instead should be incorporated into the framework in some capacity, resulting in a framework which considers the totality of the available evidence and allows for other types of research that would better lend itself to assessing how nutrients—essential or not—actually work. It is important to understand and recognize the limitations of RCTs in studying nutrients for disease prevention and health promotion, including huge cost and feasibility issues. For example, studying prevention (or disease risk reduction) where no one has the disease at outset costs orders of magnitude more than studying treatment where all subjects have the disease at outset. In this case, both a larger sample size and longer duration are needed. Add to this the subtle effect that most nutrients exert on the body, which in turn increases the number of subjects needed and duration of the study. Large (tens of thousands) and long-term (years) RCTs present logistical challenges that make them extremely difficult and costly to carry out, even impossible in some cases. Thus the hierarchy approach, whereby RCTs stand at the top of the research pyramid, and are considered the only acceptable standard is most troubling. And while bioactives may fall into a gray zone, it is clear that they behave more like essential nutrients than drugs. But back specifically to bioactives. The IOM uses a rigorous—some might say limiting—process to establish DRIs, which comprise the Estimated Average Requirement (EARs), Recommended Dietary Allowance (RDAs) and the UL. The process used is one in which a scientific committee evaluates generally the same restrictive portion of the full body of science, omitting that research which does not meet the committee’s gold standards (i.e., EBM). However, at www.nutraceuticalsworld.com

least essential nutrients are on the playing field, with government entities recognizing their potential inherent value. But bioactives, unless we as an industry act, may not stand a chance of getting in the game.

Serving the Greater Good There is a selfish interest here for our industry, as well as an interest for the greater good. If we truly believe bioactives provide important health benefits for consumers— and I for one do—then we owe it to our industry and to consumers to take this issue seriously. For companies, the lack of an established and accepted scientific framework to study and evaluate the evidence on bioactives should be a bit concerning. Companies operating in this space need to look beyond their own product portfolios and at the broader picture. Industry should think about what an established framework for studying bioactives could do for the overall market. For instance, if the potential benefits of bioactives were even more widely accepted—and that will only happen with greater acceptance of a broader type of research framework coupled with more financial support—and even more benefits demonstrated, the market for this large category of products would have the potential to grow exponentially. Right now, ingredient suppliers manufacturing bioactives often conduct their own studies on their products in an effort to support product claims. But we need to think bigger. Having widely recognized policy shaped around the bioactives category would further establish credibility, and would have much broader—and more positive—implications for the entire industry. Until policy is developed, companies in the bioactives market will only have a finite piece of the market, a piece that will shrink over time as competitors enter the arena. However, if we can help develop a recognized way to study bioactives and assess their impact on the body, we will have the opportunity to grow the entire pie, thus providing more opportunity for individual companies to increase their reach. If a bioactive or a non-essential nutrient were to be supported by the right research, making DRIs (or some equivalent) a possibility, the world could Nutraceuticals World • 65

Studying Bioactives

open up for the bioactives marketplace in ways industry might not yet think possible. So as an industry, we have several steps to take. First, we need to continue the work we’ve started on shifting from an EBM research model to an EBN research model— and we must be thinking beyond essential nutrients. With acceptance of the right research framework, we can start the next step—supporting more research. Compa-

nies need to think outside of their own selfinterest, and help support grander research for the entire category. Only in this way will we be able to have a broader impact on public policy. In other words, individual companies can continue to support small studies that serve to allow them to market competitively their ingredients to manufacturers— or we can pool resources to support research that would open up the possibility of bioac-

Save the Date! CRN is sponsoring a symposium at the American Society of Nutrition’s (ASN) annual meeting at the Experimental Biology (EB) conference in April in Washington, D.C. At this meeting, scientists, including David Heber, UCLA; John Erdman, University of Illinois; Connie Weaver, Purdue University; Elizabeth Johnson, Tufts University; and Paul Coates, the Office of Dietary Supplements, will participate in a panel on establishing a scientific framework to assess the impact of bioactives on humans. If you’re attending EB, you must consider attending this symposium. And if you haven’t yet decided to attend EB, if you’re in the bioactives market, this will be an important presentation for you. For more information, contact CRN at 202-204-7700 or www.crnusa.org.

tives being accepted for consideration in a larger stadium—the one where the IOM, National Institutes of Health (NIH), U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) play—to establish public policy and broadbased recommendations for consumers. The conversation among researchers in the scientific community about studying bioactives has started, and industry needs to be part of those discussions. But the industry needs to look at that big picture and work cooperatively to increase the visibility and acceptance of bioactives as having a real role in optimizing nutrition and health. For manufacturers, marketers and distributors of bioactive products, elevating the category is vital to achieving a higher level of success. Banding together with your competitors, attending tradeshows and panels on the topic and brainstorming with others in the industry on ways to move the category forward are imperative for growing the market. NW References furnished upon request.

66 • Nutraceuticals World

www.nutraceuticalsworld.com

March 2011

&

11th Annual Manufacturing Supplement

TABLE OF CONTENTS

& 11th Annual Manufacturing Supplement S-4 • Solid Dose Manufacturing Differentiating through technologies to handle new markets by Gil Roth

S-20 • Spray-Drying for Increased Solubility New options from a time-tested method by Dean Ross

S-12 • Nutraceutical Contract Manufacturing Increased demand for higher processing standards and certified production capabilities by Joanna Cosgrove

S-24 • Beyond GRAS Are your starting materials at risk? by Michael Baumann S-30 • PharmaSourcing & Services Preview Find out who’s exhibiting at this Interphex pavilion! Photo of Glatt GC Smart® Pan Coating System courtesy of Glatt Pharmaceutical Services

Advertisers Index Company

Page

Phone

Fax

Website

ADH Health Products Inc. . . . . . . . . . . . .S-18 . . . . . . . .845-268-0027 . . . . . . .845-268-2988 . . . . . . . . . . . . . .www.adhhealth.com Aphena . . . . . . . . . . . . . . . . . . . . . . . . . . . . .S-9 . . . . . . . .866-465-4506 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .www.aphenapharma.com Bosch/TL Systems . . . . . . . . . . . . . . . . . . . .S-7 . . . . . . . .763-424-4700 . . . . . . .763-493-6776 . . . . . . . . .www.boschpharma-us.com Cherokee Pharmaceuticals . . . . . . . . . . . . .S-3 . . . . . . . .570-275-2220 . . . . . . .570-271-2121 . . . . . . . .www.cherokee-pharma.com Consumer Product Testing Company . . . .S-17 . . . . . . . .973-808-7111 . . . . . . .973-244-7507 . . . . . . . . . . . . . . . .www.cptclabs.com Federal Equipment Co. . . . . . . . . . . . . . . .S-21 . . . . . . . .800-652-2466 . . . . . . .216-271-5210 . . . . . . . . . . . . . . .www.fedequip.com Glatt Pharmaceutical Services . . . . . . . . . . .S-5 . . . . . . . .201-825-8700 . . . . . . .201-818-5582 . . . . . .www.glattpharmaceuticals.com Globepharma . . . . . . . . . . . . . . . . . . . . . . . .S-6 . . . . . . . .732-296-9700 . . . . . . .732-296-9898 . . . . . . . . . . . .www.globepharma.com GMP Laboratories . . . . . . . . . . . . . . . . . . .S-13 . . . . . . . .714-630-2467 . . . . . . .714-237-1374 . . . . . . . . . . . . . . . .www.gmplabs.com Halo Pharmaceutical, Inc. . . . . . . . . . . . . . .S-11 . . . . . . . .973-428-4087 . . . . . . .973-428-4017 . . . . . . . . . . . . .www.halopharma.com Kleen Test Products Corp. . . . . . . . . . . . . .S-25 . . . . . . . .262-268-4747 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .www.kleentest.com National Enzyme Co. . . . . . . . . . . . . . . . . .S-19 . . . . . . . .800-825-8545 . . . . . . .417-546-6433 . . . . . . . . . .www.nationalenzyme.com Ruger Chemical Co. Inc . . . . . . . . . . . . . . .S-15 . . . . . . . .800-274-7243 . . . . . . .973-274-4921 . . . . . . . . . . .www.rugerchemical.com Sabinsa Corp . . . . . . . . . . . . . . . . . . . . . . .S-27 . . . . . . . .732-777-1111 . . . . . . .732-777-1443 . . . . . . . . . . . . . . . .www.forslean.com SGS Life Science Services . . . . . . . . . . . . .S-23 . . . . . . . .866-747-5003 . . . . . . .973-244-1823 . . . . . . . . . . .www.sgs.com/lifescience Soft Gel Technologies/OptiPure . . . . . . . . .S-14 . . . . . . . .800-360-7484 . . . . . . .323-726-7065 . . . . . . . . . . . . . . . .www.soft-gel.com UAS Laboratories, Inc. . . . . . . . . . . . . . . . .S-29 . . . . . . . .800-422-3371 . . . . . . .952-935-1650 . . . . . . . . . . . . . . . . .www.uaslabs.com Vita-Tech . . . . . . . . . . . . . . . . . . . . . . . . . . .S-16 . . . . . . . .714-832-9700 . . . . . . .714-731-8482 . . . . . . . . . . . . . . . .www.vitatech.com Watson-Marlow Pumps Group . . . . . . . . . .S-8 . . . . . . . .800-282-8823 . . . . . . .978-658-0041 . . . . . . . . . . . . . . . . .www.wmpg.com

S-2

CONTRACT PHARMA/NUTRACEUTICALS WORLD

MANUFACTURING SUPPLEMENT

• March 2011

MANUFACTURING SUPPLEMENT

Photo courtesy of Glatt Pharmaceutical Services

Solid Dosage Manufacturing Trends

Specialized technologies lead to growth and new markets By Gil Roth CONTRACT PHARMA

T

HE SOLID DOSAGE FORM REMAINS a pillar of the contract manufacturing industry. Maybe it’s not as sexy as the prefilled syringe or as esoteric as the metered-dose inhaler, but it’s still a dominant dosage form for small molecule drugs. Knowing it’s a many-headed beast, we spoke to a series of manufacturers about the state of the business in 2011. Most were optimistic and talked in terms of an upward spike in business, but some were downbeat about their prospects. While some CMOs cited a decline in major clients as a result of big pharma rationalization, and a dropoff in smaller clients because of straitened finances, others felt that differentiating technology and customer service helped them weather the storm of the recession. Lee Karras, president of Pharmalogx LLC, an advisory services company, and former chief executive officer of AAIPharma

S-4

Services, noted three major trends in solid dosage manufacturing: “First, there are more highly potent NCE compounds in development and that has a number of ramifications: smaller tablets/capsules, more immediate vs. sustained release formulations, more capital-intensive manufacturing trains due to the containment required (and, in some cases where cleaning levels are required to go too low, the need for dedicated equipment) and smaller batch sizes. The latter is a function of pharma targeting niche patient populations where they can extract the greatest return on their R&D dollar in the short term. “Second, we’re seeing a trend away from using solvents.

CONTRACT PHARMA/NUTRACEUTICALS WORLD

Gil Roth has been the editor of CONTRACT PHARMA since its debut in 1999. He can be reached at [email protected] MANUFACTURING SUPPLEMENT

• March 2011

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MANUFACTURING SUPPLEMENT SOLID DOSAGE MANUFACTURING

Where there was once a tremendous reliance on solvents in granulation and coating, now we see new solubilizers and excipients and advances in spray drying to improve bioavailability, all working to reduce the need to use solvents in manufacturing. “Third, there’s a major shift in clinical manufacturing of NCEs away from early formulation and toward powder-incapsule (PIC). Companies just want to quickly get a reasonable prototype into the clinic, and I’d say that 80% of the companies I have dealt with are taking a neat drug in capsule — or drug + lactose in capsule — into Phase I. Once they get into Phase II, they develop a more commercializable prototype. The cost of a PIC program at many U.S.-based pharma companies and CDMOs is about 30% of a full formulation program, so cost savings are a consideration as well.” These changes in technology have combined with larger market and regulatory forces to create a business environment fraught with challenges and opportunities for CMOs. The

Catalent Acquires Lyopan Technology ATALENT PHARMA SOLUTIONS has entered into a license agreement with Pantec AG for the exclusive worldwide development rights to the Lyopan fastdissolve technology for healthcare products. The acquisition provides Catalent with new oral dose capabilities, potentially enabling the delivery of improved, compliance-enhancing treatments across a broad range of applications, including central nervous system drugs, allergy medications, and dosage forms for pediatric and geriatric populations, as well as prescription and OTC products. “We are pleased to add the Lyopan technology to Catalent’s oral dose technology offering, which will enable us to provide our pharmaceutical partners with an enhanced choice of drug delivery technologies to improve the performance of their treatments,” said Ian Muir, Ph.D., president, Modified Release Technologies for Catalent. “The Lyopan technology is ideally suited to deliver a wide dose range of active pharmaceutical ingredients in a fast-dissolve tablet. These are key considerations for situations where patient adherence, ease of swallowing and lack of access to water are important issues to address.” Lyopan is a technology for development and manufacture of fast-dissolve lyophilized tablets. Lyopan requires significantly less water than existing technology, reducing energy consumption, sublimation and drying time. The technology also offers the potential for improved taste-masking capabilities and may increase the range of drugs and consumer products that can be used in a fast dissolve dosage form.

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S-6

CONTRACT PHARMA/NUTRACEUTICALS WORLD

MANUFACTURING SUPPLEMENT

• March 2011

Capsule Filling – A Solution for Every Application

Whether you are an established pharmaceutical manufacturer working with high potency product, or a startup nutraceutical manufacturer, Bosch offers a capsule filling solution for you. Pharmaceutical Recently Bosch introduced the most technologically advanced series of capsule fillers. GKF HiProTect containment capsule fillers are designed to provide complete operator safety while processing highly potent compounds. These contained systems provide a barrier to separate the production environment from the filling suite and operator along with an automated wash down system and air handling & control system. The GKF Capsule Filler Family continues to be the workhorse of the pharmaceutical capsule filling industry with models ranging from low output lab models to 3000 capsules per minute systems filling a wide variety of prod-

ucts including powder, pellets, liquids, tablets, and granules, as well as a variety of combinations. Nutraceutical The introduction of the Capsylon Capsule Filler Family brings in a new era to the nutraceutical industry. The Capsylon models take the best of our capsule filling experience and builds it into an affordable workhorse designed for the unique challenges of the nutraceutical industry for today and tomorrow. Capsylon systems are designed to handle the difficult products found in nutraceutical filling while minimizing waste and maximizing machine durability. Bosch offers over 50 years of capsule filler manufacturing excellence. Our robust designs and flexibility are well respected in the capsule filling industry. Our service and upgrade programs ensure both long life and flexibility for the future.

Meet us at Interphex in New York April 20–22 – Booth No 1319 www.boschinterphex.com Robert Bosch Packaging Technology, Inc.

Phone: +1 763 424 4700 [email protected] www.boschpharma-us.com

MANUFACTURING SUPPLEMENT SOLID DOSAGE MANUFACTURING

downbeat CMOs were understandably reticent to go on the record, but their problems tended to center around delayed approvals for commercial projects and cancellations due to large pharma network rationalizations. But the non-doom-and-gloom contingent sees plenty of opportunity in the new environment. Only a few years ago, the talk was about how large pharma only had 30% utilization of its facilities. That’s clearly changed, as they move to rationalize networks. One industry veteran contended that the reshaping of the industry is a boon for CMOs, remarking, “Pharma is getting away from brick and mortar. They’re starting to rely more on the expertise and people outside of their companies. With that comes team-building and relationship, as opposed to the old practice of, well, dictating terms to a CMO.” Oliver Mueller, executive vice president business development at Glatt Pharmaceutical Services, commented, “We’re seeing a significant number of new project and product opportunities. In particular, the activity level has picked up quite significantly in the last several months. It’s a fairly diverse range, too: branded, generic, biotech, and emerging/virtual companies.” He added, “One trend that doesn’t seem to be subsiding is lifecycle management. We continue to see companies taking

branded compounds and extending their marketability beyond patent life based on new dosage forms, like orally disintegrating tablets (ODT), or combining two different APIs to get enhanced therapeutic action or new indication altogether.” Coating Place, a manufacturer focused on Wurster fluid bed technology, has also managed to make it through the downturn without a major hiccup. Fred Schulze, the company’s vice president of sales and marketing, commented, “What we’ve seen are fewer but much larger projects. The scope of the projects is larger, stretching from development to full commercialization. The development work itself is much more broad and complex, and the volume of manufacturing in the end is much greater.” Mr. Mueller noted that Glatt decided to expand that infrastructure prior to the downturn, but chose to continue the project and make the investment in cGMP capability even when the industry was in flux. “We’ve broadened our facilities to add tablet compression, capsule filling and tablet coating. We’ve positioned ourselves to manufacture products we’ve been developing, as well as handle tech transfer for companies looking to move products out of their facilities. This way, we can be a one-stop shop for manufacturing.” (See “Glatt Adds cGMP Capacity at NJ Site” on p. S-10 for more information.) Coating Place also expanded during the downturn. “We worked diligently throughout the recession on the sales and

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• March 2011

MANUFACTURING SUPPLEMENT SOLID DOSAGE MANUFACTURING marketing side to bring in projects,” said Mr. Schulze. “We brought in a number of them in order to sustain business. At the same time, we expanded our facility by 85,000 sq. ft. and upped our staff by 30%.” Both Mr. Mueller and Mr. Schulze credited two key factors for their positive perspectives on the market: project management and specialized technologies. Mr. Mueller remarked, “We need to look back at that notion of lifecycle management, because there are novel technologies that allow the sponsor to develop a dosage form that is different from that they’ve used in the past. For example, in developing an ODT with modified release or immediate release characteristic, you’re often dealing with some degree of pellet technology. To that end, you need to produce starting pellet material small enough to avoid grittiness and to taste-mask effectively. “There’s a limit to mouthfeel around 300 microns, at which you get that gritty effect, so you need starting pellet material that’s down around 200-250 micron level. This makes pelletized technology critical in ODT forms, and having novel technologies to enable that development has benefited Glatt.” Said Mr. Schulze, “We’ve been growing dramatically in the last few years. Our experience in Wurster technology is being acknowledged by big pharma.” He noted that the company’s 40 years of coating experience translates into a value for clients, just as the technology itself does. He remarked, “If you don’t run a Wurster correctly, you’ll absolutely tear the active up. You need to treat it like a science, not an art.” He also noted that large pharma companies seem to be growing more adept at managing relationships with CMOs. He said, “Part of a good outsourcing experience is having our project teams work with each other. Perhaps it’s not as significant on the first project with a client, but by the second and the third, those teams get to know each other and work better together. It’s a case where expectations come into alignment.” Mr. Mueller echoed those sentiments: “Clients can really benefit from a CMO’s strategic location. This isn’t a small issue; a sponsor must be able to visit key people at the CMO and really get a feel for their systems.” Both upbeat and pessimistic CMOs expressed concern about sponsors choosing ostensibly less expensive CMOs in the far east, but most agreed that sophisticated clients had already come around to Mr. Mueller’s point about strategic location. Said one, “I still think, as it pertains to more difficult to craft development activities or manufacturing operations, there are advantages keeping it close to home, and I get the impression that sponsors understand that.” In addition to development-into-commercial projects from large and small pharma, solid dosage CMOs have another major client base to work with. As one CMO put it, “If you’re in this sector, generics have to be a big part of your business. Branded projects can take five, seven, 10 years. If you get them right, generics projects can only take two or three. (Well, three or four, given how the FDA is operating on approvals.)” Said Mr. Mueller, “One of the hallmarks of the generics industry has been its ability to move quickly; those companies are all about speed. First-to-file status is so critical for them.

S-10

Glatt Adds cGMP Capacity at NJ Site PHARMACEUTICAL SERVICES HAS added new commercial scale cGMP contract manufacturing capacity at its 86,000-sq.-ft. facility in NJ for tablet and capsule production. Added production capabilities include high shear wet and fluid bed granulating/drying, tablet compression and pan coating, Wurster HS pelletizing and coating, CPS technology direct pelletizing, oven tray drying/curing, blending, milling, sieving and QC. Additional capabilities include organic solvent or aqueous and DEA controlled substance (CII – CV). “We’ve made this investment in commercial scale operations in order to provide our clients the speed-tomarket and high quality standards demanded in today’s competitive market,” said Oliver Mueller, executive vice president business development, Glatt Pharmaceutical Services.

G

LATT

There’s been consolidation among generics, and that’s created new layers within the larger firms, but they haven’t shed their need for speed.” Intertwined with that need for speed is the development of higher-end generics. Several CMOs noted that generics companies are working on more time-release and sustainedrelease products. Once developed as lifecycle management techniques for branded drugs, they too are seeing patent expirations, leading generics manufacturers into more complex formulations. Mr. Schulze commented, “When you have a specialized technology like we do with Wurster technology, people come to you because they need that specialized thing. It’s not easy for a generic — or a large pharma, for that matter — to simply add it to their capabilities. It’s not like installing a tablet press.” Mr. Karras concurred that generics have a growing role in the CMO space, but was ambivalent about the ramifications of this trend. He said, “The major impact to CMOs will not come from directly from large pharma. With major patent cliffs at almost every major company, I think we’ll see a shift where specialty and large generics players will cannibalize the market for many of the largest selling drugs. Many of these companies will require manufacturing capacity to make these products, making these companies the dominant consumers of capacity in the solid dose CMO space.” That doesn’t mean it’s going to be good for manufacturers. Mr. Karras commented, “Since there will be price erosion with these ‘generic’ contracts, the CMOs will feel the pain and their margins will decline. Only those specialty CMOs and niche CMOs that have specialized manufacturing assets will remain relatively unscathed by the margin compression.” With advanced technologies and a focus on project management, some solid dosage CMOs appear poised for a bright future. I

CONTRACT PHARMA/NUTRACEUTICALS WORLD

MANUFACTURING SUPPLEMENT

• March 2011

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MANUFACTURING SUPPLEMENT

Nutraceutical Nutraceutical Contract Contract Manufacturing Manufacturing 2011 2011

Increased demand for higher processing standards and certified production capabilities characterize a contract manufacturing industry that’s banking on increased economic growth By Joanna Cosgrove NUTRACEUTICALS WORLD

G

IVEN THE ONGOING TREND OF FISCAL belt-tightening, contract manufacturing operations are an increasingly important supply chain resource for the nutritional supplement industry. But make no mistake, competence — not cost—is king, and more supplement formulators are unwilling to settle for anything less than certified and GMP-compliant facilities. For many supplement formulators, hiring a contract manufacturer is simply the most cost -effective route to producing their product. “Most marketers choose to work with a contract manufacturer because the cost to start their own manufacturing line, along with the technical issues and the experience, make it difficult to start a manufacturing line,” said Steve Holtby, president and chief executive officer, Soft Gel Technologies Inc., Los

Joanna Cosgrove is the online editor of NUTRACEUTICALS WORLD. She can be reached at [email protected].

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Angeles, CA. “By outsourcing production, there is no need to purchase or rent production facilities, buy equipment, purchase raw materials or hire and train employees to produce the goods. Instead, they are able to completely focus on making sales, advertising and marketing the product.” “Contract manufacturers should be viewed as an extension to your own company,” commented Suhail Ishaq, president, GMP Labs, Anaheim, CA. “With globalization and cGMP regulations in full effect . . . companies are mandated to ensure that their products are compliant in the U.S., and in some cases internationally for export. “Therefore, the need to have a cGMP certified, internationally registered and experienced contract manufacturer . . . should not be understated,” he continued. “In order to derive the maximum value out of your contract manufacturer, there should be an emphasis on nurturing the relationship so that both sides understand that there is more to the relationship than price alone.”

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• March 2011

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Sam Wright, president and chief executive officer of The Wright Group, Crowley, LA, agreed with a nod toward the tricky challenge of balancing costs and turning a profit. “The contract manufacturing environment today is increasingly challenging,” he said. “Commodity prices have escalated worldwide putting pressure on supply chains, while pricing power remains quite limited at the retail and consumer levels. “At the same time,” he continued, “cGMPs and other global quality standards have made it necessary to bring in new capital investments as well as personnel investments, which tend to add to costs going forward. Additional quality testing and supplier auditing in the wake of Chinese raw material adulteration scandals have also added to costs, but has also added tremendous value from the customers’ standpoint. We feel this increased focus on food safety and higher quality will benefit the stronger companies.” He went on to note that the business of contract manufacturing has become more relationship-oriented and less transactional. “The better, more sophisticated customer companies look more at total cost in use adjusted for risk rather than simply lowest price,” he said. “If the contract manufacturing firm is doing its job well, they may command the highest price and still be the lowest total cost.” “There was a time not very long ago that price was the top

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concern when someone was looking for a contract manufacturer to produce a product,” concurred Harold Fox, director of sales, National Enzyme Company, Forsyth, MO, who pointed out that proper certifications, quality and appropriate documentation are crucial points of differentiation. “Certifications that allow you to get into other markets around the world will be important as well as being able to aid your customers in navigating the various regulatory structures in those markets.”

Balancing Challenges Maintaining quality assurance while keeping abreast of regulatory issues are two of the biggest challenges for most contract manufacturers, which further underscores the crucial importance of appropriate accreditation. In fact, ongoing quality assurance regulations have increased the profile of nutraceutical contract manufacturers. “In addition to the continued presence of internationally-recognized certification groups such as NSF International and the Natural Products Association, the FDA has taken a much stronger stance on controlling quality with GMPs,” said John Yanusas, executive director, Tedor Pharma, Cumberland, RI. “In 2008 and 2009 respectively, FDA cGMP compliance enforcement began in favor of large and medium-sized manufacturers. The June 2010 requirements of manufacturers with less than 20 employees marked the final stage. “The added cost of analysis required by the new regulations increases the cost of production,” he continued. “For this reason, many small nutritional supplement companies are now looking to partner with a contract supplement manufacturer who is prepared to meet these regulations.” He went on to assert that not partnering with a properly accredited contract manufacturer could equal a risky gamble on product potency and stability. “The education process needs to start at the consumer level and move up the product distribution and supply channels, educating the parties about the need for products coming from a cGMP facility versus someone’s garage or warehouse space,” he said. “As an example, by offering products with potency claims at time of manufacture or lacking expiration dating that is not backed up with real stability studies the consumer potentially is receiving a product that is no better than a placebo or sugar pill.” Despite the consumer confidence in the nutraceutical industry, there has always been a shadow of doubt regarding product quality. This is why keeping abreast of current regulatory issues is such a crucial aspect of the contract manufacturing business, according to Soft Gel Technologies’ Mr. Holtby. “With the advent of the new FDA GMPs for dietary supplements, contract manufacturers must advise customers of the implications of the new regulations,” he said, noting the importance of conscientious record keeping. “Record keeping and documentation are crucial components to ensure GMP compliance and continued certification, [and] detailed batch records need to be maintained for traceability purposes.” This kind of accountability, said GMP Labs’ Mr. Ishaq, helps distance efficacious contract manufacturers from the increases numbers of “online pseudo-manufacturers.” “[They] purport to be real contract manufacturers when in

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MANUFACTURING SUPPLEMENT

• March 2011

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fact they are nothing but brokers or middlemen who compromise quality to make their margin,” he said. “They have created a lot of unhappy customers because of their false promises and lack of transparency. Transparency [is] a key element in building long-term and sustainable relationships . . . based on trust and performance expectations.”

Manufacturing Trends Challenges aside, contract manufacturers are uniquely able to meet market demands, especially as they relate to specific product trends. For Farmingdale, NY-based Nutricap Labs, the market niche is weight loss products. “Typically [our customers] request that these products be manufactured in tablet or capsule form, however we’re starting to see more people request their weight loss products to be manufactured in powder form,” said Jason Provenzano, the company’s executive vice president of sales and operations. “The same trend applies to people seeking to manufacture functional foods and beverages,” he added. “Powders are more attractive because of the low minimum requirement and low cost associated with them. As it relates to convenience, consumers tend to like products in powder form because they can mix it with water or another liquid and take it on the go.”

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Tedor has been focusing on combination probiotic and nutraceutical component tablets and capsules, in an effort to ensure compatibility and long-term stability to differentiate their products from manufacturers who justify their stability claims with statements like “at time of manufacturing.” Tedor has also been working in the areas of taste masking for palatable oral dosage delivery, especially as it relates to the development of children’s nutraceutical products that can be directly swallowed, chewed or dissolved in the mouth. “From a formulation perspective we constantly deal with taste issues and the incorporation of marketplace-acceptable GRAS excipients,” conveyed Lakshimi Devi Ethirajan, a formulation scientist with the company. “Since Tedor establishes a higher level of stability in its products the formulator is constantly monitoring accelerated and real-time data to make sure the product is within specifications at time of manufacturer until its expiration date. Due to the unique ingredients incorporated into some of our nutraceuticals, we experience challenges with product conformity and have adopted or incorporated many of the pharmaceutical manufacturing processes/analytical testing techniques to ensure product conformity to specifications within the individual dosage form and within the batch manufacturing process.” In the soft gel category, the hottest trend continues to center around omega fatty acid products, with a heavy emphasis on fish oil sources. Soft Gel Technologies’ EZ Mega 3 soft gels contain a stable and deodorized ethyl ester fish oil concentrate. “The highest standards were used to manufacture this fish oil concentrate, so that it is not only free of potential toxins, but it is also odorless and minimizes aftertaste and reflux,” commented the company’s Mr. Holtby. “Since the fish oil contains higher concentrations of EPA and DHA than standard fish oils, it allows us to put more omega 3 in smaller capsules.” Typical omega 3 oils have a fishy aftertaste, cause reflux (burping) and often come in large, hard-to-swallow capsules. EZ Mega 3 soft gels contain fish oil concentrate with no burp, no taste, no smell!” The flourishing joint and skin health categories have been beneficial for GMP Labs. “The joint health market alone is roughly $2 billion dollars and the skin health or ‘nutricosmetic’ market is estimated to be over a billion and growing,” said Mr. Ishaq. “Our favorite ingredient is BioCell Collagen II because it addresses both applications and customer satisfaction is extraordinary.” Increasing knowledge about the benefit of enzymes has also proven successful for National Enzyme Co. “The market for nutritional enzyme supplements is growing as consumers become more aware of the benefits, which has led to exciting advances in delivery methods,” said the company’s Olivia McRae, production manager. “As new materials become available we strive to use them to deliver our products to the consumer in the most cost effective ways possible, while at the same time retaining the time tested virtues of the natural product. Contribution from medical experts provide a more comprehensive approach to new formulations and applications.” Nutricap Labs’ Mr. Provenzano pointed to the private label sector as a valuable segment for contract manufacturing. “Nutraceuticals World recently published an article that stated approximately 73% of shoppers would either recommend a

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MANUFACTURING SUPPLEMENT

• March 2011

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tinue to hold true, there’s no reason to believe that the private labeling industry will do anything other than thrive.” From a business perspective, The Wright Group’s Mr. Wright pointed out the shift in the role of the contract manufacturer. “There has been a noticeable

store brand over a brand name or did not feel that they were giving up anything by purchasing a store brand,” he said. “Furthermore, 62% of consumers that were polled felt there was no difference in quality between name and store brands. As long as these sentiments con-

increase in the reliance on contract manufacturers to participate at the earliest stages of product development, where in the past, we manufactured based primarily on the customer’s specifications delivered to us,” he said. “It is partly a function of corporate downsizing and the tendency to outsource functions not critical to the enterprise.”

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Although the specialties of the contract manufacturers interviewed for this article are unique, they are united by a common belief: that the demand for contract manufactured supplements is poised to grow. “The growth of the contract manufacturing business has actually outstripped the growth in the overall nutraceuticals industry over the past decade because of the growth in outsourcing,” said The Wright Group’s Mr. Wright. “It is nearly impossible for a company to be totally vertically integrated while maximizing revenues and profits. The value chain has become very disaggregated. Contract manufacturers and distributors, for that matter, play an increasingly valuable cost transfer role in this value chain.” As clients continue to become more educated about what it takes to produce quality nutraceuticals, Tedor’s Mr. Yanusas said he believed there would be continued growth and opportunities for established cGMP CMO manufacturers. “Tedor anticipates further consolidation occurring as barriers to entry or FDA regulations raise the bar for higher quality products,” he said. “This ensures a number of legitimate CMO’s operating under cGMP manufacturing environments can stand out from the old school competitors who produced a product in a garage or warehouse space with little or no cGMP practices in place.” GMP Labs’ Mr. Ishaq aptly summarized how the business of contract manufacturing dovetails with current consumer and economic trends. “We see moderate growth consistent with the current rate of the recovering economy,” he said. “We see an acceleration of the business as more people turn to supplements in an effort to live a more healthy lifestyle, which is a trend that is being supported by government and media due to the rising costs of healthcare.” I

MANUFACTURING SUPPLEMENT

• March 2011

MANUFACTURING SUPPLEMENT

Spray-Drying for Increased Solubility

New options from time-tested method By Dean Ross ISP Pharmaceuticals

D

poor aqueous solubility has become more common, presenting formulators and manufacturing experts with significant new challenges. One technology that has gained momentum and a reputation for providing a relatively simple solution to these solubility challenges is solid dispersion technology. Solid dispersions are molecular (thermodynamically stable) or colloidal (kinetically stable) dispersions of amorphous compounds dispersed in a polymeric matrix. It is a well known scientific principle that the amorphous form of a molecule is easier to dissolve than the crystalline form. Until recently, pharmaceutical scientists had been reluctant to utilize this principle because of stability concerns and the threat of limited shelf-life. However, there is enough evidence reported in the literature and the marketplace demonstrating the long-term stability of properly formulated solid dispersions, thus eliminating a major barrier for evaluating the technology. Solid dispersions can be prepared by melt extrusion or spray-drying from lab through commercial scale. Both processEVELOPMENT OF DRUG SUBSTANCES WITH

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es have advantages and limitations; this article will focus on spray-drying. The advantages of spray-drying allow the formulator to choose from a wide variety of polymers, solvents and adjuvants. Because spray-drying is performed at relatively low temperatures and has short contact times with the hot processing gas, it is an excellent manufacturing option when working with temperature sensitive compounds.

Proof of Concept Before the spray drying process development begins, a stable, amorphous formulation with increased solubility needs to be developed and selected for clinical testing. The first step in developing a successful solid dispersion is to screen a variety of polymers systems. Such systems include polyvinyl pyrrolidone

Dean Ross is business development manager for ISP’s technology development and contract services business located in Columbia, MD. He can be reached at dross@ispcorp.

CONTRACT PHARMA/NUTRACEUTICALS WORLD

MANUFACTURING SUPPLEMENT

• March 2011

Pilot P ilot S Scale cale S Solid oli l dD Dosage osage EEquipment qui u pm p en e t FLUID BED DRYERS, FLUID DRYERS, CHILSONATORS, CHILSONA ATORS, QUADRO Q ADRO COMILS, QU COMILS, C OATING T PA ANS AND A MUCH MORE! COATING PANS 34301 – One O (1) ( used used d Korsch Korsch rotary rottarry model XL100, ttablet ablet press, press, m odel X L100, 10 10 station station keyed upper rremovable emovable tturret, urret, B tooled, tooled, k eyed u pper punch guides, 60KN p unch g uides, 6 0KN compression compression pressure with 15 kn pre p ressure w ith 1 5k np re ccompression, ompression, and gravity design with fforce orce ffeeder eeder a nd g ravity ffeed eed d esign w ith hopper, 16mm h opper, 1 6mm max max tablet tablet diameter, diameter, rated rated up to to 1000 ttablets/minute, ab blets/minute, 2.2 kw, kw, 220 serial# vvolt oltt motor, motor, ser rial# K1510022.

View Entire V iew Our Entir e Inventory Inventory Online. Online. Site is is Our Site Updated Updated Real Time. in Real

Glatt fluid bed 34294 – One One (1) (1) used used G latt fl uid b ed dryer, dr ryerr, modell GPCG GPCG 2, stainless stainless ssteel teel shock cconstruction, onstruction, 6.5 bar bar internal internall shoc k granulation rrating, ating, (2) sspray pray gr anulation in iinserts, serts, insert, integrally mounted (1) Wurster Wurster in sert, int egrallyy mou m nted panel with humidificatin ccontrol ontrol p anel w ith h umidificatin cabinet, cabinet, designed with de signed w ith soft sofft wall wall isolator. isolattor. 34138 – One One (1) (1) used used O O’Hara ’Hara LLABCOAT ABCOAT ccoating oating pan, pan, modell LCI, LCI, stainless stainless steel steel design with cconstruction, onstruction, change change pan pan d esign w ith pan, kg 11” perforated perfo orated p an, 1.5 k g ccapacity, a acity, ap aqueous 3 30 rpm pan 3-30 pan speed, speed, peed aqueou us operation with oper ation with with Xycom Xycom PLC PLLC controls con ntrols w ith gun, 3599, new 2004. sspray pray g un, sserial# erial# 3 599, n ew 2 004. 33694 – One (1) used used Fitzpatrick Fitzpatric a k Chilsonator, Chilsonator, model IR 220, all all stainless stainless steel steel width, horizontal cconstruction, onstruction, 8” 8” diameter diameter x .75” .75” roll roll fface ace w idth, ssine ine grooved grooved rrolls, olls, h orizontal ffeed eed with hopper driven byy 1/8 hp mot motor, driven byy 1/6-1/3 hp sscrew crew w ith hop per driv en b or, vvertical ertical feed feed sscrew crew w driv en b drive, with manual DC motor motor with with scr, scr, 3/4 hp roll roll driv e, cantilevered cantilevered rrolls, olls, rroll oll aadjustment d stment w dju ith m anual pump, on base with PLC and motor p ump, o n stainless stainless ssteel teel b ase w ith P LC ccontroller ontroller a nd m otor VFD VFD controllers, controllers, sserial# erial# 653, new 2000. 34143 34138 34121 30723 34132 33694 33574 33001 34277 34281 29827 34294 34295 30202 28976 34301 34170 34374 34140 34167 34114 34114

TF-MINI FREUND ROLLER COMPACTOR F COMP O PACT CTOR O O’HARA O HARA LAB L COAT COAT COATING COAT TING PAN, PAN, A MODEL L LCI, LCI CI, S/S IR220 FITZPATRICK FIT TZP PAT TRICK K CHILSONATOR, CHILSONA ATOR, O S/S IR520 FITZPATRICK FIT TZP PAT TRICK K CHILSONATOR, CHILSONA ATOR, O S/S QUADRO MODEL QUADRO COMIL, COMIL, O L 197S, S/S IR 220 FITZPATRICK FIT TZP PAT TRICK K CHILSONATOR, CHILSONA ATO OR, S/S MODEL S/S, 1 HP L 197 19 97 QUADRO QUADRO COMIL, COMIL, O FITZPATRICK FITZP PAT TRICK K L1A MILL FITZPATRICK FITZP PAT TRICK K L1A MILL, S/S FITZPATRICK FITZP PAT TRICK K L1A MILL, S/S M5A FITZMILL, FITZ ZMILL, 316L S/S, 3 HP GPCG S/S GPC CG 2 GLATT G ATT FLUID GLA FLUID BED DRYER, WURSTER, WURS STER, T MP-MICRO MP MICR MP-MICR RO AEROMATIC AEROMA AT TIC C FLUID FLUID BED MULTI-PROCESSOR MUL LT TI PR TI-PR ROCESSOR S MP-MICRO MP-MICR RO AEROMATIC AEROMA AT TIC C FLUID FLUID BED MULTI-PROCESSOR MUL LT TI-PR ROCESSOR S MINI-GLATT MINI-GLA ATT FLUID FLUID BED DRYER, S/S XL100 KORSCH TABLET PRESS, KORSCH O TABLET A PRE ESS, 10 STATION STAT TION STREA1 AEROMATIC FLUID PLASTIC, CONTAINMENT ST TREA1 A AEROMA ATIC T C FL UID BED DRYER, PLAS ST TIC, C O ONT TAINMENT A XP 1 K KORSCH PRESS O OR RSCH TABLET TABLET A PRESS VECTOR COATING PAN, LCDS-3, VECT TOR O C OAT TING P A AN, MODEL LL CD C S-3, S/S 16”, 12”,, 8” O’HARA LAB C COAT COATING PAN, LCI, OAT C OATING T P A AN N, MODEL LL CI, C S/S ALEXANDERWERK MODEL WP120V ALEXANDER RWERK K ROLLER R COMPACTOR, CO OMP PAC CT TOR, O MOD DEL W P120V PHARMA, PHARMA, S/S, CONTAINMENT CONT O TAINMENT A

CONTACT CON TA C T US T ODA AY FOR TODAY F AST A FAST Q U OTE AT AT QUOTE 8 800.6 5 2.2 4 6 6 800.652.2466 MAIL US OR EEMAIL AT DEALS DE AL S AT @ FEDE QU I P.C . OM @FEDEQUIP.COM WWW.FEDEQUIP.COM W W W. FEDE QUIP. COM 82 8200 200 BESSEMER AVENUE AVENUE V CLEVELAND, OHIO 44127 C LEVELAND, O HIO 4 4127 [email protected] D [email protected] WWW.FEDEQUIP.COM W WWW .FEDEQUIP.COM (800) (8 800) 652-2466 (216) (2 216) 271-5210 FAX FAX

MANUFACTURING SUPPLEMENT S PRAY-D RYING

FOR I NCREASED

homopolymers and polyvinyl pyrrolidone-vinyl acetate copolymers, HPMC and HPMC derivatives and acrylate copolymers. Formulators will typically prepare model formulations using polymers from each class and then test the formulations in in-vitro dissolution models and in accelerated stability studies. Evaluating the different polymer systems requires expertise in formulation development and analytical sciences. Once the polymer system is chosen, further process and formulation development work can be performed to enhance the solid dispersion.

SOLUBILITY

Figure 1: Solvent Based Spray Drying Process

Process Steps On the surface, the use of spray-drying to manufacture solid dispersions appears to be a relatively simple process. The poorly soluble drug substance or compound is dissolved in a solvent system along with a polymer dispersant system and any other desired adjuvants to form the spray-drying feed solution. The feed solution is then pumped into the top of the spraydryer concurrently with a heated drying gas, typically nitrogen, and atomized into fine droplets using various types of nozzles or other atomizing techniques. As the liquid droplets fall through the drying chamber, the solvent is rapidly removed, forming a dry powder with distinct characteristics. The powder is usually collected in a cyclone and then secondarily dried in a vacuum oven or fluid bed dryer to remove residual solvents to meet ICH guidelines. One of the advantages of spray-drying is its ability to control powder characteristics which can have a tremendous impact on secondary formulation and manufacturing of tablets or capsules. This is where expertise and a strong understanding of the fundamentals of spray-drying can define success or failure of a solid dispersion. Powder characteristics such as particle size and distribution, bulk density, residual moisture and solvent level, wettability, dispersability and flow properties can all be controlled through proper selection of spray-drying equipment and process parameters, such as nozzle selection, inlet and outlet temperatures and feed solution characteristics.

Feed Solution Development Feed solution development is critical for determining powder characteristics, throughput and capacity for any given spraydryer. Factors such as solvent selection, solids concentration, and physical properties of the solutions greatly influence powder characteristics. For example, lower solids concentration typically results in smaller particle size while higher solids concentration or viscosity will produce a larger particle. These factors also influence throughput which dictates capacity. Spraydryers are sized based on their evaporative capacity for a given solvent under a specific set of conditions. Lower boiling solvents are easier to evaporate and result in higher throughputs and production capacity. Similar results are achieved with higher solids concentration in the feed solution which results in less solvent to evaporate. Another factor to consider when selecting solvents is the ICH residual solvent limits. Once feed solution development is complete, it is important to determine feed solution stability. A feed solution can be a reactive system and must be evaluated for chemical stability

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1) Dissolve API and polymer(s) in solvent 2) Spray dry solution, produce powder 3) Collect product, test attributes

over several days due to potential chemical interactions with the solvent, drug substance, polymeric dispersant and other adjuvants.

Atomization The most common atomizers in pharmaceutical use are rotary atomizers (spinning wheel), two-fluid (pneumatic) and pressure (hydraulic) nozzles. Atomization through a two-fluid nozzle typically produces small particles in the range of 2-75μm while atomization through pressure nozzles produces a larger particle in the range of 50-200μm. Rotary atomizers span both ranges (2-200μm).

Process Temperatures Evaluating inlet, outlet and condenser temperatures allows the engineer to design a highly efficient and reproducible spraydrying manufacturing process for solid dispersions. Bulk density, flowability and residual solvent levels are highly impacted by the process temperatures. For example, spray-drying at lower outlet temperatures will produce a powder with greater bulk density but a higher residual solvent level. Although most spray-dried solid dispersions will require some level of secondary drying, residual solvent levels of the powder must be evaluated as they can have a significant impact on the short term, and thereby long-term physical stability. Different rates of evaporation and secondary drying can plasticize the solid dispersion, leading to the formation of small levels of crystallinity that can serve as nucleation sites for crystal growth during storage. Careful evaluation must be conducted to determine the impact of the process outlet temperatures on the physical stability of the amorphous powder and other characteristics that may influence secondary dosage development.

CONTRACT PHARMA/NUTRACEUTICALS WORLD

continued on page 28 MANUFACTURING SUPPLEMENT

• March 2011

THE LARGEST NETWORK OF CONTRACT ANALYTICAL LABS SGS Life Science Services SGS Life Science Services is a leading contract service organization providing analytical development, biologics characterization and quality control product release. Whether your organization is large and global or small and regional, rely on SGS as your partner for outsourced testing. Operating a harmonized network of 17 laboratories in 11 countries, SGS offers lean quality standards, reliability and regulatory/technical expertise... all within close proximity to you. Contact us: EUROPE: +32 10 42 11 11 NORTH AMERICA : +1 866 747 5003 ASIA : +65 63790 111 [email protected] SGS IS THE WORLD’S LEADING INSPECTION, VERIFICATION, TESTING AND CERTIFICATION COMPANY

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WHEN YOU NEED TO BE SURE

MANUFACTURING SUPPLEMENT

Beyond GRAS

Creating a pathway to regulatory success By Michael Baumann Integrated Project Management Co.

W

HEN DEVELOPING A TRULY UNIQUE functional food, the more robust your development program, the stronger the claims you can make. The stronger your claims, the more you can differentiate your product and capture market share. How can you take your product to the next level? By creating an airtight but flexible process to guide your development effort. Careful planning and rigorous execution enable you to design effective clinical trials, navigate complex regulatory requirements, drive cross-functional teamwork and solve problems quickly. The results: a timely launch and the best possible labeling.

Transforming an Iconic Product A global powerhouse had a top-secret product under development. By adding an obscure but promising nutraceutical ingredient, it sought to boost the performance of one of its iconic brands, transforming it from a conventional product into a revolutionary functional food. This product would not only be

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“new and improved,” but would also provide first-of-its-kind physiological benefits. However, due to a series of missteps— including a quarter-million-dollar clinical trial riddled with errors—the firm faced a timeline delay costing $6 million in lost opportunity.

What Went Wrong? As with most disasters, the breakdown was caused by a faulty system, not one person or a discrete event. So what led to the collapse? While the clinical group had performed safety studies before, efficacy studies were new to them, but also necessary to support product claims. The firm hired consultants from the pharmaceutical world to design the trials, which was sensible. However, while the consultants knew drugs forward and backward, both they and the internal clinical staff were not thoroughly versed in food-related regulatory requirements. Due to the high cost of efficacy trials, they decided to launch their

CONTRACT PHARMA/NUTRACEUTICALS WORLD

MANUFACTURING SUPPLEMENT

• March 2011

In the race to market, think of us as your competitive advantage.

As a leading, full-service contract manufacturer, we’ve been helping brands put innovation in consumers’ hands for more than 65 years. Whether your aspirations are regional, national or global, our experience, flexibility and quality control can drive speed to market for you. To discover the powerful competitive advantage we can be, call 262.268.4747 or e-mail us at fi[email protected].

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MANUFACTURING SUPPLEMENT B EYOND GRAS

study outside of the U.S. to economize—this is a common practice in the pharmaceutical industry. After all, arthritis affects someone in Minsk the same way it affects a person in Miami. However, FDA requires U.S.-based trials for U.S.-sold foods, since diets vary so vastly across countries. So test results from people eating mostly fish and rice, say, are unlikely to apply to the average burger-eating, soda-swilling American. Why didn’t anyone catch the error? The firm’s regulatory affairs leader was fully aware of FDA’s requirements. But, as in many large corporations, functional groups became isolated. There was no formalized process for sharing information or making collaborative decisions. As a corollary, it was difficult to achieve consensus when conflicts arose, which strained relations—and communications—across functions. Moreover, as a busy senior executive, the regulatory affairs leader did not routinely attend project team meetings, missing discussion of the faulty clinical plans. So the regulatory knowledge base continued to reside almost exclusively with one person, with no process for disseminating critical information, which simply fell between the cracks. Beyond the regulatory miscue, project communication was hobbled in general. The project’s day-to-day technical lead said that reports on project status were routinely outdated by as much as three or four weeks. That meant he had no way to track real-time progress, coordinate activities or detect emerging issues. A contract research organization (CRO) had been engaged to execute the clinical trial on the ground. While the trial’s design was top-notch, the CRO wasn’t conducting sufficient follow-up with study investigators to ensure that they were following the protocol properly—turns out they weren’t. In fact, protocol deviation was so significant that it invalidated the primary outcome of the study and the results looked too good to be true—they were. Transcription errors had skewed the data, which the CRO hadn’t fully reviewed before releasing them to its client, who immediately questioned the outcome. After the trial was complete, the CRO inadvertently allowed the principle investigators to delete the primary study data from their computers. All that remained were results. Clearly, the contractor was in over its head. And because there was no system for vendor oversight, no one in the company knew it until a lot of money and months of work had been wasted. Although the company had arranged for sophisticated blood testing in the U.S., the CRO was unable to ship the samples from the study country. The host government required preapproval for such a transfer, so the samples were never released. Charged with securing a U.S. study site for a new efficacy trial, the CRO found itself floundering. With no backup plan, it suggested instead that the company change its study protocol. The clinical group had a plan. So did regulatory and packaging and manufacturing. But each plan was separate and didn’t interconnect with the others. That doesn’t work when executing a complex regulatory project. Clinical studies feed into product claims, and product claims lead to labeling and packaging, which depends on type of manufacturing process. How

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would functional groups collaborate? When and where were the handoffs? If a problem occurred at one link in the chain, how would it affect the others down the line? No one knew.

The Turning Point Millions of dollars were in peril. The project was in crisis. But all was not lost. The firm regrouped to examine its options. To salvage what it could, the company decided to pursue a process-driven approach based on project management best practices. Building a ‘living’ project plan. “We’re great at planning, but we don’t follow the plan.” So said several employees, and it was no wonder. The company’s plans consisted largely of static spreadsheets listing dates and milestones. Once goals or activities changed (as they inevitably do), plans became essentially obsolete, and people were left to their own devices. A skilled project manager with drug/device industry experience led the initiative to retool the company’s product development process. Mapping interdependencies. The project manager first asked the team basic but critical questions: What regulatory, commercial and manufacturing requirements must we meet? What are our deliverables? What activities are required to deliver them? Where are the logjams, and how can we remove them? Using the detailed findings, together they developed a plan that interconnected all activities—from data analysis to package design—required to bring the product to fruition. Team members now had a clear map to guide who did what and when, within and across functions. Enabling sound decision-making. Since all activities and dates were linked by a software program, any potential change—which the project manager would insert real-time— triggered an update across the plan. The team could then analyze what kind of impact that change would have on the project goal. If an unexpected illness slowed the creation of the FDA dossier, was there wiggle room in the timeline, or would that mean missing a critical submission milestone? If the latter, what was the cost/benefit of engaging an additional professional to complete the document? Not only a project guide, the plan served as a robust decision-making tool. Foster team unity. The process of creating an integrated plan was one way of alleviating cross-functional conflict, which had been an insidious factor in the project’s breakdown. By focusing everyone on how to achieve mutual goals, the project manager facilitated a more collaborative environment. Do deliverables and due dates work for all parties? If not, why? What’s realistic? What’s not? Creating group buy-in on how to proceed helped dissipate suspicion and create a more unified team. That, in turn, eased communications overall. Orchestrate communications. A highly structured communications system was created to ensure that project members, spread across multiple sites, were neither bombarded with unnecessary information nor inadvertently left out of the loop. Together, the team identified which functions should attend certain meetings, and who should be copied on which communications. They created project dashboards, constantly updated, to summarize the latest critical activities, as well as other

CONTRACT PHARMA/NUTRACEUTICALS WORLD

MANUFACTURING SUPPLEMENT

• March 2011

MANUFACTURING SUPPLEMENT B EYOND GRAS

communications tools to inform and apprise. As a result, team members knew what they needed to know on a real-time basis and could act far more effectively. Create centralized repository for project information. To keep the project on track, it was critical to have quick access to documents and data, which were scattered throughout paper and online files. In response, the team created a centralized password-protected e-room, which housed everything from meeting minutes to regulatory reports. No more circuitous searches or guessing which draft was the latest. The e-room files were highly organized, with an e-room “master” to keep it that way. Team members could share documents by simply emailing a link. Once people realized they could find what they needed with a click of the mouse, the pace of work picked up almost immediately. Drive execution. The new project plan was now in place. But even the best project plan fails unless executed with rigor. The project manager’s role included ensuring that the team successfully completed each day’s activities. Is an investigator late on delivering data? Did a technical snag emerge in the manufacturing process? When a problem arose, the project manager facilitated a swift resolution by the team. How serious is the issue? What impact, if any, does it have on the timeline or budget? What options do we have to address it, and what does each of them cost? Such an objective trouble-shooting process served to maximize outcomes and ratchet down tensions. Assess risks in advance. What if clinical enrollment lags? Data miss the mark? Budget is cut? Identifying risks and establishing contingency plans before a project begins enable a faster, more effective response—and may prevent the problem altogether. Although the company’s efficacy trial had already imploded, the team sprang into problem-solving mode using a decision-point process. • Did their safety data satisfy GRAS requirements? If not, the project should be killed. The data were strong. • Since the efficacy data couldn’t support an enhanced product claim, did scientific literature exist on its nutraceutical ingredient to support a lesser but marketable “baseline” claim? Yes, it did.

S PRAY-D RYING

The team prepared the GRAS submission. They initiated marketing plans for a baseline claim. And they hired a new, vigorous CRO that was able to quickly secure a U.S. site for a new efficacy study. The company now had options — and a game plan.

Tenfold Savings in Capital Expense The company’s newly structured, collaborative approach was yielding more and more benefits. The new product required testing to demonstrate that an exact amount of nutraceutical ingredient was present in each unit sold. The supply chain, quality, product development and analytical groups came together well in advance to explore how to accomplish this task. They had two options: buy a $100,000 HPLC testing instrument that required a highly educated (and expensive) professional to operate it; or send samples to a third-party lab, which required a 72-hour hold time in company warehouses, straining the firm’s just-in-time inventory system. Was there a third option? The analytical group approached the problem as an exciting challenge. In the end, they created a simple test using a $9000 spectrometer, which could be operated by someone with a high school degree and produced valid results in about an hour. An HPLC test, while far more sophisticated, yielded unnecessarily refined results. Problem solved.

A Template for Future Success With the FDA dossier at the agency’s door and existing scientific literature available to support baseline claims, the firm had its new product back on track. In the end, it lost only one month to delays, instead of the six originally anticipated. If its U.S. efficacy trial yielded stellar results, the company could enhance its claims even further. Most important, the organization now had a well-defined yet flexible process that it could tailor to future nutraceutical product development efforts, for a smooth pathway to regulatory success. I

FOR I NCREASED

continued from page 22

Summary Solid dispersion technology has become an accepted and proven technology for increasing the solubility and bioavailability of poorly soluble compounds. These dispersions can be manufactured by spray-drying, which is one of the most efficient processes for removing solvent to form a dry powder in a

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• Should they pursue an enhanced claim for future use? Yes. The ingredient had such potential that it was worth investing in a new study.

SOLUBILITY

single step. It is a well known industrial process that is scalable and easily adapted to meet expected QbD manufacturing conditions. A host of factors influence the design and quality of the process and product including feed solution, atomization and process temperatures. Careful evaluation of each of these factors will result in the successful development of a manufacturing process to produce a stable solid dispersion with increased solubility and bioavailability. I

CONTRACT PHARMA/NUTRACEUTICALS WORLD

MANUFACTURING SUPPLEMENT

• March 2011

MANUFACTURING SUPPLEMENT SOURCING & S ERVICES P REVIEW

I

NTERPHEX 2011 WILL BE HELD MARCH 29-31 at the Jacob K. Javits Center in New York City. INTERPHEX covers the gamut of drug production products and services aimed at providing solutions to improve the manufacturing, packaging and supply of pharma/biopharmaceuticals. The event features educational sessions and products and services for drug manufacturing from development to market, and provides the opportunity to find more cost-effective alternatives to existing processes and procedures and efficient new technologies to increase productivity. The event showcases products and services via the following Product Zones: Automation System & Controls, Facilities,

Manufacturing & Packaging, and Sourcing & Services. The Sourcing & Services Zone serves the full range of pharmaceutical contracting needs and will feature service providers specializing in contract manufacturing, lab services, packaging, validation, and more. Also, new for 2011, Interphex has introduced INTERPHEXConnects One2One Meetings, a partnering solution sponsored by Contract Pharma, allowing one-to-one meetings with sourcing and service providers during the show. Attendees can arrange as many as five meetings with Sourcing and Service Providers at the show (see list below). For more information visit: www.interphex.com

INTERPHEX 2011 PHARMA SOURCING & SERVICES EXHIBITORS Company Booth AAIPharma Services 1019 Abbott Laboratories 1453 Aesica Pharmaceuticals, Ltd. 1253 Alliance Medical Products, Inc. 1462 Alloy Products Corp. 1008 Almac Pharma Services 1131 Althea Technologies, Inc. 1141 Amcor Flexibles and Amcor Rigid Plastics 1145 Amcor Glass Tubing 1140 Amcor 1145 AMRI 1020 Aphena Pharma Solutions 1436 Apotex Fermentation Inc. 1479 Aptar Pharma 1046 Aqua-Chem, Inc. 1357 Associates of Cape Cod, Inc. 1041 Astro Pak Corporation 1124 AustarPharma, LLC 1281 Baxa Corporation 1114 Baxter 1225 BD Medical - Pharmaceutical Systems 1163 Ben Venue Laboratories, Inc. 1259 BioPure Technology, Ltd. 1365 Boehringer Ingelheim 1276 Boehringer Ingelheim Pharma Gmbh & Co. 1276 Brink’s Global Services USA, Inc. 1307 Bushu Pharmaceuticals, Ltd. 1032 Cangene bioPharma, Inc. 1157 Carltex, Inc. 1033 Catalent Pharma Solutions 1219 CCL Label 1270 CE&IC 1129 Celeste Contract Packaging Group 1436 (Aphena Pharma Solutions) 1436 Challenge Printing Company 1153 Chartwell Pharmaceuticals 1063 Chemic Laboratories, Inc. 1377 Chesapeake Pharmaceutical and Packaging 1376 Clinical Systems, Inc. 1004 Coldstream Laboratories, Inc. 1272 Columbia Analytical Services, Inc. 1374 Commissioning Agents, Inc. 2133 Confab known as Confab Laboratories, Inc. 1208 Confab Laboratories, Inc. 1208 Constantia Hueck Foils, LLC 1125 Contec, Inc. 1228 Contract Manufacturing Services/Abbott Labs 1453 Contract Pharma 1000, 1183 Cook Pharmica 1265 Corden Pharma GmbH 1010 Cortegra 1470

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Company Booth Covaris, Inc. 1478 CurTec USA, Inc. 1488 Cyanta Analytical Services 1029 DataTrace, known as Mesa Laboratories, Inc. 1018 David Round Inc. 1105 Dermolab Pharma, Ltd. 1457 Dickson 1011 DPT Laboratories 1416 DSM Pharmaceuticals 1424 Dycem, Ltd. 1110 Dyson Airblade /Young Equipment Sales Inc. 1677 Elan Drug Technologies 1432 Elpro Services known as Elpro 1144 Eurofins Pharma Services 1367 Fresenius Kabi Product Partnering 1465 Galbraith Laboratories, Inc. 1354 Gevis Srl 1171 Gibraltar Laboratories Inc. 1009 GlaxoSmithKline 1013 Global Headquarters known as Patheon 1233 Grand River Aseptic Manufacturing, Inc. 1459 Halo Pharmaceutical, Inc. 1071 Haupt Pharma, Inc. 1262 Helix Medical 1118 Hospira One 2 One® 1113 IGI Laboratories, Inc. 1311 Importfab, Inc. 1111 Intertek Expert Services 1461 Intini Marketing, Inc. 1160 Jeiven Pharmaceutical Consulting, Inc. 1042 JHP Pharmaceuticals, LLC 1043 Jubilant HollisterStier Contract Manufacturing 1404 Lancaster Laboratories, Inc. 1005 Lyne Laboratories, Inc. 1116 Lyophilization Services of New England 1128 Mar Cor Purification 1132 Masy Systems, Inc. 1014 Medisize Corporation 1058 Mesa Laboratories, Inc. 1018 Metrics, Inc. 1119 Microbac Laboratories, Inc. 1037 Micromeritics Instrument Corporation 1230 Micromeritics Pharmaceutical Services 1474 Midas Pharmaceuticals Inc. 1179 Mission Pharmacal 1067 MM Industries, Inc. / Vorti-Siv Division 1017 Moorfields Pharmaceuticals 1177 NextPharma Technologies Holding Ltd. 1031 Nor-Lake Scientific 1266 Oregon Freeze Dry, Inc. 1371 Overlook Industries, Inc. 1038

CONTRACT PHARMA/NUTRACEUTICALS WORLD

Company Booth Pace Analytical Life Sciences, LLC 1158 Packaging Digest 1212 Panacea Biotec Ltd. 1012 Patheon 1233 Perfecseal, a Bemis Company 1135 Perritt Laboratories 1022 Pfeiffer/Valois 1046 Pharma Packaging Solutions 1072 Pharmaceutical & Medical Packaging News 1212 PharmaSys, Inc. 1167 Pii 1109 Pillar5 Pharma, Inc. 1162 PrePak (Aphena Pharma Solutions) 1436 Prime Environmental, Inc. 1030 ProPharma Group 1108 Q Laboratories, Inc. 1028 QS Pharma LLC 1476 Quality Chemical Laboratories 1130 Reed-Lane, Inc. 1045 Rommelag USA, Inc. 1234 Rottendorf Pharma GmbH 1064 Rovi Contract Manufacturing, SL 1060 SafeBridge Consultants, Inc. 1273 Schreiner MediPharm 1353 SCM Pharma 1256 Seiberling Associates, Inc. 1213 SGS Life Science Services 1152 Sharp Corporation 1211 Shionogi & Co./Bushu Pharmaceuticals, Ltd. 1032 Solid Form Solutions Ltd. 1379 Southern Testing & Research Div /Microbac 1037 SPI Pharma 1036 Stability Environments, Inc. 1057 Stonhard 1040 Technoflex 1156 TestPak (Aphena Pharma Solutions) 1436 Therapex Division of E-Z-EM Canada 1463 Therapure Biopharma, Inc. 1372 TSI, Inc. 1373 UBM Canon known as Packaging Digest 1212 UPM Pharmaceuticals 1104 Veltek Associates, Inc. 1724 VirTis / FTS, SP Scientific Brands 1044 Vorti-Siv Division 1017 VWR International, Inc. 1035 Warnex, Inc. 1378 WellSpring Pharmaceutical 1048 Winpak Heat Seal Packaging, Inc 1025 Young Equipment Sales Inc. 1677 Zymo Research Corporation 1380

MANUFACTURING SUPPLEMENT

• March 2011

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“Researchers believe anthocyanins and some flavone and flavan-3-ol compounds may contribute to the prevention of hypertension.”

Nutraceutical: Blueberries (flavonoids) Indication: Blood pressure Source: Am J Clin Nutr, February 2011;93(2):338-47. Research: Dietary flavonoids have beneficial effects on blood pressure in intervention settings, but there is limited information on habitual intake and risk of hypertension in population-based studies. Researchers examined the association between habitual flavonoid intake and incident hypertension in a prospective study in men and women. A total of 87,242 women from the Nurses’ Health Study (NHS) II, 46,672 women from the NHS I, and 23,043 men from the Health Professionals Follow-Up Study (HPFS) participated in the study. Total flavonoid and subclass intakes were calculated from semi-quantitative food-frequency questionnaires collected every four years by using an updated and extended USDA database. Results: During 14 years of follow-up, 29,018 cases of hypertension in women and 5629 cases of hypertension in men were reported. In pooled multivariateadjusted analyses, participants in the highest quintile of anthocyanin intake (predominantly from blueberries and strawberries) had an 8% reduction in risk of hypertension compared with that for participants in the lowest quintile of anthocyanin intake. Researchers believe anthocyanins and some flavone and flavan-3-ol compounds may contribute to the prevention of hypertension. These va-

sodilatory properties may result from specific structural similarities (including the B-ring hydroxylation and methyoxylation pattern). Nutraceutical: Essential fatty acids Indication: Premenstrual syndrome (PMS) Source: Reprod Health, January 17, 2011;8(1):2. Research: Investigators conducted a randomized, double-blind, placebo-controlled study on 120 women with PMS. They were divided into three groups and treated with 1 or 2 grams of the medication or placebo. Symptoms were recorded over a 6-month period using the Prospective Record of the Impact and Severity of Menstruation (PRISM) calendar. Total cholesterol and prolactin levels were also measured. Results: There were no differences in age, marital status, schooling or ethnicity between the groups. In the group treated with 1 gram of the medication, a significant reduction was found when the median PRISM score recorded in the luteal phase at baseline (99) was compared with the median score recorded in the 3rd month (58) and in the 6th month of evaluation (35). In the 2-gram group, these differences were even more significant (baseline score: 98; 3rd month: 48; 6th month: 28). In the placebo group, there was a significant reduction at the 3rd but not at the 6th month (baseline: 96.5; 3rd month: 63.5; 6th month: 62). The differ-

—Nutraceuticals Research is brought to you in part by Natural Standard. The Natural Standard© database is an evidence-based decision support tool that is designed to help users navigate research on the safety and efficacy of herbs, supplements, vitamins, minerals, diet and exercise and nutrition products. It also assists in: Structure/Function Claims • Regulatory Affairs & Product Registration Research & Development • Employee & Consumer Education

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March 2011

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Nutraceuticals Research

ence between the phases of the menstrual cycle was greater in the 2-gram group compared to the group treated with 1 gram of the medication. There were no statistically significant differences in prolactin or total cholesterol levels between baseline values and those recorded after six months of treatment. The difference between the groups using the medication and the placebo group with respect to the improvement in symptomatology appears to indicate the effectiveness of the drug (i.e., essential fatty acids), according to researchers. Nutraceutical: Fish/shellfish Indication: Age-related macular degeneration (AMD) Source: Ophthalmology, December 2010; 117(12):2395-401. Research: A food frequency questionnaire was used to estimate weekly fish/shellfish consumption for 2520 random residents of Salisbury, MD. Age-related macular degeneration (AMD) status was determined from fundus photographs obtained at baseline and graded by two masked readers for drusen size, retinal pigment epithelium abnormalities, geographic atrophy (GA) and choroidal neovascularization (CNV). The association between weekly fish/shellfish intake and risk of AMD was investigated using logistic regression while adjusting for risk factors and correlation between eyes. Results: The distribution of weekly fish/shellfish consumption was not different between specific AMD categories compared with controls. Those with advanced AMD (CNV or GA) were significantly less likely to consume fish/shellfish high in omega 3 fatty acids. There was no relationship of AMD with intake of crab and oysters combined, each of which has high levels of zinc. These data support a protective effect of fish/shellfish intake against advanced AMD. Nutraceuticals World • 99

Nutraceuticals Research

Nutraceutical: Fish oil (DHA) Indication: Weight loss Source: J Nutr, February 2011;141(2):207-13. Research: Fish oils containing both EPA and DHA have been shown to have beneficial cardiovascular effects, but less is known about the independent effects of DHA. This study was designed to examine the effects of DHA on plasma lipid and lipoprotein concentrations and other biomarkers of cardiovascular risk in the absence of weight loss. In this randomized, controlled, double-blind trial, 36 overweight or obese adults were treated with 2 grams per day of algal DHA or placebo for 4.5 months. Markers of cardiovascular risk were assessed before and after treatment. Results: In the DHA-supplemented group, the decrease in mean VLDL particle size and increases in mean LDL and HDL particle sizes were significantly greater than changes in the placebo group. DHA supplementation also increased the concentrations of large LDL and large HDL particles and decreased the concentrations of small LDL and medium HDL particles. Plasma IL-10 increased with DHA supplementation to a greater extent than placebo, but no other significant changes were observed in glucose metabolism, insulin sensitivity, blood pressure or markers of inflammation with DHA. In summary, researchers said DHA supplementation resulted in potentially beneficial changes in some markers of cardiometabolic risk, whereas other markers were unchanged. Nutraceutical: Meriva (curcumin-phosphatidylcholine phytosome complex) Indication: Osteoarthritis Source: Altern Med Rev, December 2010;15(4):337-44. Research: In a previous 3-month study of Meriva, a proprietary curcumin-phosphatidylcholine phytosome complex, decreased joint pain and improvement in joint function were observed in 50 osteoarthritis (OA) patients. Since OA is a chronic condition requiring prolonged treatment, the long-term efficacy and safety of Meriva were investigated in a longer 8-month study involving 100 OA patients. The clinical endpoints (Western 100 • Nutraceuticals World

Ontario and McMaster Universities [WOMAC] score, Karnofsky Performance Scale Index, and treadmill walking performance) were complemented by the evaluation of a series of inflammatory markers. Results: This study represents the most ambitious attempt, to date, to evaluate the clinical efficacy and safety of curcumin as an anti-inflammatory agent. Significant improvements of both the clinical and biochemical endpoints were observed for Meriva compared to the control group. This, coupled with an excellent tolerability, suggests that Meriva is worth considering for the long-term complementary management of osteoarthritis. Nutraceutical: Multivitamins Indication: Diabetes Source: Diabetes Care, October 26, 2010; [Epub ahead of print]. Research: Understanding the relationship of multivitamin use with diabetes risk is important given the wide use of multivitamin supplements among U.S. adults, researchers say. For this study, investigators prospectively examined supplemental use of multivitamins and individual vitamins and minerals assessed in 1995-1996 in relation to self-reported diabetes diagnosed after the year 2000 among 232,007 participants in the NIH-AARP Diet and Health Study. Multivitamin use was assessed by food frequency questionnaires at baseline. In total, 14,130 diabetes cases diagnosed after the year 2000 were included in the analysis. Results: Frequent use of any multivitamins was not associated with risk of diabetes after adjustment for potential confounders and uses of individual supplements. However, significantly lower risk of diabetes was associated with the use of vitamin C or calcium supplements. Use of vitamin E or other individual vitamin and mineral supplements were not associated with diabetes risk. Researchers concluded that multivitamin use was not associated with diabetes risk and that the findings of lower diabetes risk among frequent users of vitamin C or calcium supplements warrant further evaluations. www.nutraceuticalsworld.com

Nutraceutical: Prolonged Release Melatonin (PRM) Indication: Insomnia Source: Curr Med Res Opin, January 2011;27(1):87-98. Research: A total of 930 males and females aged 18-80 years with primary insomnia who reported mean nightly sleep latency (SL) >20 minutes were enrolled; 791 entered the active phase of the study. The study comprised a 2-week, singleblind placebo run-in period followed by 3 weeks of double-blind treatment with PRM or placebo, one tablet per day at 2 hours before bedtime. PRM patients continued whereas placebo completers were re-randomized 1:1 to PRM or placebo for 26 weeks followed by 2-weeks run-out on placebo. Results: In all, 746 patients completed the 3-week treatment and 555 (421 PRM, 134 placebo) completed the 6-month period. The principal reason for drop-out was patient decision. At 3 weeks, significant differences in SL (diary, primary variable) in favor of PRM vs. placebo treatment were found for the 55-80-year group but not the 18-80-year cut-off, which included younger patients. Other variables improved significantly with PRM in the 1880-year population, more so than in the 55-80-year age group. Researchers believe the results demonstrate short- and longterm efficacy of PRM in insomnia patients aged 18-80 years, particularly those aged 55 and older. PRM was well-tolerated over the entire 6-month period with no rebound or withdrawal symptoms following discontinuation.

Log on, learn more @ nutraceuticalsworld.com Find out everything you wanted to know and more about Curcumin when you visit our online “Research” section and download the Natural Standard monograph from our “Monograph Center.”

March 2011

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Supply Source

Ecuadorian Rainforest: South America And Beyond Offering ingredients from all over the world, Ecuadorian Rainforest, LLC (ER), Belleville, NJ, has evolved into a supplier of high quality powdered botanicals that are found in dietary supplements, functional foods and beverages, cosmetics and other products available in a variety of channels. Ecuador native and natural products enthusiast Marlene Hurtado-Siegel founded the company in 1997. “From a home office, Marlene coordinated her small wholesale business dealing strictly with botanicals from South America,” said Steve Siegel, vice president of marketing and sales. “Using her knowledge gained while growing up in Ecuador, a culture that heavily emphasizes natural product use, as well as the contacts from her native country, Marlene established a small but growing business.” Steady growth would allow the company to expand its offerings, eventually adding botanicals from the U.S. and other countries to its product catalog. “Today, ER offers ingredients from every continent in the world,” said Mr. Siegel. “Our ingredients are found in dietary supplements, functional beverages and foods, cosmetics and more, from local momand-pop shops to big box stores.” The company’s botanical products include fruits, herbs, spices, vegetables and ingredients from marine sources. In addition to these basic categories, the company has been quick to respond to consumer demands, offering high antioxidant superfruits as well as conditionspecific products designed to target joint health, blood sugar management, weight management, eye health and other health categories. “All of our ingredients have nutritional benefits that can assist man102 • Nutraceuticals World

ufacturers in creating products that will entice consumers looking for all-natural and healthy options,” said Mr. Siegel. And the company continues to expand its ingredient offerings. It recently introduced Irvingia gabonensis, a weight management ingredient from South Africa that has strong scientific backing. In January, ER also debuted “Napoleon’s Choice” a line of all-natural, “pawpicked” botanicals that are designed for domestic animals. Mr. Siegel emphasized quality, meeting regulatory requirements and exceeding standards. Good Manufacturing Practices

The company’s botanical products include fruits, herbs, spices, vegetables and ingredients from marine sources.

(GMPs) and other FDA regulations continue to be top-of-mind for responsible businesses in the nutraceuticals industry, he said. In fact, ER has hired an internal legal and regulatory affairs counselor.“This individual’s sole responsibility is to make sure ER is up-to-code and up-to-speed on requirements set by the government here in the U.S. and when importing ingredients into foreign markets.” In 2011, ER will be moving to a larger facility in Belleville, NJ, increasing its www.nutraceuticalsworld.com

warehouse capacity and, in turn, offering manufacturers larger volume and a wider variety of products, according to Mr. Siegel. “Additionally, this move will include the hiring of new talent that will surely help us better serve our clients.” In spite of the faltering global economy, ER continued to see growth during the past few years.“Any economic turbulence can really test a business,” Mr. Siegel noted. “During that time a company must get creative in not only how it spends money, but also how it communicates with its clients. A combination of spending smart and working harder can get a company through tough times. Ecuadorian Rainforest met the economic adversity by spending smarter and working harder during these tough times.” For the future, he said the company would strive to maintain its current presence while also looking for possible expansion opportunities.“While it would be nice to have an all-over-the-world presence, ER believes in doing the best we can, where we can. Focusing on our existing clients, whose patronage over the years has been a gift, is priority number one. Reaching new clients in budding markets is also important. The nutraceuticals market is still very young. In some parts of the world it is only beginning.” As the company looks to continue growing its business globally, ER will be exhibiting at a nutritional tradeshow in Asia for the first time. “This opportunity will allow ER to reach a whole new world of manufacturers and help them create health products for consumers there.” —S.M. Ecuadorian Rainforest, LLC 25 Main Street, Bldg #6 Belleville, NJ, 07109 Telephone: 973-759-2002 Fax: 973-759-3002 E-mail: [email protected] Website: www.intotherainforest.com March 2011

Supply Source

Indena: Naturally Rooted in Science Defined by its commitment to the research of active ingredients from plant sources, Indena S.p.A., Milan, Italy, serves the pharmaceutical, dietary supplement, functional food and cosmetic markets by developing botanical active ingredients and proprietary botanical formulations. Founded in 1921, the company has built an international infrastructure with four branch offices in Europe, Asia and the U.S., along with five production sites that process more than 20,000 metric tons of raw materials per year. “Indena sources plant material through a worldwide network of plantations owned by the company or controlled by the company through multi-year contracts with farmers under GACP (Good Agricultural Collection Practices),” said Christian Artaria, marketing director and head of functional food development. Sales in the pharmaceutical sector generate about 65% of Indena’s business, with health food and cosmetic products accounting for 30% and 5%, respectively. In the pharmaceutical industry, the company mainly focuses on anti-cancer drugs—the goal being to document patented molecules up to Phase I/II clinical studies, and then license them to pharmaceutical companies. Indena has also been active in the dietary supplement and functional food markets for more than two decades. Researchers are particularly interested in plant-based principles with antioxidant properties that can prevent damage caused by free radicals and chronic degenerative diseases. In the cosmetic field, Indena develops functional ingredients with specific applications for the skin care sector. The company’s botanical ingredients include Mirtoselect bilberry, Leucoselect March 2011

grape seed, Greenselect green tea, Opextan olive pulp and Siliphos silybin. New ingredients include Virtiva ginkgo biloba-phosphatidylserine complex and Meriva bioavailable curcumin, which launched in 2010. “Meriva represents a breakthrough in curcumin ingredients,”according to Mr. Artaria. “Curcumin’s effectiveness has always been hampered by its poor absorption. To

As the company moves forward with its strategic goals, Indena’s founding principles of research and development remain firmly rooted.

overcome this, Indena developed Meriva, a lecithinized curcumin formulation capitalizing on the basic tenets of the phytosome strategy to improve bioavailability.” Formulation with soy lecithin increases the hydrolytic stability and significantly improves oral absorption, he added. “Its clinical benefits were proven in three long-term studies published in 2010. These studies, with more than 250 participants, demonstrated the effectiveness of Meriva for the management of two important and difficult to treat chronic inflammatory conditions: osteoarthritis and uveitis (inflammation of the middle layer of the eye).” www.nutraceuticalsworld.com

At Indena’s state-of-the-art research center in Settala, near Milan, about 70 of the company’s more than 700 employees are engaged exclusively in research. Cutting-edge technologies are used to develop processes and design new production equipment. Most of Indena’s production takes place at the Settala site, where 800010,000 tons of raw materials are processed each year. The site recently received ISO 14001 certification. While economic uncertainty has impacted various industries, the nutrition sector has performed well, as consumers continue to use and evaluate nutritional products. To that end, a strong research and quality profile can make all the difference, according to Mr. Artaria. “Supplement manufacturers are more and more concerned with quality aspects due to increasing regulatory requirements (GMPs for finished products) and regulatory enforcement both from FDA as well as FTC. As a company, Indena is continuing to invest in its ingredients by maintaining and implementing its core differentiation aspects: quality and efficacy.” As the company moves forward with its strategic goals, Indena’s founding principles of research and development remain firmly rooted. “Our primary goal with existing products is to further support their clinical evidence and to eventually look for new applications,” said Mr. Artaria. “For new ingredient identification, Indena is constantly screening entities from the plant kingdom to address unmet needs in the pharmaceutical and dietary supplement industries.” —S.M. Indena S.p.A. Viale Ortles, 12 20139 Milan, Italy Telephone: 39-2-57496-1 Fax: 39-2-57404620 E-mail: [email protected] Website: www.indena.com Nutraceuticals World • 103

New Products

Tropicana Tropolis

Daily Omega

Tropicana Products, Chicago, IL, has introduced Tropicana Tropolis, a blend of squeezable fruit designed for kids. The product is a “good source”of fiber, and contains 100% of the recommended Daily Value of vitamin C. It has no added sugars, artificial sweeteners or high fructose corn syrup, or artificial fla-

Nordic Naturals, Watsonville, CA, has launched Daily Omega, a line of three products designed to address varying needs for omega 3 fatty acids. Daily Omega with vitamin D3, for a healthy heart, contains more than 500 mg of omega 3 EPA and DHA in one Lemon-flavored soft gel. Daily DHA, for healthy brain and mood, contains 450 mg of DHA in one Strawberry-flavored soft gel. Daily Omega Kids, for brain and visual function, contains 275 mg of EPA and DHA in one chewable Strawberry-flavored soft gel.

Organic Teas

vors, colors or preservatives. It is available in CherryWorld, GrapeWorld and AppleWorld varieties. Tropicana Tropolis is available in select stores in limited markets. If successful, expanded distribution is expected in 2012.

Swanson Health Products, Fargo, ND, has released seven varieties of 100% certified organic tea, including Green Tea, Decaffeinated Green Tea, Rooibos Tea (Aspalathus linearis), Chamomile (Matricaria recutita), Red Clover (Trifolium pratense), Dandelion Root (Taraxacum officinale) and Ginger Root (Zingiber officinale).

MonaVie RVL

Super Juice

MonaVie, South Jordan, UT, has launched MonaVie Reveal (RVL) Premier Weight Solution, available as a shake mix, a nutrition bar and a dietary supplement. The formulas contain acai berry as well as a range of macro-, micro- and phytonutrients. The MonaVie RVL nutrition shake mix contains AcaVie acai along with a prebiotic fiber and whey protein. MonaVie RVL nutrition snack bars feature 24 vitamins and minerals. The MonaVie RVL dietary supplement features AcaVie and green tea.

U.K. retailer Marks & Spencer has launched a new Super Juice designed to lower cholesterol. The product contains 0.75 grams of Prom-Oat oat beta-glucan soluble fiber per 300 ml serving, providing consumers with 25% of the 3 gram daily intake of oat beta-glucan recommended by FDA and the European Food Safety Authority (EFSA) for the reduction of cholesterol and subsequent maintenance of healthy cholesterol levels. The juice is available in Red Grape, Blueberry and Blackcurrant flavors.

Hearty Wheat with Flax Bread

Rescue Water

Interstate Bakeries Corporation, Kansas City, MO, has expanded its Nature’s Pride line of breads with Hearty Wheat with Flax. The 100% natural bread is baked using pure olive oil and is a“good source”of omega 3 ALA. It is also a “good source” of fiber and contains 22 grams of whole grains per slice.

AriZona Beverage Company, Woodbury, NY, has launched its Rescue line of enhanced waters, which contain a proprietary blend of vitamins and antioxidants. The line features AriZona’s green tea extract for antioxidants as well as a vitamin formula. According to the company, Berry Blend flavor is meant to

104 • Nutraceuticals World

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help the body deal with daily stressors and relax; Lemon-Lime formula is designed to provide a boost in energy; and Orange Citrus blend is meant to help the body detox by supporting liver function and replenishing necessary nutrients. Other flavors include Pomegranate Punch, which is designed to support immunity, and Blueberry Coconut, which is tailored to help replenish hydration levels. Sweetened with Reb A, each 8-oz. serving contains 25 calories.

Probiotic Fruit and Yogurt Blends Jamba Juice Company, Emeryville, CA, has launched Jamba Probiotic Fruit and Yogurt Blends, which contain more than 500 million active probiotic cultures per serving from Jamba’s Probiotic Boost. The blends are

available in three flavors: Vibrant Blueberry, Strawberries Alive and Thrivin’ Mango. All Jamba Juice Probiotic Fruit andYogurt Blends are made with whole fruits and probiotics and are an“excellent source”of vitamin C.

Fit System Tahitian Noni International, Provo, UT, has released its Fit body composition system, which includes a variety of products. Fit Reset, a natural fruit-based cleanse formula contains licorice root extract, dandelion root and aloe vera. This combination, with a fruit and botanical blend that includes noni, helps to detoxify the digestive system, accordMarch 2011

New Products

ing to the company. Fit Restore is a probiotic formulated with three bacteria sources that provide 5 billion CFU’s (colony forming units). Fit Restore is designed to help the digestive system maintain a healthy bacteria balance, the company said. The Fit line also includes Fit Replenish, a new multivitamin supplement for consumers on the Fit Program. Fit Rebuild is a protein shake that contains 15 grams of protein and all 22 amino acids the body needs to build lean muscle. Formulated with five types of protein—soy, whey, milk, pea and noni pulp—Fit Rebuild also helps people stay full and prevents the lactic acid and soreness that come with working out. Fit Rebuild protein shakes are available in Vanilla, Chocolate and Peach flavors. Fit Reduce is a bioactive blend of nutrients that includes soluble and insoluble fibers to help block the absorption of some dietary fat, promoting elimination before it becomes fatty tissue. Fit Reduce contains psyllium husk, oat fiber and in-

March 2011

ulin. It is available in Orange and Pink Lemonade flavors.

contains white bean extract, and the Hispanic Descent formula contains graviola.

MiGenetics

Be Happy

MiGenetics, Washington, D.C., has introduced a new line of dietary supplements specifically designed for people based on ethnic origin and native background. The four products include African Descent, Asian Descent, European Descent and Hispanic Descent. The products feature more than 100 all-natural whole foods, herbs, vitamins and minerals compatible for each origin of people. The African Descent supplement contains amaranth, a high-fiber grain, as well as dozens of rare, all-natural native whole foods, ancient grains and antioxidant rich berries of African origin. The Asian Descent supplement contains brown seaweed. European Descent

HealthGuard Wellness, LLC, has launched Be Happy, a 2-oz. shot that contains amino acids and antioxidants, including Chocomine (a patented proprietary cocoa extract) and L-theanine. The product is designed to promote calm and focus, according to the company. It is available in Chocolate Cherry flavor.

www.nutraceuticalsworld.com

Herbal Retreat Teas Tea Forte, Concord, MA, has launched Herbal Retreat Teas, a new line of organic, Fair Trade Certified herbal relaxation teas that are naturally caffeine-free. Blends include: Mojito Marmalade, Apricot Amaretto, Blueberry Merlot, Kiwi Lime Ginger and Cherry Cosmo.

Cooper Complete Supplements Cooper Concepts, Dallas, TX, has launched

Nutraceuticals World • 105

New Products

Cooper Complete Dermatologic Health, a dietary supplement that contains lutein, vitamins A, C and E and Polypodium leucotomasa to promote healthy skin, hair and nails. The company has also introduced Cooper Complete Eye Health, formulated to provide key nutrients that have been clinically shown to provide eye health benefits.

high in fiber, according to the company. Baobab Foods has also released BaoBest Fruit Powder, a soluble powder that is suitable for mixing into a wide range of foods and drinks, including smoothies, sports drinks, yogurt and water.

Prebiotic Soft Chews ProActive Health Products, Cedar Rapids,

True Grains Orlando Baking Company, Cleveland, OH, has introduced True Grains, a line of whole wheat breads that contain the patented probiotic GanedenBC30. Varieties include Honey Wheat, which is made with whole wheat flour and contains zero trans fat, as well as Seed’licious, which is textured with flax seeds, sunflower seeds, chia seeds and millet.

is designed to support immune health and is available in Mixed Berry flavor.

Vemma PM Vemma Nutrition Company, Scottsdale, AZ, has addedVemma PM to its line of liquid supplement products. According to the company, Vemma PM promotes rest and restoration. It contains antioxidants from mangosteen along with vitamins and minerals.

Calcium Plus Milk Shamrock Farms, Phoenix, AZ, has released its Calcium Plus line of milk products that contain nine essential nutrients, including calcium, vitamin D and potassium. Varieties include Whole, 2% Reduced Fat and Fat Free white milk, 1% Lowfat Chocolate Milk, as well as 2% Reduced Fat and Fat Free Lactose Free.

Baobab Fruit Bars & Powder Baobab Foods, Bellevue, WA, has introduced Baobab Fruit Bars, available in Apricot, Apple and Cherryberry flavors. They have a very low glycemic index and are

106 • Nutraceuticals World

IA, has launched Prebiotic Soft Chews, which contain 250 mg of EpiCor and 400 IUs of vitamin D3 (cholecalciferol). The product

www.nutraceuticalsworld.com

Digest HPE & Ester-C with D3 American Health, Ronkonkoma, NY, has launched Digest HPE, which contains 13

March 2011

New Products

naturally derived protein, carbohydrate, fiber and fat-digesting enzymes at activity levels designed to aid in more thorough and efficient digestion. The company has also added Ester-C with D3 Bone & Immune Health Complex to its Ester-C Specifics product family. Non-acidic EsterC with D3 contains Ester-C vitamin C (1000 mg) and 5000 IU of vitamin D3.

Rice Protein Concentrate & Citicoline Jarrow Formulas, Los Angeles, CA, has unveiled its Rice Protein Concentrate in new Chocolate and Mixed Berry flavors. Brown Rice Protein Concentrate is made

Spirit of Health Clean Power Concepts, Regina, Saskatchewan, Canada, has unveiled its new Spirit of Health brand, which includes a line of natural health supplements made from essential camelina oil. Camelina is high in omega 3, omega 6 and vitamin E. Initially, the line will consist of three products: camelina oil capsules, gourmet cooking oil and a skin care health and beauty formulation intended as a remedy for several skin maladies. Plans are also underway to expand the product base into flax, canola and hemp oil based essential oil products.

March 2011

GMO brown rice. The company has also unveiled Citicoline (CDP Choline) in an all-new 120capsule size—the latest offering in its line of brain nutrition supplements. Citicoline has been tested extensively in clinical trials in the areas of memory, verbal memory, recognition, recall and cognition. Recent studies have also indicated support for visual acuity. Citicoline is a naturally occurring intermediate involved in the synthesis of phosphatidylcholine, a major constituent of the gray matter of brain tissue.

Astravar & N.O.370 from whole grain organic brown rice, is easily digested, gluten-free, hypoallergenic and a vegetarian/vegan source of protein. It is ideal as a high-protein alternative to soy and animal products, according to the company. Both new flavors are made with certified non-

www.nutraceuticalsworld.com

Top Secret Nutrition (TSN), Miami, FL, has launched Astravar, a “cellular absorption amplifier,” and N.O.370, a “performance enhancement potentiator,” according to the company. Both products are based on Astragin, a new and exclusive ingredient that has been clinically tested to increase the body’s absorption of nutrients at the cellular level.

Nutraceuticals World • 107

Suppliers Corner

BLIS M18 Frutarom USA has introduced BLIS M18, a patented oral cavity probiotic intended for complete oral protection. Developed from a specific strain of S. salivarius—a common and beneficial oral bacteria—BLIS M18 has been clinically proven to promote the health of the mouth and oral cavity by continuously

supporting and increasing the underlying health of the teeth and gums, according to the company. Ideal applications are those that allow direct contact with the mouth, such as lozenges and chewable tablets, chewing gums, stick packs, fast-melt tablets and powder drinks. For further information: www.frutarom.com

Research Highlights Superba Krill Oil Shows Benefits for ADHD A clinical study in children with attention deficit hyperactivity disorder (ADHD) suggests that Superba krill oil from Aker BioMarine offered significant improvements in clinical scores and identified EEG patterns as compared to typical ADHD EEG patterns. Eighteen boys (age 7-11 years) with ADHD received Superba krill oil daily for a period of 13 weeks. The EEG patterns for the study participants were compared to a database of more than 400 children with an established ADHD diagnosis to provide comparative data. For further information: www.akerbiomarine.com Meriva May Reduce Eye Inflammation A new study indicates Meriva, a patented complex of curcumin with soy phosphatidylcholine from Indena, helps reduce frequency and severity of relapses in patients with recurrent anterior uveitis (RAU). Published in Clinical Ophthalmology, this study showed that Meriva could play an important role in the adjunctive therapy of RAU, the most common form of uveitis, a form of inflammation involving the interior of the eye that in some cases can lead to blindness. Symptoms of RAU—also termed iritis—include pain, redness, photophobia and, to a variable degree, decreased vision. Researchers administered two tablets of Norflo (Eye Pharma Co), containing 600 mg of Meriva, for 12 months to 122 patients diagnosed with RAU for at least 2 years before the beginning of the trial, and during which they had suffered 1-4 relapses per year. Among the 106 patients who completed the study, only 19 (18%) had relapses. An improvement in symptoms, including ocular pain and blurring of vision, was also observed, and 86% of patients reported a subjective systemic well-being, progressively developing after 4 to 6 weeks of treatment. For further Information: www.indena.com

108 • Nutraceuticals World

Adulteration Screening Method Addressing an increasingly problematic practice by fringe companies, scientists at NOW Foods have developed a method for screening dietary supplement ingredients for adulteration. A scientific report describing the method has been accepted for pub-

Probiotic BB-12 May Reduce Respiratory Illness in Infants Daily supplementation with Chr. Hansen’s probiotic strain BB12 may significantly reduce the occurrence of respiratory infections in early childhood, according to a federally-funded, clinical study published in the September issue of the British Journal of Nutrition. In this double-blind, placebo-controlled study, 109 newborn infants were randomly assigned to a probiotic group receiving BB-12 or to a control group receiving placebo. BB-12 was administered to the healthy breastfed infants twice a day from the age of 1-2 months to 8 months with a pacifier or a spoon. The main finding was that BB-12 reduced respiratory infections, as 65% of children in the BB-12 group and 94% in the control group had experienced one or more episodes of respiratory infections at the 8-month examination. For further information: www.chr-hansen.com Study Shows Bioavailability of FloraGLO Lutein with Actilease Kemin Health, L.C., creator of FloraGLO lutein, and DSM Nutritional Products recently presented new research demonstrating the bioavailability of FloraGLO lutein with Actilease technology. Lutein bioavailability, or the delivery of the ingredient to the beneficial sites of action—including the macula where lutein is quantified as macular pigment optical density (MPOD)—is essential for eye health. Research supports that MPOD has the potential to become a commonly tested biomarker in the assessment of visual function and risk for eye disease. FloraGLO lutein beadlets utilize Actilease beadlet technology, a branded, patented technology from DSM that formulates FloraGLO lutein into micro-sized particles that are protected in a water-soluble shell. Published research shows that FloraGLO lutein, with Actilease technology, is absorbed by the body into the bloodstream and, more importantly, deposited into the macula, increasing MPOD. For further information: www.kemin.com; www.dsmnutritionalproducts.com

www.nutraceuticalsworld.com

March 2011

Suppliers Corner

lication in the peer-reviewed journal Vibrational Spectroscopy. The method requires only 30 seconds grinding in an analytical mill before performing the scan. Including milling the samples, the entire screening process can be performed in less than 10 minutes per sample. For further information: www.nowfoods.com

Teavigo Pharmachem Laboratories has obtained exclusive distribution rights for Teavigo green tea extract for the dietary supplement marketplace. Developed by DSM Nutritional Products, Teavigo is extracted through a proprietary process that ensures

a minimum of 90% EGCG (epigallocatechin-3-gallate). For further information: www.pharmachemlabs.com

Probiogreen UAS Laboratories has entered an agreement with Valensa International and Parry Nutraceuticals to launch Probiogreen, which combines DDS probiotics from UAS and organic spirulina from Parry. Probiogreen will be available as a finished product or as a raw material that can be added to food products or other multiple-ingredient supplements. Possible applications include supplement powders, smoothie mixes, beverages and

Sharp-PS GOLD May Have Positive Effects on Memory A new study published in the peer-reviewed journal Clinical Interventions in Aging indicates that phosphatidylserine containing omega 3 fatty acids (PS-omega 3) may have a favorable effect on memory recall in subjects with subjective memory complaints. This pilot study tested the effect of PS-omega 3 (SharpThoughts—the commercial product containing Sharp-PS GOLD from Enzymotec) consumption on the memory abilities of elderly volunteers. Following supplementation with PS-omega 3, the ability to recall words after a delay improved by 42%. Study findings indicate that Sharp-PS GOLD may have a beneficial effect on the ability to store, hold and retrieve information. For further information: www.enzymotec.com Glucosamine Doesn’t Impact Glucose Metabolism A comprehensive review from a team of experts in diabetes and glucose metabolism recently concluded that consuming glucosamine as an oral supplement at typical levels does not adversely affect glucose metabolism in normal and diabetic individuals. The review has been accepted for publication in Diabetes Metabolism Research and Reviews. The purpose of the review, commissioned by Cargill, was to investigate concerns that have been raised about glucosamine’s purported effects on glucose tolerance in healthy people, and worsening of diabetes in the afflicted. Authors found the concentration of glucosamine in plasma is several orders of magnitude below what has been reported to impair glucose metabolism in vitro. For further information: www.cargill.com Resveratrol Study to Investigate Metabolic Syndrome The Danish Council for Strategic Research has granted more than $3 million for a research project that will investigate the use of resveratrol for management of metabolic syndrome, osteoporosis and inflammation in humans. Fluxome A/S will supply Fluxome Resveratrol for the trials. The 5-year project starts in June 2011 and participants will

March 2011

supplements. The recommended dosage of the product is 500 mg of DDS probiotics (5 billion CFU/gram) and 500 mg of spirulina. For further information: www.uaslabs.com

YO-MIX Danisco has introduced YO-MIX yogurt cultures that meet the need for a culture with low post-acidification in different processing and storage conditions. Following success in China, the Middle East and North Africa, the company is planning to expand YO-MIX into other regions. For further information: www.danisco.com

consume resveratrol for 12 months. The objective of the project is to determine if resveratrol can neutralize the detrimental effect of obesity on the whole body metabolism such as low-grade chronic inflammation, insulin resistance and lipid infiltration/inflammation in liver and skeletal muscle. For further information: www.fluxome.com Slimaluma May Curb Obesity A study recently published in the Journal of Nutrition and Metabolism indicates Slimaluma (Caralluma fimbriata) extract, from Gencor Nutrients, has the potential to curb obesity and the pathologies linked to obesity. This study evaluated the extract for appetite suppressing, antiobesogenic and antiatherogenic properties in a DIO rat model. Results showed pronounced dose-dependent appetite suppressant and antiobesogenic effects on a sample of rats fed a cafeteria diet. For further information: www.gencorpacific.com Study to Analyze Magnesium, Whey Protein Relation to Physical Performance Albion Human Nutrition has agreed to fund a new clinical study that will analyze the impact of magnesium creatine chelate (Creatine Magna Power), magnesium creatine chelate plus whey protein stack and placebo on physical performance. The 10-week, double-blind study will be conducted under the direction of L.R. Brilla, PhD, at Western Washington University. Supplementation regimens will be conducted for 8 weeks. Baseline and ending information will include a 3-day dietary analysis and 3-day physical activity log to determine energy expenditure. The physiological attribute tests include body composition, body water, muscle strength and power. Data will be collected before and after each treatment phase. Data analysis will determine if different supplementation regimens, inclusive of Creatine Magna Power affect variables associated with physical performance compared to regimens with or without protein stack and to placebo. For further information: www.albionminerals.com

www.nutraceuticalsworld.com

Nutraceuticals World • 109

Suppliers Corner

Chia Seeds BI Nutraceuticals has introduced chia seeds that have been steam sterilized using the company’s Protexx HP process, which uses super-heated, dry steam to ensure the material is free of any potential pathogens while preserving all of the seeds’ healthful properties. Chia seeds can be used in various applications, including cereals, breads, soups, salad dressings and nutrition bars. For further information: www.binutraceuticals.com

Quality Training Program NSF-DBA has entered a partnership with the United Natural Products Alliance (UNPA) and the National Center for Natural Products Research (NCNPR) at the University of Mississippi to offer a new training program to the dietary supplement industry. The program,“The Dietary Supplement Quality Professional Training” (DSQP), is designed for dietary supplement quality and technical professionals and will offer participants technical, scientific and regulatory knowledge. The training will be offered in three locations throughout the country: Ann Arbor, MI; Salt Lake City, UT; and Oxford, MS. Based on the requirements set forth in the current GMPs (good manufacturing practices) in manufacturing, packaging, labeling or holding operations for dietary supplements (21 CFR 111), the DSQP training consists of a series of 12 modules offered over a one-year period. They are designed to provide the knowledge and skills expected of today’s dietary supplement quality and technical professional. Each module consists of a mix of lectures and group exercises, maximizing the learning for the participants. For further information: www.nsf.org

Roadmap For Retailers The Council for Responsible Nutrition (CRN) has released its “Roadmap for Retailers: Safely Navigating What You Say About Dietary Supplements.”The document provides suggestions for selling and marketing supplements without running afoul of the law. Sections include a brief explanation of the history of supplement laws, an overview of retailer’s responsibilities, a chart of “Do’s and Don’ts,” tips on educating con110 • Nutraceuticals World

sumers, as well as warnings for retail clerks who offer personal testimonies. “Roadmap for Retailers” also includes a guide to understanding supplement labels and a glossary of terms. For further information: www.crnusa.org

Organic Green Grass Superfoods NP Nutra has released a new line of certified organic Green Grass Superfoods, including wheatgrass, barley grass and alfalfa grass powders, as well as oat grass, buckwheat grass powder and rye grass powders. Also available is a line of Green Grass juice powders. Green Grass Superfoods have application in the manufacture of nutritional supplements and powdered blends, along with functional foods and drinks. For further information: www.npnutra.com

WellBody 365 Nutragenesis LLC has launched WellBody 365, an immune support nutraceutical that combines the multi-patented, immune-modulating maitake mushroom extract with Sensoril, a standardized extract of Ashwagandha that is clinically proven to increase the body’s resistance to stress and lower serum cortisol levels. WellBody 365 is Generally Recognized As Safe (GRAS) for use in dietary supplement formulations as well as food and beverage applications. For further information: www.nutragenesisnutrition.com

Enzyme & Antioxidant Compositions Deerland Enzymes and Thione International, Inc. have formed a joint product development alliance. This exclusive alliance will target applications that combine Thione’s research of antioxidants with Deerland’s expertise in multi-component enzyme blends and formulations. The companies intend to develop enzyme and antioxidant compositions with significant clinical applications in order to ameliorate gastrointestinal symptoms, improve digestive function and enhance nutrition. For further information: w w w. d e e r l a n d - e n z y m e s . c o m ; www.thione.com

MicroActive Curcumin-SR BioActives LLC and Maypro Industries have www.nutraceuticalsworld.com

launched sustained release MicroActive Curcumin as a micronized, multi-stage, time-release curcumin. Developed by Bioactives as a more bioavailable curcumin formulation, MicroActive Curcumin solubilizes curcuminoids, thereby reducing particle size. A portion of the micronized particles are then encapsulated creating a formulated ingredient that releases bile acid in the stomach and then in the higher pH small intestine. The sustained release form can be combined with standard curcumin for more precise cost-benefit formulations. Maypro Industries will distribute MicroActive Curcumin worldwide. For further information: www.bioactives.com; www.maypro.com

Supro Nugget 173 Solae has introduced Supro Nugget 173, a protein multigrain nugget, using patentpending technology for use in a variety of products, including bars, snacks, baked goods and cereals. Supro Nugget 173 is comprised of 60% soy protein and 40% multigrain (rice, oat and barley). For further information: www.solae.com

Flavors for High-Protein & Stevia Products Synergy Flavors, a division of Carbery Ingredients, has developed a range of flavors designed to tackle challenges associated with negative taste profiles and bitter off-notes of whey protein and the natural sweetener stevia. Flavors include Chocolate, Strawberry and Vanilla, as well as Honey Cream and Baked Oatmeal. For further information: www.synergytaste.com

Amizate Zymtech Production AS has launched Amizat, a patented, full-spectrum amino acid complex positioned for the sports nutrition market. The all-natural, marine-derived ingredient contains the optimal amino acid profile for human protein synthesis. The amino acids contained in Amizate are primarily in the free form (nearly 60%), with the remaining bound in short peptides. A patented enzymatic process fully hydrolyzes the marine protein source, creating an ingredient that is easily digested and assimilated. For further information: www.zymtech.no March 2011

People in the News Ramirez

Larson

Daniel Fabricant, PhD, has joined FDA as director, Division of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition (CFSAN). He previously served as vice president of global government and scientific affairs with the Natural Products Association, Washington, D.C. Cara Welch, PhD, and Liz Hurst will manage and oversee NPA’s collective scientific, regulatory and government affairs portfolio. Andrew Shao, PhD, has joined Herbalife Ltd., Los Angeles, CA, as vice president, Global Product Science and Safety. He will be responsible for assuring that all products sold by Herbalife are safe, meet regulatory safety requirements, and that all product claims are scientifically supportable. He will report to Dr. Vasilios (Bill) Frankos, former FDA director, Division of Dietary Supplements Programs, (CFSAN), who joined the company last April. Dr. Shao joins the company from the Council of Responsible Nutrition (CRN). In other personnel news, Herbalife has named Ibi Fleming senior vice president and managing director of its North America region. She will be responsible for all business, strategic, sales and marketing functions across the region, which includes the U.S., Canada, Jamaica and the Caribbean. Ms. Fleming, who joined Herbalife in 1998,

Fallon

most recently served as vice president of sales and marketing for the U.S. Latin market. She replaces Tom Zimmer who is retiring from the company. Nuriche, Draper, UT, has appointed Manuel Ramirez as vice president of Latin America. He will be responsible for overseeing the company’s expansion into key Hispanic markets in Mexico, Central and South America. Mr. Ramirez has more than 17 years of network marketing experience. The company has also hired Kevin Larson as vice president of marketing. He will be responsible for overseeing the company’s strategic marketing needs, including creation and implementation of marketing tools, promotions and a recognition and incentives program to support the company’s network of independent business owners who market and sell Nuriche products. He will also work with Nuriche’s product development team to create and promote new product lines. Elaine Paterson, PhD, clinical research manager at Standard Process Inc., Palmyra, WI, has earned her clinical research certification from the Society of Clinical Research Associates (SoCRA). Dr. Paterson has more than 10 years of human study management experience, which spans international research, research with the Department of Vet-

erans Affairs and industry-based research management. The SoCRA certification acknowledges Dr. Paterson has demonstrated her knowledge, experience and skill in the field of clinical research and clinical trial management. SoCRA established the Certification Program for Clinical Research Professionals to create an internationally accepted level of knowledge, education and experience by which clinical research professionals would be recognized by the medical research community. BI Nutraceuticals, Long Beach, CA, has hired Betsy Fallon as West Coast regional sales manager. She will be responsible for supporting and expanding BI’s position with West Coast customers, as well as growing the company’s customer base within the region. Ms. Fallon previously served as U.S. sales manager with Martin Bauer, Inc. The company has also hired Theresa Aranda as director of procurement and Lindsay Monsivaiz as buyer. As procurement director, Ms. Aranda will be the main point of contact with suppliers and conduct price negotiations with vendors, while also developing strategies and objectives to drive improvements in the supply chain and sourcing processes. In her position of buyer, Ms. Monsivaiz will be responsible for the purchasing of raw

CRN Board Elects New Chairman & Officers The Council for Responsible Nutrition (CRN), Washington, D.C., has elected Jim Hamilton chair of the association’s Board of Directors. Mr. Hamilton, president of DSM Nutritional Products, will hold the chairman post through 2012. He succeeds Mark LeDoux, CEO of Natural Alternatives International, who will continue to serve on the board as immediate past chair. CRN’s new Board of Directors is comprised of 31 member company representatives and CRN president and CEO Steve Mister. CRN’s board elected a slate of new officers to serve alongside Mr. Hamilton during his two-year term: Chair-elect—John Blair, NSA, LLC (Juice Plus+); Treasurer—Ron Fugate, Alacer Corporation; Secretary—Kristen Blanchard, Nutramax Laboratories; and Immediate Past Chair— Mark LeDoux, Natural Alternatives International. In his capacity as CRN president and CEO, Mr. Mister will conHamilton tinue to serve as a board officer. The following executives were recently re-elected to serve on CRN’s Board of Directors: Ona Scandurra, Country Life Vitamins; Greg Dodson, Archer Daniels Midland; and David Henstrom, Cargill Health & Nutrition. Michael Zeher, Nutrition 21, was newly elected to serve on the board.

March 2011

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Nutraceuticals World • 111

People in the News

materials, services, supplies and equipment. She will also ensure that all raw materials meet company quality and regulatory requirements. Ms. Aranda previously spent 13 years at BI Nutraceuticals in customer service, sales and operations capacities, including vice president of operations. Ms. Monsivaiz previously served as regional sales manager for High Quality Organics. Deerland Enzymes, Kennesaw, GA, has named Dr. Theodore (Ted) Hersh chief science officer. He will work closely with Hilton Dawson, Deerland’s chief technology officer, to lead product development efforts. Deerland recently formed a joint product development alliance with Thione International, a healthcare technology

company that Dr. Hersh founded in 1995. Alkemists Labs, Costa Mesa, CA, has hired Kelly Reins as executive director of laboratory operations and compliance. She will be responsible for leading the overall strategic growth of the analytical services division. Ms. Reins previously served as quality control director at Robinson Pharma. Frank Lampe has joined the American Herbal Products Association (AHPA), Silver Spring, MD, as director of communications. He will oversee AHPA’s communications, media and marketing initiatives as well as contribute to member support and development. Mr. Lampe brings more than 22 years of media and

communications management experience. As a co-founder of Natural Business Communications, he and his team introduced and quantified the Lifestyles of Health and Sustainability (LOHAS) concept and produced the LOHAS Journal business magazine and the LOHAS Market Trends Conference. The Natural Products Association (NPA), Washington, D.C., has appointed Seva Raskin as membership recruitment manager. She will be responsible for recruiting new members to the association as well as retaining current members. Ms. Raskin previously served as director of supplier relations at the National Association of Convenience Stores.

2011 Calendar

MARCH

MAY

Mar. 17: Building a Regulatory Strategy for Marketing Food Supplements in Europe, Brussels, Belgium: European Advisory Services (EAS), Contact: Cindy Garcet, 32-2-218-14-70; E-mail: [email protected]; Website: www.eas.eu Mar. 23-24: Wellness 11, Chicago, IL: Institute of Food Technologists (IFT), Contact: Mindy Weinstein, 312-604-0231; E-mail: [email protected]; Website: www.ift.org/wellness Mar. 28-30: Functional Food & Beverage Innovations, Chicago, IL: IQPC, 800882-8684; E-mail: [email protected]; Website: www.functionalfoodandbev.com Mar. 29-31: Interphex, New York, NY: Reed Exhibitions, 203-840-5314; E-mail: [email protected]; Website: www.interphex.com

May 2-4: SupplySide East, Secaucus, NJ: Virgo Publishing, Contact: Amy Sharman, 480-990-1101; E-mail: [email protected]; Website: www.supplysideshow.com May 10-12: Vitafoods, Geneva, Switzerland: IIR Exhibitions, Contact: Phil Hawkins, 44-20-7240-2444; E-mail: [email protected]; Website: www.vitafoods.eu.com

APRIL

SEPTEMBER

Apr. 18-20: Pharma-Nutrition: Discussing the Interface Between Pharma and Medical Nutrition, Amsterdam, The Netherlands: Elsevier, Contact: Robyn Camilleri, 44-1865843122; E-mail: [email protected]; Website: www. pharma-nutrition.com

Sep. 7-9: Vitafoods Asia, Hong Kong: Vitafoods, Contact: Phil Hawkins, 44-207240-2444; E-mail: [email protected]; Website: www.vitafoodsasia.com

112 • Nutraceuticals World

Sharman, 480-990-1101; E-mail: [email protected]; Website: www.supplysideshow.co

NOVEMBER Nov. 29-Dec. 1: Food Ingredients Europe, Paris, France: United Business Media, 3120-40-99-544; E-mail: [email protected]; Website: www.ingredientsnetwork.com

Classifieds

JUNE Jun. 11-15: IFT Annual Meeting & Food Expo, New Orleans, LA: Institute of Food Technologists (IFT), 312-782-8424; Email: [email protected]; Website: www.ift.org Jun. 28-30: HBA Global Expo & Conference, New York, NY: 609-759-4700; Email: [email protected]; Website: www.hbaexpo.com

OCTOBER Oct. 10-14: SupplySide West, Las Vegas, NV: Virgo Publishing, Contact: Amy www.nutraceuticalsworld.com

CLASSIFIED ADVERTISING For more information: Tel: 201-825-2552 | Fax: 201-825-0553 E-mail: [email protected] March 2011

Advertisers Index

Advertiser

Page No.

Telephone

A. Holliday & Co. BASF Bio Serae Laboratories Bioactive Resources, LLC Biotropics Malaysia Brunswick Labs, Inc. Capsugel Cargill Health & Food Technology Cognis Nutrition & Health ConnOils DSM Nutritional Products Inc. Ecuadorian Rainforest Ganeden Biotech, Inc. HBA Improve USA Indena iTi tropicals Jost Chemical Co. Kyowa Hakko Lonza Inc. Mitsubishi International Food Ingredients, Inc. OmegaPure P.L. Thomas Pharmachem Laboratories Pharmachem Laboratories Pharmachem Laboratories Polyphenolics Proprietary Nutritionals Inc. RFI San Francisco Herb and Natural Food Co. SanHerb Sigma-tau HealthScience Stepan Company Vitafoods Int’l Wacker Chemical Corp. Welch, Holme & Clark ZMC-USA

40 5 49 47 27 38 3 19 Cov. 2 33 45 7 11 63 23 39 66, 107 Cov. 3 Cov. 4 51

416-225-2217 800-527-9881 616-786-4000 908-561-3114 + 603 2245 8000 508-281-6660 888-783-6361 866-456-8872 800-673-3702 262-617--8670 800-526-0189 973-759-2002 440-229-5214 212-600-3322 972-230-9155 206-340-6140 800-223-5484 314-428-4300 212-319-5353 866-581-9373

13 29 57 59 53 24, 25 37 41 43

800-628-3092 877-866-3423 973-984-0900 800-526-0609 800-526-0609 800-526-0609 559-661-5556 519-647-2071 845-358-8600

105 40 55 52 101 61 105 35

800-227-2830 917-887-0262 212-645-5202 201-712-7642 44(0) 870 429 4686 517-264-8794 973-465-1200 281-419-6050

ADH Health Products Inc. Consumer Product Testing Company GMP Laboratories Kleen Test Products Corporation National Enzyme Co. Sabinsa Corp Soft Gel Technologies/OptiPure UAS Labs Vita Tech

S-18 S-17 S-13 S-25 S-19 S-27 S-14 S-29 S-16

845-268-0027 973-808-7111 714-630-2467 262-268-4747 800-825-8545 732-777-1111 800-360-7484 800-422-3371 714-832-9700

Fax

416-225-2745 973-4256843 616-786-2864 908-561-3115 +603 2245 8008

Website

972-230-8824 206-340-0863 609-987-0252 314-428-4366 212-421-1283 201-794-2695

www.teacoff.com www.nutrition.basf.com www.neopuntia.com www.bioactiveresources.com www.biotropicsmalaysia.com www.brunswicklabs.com www.capsugel.com www.cargill.com www.cognis.com www.connoils.com www.unlimitednutrition-na.dsm.com www.intotherainforest.com www.ganedenlabs.com www.hbaexpo.com www.aloewholesale.com www.indena.com www.iTitropicals.com www.jostchemical.com www.kyowa-usa.com www.lonza.com

713-940-6122 973-984-5666 201-246-8105 201-246-1000 201-246-8105 559-661-5630 519-647-3986 845-358-9003

www.mifiusa.com www.omegapure.com www.plthomas.com www.phase2info.com www.lactiumusa.com www.pharmachemlabs.com www.polyphenolics.com www.pnibrands.com www.rfiingredients.com

864-942-3079 952-742-7573 513-482-5516 973-257-8414 973-759-3002 440-229-5239

510-770-9021 212-645-0652 201-712-7648

973-465-7332 281-419-6049

www.herbspicetea.com www.sanherb.com www.sigmatau.com www.stepan.com www.vitafoods.eu.com/nw www.wacker.com/food www.welch-home-clark.com www.zmc-usa.com

Manufacturing Supplement

March 2011

845-268-2988 973-244-7507 714-237-1374 417-546-6433 732-777-1443 323-726-7065 952-935-1650 714-731-8482

www.nutraceuticalsworld.com

www.adhhealth.com www.cptclabs.com www.gmplabs.com www.kleentest.com www.nationalenzyme.com www.forslean.com www.soft-gel.com www.uaslabs.com www.vitatech.com Nutraceuticals World • 113

Nutraceuticals Multiverse A quirky account of what could/may be happening in parallel universes/dimensions.

Setting: All-Mart Mega Store, near Antinomos provincial capital, 19 April 2011. Kanye Moody, MD, Outer MVTV medical journalist: “Last month my colleague Nima Amin visited this exact store, querying Antinomians about the impact of the recently enacted Repeal and Exemption of Advertising Policies, or REAP Law, upon their buying habits. We are here this busy Saturday after-

Energy Deficit What if there were no regulations (and thus no enforcement) regarding nutraceutical ingredient or product safety?

By Anthony Almada

Anthony L. Almada, BSc, MSc, FISSN, is the president and CEO of GENr8, Inc., an innovator/marketer of evidence-based performance nutrition products, and of Fein Innovations, LLC, an innovator/marketer of taste-free caffeine food products. He has worked throughout the entire value chain in the nutrition industry since 1975. Mr. Almada can be reached at 32565 B Golden Lantern, PMB 477, Dana Point, CA 92629; 949-218-9779; E-mail: [email protected]; Websites: GENr8speed.com; GetFein.com. 114 • Nutraceuticals World

noon with a slightly different probing intent: What do health-minded shoppers think in relation to the virtually eclipsed provision in REAP that removes the need for companies to demonstrate to the Food and Dietary Supplement Administration, or FDSA, the safety of new ingredient or finished goods, specifically foods, beverages, nutraceuticals, and cosmetics.” [Dr. Moody, approaching a lean, muscular, 30-something male consumer exiting the store] “Good morning. I’m Dr. Kanye Moody with MVTV. What’s your name, sir?“ Shopper:“Hi. My name is Shane Rodgers.” Dr. Moody:“Nice to meet you, Shane. You look like you work out hard—you’re in great shape. Has REAP affected or influenced the way you shop for… [Dr. Moody pauses, looking into hand transporter pod] sports nutrition and energy products? I see you have a few here.” Shane:“Not at all. I consider myself an educated consumer. I read a lot on the supranet, and I was a biochemistry major at university. I’m also the strength coach at Antinomont Prep School, so I have to know what’s out there because my guys hammer me with questions about what’s safe and what works.” Dr. Moody:“Cool, Shane. I, too, was a biochemistry major before medical school. So then you are one of the very few, enlightened consumers who is aware that this [Moody gestures to place hand into transport www.nutraceuticalsworld.com

pod]—may I? [Shane nods his head, affirmatively] …Torched Pre-Workout Energy Concentrate powder [Moody lifts product out of pod and MVTV camera frames it] contains an ingredient that was a drug 60 years ago, and in some animal studies was shown to be more lethal than ephedrine, and in higher doses—in humans—produces hypertension and mental confusion. [Camera focuses on Shane, who is visibly disturbed] And you recognize that the safety of this actual product—as you take it—is unknown, despite the ‘GMP Made’ seal on the top and sides?” Shane [defiantly]: “I respect you but I think you’re mistaken, Doc. I’ve done my homework on this product. All of the ingredients are proven safe, and GMP means that the product is safe and effective. You’re going to have to show me some proof, especially about the ingredient that you said was MORE lethal than ephedrine.” Dr. Moody [after being handed a binder]: “Shane, I respect your skepticism but here is the evidence [camera focuses on select scientific studies in the binder]. We, too, have done our homework. First, here are the studies showing one ingredient, purported to be an extract of geranium grown on Earth, is more lethal than ephedrine when given via injection in animals. Here is the human study showing this ingredient, when orally ingested, has hypertensive effects and creates mental confusion. Finally, here is the section of the FDSA law related to the manufacture of dietary supplements under Good Manufacturing Practices, or GMPs. Nowhere does it state that a finished product has to be systematically evaluated for safety, in hamsters nor humans, and REAP removed the requirement for pre-market safety validation. In fact, we contacted this company and they admitted they have no safety data on the actual product, in animals or humans.” Shane: “Ouch, Doc. REAP paints a grim picture. I knew a lot less than I thought. Thanks for enlightening me. This is game NW changing…” March 2011

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