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Table of Contents January/February 2011 • Volume 14, No. 1

30 The Next Frontier for Nutrition Bars The market continues to hold its own, but falling consumption and product saturation may threaten future growth.

Cover design by: Jessica Carlin

35 Mood Health:

35

Ingredients for a Healthy Mind Consumers want to strike a healthy balance in their lives, and mood is a very important part of that equation.

40

40 Delivery Strategies In Transit The days of bulky, chalky ‘horse pills’ are virtually over, along with the notion that gummies, chews and other fun delivery formats are reserved for kids.

Columns 22 • Business Insights by Greg Stephens

26 • Eurotrends by Joerg Gruenwald

24 • Capitol Comments by Todd Harrison & Andrew Bigart

28 • Quality Focus by Paula Brown, Melissa Phillips, Catherine Rimmer & Laura Wood

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January/February 2011

Table of Contents

18

45

46

Departments 8 • Top Of The News • Dietitians are healthiest; IOM sets new DRIs for calcium & vitamin D 10 • Editorial • a word from the editor 12 • Nutraceuticals World In Print & Online • line-up of expanded coverage @ nutraceuticalsworld.com 14 • Industry News • Healthy eating habits vary by generation; ConsumerLab.com spars with AHPA 44 • Nutraceuticals Research • a recap of the latest clinical trials 45 • Supply Source • a profile on Fluxome 46 • New Products • recent nutraceutical product introductions 47 • Suppliers Corner • new developments from industry suppliers 48 • People In The News • who’s who and who’s moving where 48 • Classified Section • classified advertising section 49 • Calendar • upcoming industry events 49 • Advertisers Index • cross reference of advertisers in this issue 50 • 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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January/February 2011

“…96% of registered dietitians report using dietary supplements at least seasonally—

Top Of The News

74% say they take them regularly…” —CRN Life…supplemented” Healthcare Professionals Survey

Dietitians Are Healthiest, According to CRN Survey

When it comes to eating a balanced diet, taking vitamins or other dietary supplements, exercising regularly and engaging in other wellness behaviors, registered dietitians come out on top among eight healthcare professional populations, according to the “Life…supplemented” Healthcare Professionals (HCP) Impact Studies. The research studies, conducted in 2007, 2008 and 2009, are part of the “Life… supplemented” consumer wellness campaign, which is dedicated to helping Americans live a healthy lifestyle by engaging in the three pillars of health: a healthy diet + supplements + exercise. The 2009 study shows that 96% of registered dietitians report trying to eat a balanced diet; 96% of registered dietitians report using dietary supplements at least seasonally—74% say they take them regularly; 83% say they exercise regularly; 80% say they maintain a healthy weight; 86% say they regularly visit their own healthcare professional and 72% claim they get a good night’s sleep.

IOM Sets New DRIs for Calcium & Vitamin D

Most Americans and Canadians up to age 70 need no more than 600 international units (IUs) of vitamin D per day to maintain health, and those 71 and older may need as much as 800 IUs, says a new report from the Institute of Medicine (IOM). The amount of calcium needed ranges, based on age, from 700 to 1300 mg per day, according to the report, which updates the nutritional reference values known as Dietary Reference Intakes (DRIs) for these interrelated nutrients. The Council for Responsible Nutrition (CRN), Washington, D.C., called IOM’s newly-released report on the DRI levels for vitamin D “a modest step in the right direction that fell short of truly capturing the extensive and positive research that has consistently supported the need for people to significantly raise their vitamin D levels.” “While an increase in the recommendations for vitamin D will benefit the public overall, such a conservative increase for the nutrient lags behind the mountain of research demonstrating a need for vitamin D intake at levels possibly as high as 2000 IU/day for adults,” said Andrew Shao, PhD, senior vice president, Scientific and Regulatory Affairs, CRN. “However, CRN recognizes the challenges associated with the DRI process, and the difficulty in making broad-based recommendations for an entire population. That is why it is so important for consumers to talk with their doctors or other healthcare professionals, to get their vitamin D levels tested, and determine personalized recommendations that would enable them to increase blood levels of vitamin D as appropriate.” CRN noted that the recommendations for calcium changed slightly, with minor adjustments to recommendations for infants, children and the elderly. Commenting on this development, Dr. Shao noted, “based on the current body of science surrounding calcium, this is what we would have expected.”

8 • Nutraceuticals World

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January/February 2011

NEW DATE:

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

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

From The Editor

Top 10 Predictions for 2011 10. Health Claims Limbo Part II. The industry is still in the unfortunate position of health claims limbo. In the U.S., agencies are taking a hard look at substantiation, with companies facing the potential of having to provide two good clinical trials to support product claims. In Europe, EFSA is butchering the health claims system with its negative opinions. This means companies will likely pull back on claims and go for softer messaging, at least for now.

9. A Time to KISS [Keep It Simple Stupid]. Consumers are turning away from complicated product labels—and that goes for foods, beverages and supplements. Their goals are simple: to be able to pronounce and understand the ingredients in these products, and know their origin as well. And the fewer the ingredients, the better!

8. Two for the Price of One. Consumers are actively seeking more value in the products they buy—from cell phones to computers to cars to food. But it’s not just about price. For this industry in particular, this translates into developing products that deliver on multiple promises (e.g., health benefits, better flavor, natural ingredients, etc.). And remember, in this economy low price is a given.

7. Relaxation in a Bottle. Running counter to the dramatic rise in energy beverages, companies are initiating a new trend toward relaxation products. According to Innova Market Insights, consumers are asking for products that can help them minimize stress and encourage relaxation— beyond yoga and xanax. And it’s not only about the ingredient; it’s about the experience.

6. Prevention is Still the New Healthcare. Americans are still unhappy with the healthcare

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.

situation and they continue to turn toward supplements and health foods to stave off illness. This is a great time of year to win consumers’ loyalty, by getting them through the winter cold- and flu-free.

RFI Ingredients, Inc.

5. Is the Sustainability Trend Sustainable? Innova Market Insights says as the sustain-

British Columbia Institute of Technology

ability trend continues to gather pace, whether for environmental or humanitarian reasons, manufacturers are increasingly answering calls for more sustainable practices to benefit both humans and animals. But do consumers care? According to a recent Hartman Group report, 15% more consumers are now aware of the term “sustainability” compared to three years ago (69% in 2010 say they are familiar with“sustainability”vs. 54% in 2007), BUT only 21% can identify a sustainable product. Even fewer, 12%, can name specific companies as“sustainable.”

4. Election Hangover. According to John Gay, executive director and CEO of the Natural Products Association, there could be significant changes for the industry as a result of the November 2010 elections.“The natural products sector has champions and threats coming from both sides of the aisle, so the fact that one party or the other is in control does not make or break us—the champions and a number of threats remain,” he said. “But the shift in leadership in the House may help as Representative Henry Waxman must now give up the chairmanship of the Energy and Commerce Committee, although he remains in Congress.”

3. Natural Intervention. The term“natural”is one of the most important claims on products across a range of markets. However, it has been abused and regulatory bodies are ready to pounce. Mintel says terms that are vague or not well understood will come under fire in 2011, and that“we are due to see an intervention of regulatory bodies”as a result.

Paul Altaffer Paula Brown 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)

2. Supplement Science. The supplement market has a core of loyal followers. Still, the category could always benefit from an injection of new users. Turns out, according to Nutrition Business Journal, non-users of supplements can be lured to the category with science. When asked in a recent survey what might convince them to begin taking supplements regularly, 56% said“scientific studies demonstrating benefits.”

Loren Israelsen United Natural Products Alliance (UNPA)

Alex Merolli Nutri+Food Business Consultants

Paul Paslaski BioVittoria Limited

Ellen Schutt

1. Three Cheers for Probiotics, Vitamin D & Omega 3s. These continue to be the cat-

LaunchNatural

egories to watch. Consumers are impressed by the wealth of scientific data on these nutrients, and continue to seek them out in a variety of product formats.

Gregory Stephens, RD (Business Insights Columnist) Natural Marketing Institute

Rhonda Witwer National Starch Food Innovation

10 • Nutraceuticals World

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January/February 2011

Stay connected with

nutraceuticalsworld.com

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, 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 AMR101 Takes on Lovaza Amarin enters final phase of testing for its promising fish oil medication for high cholesterol.

Finding Success in Functional Foods Companies need to look beyond hot ingredients and focus more on packaging, health benefits and what consumers want most.

Blood Sugar Management Companies are investigating label claims that discuss low glycemic index in the blood sugar management category.

‘Naturally Filtered’ Blog Join associate editor Sean Moloughney in January as he offers his Top 11 Predictions for 2011. You can find his blog under the “Opinions” tab of our website.

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Industry News

Healthy Eating Habits Vary by Generation While the majority of adults recognize the

“Older consumers, ages 54 and up, often have the greatest need to eat healthy due to underlying medical conditions, and are driven to do so.” —NPD Group need to eat healthy, eating behavior varies by generation, according to a new report by market researcher NPD Group. The report

found that older generations eat more healthfully than younger generations, but four out of five adults (nearly 170 million

ConsumerLab.com Spars with AHPA Over Valerian Review

in at least one case caused CL to classify a product with proven efficacy as ‘not approved.’” Tod Cooperman, MD, president of ConsumerLab.com, issued several responses to AHPA’s evaluation of the review. “In an apparGroups dispute appropriate standards for product testing. ent attempt to defend the reputation of products that have failed to After ConsumerLab.com, White Plains, NY, released a recent report meet our quality criteria, the AHPA trade group has overlooked key stating most valerian herbal supplements failed its quality tests, the facts that clearly support ConsumerLab.com’s findings and concluAmerican Herbal Products Association (AHPA), Silver Spring, MD, sions,” he said. “AHPA is misleading the public with false informaissued a challenge to the assessment. After ConsumerLab.com tion. We encourage AHPA to instead use its resources to improve (CL) responded, defending its procedures and conclusion, AHPA the quality of valerian supplements in the marketplace, as there are reissued its assessment, drawing further criticism from CL. products containing little of their listed ingredients.” Among nine products selected for review, only two passed testAs for lead levels, CL utilized the California limit (0.5 mcg/day is ing, according to CL. Of the seven that failed, one contained no dethe level above which products sold in the state of California are retectable key valerian compounds and four others had only 26.7% quired to bear warning labels). to 82.5% of amounts expected from ingredient listings. One of But this California standard is inconsistent with other established these products was found to be contaminated with lead, as were limits on lead, according to AHPA. For example, Health Canada altwo other products. lows up to 20 mcg/day of lead in natural health products (the CanaThe amounts of lead found in the products (which ranged up to dian equivalent of dietary supplements in the U.S.). And while FDA 3.5 mcg of lead per daily serving) are not likely to has not issued a regulation to provide quantitative limcause toxicity alone, CL said, but it is best to avoid units for lead or other heavy metals in supplement prodnecessary lead exposure. Lead contamination was ucts (or in most conventional foods), FDA’s Principal found to be an issue in products consisting primarily of Deputy Commissioner Joshua Sharfstein, MD, refervalerian root powder as opposed to valerian root exenced 6 mcg/day as “FDA’s tolerable daily intake” for tract. The extraction process removes heavy metals. lead in testimony before Congress earlier this year, reAHPA’s review called into question some of CL’s ferring to the agency’s long-established provisional procedures and suggested that most of the tested total tolerable intake (PTTI) of lead in the most sensiproducts meet standards established by the European tive population of children under 7. Pharmacopoeia (EP) and FDA. According to AHPA, In his latest remarks about the dispute, Dr. Coopertested products include some that specify the level of man said: “The question in our minds at ConsumerA popular herbal sleep aid, valerenic acids and others that list only the amount of valerian accounted for $68 Lab.com when we choose criteria for evaluating million in sales in the U.S. in supplements is not ‘what are the minimum standards valerian root. In the latter case, CL states that a prod2009, up 10% from the prior uct passed if the amount of total valerenic acids derequired by a manufacturer?’ but ‘what criteria best year, according to Nutrition tected was at least 0.17% of the amount of valerian meet the needs of consumers, including our own famiBusiness Journal. root in the product. This is the minimum amount eslies, who rely on our information?’ It should not be surtablished by the EP for whole, dried valerian root. But the EP level prising that the criteria selected by ConsumerLab.com often for valerenic acid from dried valerian root in cut form is 0.10%, reexceed the minimums chosen by the industry. This explains why, flecting changes that may occur during processing. for example, we hold herbal products to the strict California State Additionally, Steven Dentali, PhD, chief science officer of AHPA, limit of 0.5 mcg of lead per daily serving, as opposed to AHPA’s said “While valerenic acids are useful markers for identifying a valerpreferred limit of 10 mcg of lead per daily serving. Eleven years of ian ingredient, you can’t ‘test in the quality’ of a valerian product product testing show that our standards are not only achievable, simply by measuring these compounds. This narrow approach has but that many of the products on the market can meet our criteria.”

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Industry News

people) still have a diet that needs improvement. Titled“Healthy Eating Strategies by Generation,” the report identifies the gaps between actual consumption behaviors and intentions. It also found that younger generations—Generations X,Y and younger Boomers, ages 21 to 54—have the least healthful diets. Older consumers, ages 54 and up, often have the greatest need to eat healthy due to underlying medical conditions, and are driven to do so. All the generations appear to share an understanding of what constitutes healthy eating. Adult consumers, across generations, define healthy eating consistently and are aware of the top characteristics of healthy eating and of a healthy lifestyle: exercise regularly, eat well balanced meals, eat all things in moderation, limit/avoid foods with saturated fat or cholesterol or trans fats and drink at least eight glasses of water per day. Almost 85 million adults ranked nutritional value/healthful as #1 or #2 in importance as a need driver in deciding what to eat and drink; taste and price/value are in the top three for the three younger generations. For older consumers, freshness replaces price/value in ranked importance. While many aspects of their diets could use improvement, overall, the largest deficiencies in adults’ diets are insufficient intake of fruits, vegetables and dairy products and over consumption of total fats.

GSK Acquires U.K.’s Top Sports Nutrition Company U.K.-based GlaxoSmithKline has entered a deal to acquire Maxinutrition, another U.K. company that manufactures protein-enhanced functional nutrition products, from Darwin Private Equity. Subject to approval from the Office of Fair Trading, GSK will acquire 100% of the shares of Maxinutrition for a cash consideration of approximately £162 million, including the repayment of outstanding debt. Maxinutrition is Europe’s top sports nutrition company by market share and has delivered sales growth of approximately 21% CAGR over the last three years. The company recorded sales of approximately £36 million for the fiscal year ended April 2010. Under the terms of this agreement, GSK will acquire Maxinutrition’s brands, including Maximuscle, the leading brand in the U.K. and European January/February 2011

sports nutrition market. The deal will extend GSK’s reach into wider categories, complementing its existing Nutritional Healthcare business.

Weight Managers Value Protein With more than 1.6 billion overweight adults in the world today, weight management represents one of the largest and most dynamic growth opportunities in the global health and wellness market. Solae, St. Louis, MO, recently conducted a weight management consumer research study across 11 countries to better understand consumers’ behaviors, motivations and practices in managing weight and their usage of foods providing weight management benefits. The study also looked at product attributes important to consumers in selecting foods to support their weight management goals, and specifically, consumer understanding and awareness of protein in weight management. “Consumers are increasingly looking for ways to manage their weight through convenient foods and beverages,” said Michele Fite, vice president of global marketing and strategy, Solae. “As Solae continues to invest in future ingredient innovation, this research helps us identify and better understand opportunities for proteinenhanced foods targeting weight management. Our data indicate that today’s consumer understands the important role protein plays in helping manage hunger. As a high-quality plant-based protein, soy protein can help food manufacturers develop great-tasting, satisfying food products targeting this growing segment.” Solae’s weight management consumer research study collected insights from more than 5300 weight managers. According to results, weight managers are most interested in satiety-enhanced versions of“everyday”foods that they already consume regularly. While results varied slightly by country, soup, yogurt and breakfast cereal consistently ranked high as categories where added satiety benefits would be of interest to weight managers. As expected, taste was the most important product attribute in 10 out of 11 countries when choosing foods for weight management. However, a food’s ability to sustain energy levels and control hunger were www.nutraceuticalsworld.com

other attributes consumers rated quite high in importance. Across all countries, 78% or more of weight managers rated protein’s ability to sustain energy levels and control hunger as very or somewhat important to them.

Study Shows U.S. Joint Health Below Average About 63% of respondents to a joint health assessment from Joint Juice, Inc., San Francisco, CA, have below average or poor joint health, and more than 70% of Baby Boomers have below average or poor joint health. Since the launch of the joint health assessment on www.jointjuice.com, more than 7500 people have taken the test to evaluate their personal joint health. This assessment, created by Kevin Stone, MD, renowned orthopedic surgeon and founder of Joint Juice, Inc., determines the condition of an individual’s joints based on a series of 15 questions regarding Body Mass Index (BMI), diet, exercise, lifestyle and joint health history. Results were collected from July through September 2010 and summarized in five categories: Excellent, Good, Average, Below Average and Poor. “These results not only reinforce the need for a healthy joint regimen, but also reiterate that people are interested in learning about the state of their joint health,” said David Ritterbush, CEO of Joint Juice, Inc. “Joints are the foundation to an active and healthy lifestyle, yet are often overlooked.”

EFSA Issues Positive Opinion for Oat Beta-Glucan A scientific panel of the European Food Safety Authority (EFSA) has issued a positive opinion on a disease risk reduction health claim dossier for oat beta-glucan following an application from Switzerland-based CreaNutrition AG. According to the opinion, foods providing 3 grams of oat beta-glucan per day can bear the health claim: “Oat beta-glucan has been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of heart disease.” The health claim still needs to be approved by the EU Commission. Bioactive oat beta-glucan is the cholesterol-lowering constituent of CreaNutrition’s OatWell oat bran ingredients. Nutraceuticals World • 15

Industry News

CRN Scientists Discuss Evidence-Based Nutrition Paradigm In commentary published in Natural Med-

icine Journal, Andrew Shao, PhD, senior vice president of scientific and regulatory affairs, Council for Responsible Nutrition (CRN), Washington, D.C., and Douglas

Getting Ahead of the Curve: Saturated Fat

Mackay, ND, vice president, scientific and regulatory affairs, urge the scientific community to establish a new paradigm of evidence-based nutrition that sets criteria

ternatives, the opportunity for products with a low saturated fat profile will grow larger still. Sales of foods/beverages touting a fat-related claim hit more than $46 billion in mass channels in 2009 excluding Wal-Mart per the Nielsen Co.; those with a specific fat claim, e.g., no trans fat, $14.8 billion. More than one-third (37%) of grocery shoppers bought more lower-fat products in 2010 than last year reports FMI. One in five (17%) of the best-selling new foods/drinks in 2009-10 had a lower in fat claim, according to SymphonyIRI’s “2010 Pacesetter Report.”

By Dr. A. Elizabeth Sloan Saturated fat is the new leader in the fat avoidance market. Twothirds (67%) of Boomers, 66% of Gen Xers and 46% of Gen Yers are reducing/avoiding saturated fats, vs. 63%, 61% and 49%, respectively, for trans fats, according to the Hartman Group’s 2010 “Reimagining Health and Wellness” report. Eight in 10 (79%) shoppers believe that saturated fats are bad; 77% trans fats, reports the Food Marketing Institute’s (FMI) 2010 “U.S. Grocery Shopper Trends” survey. Moreover, in unaided questioning, low in saturated fat is now the 4th most important component of healthy eating cited by 22% of consumers, ranking right behind vegetables, fruits and limiting processed foods per Mintel’s 2009 “Attitudes Towards Food: Weight and Diet” report. With the 2010 Dietary Guidelines Advisory Committee recommending a reduction of saturated fat from <10% of calories to <7% and replacement of saturated fat with more unsaturated al-

Market Potential According to Sloan Trends’ TrendSense model, saturated fat has overtaken trans fat as the most important fat issue in the mass market. When FDA mandated trans fat labeling in 2006, both trans and saturated fat enjoyed an enormous jump in Consumer Counts and marketability, with Consumer Counts for trans fat outpacing saturated fat. However, after a peak in Medical Counts for trans fat in 200607 correlating to the Institute of Medicine/FDA decision to eliminate trans fats, research activity has fallen off, resulting in lower level Consumer Counts, which caused trans fat to fall out of the mass market or Commercialization Phase in 2008 and 2009, clearly losing some of its momentum. On the other hand, Medical Counts for saturated fat have continued to build throughout the decade, and are now pushing saturated fat ahead of trans in terms of its mass-market appeal. Like other market categories, the fat category is segmenting

* 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 guidelines for how to study the effects of nutrients in humans. Titled “A Commentary on the NutrientChronic Disease Relationship and the

New Paradigm of Evidence-Based Nutrition,” the article states that understanding the role of nutrition in preventing chronic disease is “one of the greatest challenges

into individual components. When looking at the Nutrition Facts Label, Americans are focusing on total fat less often—62% in 2010 vs. 69% in 2009, reports The International Food Information Council (IFIC). The number of shoppers looking for low fat health claims fell 5 points from 51% in 2009 to 46% in 2010 and 4 points for trans fat, down from 48% to 44%, per FMI. Growth Opportunities • The type of fat/oil is the most looked for item on the ingredient listing (IFIC, 2010). • 70% of those aged 50+ are avoiding saturated fat; 96 million Americans are aged 50+ (HealthFocus, 2009). • 38% of those aged 65+ are on a low fat diet, 31%, 50-64, 17% younger (IRI MedProfiler, 2009). • Fast food operators ranked “low fat” menu items on their list of hot menu trends for 2010; (National Restaurant Assn., 2009). • One-third look for low fat alternatives in restaurants (Technomic, Inc. 2010). • 6 in 10 households with children are practicing a healthy eating strategy; eating more low fat dairy foods and low trans fat foods ranked just below eating more fruits, vegetables and whole grains (FMI, 2009). • The Am. Academy of Pediatrics has mandated that pediatricians perform a blood lipid profile on children as early as age 2 if they have a family history of heart disease but not later than age 8. • 81 million Americans have some form of cardiovascular disease (AHA, 2010). • The risk of stroke is 2-4 times higher in diabetics, the death rate from heart disease 2-4 times; there are 1.5 million new cases of diabetes per year (Am. Diabetes Assn.). • 28% of consumers believe that calories from fats are most likely to cause weight gain (IFIC, 2010).

facing the health sciences field today.” The authors write that evidence-based medicine (EBM) is currently being misapplied to evaluate the relationship be-

“2010 SnaxPo” presentation. With 49% of all consumers cooking more from “scratch” than they did in 2009, healthier cooking oils will become a hotly contested market segment. Most important, low-income consumers (HH income <$35K)—who are estimated to deliver $115 billion in incremental food CPG sales in the next 10 years and are heavy users of cooking oils—are also avoiding unhealthy fats. Half (48%) are looking for lower fat and 53% no trans fats alternatives, according to SymphonyIRI’s “2010 Low Income Report.” Sales of store brands carrying a specific fat claim reached $561 million in 2009 per Nielsen, up 53%.

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

Functional Foods & Beverages It’s time for food manufacturers to check their oil and to begin reducing—and touting—the lower saturated fat content of products. Many popular oils are comparatively higher in saturated fats (e.g., palm oil vs. canola or safflower). Hidden saturated fats will clearly become an issue. On the positive side, consumers are opting for healthier oils. The Hartman Group’s report found that 66% of Boomers, 58% of Gen Xers and 40% of Millennials were trying to get more olive oil in their diet; one-quarter (23%) more vegetable oil. Healthier premium oils are of particular interest to those 55+, the #1 buyer of gourmet cooking oils according to NAFST. Snacks and fried food remain critical targets for lower saturated fat foods; 56% want lower fat snacks; 37% of parents want lower fat snacks for their children, according to SymphonyIRI’s

January/February 2011

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. Appropriate 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

tween nutrients and bioactive food components with human health. “Unlike drugs, nutrients work in complex networks, are homeostatically controlled, and cannot be contrasted to a true placebo group. The beneficial effects of nutrients are small and can take decades to manifest. A new paradigm of evidence-based nutrition (EBN) needs to be established that sets criteria and guidelines for how to best study the effects of nutrients in humans. EBN must consider the complex nuances of nutrients and bioactive food components to better inform the design and interpretation of nutrition research.

Experts Emphasize Importance of Beta-Carotene The intake of preformed vitamin A from animal products is not sufficient in portions of the population in the U.S., Europe and Asia. The vitamin A precursor betacarotene therefore has an important function in providing for an adequate supply of total vitamin A, international carotenoid experts state in a recently published consensus answer. An appropriate intake of beta-carotene from diet, fortified foods and/or dietary supplements could safely compensate for the lack of vitamin A. However, based on recent data from national nutrition surveys, the dietary intake of beta-

carotene from food sources is insufficient in a substantial part of the population. Moreover, many people may suffer from a reduced ability to produce sufficient amounts of vitamin A from beta-carotene due to genetic variations. Consequently, experts are calling for guarantees that recommended intakes of beta-carotene are met, or if the current recommended dietary amounts for vitamin A are not met, that beta-carotene intake should be increased. Leading experts in the fields of medical and nutritional science from the U.S., Europe and Asia met at a Consensus Conference to elucidate the current knowledge with respect to physiological function, supply situation and intake

PepsiCo Investments Mark Growth in Functional Foods

In other investment news, PepsiCo agreed to acquire 66% of Wimm-Bill-Dann, Russia’s leading branded food and beverage company, for $3.8 billion pending the required government apCompany looks to expand coconut water and dairy provals. Following successful completion, PepsiCo will offer to acproducts. quire the remaining shares. According to PepsiCo, the transaction will raise the company’s annual global revenues from nutritious and Acquiring a majority stake in O.N.E. (One Natural Experience), Los functional foods from approximately $10 billion today to nearly $13 Angeles, CA, PepsiCo, Inc., Purchase, NY, has increased its investbillion. This moves the company closer to its strategic goal of buildment in the coconut water company. Terms of the transaction were ing a $30 billion nutrition business by 2020. Wimm-Bill-Dann is a not disclosed. This represents a second round of investment in leader in both traditional and value-added dairy products, with a O.N.E. by PepsiCo and Catterton Partners, a private equity firm solid position in juice. based in Greenwich, CT. “With demand, supply, distribution, con“Adding Wimm-Bill-Dann to PepsiCo’s portfolio is financially atsumer education and the capital to fuel tractive and gives us a strong, high-growth Rodrigo Veloso, O.N.E. founder and CEO, them all lining up, we expect 2011 to be the platform in the dairy category,” said Indra expects 2011 to be the year coconut year that coconut water goes mass marNooyi, PepsiCo chairman and CEO. “It also water goes mass market. ket,” said Rodrigo Veloso, O.N.E. founder gives us clear leadership in the food-andand CEO. beverage industry in Russia, a fast-growing, “Coconut Water is one of the fastest strategically important market offering growing categories in the U.S. beverage abundant opportunity. At the same time, market and one in which we see a great Wimm-Bill-Dann’s strong, value-added deal of potential. Our investment in O.N.E. dairy business immediately advances our is an investment in the future,” said Masglobal nutrition strategy to provide consimo d’Amore, CEO, PepsiCo Beverages sumers around the world nutritious foods Americas. “Since we first invested in O.N.E., just over a year ago, and beverages that are accessible, affordable and advantaged by the company has demonstrated to us that they have what it takes science. Dairy has a huge, untapped potential to bridge snacks and to succeed—a great product, a strong brand, experienced leaderbeverages. We see the emerging opportunity to ‘snackify’ bevership, deep understanding of the marketplace and robust supply.” ages and ‘drinkify’ snacks as the next frontier in food and beverage Supply had been a limiting factor for coconut water producers in convenience.” 2010, but O.N.E. has successfully addressed the issue by developHealth and wellness trends around the globe are accelerating, ing strong partnerships with three of the largest coconut processors and dairy products offer several fundamental health and nutrition in the world, based in the Philippines and Indonesia. With the inbenefits, including natural ingredients like calcium and protein, as vestment, distribution of the full line of O.N.E. coconut water-based well as functional benefits like bone health. In Russia, the dairy marbeverages—including O.N.E. Coconut Water, O.N.E. Active and ket has grown at a rate of 22% since 2006 to $17 billion, and is exO.N.E. Kids—will extend beyond the current predominantly warepected to grow at a low-double-digit rate for at least the next three house distribution to include expanded DSD distribution through years. Over the next five years, Russia is forecast to be one of the PepsiCo’s bottling arm, Pepsi Beverages Company, in 2011. largest contributors to global dairy growth.

18 • Nutraceuticals World

www.nutraceuticalsworld.com

January/February 2011

Industry News

recommendations of beta-carotene. The experts reached an agreement formulated in a consensus answer published recently in The Journal of Nutrition.

Clinical Review Concludes Probiotics Offer Kids Benefits An American Academy of Pediatrics report published in the journal Pediatrics has reviewed the currently known health benefits of probiotic and prebiotic products, including those added to commercially available infant formula and other food products for use in children. According to the report, use of probiotics has been shown to be modestly effective in randomized clinical trials (RCTs) in treating acute viral gastroenteritis in healthy children and preventing antibiotic-associated diarrhea in healthy children. There is some evidence that probiotics prevent necrotizing enterocolitis in very low birth weight infants (birth weight between 1000 and 1500 grams), but more studies are needed, the report says. The results of RCTs in which probiotics were used to treat childhood Helicobacter pylori gastritis, irritable bowel syndrome, chronic ulcerative colitis and infantile colic, as well as in preventing childhood atopy, although encouraging, are preliminary and require further confirmation. Probiotics have not been proven to be beneficial in treating or preventing human cancers or in treating children with Crohn’s disease. There are also safety concerns with the use of probiotics in infants and children who are immunocompro-

mised, chronically debilitated or seriously ill with indwelling medical devices. There is a paucity of RCTs examining prebiotics in children, although there may be some long-term benefit of prebiotics for the prevention of atopic eczema and common infections in healthy infants. Confirmatory well-designed clinical research studies are necessary, the report concluded.

Private Equity Firm Acquires Santa Cruz Nutritionals Levine Leichtman Capital Partners (LLCP), Los Angeles, CA, a private equity firm, has partnered with management to complete the acquisition of Santa Cruz Nutritionals (SCN), Santa Cruz, CA, a manufacturer of gummy-based nutritional products and dietary supplements. The company has developed proprietary formulations and a unique manufacturing process that deliver active ingredients through chewable products. SCN maintains longstanding relationships with many of the leading retailers and consumer product companies in the world. SCN is the seventh investment from Levine Leichtman Capital Partners, IV, L.P., a $1.1 billion private equity fund.

SunOpta Fortifies Healthy Foods Platform SunOpta Fruit Group, a subsidiary of SunOpta Inc., Toronto, Ontario, Canada, has signed an agreement to acquire Edner of Nevada, Inc. for $4 million. Edner produces a variety of nutritious portable foods—such as nutrition bars and grains

and fruit-based snack bars serving the fastgrowing wholesome and convenient healthy snacks category—from its 104,000 square foot facility in Carson City, NV. Current revenues are approximately $10 million, with equipment and capacity available to support an increase of revenues to approximately $50 million without significant capital investment. Edner’s existing operational capabilities will also enable SunOpta to extend the breadth of its fruit-based product offerings via the introduction of new products utilizing the capabilities that exist within this facility.

Resveratrol Supplement Price Inconsistent with Quality ConsumerLab.com, White Plains, NY, reported that tests of supplements containing resveratrol—a compound promoted as “life-extending”—revealed that two products provided only 43.4% and 86.7%, respectively, of their listed amounts of resveratrol. These two products were among the most expensive supplements of the 10 products selected for testing. All of the lower-priced products fared well in the tests. An additional nine products that passed the same testing through ConsumerLab.com’s Voluntary Certification Program are included in the report as well as another product similar to one that passed testing but sold under a different brand name. Resveratrol products have proliferated following reports in 2006 of life-extending and athletic endurance-enhancing effects of resveratrol in animals.

Recent Certifications & Approvals India-based Natural Remedies has obtained GMP certification from NSF International. The certification ensures the company’s manufacturing facility is compliant with NSF/ANSI Standard 173, Section 8 Dietary Supplements, which is consistent with FDA’s GMP requirements. Van Drunen Farms (VDF) FutureCeuticals, Momence, IL, has obtained Generally Recognized As Safe (GRAS) approval for its patented CoffeeBerry products, including CoffeeBerry whole fruit powder, CoffeeBerry juice concentrate powder and CoffeeBerry Forte soluble concentrate, following a comprehensive evaluation of CoffeeBerry, its toxicology profile and published research by an independent expert panel. NP Nutra has received new kosher certification from Earth Kosher for more than 200 ingredients, including several acai extracts, acai juice powder, various acerola extracts, bamboo, beet, bilberry, camu camu, cha de bugre, chlorella, cocoa, coconut, cranberry, goji, guarana, maca, mangosteen, maqui, noni, pomegranate, spirulina and yumberry. NP Nutra’s kosher certificate is valid worldwide and is good through November 2011.

January/February 2011

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Nutraceuticals World • 19

Industry News

Sales of resveratrol supplements reached $31 million in the U.S. in 2009, according to Nutrition Business Journal. In addition to quality issues, ConsumerLab.com found the daily suggested dosage among resveratrol products to range from 50 to 1020 mg of resveratrol. The cost to obtain 100 mg of resveratrol from products ranged from $0.15 to as much as $2.76— more than a 17-fold difference. Based on a daily dose of 400 mg of resveratrol, the daily cost would range from $0.60 to $11.04. None of the products were contaminated with lead or cadmium, which can occur in plant-based supplements, and all tablets were able to properly break apart in solution.

U.S.-China Trade Association Presents at China Conference Jeff Crowther, executive director of the U.S.-China Health Products Association (HPA), recently gave a presentation on the U.S. regulatory and market environment for dietary supplements in Hangzhou, China. In his speech, Mr. Crowther discussed how DSHEA allows access to a wide variety of supplements to consumers, but at the same time has created one of the

safest environments in the world, which has been further enhanced by the passing of Good Manufacturing Practices (GMPs) and Adverse Event Reporting legislation. He also highlighted the need for regulatory change in China. The potential for China to transform itself from a destination to source ingredients to a leading market of finished products can be achieved with appropriate regulatory reform, he said. However, China’s current regulations are among the most stringent in the world, resulting in a lack of product variety and encouraging the creation of gray and black market activity that is becoming detrimental to the safety and confidence of the entire industry. China’s regulators have created a system that lacks transparency, resulting in barriers to trade, which are hindering the further development of the industry. The conference in Hangzhou, China follows two previous symposiums Mr. Crowther attended in Hefei and Beijing in which he lectured on similar topics. Both of these events were organized by China’s Ministry of Commerce’s Chamber of Natural Products and Pharmaceuticals as well as some of China’s top firms dealing with dietary supplement ingredients and finished goods.

Patents Albion Human Nutrition, Saint Clair Shores, MI, has received a new patent, titled “Hypoallergenic Metal Amino Acid Chelates and Metal Amino Acid Chelate Containing Compositions.” U.S. Patent #7,838,042 relates to the composition, preparation, administration and formulation of hypoallergenic metal amino acid chelates and products containing hypoallergenic metal amino acid chelates. It addresses a growing health problem throughout the world: the increasing incidence of food and chemical sensitivities and allergies. The chelates produced via this patented method may be able to be used by the vast majority of people reported to suffer from these allergy and sensitivity problems. PureCircle, Oak Brook, IL, has obtained three new patents from the U.S. Patent and Trademark Office. The three patents cover a wide range of processes and methods across PureCircle’s entire stevia product portfolio and date back as early as December 21, 2004. Specifically, the technologies in these patents establish the process that can be used for manufacturing high purity steviol glycoside extract (SG95) and different components, such as Reb A and Stevioside, which could not be achieved with earlier technology on a commercial scale. As part of these patents, the processes and methods for developing PureCircle’s products such as Reb A 97, SG95 and enzyme treated stevia products are covered, including their usage across the entire breadth of product categories, from food and beverage to cosmetics.

20 • Nutraceuticals World

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January/February 2011

Business Insights

The healthy human gastrointestinal tract is home to 100 trillion microorganisms (roughly), which help promote healthy GI function, systemic metabolism and immune function. Unfortunately, many diets today are deficient in these essential microorganisms or “healthy” bacteria for a variety of reasons, including processing of foods and sterilization of the food supply. As awareness of the

Probiotics: Benefits Beyond Gut Health The future of probiotics presents both challenges and opportunities.

By Gregory Stephens, RD

Greg Stephens is vice president of strategic consulting with The Natural Marketing Institute (NMI), Harleysville, PA. His background includes 25 years of specialized expertise in the nutritional and pharmaceutical industries. Most recently he was vice president of Nurture, Inc. Prior experience also includes a progressive series of management positions with the Ross Products Division of Abbott Laboratories, including development of global nutrition strategies for disease-specific growth platforms and business development for Ross’ medical foods portfolio, including such products as Ensure and Glucerna. He can be reached at [email protected]. 22 • Nutraceuticals World

benefits of probiotic consumption emerges, the need for more effective and consumer-friendly sources will continue to grow so consumers can benefit from these mighty bacteria. During focus groups with primary grocery shoppers about 10 years ago, the concept of foods with added probiotics elicited fairly consistent reactions. In fact, a question from one participant summed up the consensus from multiple groups in several U.S. cities: “Let me get this straight—you expect me to eat food that you’ve added live bugs to?”

Fortunately, U.S. consumers have become more educated since then, which means probiotics are reaching more mainstream consumers and becoming a significant mass market opportunity. As the probiotic market continues to gain momentum, it will represent significant opportunities in both dietary supplement and functional food applications. Recent research from the Natural Marketing Institute (NMI) provides insights into how consumers perceive these healthy bacteria. These insights underline both the challenges and opportunities in this rapidly growing market. Awareness of Probiotics Consumer awareness of the term “probiotics” has grown from a mere 9% in 2002 to 60% of U.S. adults in 2009—a 567% increase in awareness in only eight years. Much of the increase may be attributed to media exposure and marketing of yogurts and other dairy products praising the benefits of healthy bacteria. In fact, much of the rapid increase in awareness occurred after 2006, the year Activia was launched in the U.S. There is an unmet need affecting the increasing awareness, however, including an aging population with a high inci-

Figure 1: Percent of Consumers who Associate Specific Benefits with Probiotic Consumption

Source: Natural Marketing Institute (NMI) www.nutraceuticalsworld.com

January/February 2011

Business Insights

dence of digestive conditions and emerging research substantiating a link between a healthy GI tract and increased immune health, energy, skin health and weight loss. But still, while awareness has shown some dramatic gains, the use of probiotic foods is much lower, with about 17% of the population indicating they have used probiotic-enriched foods in the past 30 days. And slightly more than one in 10 indicates they use probiotics in supplement forms. There are many ways to increase probiotic usage rates. But perhaps most crucial, many consumers simply lack clear understanding of the benefits. This factor may be one of the major barriers to consumer usage, as NMI research reveals consumers show very low and fragmented understanding of how probiotics can benefit their health. Perceived Benefits Figure 1 (previous page) illustrates the

benefits consumers associate with probiotic use. Only one of five associates probiotics with digestive health. After digestive health, very few understand any other benefits of probiotics, thereby limiting the value of probiotics in their minds. Since most digestive problems are acute, consumers may not be concerned about digestive problems until a problem actually occurs, lessening the perceived need for continued use of a probiotic product. According to NMI’s Supplement/OTC/Rx Database, the top reasons probiotic users listed as to why they stop using probiotics center around lack of perceived need: “I only use it when I need it” (28%); “No longer managing the issue I was taking the product for” (25%). Increasing Consumption While government regulations limit communication of the benefits of probiotics via health claims, the industry may need to expand messaging of these bene-

fits to increase both trial and compliance. Interestingly, current users of probiotics index high compared to the general population for many “emotional” conditions, including stress, sleeplessness, anxiety and depression. This connection opens up an array of opportunities for expanded indications (supported by research), line extensions or simply a novel point of differentiation. Consumers are taking more responsibility for their health and are increasingly looking toward food and supplements to help them meet their needs. This marks a slow but progressive movement toward a preventative form of health management. Consumers want to be involved in their health management and show a strong willingness to use nutrition as well as other new and emerging methods to ensure their health. This openness to new methods of maintenance should allow continued growth for the probiotics industry across a variety of health issues NW and product applications.

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Nutraceuticals World • 23

Capitol Comments

One of the biggest stories of 2010 should be Congress’s effort to pass legislation increasing the regulation of dietary supplements and similar products. The first shot was fired in February when Senator John McCain introduced the “Dietary Supplement Safety Act of 2010,” which proposed tough, and many would say, unreasonable provisions regarding adverse event reporting, new dietary in-

Congress & Food Safety Reform Efforts to secure the food supply may spill over to dietary supplement territory.

By Todd Harrison & Andrew Bigart

Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004; Telephone: 202-344-4724; Email: [email protected]. Andrew Bigart is an associate at Venable LLP where he focuses on consumer protection and business counseling. 24 • Nutraceuticals World

gredients (NDIs) and mandatory recall authority for FDA. Although the McCain bill stalled in response to strong industry opposition, it remains to be seen—as this issue goes to press—whether Congress will get off a final shot in the form of FDA’s Food Safety Modernization Act (S. 510, the “bill”) before the end of the lame duck session in December. The bill, which addresses food safety generally, includes several controversial provisions that could impact the dietary supplement industry, including facility registration, mandatory FDA recall authority and provisions that require the FDA to promulgate NDI guidance. What to Expect if the Food Safety Bill Passes After months of false starts, on November 30, 2010 the Senate passed the bill by a 73-to-25 vote. To expedite passage of the bill during the lame duck session, and to avoid a Conference session, the Senate and House struck an agreement that the House would vote directly on the Senate version of the bill, thus avoiding the need for a conference committee to reconcile the differences bewww.nutraceuticalsworld.com

tween the Senate and House versions. As mentioned previously, the Senate bill contains several controversial provisions that could directly impact the dietary supplement industry. Many industry experts believe the reforms are unnecessary and that FDA already has sufficient regulatory authority to ensure consumer safety. In this vein, adoption of the bill would substantially expand the scope of regulation and impose undue hardship on the dietary supplement industry without any corresponding gains in safety. Congress, however, seems determined to pass comprehensive food safety reform—whether in 2010 or 2011. The following summarizes the key provisions that could impact the dietary supplement industry. Importantly, from the dietary supplement perspective, the bill does not include any provisions requiring harmonization with CODEX, or any of the provisions that would have imposed a 10-year jail sentence for certain violations of FDA rules. New Dietary Ingredients: Perhaps of most interest to the dietary supplement industry, the bill would require FDA, within 180 days of enacting this legislation, to publish guidance that clarifies: • When a dietary supplement ingredient is an NDI; • When the manufacturer or distributor of a dietary ingredient or dietary supplement must provide FDA with information concerning the history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe; and • The evidence needed to document the safety of NDIs, and appropriate methods for establishing the identity of an NDI. January/February 2011

Capitol Comments

The NDI provision in particular has caused a stir among many in the dietary supplement industry. An aggressive interpretation of the NDI provisions could force notifications for ingredients that have been on the market for years with no reported safety problems, such as probiotics. A few examples of aggressive FDA interpretation include: • FDA has taken the position that potato protein is an NDI, despite the long history of use of potatoes as food. • FDA could require an NDI notification for each product containing an ingredient. In other words, every company in the stream of commerce that combined the ingredient with other ingredients would need to submit a new NDI notification. • FDA has taken the position that affidavits are not sufficient evidence to substantiate prior marketing of a product. Rather, FDA has indicated that companies must provide actual marketing materials. Mandatory Recall: The bill authorizes FDA to order the mandatory recall of food that has a reasonable probability of being adulterated or misbranded and where exposure would cause serious adverse health consequences or death to humans or animals if the responsible party does not voluntarily recall the food. The wording of this provision represents a small victory for the dietary supplement industry, as a similar provision proposed in the McCain bill would have required mandatory recalls for misbranded supplements, even where there was no risk of serious adverse health consequences. Biennial Facility Registration: The bill requires each facility engaged in manufacturing, processing, packing or holding of dietary supplements to register with FDA and re-register every two years. The FDA may suspend a facility’s registration if there is a reasonable probability that food from the facility could cause serious adverse health consequences or death to humans or animals, and such suspension may be extended to any facility that created, caused or was otherwise responsible for creating the health risk, or any facility that knew of, or had reason to know of, such risk, and packed, received, or held such food. January/February 2011

Hazard & Risk-Based Preventative Controls: Although the bill requires food facilities to implement hazard analysis and risk-based preventative controls, it also provides that no additional obligations be imposed on dietary supplement facilities already in compliance with the dietary supplement cGMP provisions in the Federal Food, Drug, and Cosmetic Act. Miscellaneous Provisions: Finally, the bill contains numerous other provisions that could impact the dietary supplement industry, including the requirement that importers establish a foreign supplier verification program, increased FDA authority to access food-related records and test results, and revised standards for food detention, among others. As We Went to Press… Just when it looked like the passage of the bill was a done deal, and as this issue went to press, House staffers discovered the Senate bill contained a revenue-raising provision that violates the Constitution’s requirement that all revenue-raising bills originate in the House. The House has sent the bill back to the Senate with instructions to fix it. The Senate, however, has few options for a quick fix—and any modifications to the bill will require unanimous vote. As a side note, Sen. Tom Coburn (R-OK), a noted fiscal hawk, has already stated that he will oppose the bill. Moreover, all 42 of the Senate Republicans have signed a pledge that they will filibuster any legislation during the remainder of the lame duck session that is not directly related to taxes and spending. Given the number of times the food safety bill has been pronounced dead, it seems pointless to speculate on whether Congress will pass the bill before the end of the lame duck session in December. What is clear, however, is that Congress is keenly interested in food and dietary supplement reform. And whether this year or next, the dietary supplement industry should brace for the possibility of sweeping regulatory changes, touching on many of the core principles included in the food safety bill—especially facility registration, mandatory recall and guidNW ance on NDIs. www.nutraceuticalsworld.com

Nutraceuticals World • 25

Eurotrends

The Health Claim Regulation, meant to unify all of Europe as far as product labeling is concerned, continues to make headlines. Most recently, the widespread rejection of generic article 13.1 claims are causing the stir. These claims were in use before the new regulation came into effect, e.g. “calcium is good for bones.” Of the 44,000 claims originally submitted to the national authorities, 4185 claims ended up

EU Health Claims Update EFSA has issued more rejections for the latest batch of generic claims.

By Joerg Gruenwald

Dr. Joerg Gruenwald is president of analyze & realize ag, a specialized business consulting company and contract research organization (CRO) in the fields of nutraceuticals, dietary supplements, herbals and functional food. He is also the author of the PDR for Herbal Medicines. He can be reached at analyze & realize ag, Waldseeweg 6, 13467 Berlin, Germany; 49-3040008100; Fax: 49-30-40008500; E-mail: [email protected]; Website: www.analyze-realize.com. 26 • Nutraceuticals World

on the Commission’s consolidated list—the rest were considered duplicates or badly documented claims. The consolidated claims are currently being evaluated by the European Food Safety Authority (EFSA) based on “generally accepted scientific evidence”—the goal being to evaluate all nonbotanical claims by June 2011. The evaluation of claims on botanicals or herbal extracts will be postponed for the time being, since the present EFSA criteria on scientific evidence for claim substantiation are conflicting with the low requirements for claim substantiation for traditional herbal medicines. This would lead to an absurd situation in which claim substantiation for an herbal supplement would have to fulfill higher scientific standards compared to herbal drugs. The industry is awaiting a resolution for this discrepancy, which will hopefully come by next fall. The third batch of generic article 13.1 claims was published last October, again with a devastating result for the industry. With each batch of published opinions, it has become clearer that EFSA is applying the same strict criteria it does for article 13.5 and 14 claim opinions. Of about 500 claim opinions published in October 2009, 105 www.nutraceuticalsworld.com

opinions were positive. Of 416 claim opinions published in February 2010, only six were positive. Of 808 health claims assessed in October 2010, 162 were positive. It is important to know, however, that the evaluations by EFSA are not yet legally binding. The positive list of generic claims has to be enforced by the EU Commission, which is expected to happen by the end of 2011. The transition period for negatively evaluated claims will therefore end by mid-2012. The consequences of the many rejections are far-reaching for the industry. Labeling needs to be changed, as no longer permissible claims must be removed. In many cases, packages need to be redesigned. The compositions and formulations of products must be changed. All this will incur costs that will lead to a shake-up in the market and put certain products at a competitive disadvantage. The industry is responding with heavy lobbying activities, headed by food associations such as CIAA, ERNA and EHPM. Their efforts are directed toward the submission of additional scientific material, the stop of batch-wise approval of article 13.1 claims, for a better dialogue with EFSA and the Commission, and for more transparency of the evaluation criteria. But criticism directed toward EFSA’s handling of claim applications does not originate from within the industry alone. Voices being raised from within EFSA point out that the EC’s guidance on article 13.1 claim evaluation has been inadequate. While for articles 13.5 and 14 claims the applicant submits a full dossier with all the available evidence, the article 13.1 claims are generic. This means that there is no“full body of scientific evidence” readily available to the EFSA panel that evaluates the claims, and the EC never clearly stated what level of evidence would be considered sufficient. Also, since no single applicant submitted the claims, EFSA had no point of contact for follow-up questions. January/February 2011

Eurotrends

“Voices being raised from within EFSA point out that the EC’s guidance on

tween a food and a health benefit has been demonstrated, rather than seeking absolute proof,”one critic said. In any case, implementation of the new Regulation is causing a lot of money to be spent, and another point raised against it is the fear that it will stifle innovation. At the same time, supporters are claiming the exact opposite (i.e., that innovation will be

stimulated). Regardless, it is a highly controversial situation. The EU commission has meanwhile stated that it will ditch the batch-wise assessment of article 13.1 claims. Still, the next opinions will only be issued in June, 2011. This means that, in addition to all other criticism directed at it, EFSA is way NW behind schedule.

article 13.1 claim evaluation has been inadequate.” add value to your brand

January/February 2011

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The key issue here is the“full body of evidence.” With articles 13.5 and 14 claims, it is the applicant’s responsibility to submit complete evidence, but what is the complete body of evidence for generic claims? Is it really the EFSA panel’s responsibility to “guess what is out there,” as Seppo Salminen, a member of the NDA panel at EFSA, put it in a recent statement? He went on to say, “Sometimes there were discrepancies between what data is available [to support a claim] and what was actually submitted to us for assessment.” True, the high rejection rate sounds devastating. But, as Mr. Salminen said, “Looking at the data for the 4600+ article 13.1 claims, I don’t think many people would come to different conclusions than the [NDA] panel.” There is also an issue with the woeful quality of applications. In fact, references provided to support them were in many cases far from“academic”(i.e., excerpts from the Old Testament, Wikipedia, a Tea Association press release, a Royal Air Force report and the American Heritage Dictionary, to name a few). Some critics even go so far as to say that EFSA’s approach to assessing scientific evidence is not consistent with the wording of the legislation.“The Health Claims Regulation states that we should look at the totality of the available data. It also says that you have to weigh the evidence, and look at the extent to which a causal relationship be-

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Nutraceuticals World • 27

Quality Focus

In the November 2010 issue, this column described the GMP regulation as a puzzle. With help from NIST colleagues, one piece of the puzzle was described—a program that exists to help labs demonstrate their competence. As it turns out, NIST has even more programs that can assist this industry in achieving GMP compliance. Frequently overlooked in discussions of

GMPs: The Other Pieces of The Puzzle NIST continues to learn valuable lessons about the challenges facing the dietary supplement community.

By Paula Brown, Melissa Phillips, Catherine Rimmer & Laura Wood

Paula Brown has supported the natural health and food industry for more than a decade by conducting applied research on product quality, safety and efficacy. Ms. Brown was appointed Fellow of the AOAC in 2009 after serving five years as General Referee, six years on the Dietary Supplement Task Force, participating on seven Expert Review Panels, and directing three collaborative studies. She sits on the American Botanical Council Advisory Committee, the Natural Health Products Program Advisory Committee for Health Canada, grant review committees for NCCAM, and Chairs NSF’s Joint Committee for Dietary Supplements. She is the director, Integrative Bioscience Research Cluster, at the British Columbia Institute of Technology. She can be reached at [email protected]; Website: www.bcit.ca/appliedresearch/ibrc/. 28 • Nutraceuticals World

the dietary supplement GMPs is the level of trust that FDA placed in the industry’s ability to manufacture high-quality products. The government was not prescriptive in the GMP. They did not dictate the standards and tests that this large and highly diverse industry would have to use for assuring their products were safe and of high quality. Individual manufacturers are required to set their own specifications and to test against specifications. Again, FDA didn’t tell companies how to test, it just laid out simple ground rules with descriptors like “scientifically valid” and “suitable for intended use.” With trust comes great responsibility. If the government tells you that you must do “something” but does not say exactly what that “something” is, then you’re going to have to figure it out yourself. In that context, the more options you have that allow you to fulfill the mandate, the better off you are. In past columns different sets of tools have been discussed, such as analytical methods validation, materials and test methods for identification and chemical calibration standards. One very nifty tool in the dietary supplement analytical toolbox is matrix reference materials, which can aid in the development of methods and supwww.nutraceuticalsworld.com

port laboratory performance. Previously the Dietary Supplements Laboratory Quality Assurance Program (DSQAP) run by NIST was introduced as providing an overview of relative performance within the dietary supplement laboratory community. In truth this program can provide much more than training and performance overview, so I will now turn the column over to my colleagues at NIST to explain how to get the most out of this unique (and free!) program. The NIST Program for Dietary Supplements The constantly changing dietary supplement market and the high degree of innovation that creates an enormous diversity of finished products makes repeated determination of a few target compounds in a single matrix of little use to participants. The wide range of matrices and analytes under the “dietary supplement” umbrella means that not every laboratory is interested in every sample or analyte. Instead, participating laboratories are interested in testing in-house methods on challenging, real-world matrices to demonstrate that their performance is comparable to that of the community. They aren’t interested in analyzing, say, a ginseng product if they’re not in the business of manufacturing ginseng products, and they need to know that they’re getting the right answers when they analyze their own products. In an area where there are few standard methods, the DSQAP offers a unique tool for assessment of the quality of measurements and can provide feedback to labs that lets them know how well they are performing. Importantly, it can also help them troubleshoot and improve their operations. For every analyte and matrix of the DSQAP exercises conducted to date, statistical outliers have been identified in the data. For some analytes and matrices, more laboratories were outliers than were in January/February 2011

Quality Focus

“For every analyte and matrix of the DSQAP exercises conducted to date, statistical outliers have been identified in the data. For some analytes and matrices, more laboratories were outliers than were in consensus!” consensus! While on the surface this can be upsetting for those laboratories involved, in the overall scheme of the DSQAP, these exercises offer the most important information to the dietary supplement community—a chance to identify and resolve analytical problems from a large set of independent data. Take for example the analysis of saw palmetto materials. In this exercise, participants were asked to measure phytosterols in saw palmetto berries as well as in saw palmetto extract, which is an oil. Measurement of phytosterols in saw palmetto extract by GC-MS requires only that hydrolysis and derivatization be performed, while analysis of berries requires an extraction step, followed by the hydrolysis and derivatization. The results of the first saw palmetto exercise were widely scattered and the consensus values were significantly lower than expected. The methodological information provided by participants did not elucidate the cause of problem. In the subsequent exercise, participants were sent the same two saw palmetto products, as well as a solution containing the three phytosterols in an appropriate solvent—the idea being that the solution would require only derivatization, removing one level of complication (the hydrolysis) from the analysis. The results from the second exercise were no less scattered, but based on the methodological information, it was clear that laboratories were performing all three sample preparation steps on all of the materials in an effort to use consistent practices for all products. Theoretically, this is an analytically appropriate approach to phytosterol analysis; however, January/February 2011

use of unnecessary sample preparation steps was shown to increase variability in the measurement. In spite of the increased variability, it was evident that most laboratories had properly performed the derivatization and that the most significant source of low values in the berry material was due to incomplete extraction. Several recommendations were offered to participants, including adaptation of sample preparation procedures based on prior knowledge of the sample. Another interesting problem was seen in the analysis of lead (Pb) in ginkgo leaves and extract. In general, results from elemental analysis studies have a much tighter consensus range than the studies of organic compounds like the phytosterols discussed above. The results for lead in both the control and the unknown sample showed both within- and between-laboratory precision. However, there was an apparent discrepancy between the consensus values achieved by the participating laboratories and the target values, representing the NIST certified values. After a closer look, the difference between the consensus and target values corresponded to the amount of moisture in the ginkgo materials. The NIST certified values are reported in the Certificates of Analysis as“dry-mass”basis, indicating that they have been corrected for some amount of water content determined at the time of certification. Participants, however, had been asked to report lead values“as-received.” This provided a concrete example of the importance of reading the fine print. When using a certified reference material as a quality control material, results must be compared on the same basis—either as-received or dry mass, dewww.nutraceuticalsworld.com

pending on how the values are expressed in the Certificate of Analysis. For a final example, consider the analysis of niacinamide in infant formula. Niacinamide was chosen as a test case because it is water-soluble, easy to extract and stable compared to other vitamins. In addition, the fortified levels in infant formula are relatively high, at around 100 µg/g. The results of the first niacinamide study were shocking—participants reported values ranging from 5 µg/g to 500 µg/g. The methodological information provided by participants did not indicate that the extraneous data were correlated with a specific type of analysis (i.e., microbiological assay or LC determination). In the subsequent exercise, the same infant formula sample was distributed, accompanied by a common reference standard (500 mg USP niacinamide, donated by the USP). The reported range for the second study was 90 µg/g to 150 µg/g, and if the maximum and minimum reported values are excluded, the range tightens to 100 µg/g to 115 µg/g. In addition, the consensus range was contained within target range—an ideal situation for the DSQAP. The take-home message here is that characterization of the chemical reference standards used in calibration is of utmost importance. When reference standard purity is removed from the equation, as demonstrated here by having all participants use a common, high-quality chemical reference material, the consensus range is much tighter. Through the first five exercises, NIST staff and participants have learned valuable lessons about the challenges facing the dietary supplement community. Based on participant recommendations, future exercises will include a wider variety of samples to allow participants to demonstrate their comparability to other laboratories in NW the community. Editor’s Note: To get your laboratory involved in the DSQAP, send an email to [email protected]; you will be added to the mailing list for notification of upcoming exercises and events. For more information or to see reports from past exercises, visit the website at www.nist.gov/mml/analytical/dsqaprogram.cfm. Nutraceuticals World • 29

The

Next Frontier

for Nutrition Bars

The market continues to hold its own, but falling consumption and product saturation may threaten future growth. By Rebecca Wright Editor

W

hile the economy has not been kind to businesses, the nutrition bar market may be an exception. According to Lu Ann Williams, head of research at Netherlands-based Innova Market Insights, the downturn has not had a great impact on global new product launch activity for nutrition bars, with 2010 product launch numbers being similar to that of 2009. “Innovation has also not been stifled, with various ingredient, flavor and format innovations apparent in recent times,” she said. “If anything, consumption rates would have increased as consumers are eating out less to save money and nutrition bars offer healthy convenience for multiple consumption occasions,” she added. That being said, nutrition bars seem to be struggling with a demographics problem. According to a 2009 “Nutrition & Energy Bars” report from Mintel, Chicago,

30 • Nutraceuticals World

IL, Hispanics and males with children are two demographics that are avid consumers of nutrition/energy bars. Yet a review of commercial spots and web pages reveals that energy bars are typically marketed to men aged 18-24, and dads are left out, the market research firm claims. Mintel’s exclusive research also shows a pronounced link between exercise, performance and purchase. Therefore marketers may want to explore and leverage this finding by creating sport-specific nutrition/energy bars—products customized to improve the performance of the individual based on the activity (i.e., golf, football, baseball, etc.). Satiety is another angle bar companies may want to consider. According to a 2010 Gallup study on satiety, more than half (55%) of current dieters/weight managers have heard of or read about specific types of foods/beverages that can help www.nutraceuticalsworld.com

them feel fuller longer. And according to Ms. Williams, the satiety benefit is ripe for growth.“Various manufacturers are using protein and fiber combined in formulations to keep hunger at bay,” she said. “Common claims include ‘to help you stay satisfied’ or ‘keeps you fuller for longer.’ Kashi GoLean Chewy Bars is a current product exemplifying this trend.” In a similar vein, Ms. Williams pointed out, “Product launch numbers with a weight management positioning have remained steady over recent years. Ingredients such as CLA (conjugated linoleic acid) may find more nutrition bar appli-

This article in a nutshell: • The numbers • The latest launches

January/February 2011

Nutrition Bars

cations and this may well be the next trend for weight management. “The primary benefit of nutrition bars is the convenience they provide for snacking on-the-go, and for this very reason products that can offer a secondary benefit such as satiety and other weight management attributes are well received by consumers, particularly weight conscious females,” she added. Bars that are condition-specific could also be another positioning to exploit. “Marketers may also want to start looking to the Asian functional beverage market for inspiration and direction. Product claims that ameliorate certain common ailments and complaints may be enticing for those purchasing nutrition and energy bars,” Mintel said in its 2009 report.“Antiaging properties, ingredients to build muscle mass, functional ingredients that improve skin tone or help keep away wrinkles are but a few examples of benefits that can be touted.” On the other hand, a return to basics may sell more bars as well, Mintel says. A January 2009 article in The New York Times suggests that fruit and nut bars made from a small number of ingredients and with little processing are generally healthier, and more importantly, may mark the next step in the evolution of the nutrition/energy bar. Kerry Watson, Manager, SPINS Product Library, agreed. “Many shoppers

today tend to look for healthy options like whole-food-based bars or even raw food varieties,” she said. “Gluten free is another trend that has found it’s way into this category.” In terms of ingredient developments, Ms. Watson said prebiotics, probiotics, EFAs (flax, hemp, pumpkin seed) and green foods are the most popular right now. As far as flavors go, she added that chocolate and peanut, both alone and in combination, as well as berries, nuts and seeds are all happily accepted by consumers. She said certain brands have also won consumers with less common flavors, such as coconut, lime, coffee, cinnamon and tropical fruits. As far as actual product launches, Tom Vierhile, director—Product Launch Analytics, Datamonitor, Canandaigua, NY, said as of December 6, 2010 there were 526 new SKUs for bars in the market compared to 383 SKUs in 2009. See Table 1 for his rundown of the latest trends among bar products.

The Numbers SymphonyIRI Group (Chicago, IL) estimates show that the snack bar/granola bar category brought in a little more than $3 billion in 2010 (Latest 52 Weeks Ending Oct 31, 2010; TOTAL U.S. FDMxC—supermarkets, drugstores, gas/c-stores and mass market retailers, excluding Wal-Mart,

Table 1: Nutrition Bar Trends At-A-Glance

High fiber products (Examples: Life Soft Baked Nutrition Bars, Kellogg’s FiberPlus Antioxidants Bars Nuts as the main attraction (Examples: Planters Nut-trition, Balance Bare) “Naked” or raw food bars that are not enrobed in chocolate so you can see the ingredients (Examples: Balance Bare, PowerBar Pure & Simple, KIND Fruit & Nut Bars) High antioxidant levels and/or superfruit ingredients (Examples: PomX Antioxidant Superbar, Nutri-Grain Superfruit Fusion) Increasingly functional (Examples: FullBar, Winetime Resveratrol Bar) Launching bars that don’t look like traditional bars or candy bars (Examples: Corazonas Heart Healthy Squares, Quaker True Delight Squares) High protein contents and other “good for you” ingredients like whole grains (Example: Wheaties Fuel Energy Bars) Focusing on weight control/management (Example: FullBar) or longer-lasting energy Source: Datamonitor, Product Launch Analytics January/February 2011

www.nutraceuticalsworld.com

club stores and liquor stores). This includes everything from granola bars to cereal bars to nutrition bars. The latter posted $1.13 billion in 2010 (Latest 52 Weeks Ending Oct 31, 2010; TOTAL U.S. FDMxC—supermarkets, drugstores, gas/cstores and mass market retailers, excluding Wal-Mart, club stores and liquor stores). Per SymphonyIRI figures, some of the top performers in the nutrition bar category include: General Mills Fiber One Bars ($156 million); Clif Bar ($112 million); Kellogg’s Special K Protein Bars ($89 million); Zone Perfect ($67 million); and Clif’s Luna Bars ($56 million). SPINS data show that “Energy Bars & Gels” brought in $462 million in 2009 between the natural and conventional channels, which had sales of $61 million and $401 million, respectively. Sales growth dipped into the negative in the natural channel (-.5%), while in the conventional channel the category made a modest gain of 4.5%. Commenting on the performance of specific bar categories in its latest report, Mintel said diet bars are falling out of favor, wellness bars are on the rise and athletic bars are declining. In actuality, wellness bars are stealing market share from diet bars and athletic bars. Based on Mintel figures, the overall nutrition bar market posted $570 million in sales in 2008. Broken down further, the diet category raked in $221 million, the wellness category $240 million and the athletic category $109 million. Although diet bars are struggling, Mintel says 33% of consumers eat nutrition/energy bars as an alternative to dieting. To capture these consumers, the market research firm suggested companies position bars as less expensive alternatives to diet plans—an appealing message in a down economy. Brands such as Kellogg’s Special K and Zone have survived for the most part, Mintel claims, because these bars appeal to consumers who may not be on specific diet plans but are seeking convenient healthy snacks and meal replacements. The Innova Database records that globally more than 1600 cereal bars were launched in the first 11 months of 2009, up from the same period in 2008, but well Nutraceuticals World • 31

Nutrition Bars

down from the total of more than 2000 launched in the same period in 2007. Innova says further that the majority of launches have a health positioning, particularly in the U.S., where more than 90% of the launches recorded had a health positioning of some kind, compared with just more than 80% in Western Europe. Innova’s Ms. Williams commented on more specific developments. “Within the nutrition bars market, traditional-style energy bars are having to compete with a range of other health-oriented bars, not only those positioned on a general or multibenefit platform, but also on a range of formats that are currently very much in vogue, including wholegrain, high fiber, weight management, digestive health, free-from and natural,” she said. For the future, Ms. Williams predicted, “With the high levels of product activity apparent in the bars market in recent years, it may be that a saturation point is approaching, with market maturity and segmentation reaching a point where further innovation opportunities are going to be more limited, possibly causing further shakeouts in the market and creating an even more challenging environment.”

The Latest Launches (This information was compiled over the course of several months, using several sources, including press releases, promotional materials and Datamonitor Product Launch Analytics.) During the last six months KIND Healthy Snacks (KIND), New York, NY, added six new flavors to its line of whole nut and fruit bars and introduced KIND minis. And if that’s not enough, it also

partially funded a clinical trial geared toward weight management. As for the fruit and nut bars, each bar contains between 170 and 190 calories, approximately 4 grams of fiber and 3-7 grams of protein. The new varieties include Apple Cinnamon & Pecan and Peanut Butter & Strawberry. New KIND PLUS flavors include Blueberry Pecan + Fiber, Dark Chocolate Cherry Cashew + Antioxidants, Peanut Butter Dark Chocolate + Protein and Pomegranate Blueberry Pistachio + Antioxidants. KIND minis are available in four varieties: KIND Fruit & Nut Delight, KIND Almond Apricot, KIND PLUS Almond Cashew and KIND PLUS Cranberry Almond. The product contains all-natural fiber, protein and heart-healthy fats. Each 24-gram bar is less than 115 calories and contains about 3 grams of fiber and 3 grams of protein. Lastly, a study conducted by the YaleGriffin Prevention Research Center showed that when it comes to effects on weight, not all snacking is created equal. In contrast to some recent studies linking snacking to weight gain, this study, which provided two KIND Fruit & Nut bars per day as snacks to 94 overweight adults, found that no weight gain occurred. Study participants were assigned to either the control group or the experimental group. Members of the control group were advised to follow their normal daily diet while members of the experimental group were asked to add two KIND Fruit & Nut bars to their habitual diet for the duration of eight weeks. At the culmination of the study, researchers found that members of both groups successfully maintained their

KIND Healthy Snacks has launched a variety of new flavors and partially funded a clinical trial. 32 • Nutraceuticals World

www.nutraceuticalsworld.com

weight, body mass index (BMI) and waist size—despite the fact the experimental group had added approximately 350 calories to their daily diet. Exploiting the rising popularity of chia, Pure NRG, Detroit, MI, unveiled its Chia Breakfast Bar, which is vegan, dairy-free, gluten-free and wheat-free. The 2.5-oz. bar contains 8 grams of fiber, 16 grams of protein, 230 calories and 5 grams of fat. The company’s products combine coconut flour, brown rice, tapioca, hemp protein, chia seeds, quinoa flour and agave nectar, along with the natural sweetener xylitol. The company also unveiled its “Plus” line of vegan, gluten-free, shelf-stable and raw bars. Available in Chocolate Coconut, Cherry Pecan, Autumn Apple and Cinnamon Raisin flavors, all four “Plus” bars contain at least 10 grams of fiber and 7 grams of protein. Maintaining its presence in the bar arena, Odwalla, Half Moon Bay, CA, added two new flavors to its line-up. Its Chocolate Peanut Butter Protein bar contains 12 grams of protein, along with calcium and vitamins E, B6 and B12. The Blueberry Swirl Superfood bar contains calcium, folate and vitamins A, C and E. It also features blueberries, organic oats, dates and crisp rice. Looking to take advantage of the rising consumer demand for protein, Clif Bar & Company, Emeryville, CA, added Mint Chocolate Chip and Chocolate flavors to its LUNA Protein nutrition bar line. LUNA Protein bars contain 12 grams of protein and 3 grams of fiber, along with calcium, iron, folic acid and vitamin D. In other news, the company has also added Chocolate Dipped Coconut and Chocolate Chunk flavors to its LUNA bar line. Both flavors contain 9 grams of protein, 3 grams of fiber and are low glycemic. On the Clif Bar side of the business, the company launched CLIF C, a new double-layered fruit and nut bar that contains nine all-natural and organic ingredients. Each CLIF C bar contains 130 calories, provides one full serving of fruit and is a “good source” of fiber, offering 4 grams or 16% of the recommended Daily Value. It is available in Raspberry, Apple, Blueberry and Cherry Pomegranate flavors. January/February 2011

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The National Eye Institute is conducting its second comprehensive Age-Related Eye Disease Study (AREDS2) to assess the effects of these nutrients on the progression of age-related macular degeneration and is using DSM’s FloraGLO® Lutein, OPTISHARP® Zeaxanthin and ROPUFA® Omega-3 fatty acids in this key clinical trial. A recognized global leader in eye health, with more than 100 years of experience in health and nutrition, DSM is proud to participate in this groundbreaking NEI study. To find out more about how DSM solutions and our protective Actilease® beadlet technology can enhance your eye health products, visit www.unlimitednutrition-na.dsm.com or call 1-800-526-0189.

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Nutrition Bars

CLIF C bars contain all-natural and organic ingredients.

Abbott Nutrition, Abbott Park, IL, introduced ZonePerfect Cookie Dough Bars, which contain 170-190 calories per serving. The bars are a “good source” of 17 vitamins and minerals, and are rich in antioxidant vitamins C and E, as well as selenium. They are also an “excellent source” of protein (10 grams). ZonePerfect Cookie Dough Bars are available in Chocolate Chip, Peanut Butter and Oatmeal Raisin flavors. Since the company and brand was acquired in November 2009 by Greenwich, CT.-based Brynwood Partners VI L.P., Balance Bar added three new flavors to its main line—Double Chocolate Brownie, Lemon Meringue Crunch, S’mores—as well as new varieties to its Pure, Bare and Gold lines. All three new flavors in the main line contain 14 grams of protein, 200 calories, 23 vitamins and minerals, as well as an “excellent source” of antioxidants and vitamin D. They also adhere to the 40/30/30 nutritional model (40% of calories come from healthy carbohydrates, 30% from quality protein, and 30% from dietary fat). Balance Pure Gluten Free Fruit & Nut Energy Bars come in a Cherry Pecan flavor. According to the company, it is made with simple ingredients and contains 9 grams of protein and 2 grams of fiber. Balance Pure Bars also come in a Chocolate Cashew variety. 34 • Nutraceuticals World

Balance Bare Nutrition Energy Bars come in a Sweet & Salty Peanut Butter variety touted as “Real roasted peanuts and creamy peanut butter flavor, plus rolled oats’ whole grain goodness—with soy protein to help provide lasting energy.” The company has positioned this bar as low glycemic, and it contains 23 vitamins and minerals and 5 grams of whole grain. The bars also come in Trail Mix Fruit & Nut, Trail Mix Chocolate Chip and Trail Mix Cinnamon Oats & Honey flavors. The Balance Bar Gold Balanced Nutrition Bar with Three Indulgent Layers comes in “reformulated” Chocolate Peanut and Triple Chocolate Chaos flavors. Also looking to keep it simple, PowerBar, Glendale, CA, unveiled PowerBar Pure & Simple Long Lasting Energy Bars. They are available in Cranberry Oatmeal Cookie and Roasted Peanut Butter varieties. Billed as “all-natural” snack bars, they are high in protein, whole grains and fiber and contain “nothing artificial.” Satiety is the main health attribute for a new product called FullBar, Greenwood Village, CO. Designed to be eaten 30 minutes before every major meal, it was developed by a leading weight-loss surgeon, and comes in several varieties, including: Cinnamon Roll, Banana Nut Bread, Berry Bliss, Caramel Apple Crisp, Cocoa Chip, Cranberry Almond, Peanut Butter Crunch and Zesty Lemon Lime. www.nutraceuticalsworld.com

Stepping outside of the beverage world, POM Wonderful, Los Angeles, CA, introduced Antioxidant Superbars Dipped in Chocolate, which contain POMx, “an ultra-potent natural antioxidant.” In addition to being natural, the company says the bars are gluten-free and made with real fruits and nuts. Pomegranate and Peanut Butter varieties are available. Building on the momentum from its Wheaties Fuel line, General Mills, Minneapolis, MN, rolled out Wheaties Fuel bars. They contain 15 grams of protein, 100% of the daily value of five B vitamins and are available in Double Chocolate and Chocolate Peanut Butter flavors. Produced in Australia by Slim Secrets Pty. Ltd., new Slim Secrets Snack Bars are distributed in the U.S. by Sandbar Distributors, Inc. The varieties include Night Time Binge-Buster! (Berries Drizzled With White Chocolate); Afternoon Snack-Attack! (Choc-Nut Caramel Decadence); Morning Rev-Up!, (Cafe Latte Brewed to Perfection); and Mintabolism Boost! (Cool Mint Chocolate with Added Green Tea Extract). Kellogg's has introduced Nutri-Grain Superfruit Fusion Flavored Cereal Bars, which feature Cherry Pomegranate and Strawberry Acai varieties. They are billed as having “antioxidant vitamins C and E, and a hearty whole grain texture.” In other news, Kellogg’s FiberPlus Antioxidants Chewy Bars now come in a Chocolatey Peanut Butter flavor. The bar offers 35% of the daily value of fiber, plus antioxidants vitamin E and zinc and whole grains. Granola Gourmet, LLC, Santa Clarita, CA, has introduced Granola Gourmet 100% Natural Energy Bars, which are kosher and vegan and come in Ultimate Berry, Ultimate Fudge Brownie, Ultimate Mocha Fudge and Ultimate Cran-Orange flavors. They contain 10-12 whole grains, 530-590 mg of omega 3s, no refined sugar or fat and “are free of wheat and dairy and very low in sodium.”According to the company, these bars are made from low-glycemic-impact ingredients and are claimed to meet the needs of diabetics, as well as athletes and health NW conscious consumers. January/February 2011

Mood Health: Ingredients for a Healthy Mind

Consumers want to strike a healthy balance in their lives, and mood is a very important part of that equation. By Rebecca Wright, Editor & Lisa Schofield, Contributing Editor These days people will do anything to relax, even if just for a few minutes. Some will take a short walk, some will meditate and some will even play a video game to get their mind off things. The same goes for depression. Many consumers who struggle with this health issue will do anything to pull themselves out of the doldrums. But it’s not about getting rid of these mood states entirely. Rather, it’s about finding an appropriate range of emotions that makes for a healthy mind. As Robi Ludwig, PsyD, psychotherapist, contributor to CARE.com, television commentator and author of Till Death Do Us Part: Love, Marriage and the Mind of the Killer Spouse, points out,“There is a misperception that we should always feel good and happy all the time. The truth is that we all have a normal range of moods as part of life; having a range of appropriate emotions is part of being mentally healthy.” “Sometimes it is normal and appropriate to feel depressed as a reaction to a set of circumstances. People put pressure on themselves constantly to always feel good and happy,”she added.“When low mood is perJanuary/February 2011

sistent in a way that is creating trouble, this is when an intervention may be a wise step.” Besides a person’s biological make-up, there are several external factors that can lead to anxiety and depression. Mitch Skop, senior director/new product development, Pharmachem Laboratories, Kearny, NJ, offered some contemporary examples. “The economic downtown, which will be going into its third year, unemployment, foreclosures and an overseas war in its ninth year are all factors negatively affecting the mood of the masses. Add these events to everyday stresses and strains, and you have a perfect prescription for a melancholy mood, interrupted sleep and poor health.”

Recent Mental Health Data Most sources for mental health statistics cite data from the National Institute for Mental Health (NIMH), which bases its estimates on 2004 census data, offering an outdated picture of the current situation, according to John Grohol, PsyD, founder, CEO and editor-in-chief of Psychcentral.com, a mental health portal. Instead of the one-inwww.nutraceuticalsworld.com

four statistic used by NIMH, Dr. Grohol claims more recent data show that one in three people are diagnosed with a mental disorder in any given year, which translates to 75 million people. Putting the most recent data into context, he explained,“Women are at a significantly greater risk for any anxiety disorder (more than double the risk for a specific phobia, like a fear of spiders, for panic disorder and for post-traumatic stress disorder). They are also at slightly more risk for a mood disorder—especially for depression, where their rate is nearly double that of men’s risk for depression. “Men are at greater risk for impulse-control disorders, but no disorder significantly stands out except conduct disorder (more than four times the risk),” he continued. “Men are at more risk for substance disor-

This article in a nutshell: • Recent mental health data • Market activity • Ingredients to watch

Nutraceuticals World • 35

Mood Health

ders across the board as well, with more than twice the risk for alcoholism and three times the risk for drug abuse.” Looking at lifetime prevalence rates is also interesting and quite eye opening, Mr. Grohol pointed out. In fact, he said, for any mental disorder (including substance disorders), the lifetime prevalence rate is an astonishing 57%. “That’s more than one in two Americans,”he said.“If you don’t think mental illness will impact your life, you’re sadly mistaken. If it doesn’t hit you, it’s going to hit someone you love or are close to.”

Market Activity So what are consumers doing about their mood health issues? According to Nutrition Business Journal (NBJ) estimates, U.S. sales of supplements for mood health reached $430 million in 2009, up 7% over 2008. Growth averaged 4% from 2000-2009, but has seen large swings up and down from year to year, says Carla Ooyen, director of market research for NBJ. For that time period, she said the top sales contributors in the mood health category were 5-HTP, homeopathics, multivitamins and St. John’s Wort. Beyond supplements, consumers are also seeking relief in the form of foods and beverages. In fact, relaxation beverages are in the embryonic stages of development, particularly in the U.S., and this market is poised to advance rapidly in the coming years, based on recent product launches. “In the U.S., relaxation drinks have become a legitimate niche with some 350 startup brands (worth about $10 million) contending for space,”said Julian Mellentin, editor, New Nutrition Business, London, U.K. “No company has yet established a winning template for cracking relaxation drinks. Unlike energy shots, there’s no unassailable strategy in relaxation beverages for formulation, positioning, packaging, distribution or marketing.” Featured in a recent report from New Nutrition Business (“10 Key Trends in Food, Nutrition & Health 2011”), some of the notable players in this market include Drank, an estimated $6.5 million brand, which contains melatonin, valerian and rose hips; Vacation in a Bottle, or ViB, which is formulated with green tea extracts, B vitamins and the 36 • Nutraceuticals World

Vacation in a Bottle (ViB) is formulated with green tea extracts, B vitamins and the amino acids

And exactly how relaxed do people want to be? New Nutrition Business reports that so far the biggest divide in this segment is over whether to promote sleep or just relaxation.“A relaxation drink might include kava, valerian root and other herbal ingredients, while melatonin, a hormone that induces sleep, is found in both kinds of drinks,” the market researcher says.“This decision determines much about the brand’s formulation, positioning and other factors.”

L-theanine and L-threonine.

amino acids L-theanine and L-threonine; Mary Jane’s Relaxing Soda, which features passion flower extract and kava kava; Mini Chill, a relaxation shot that focuses on stress reduction and includes 500 mg of valerian root per serving; and Dream Water, containing melatonin, GABA and 5-HTP, which takes stress reduction to another level by inducing sleep. So if sleeplessness and stress are such big consumer concerns, New Nutrition Business asks: Why isn’t there a huge market established for products that address them, as there is for the other top consumer concerns, digestive health and energy? “The reason is that ingredient technology is not yet at the point where ingredients can be formulated into products [that] are effective (i.e.,“I feel the benefit”is an essential element of strategy in this market), safe, produce good-tasting products and deliver claims that will pass regulatory scrutiny,”the market analyst says.“Nor has anyone yet figured out a winning strategy and winning product format. Solving these two challenges is key to creating new categories—as Red Bull did for energy drinks, 5-Hour Energy did for energy shots, Danone Activia and Fiber One have done for digestive health, and Special K has done in weight management.” Speaking of Danone, the company already attempted the launch of a stress-relieving dairy drink in selected European markets, back in 2004. Called Zen, its benefits were said to be based on its added magnesium. “Though Zen failed to meet sales expectations and was withdrawn, it signals that the ‘mood food’ area is being looked at seriously—and that figuring out how to succeed will not be easy,” New Nutrition Business contends. www.nutraceuticalsworld.com

Ingredients To Watch There is a long list of ingredient contenders for mood health products, whether product developers are designing formulations for supplements or foods and beverages. Don Stanek, director of sales, Linnea, Inc., Easton, PA, says many dietary supplements are keys to good health and by association, good mood. “Of course a healthy lifestyle, which includes a balanced diet, exercise, a good night’s sleep and supplementation are all key ingredients for an individual’s wellbeing,” he said, adding that 5-HTP (HTPure), vinpocetine and ginkgo biloba are appropriate ingredients that would fit nicely into a mood health formulation. Going into more detail, he said, “5-HTP has been shown over the years to be an effective and natural way to increase serotonin levels. With healthier serotonin levels individuals tend to have a better outlook on life and improved sleep. It also diminishes carbohydrate cravings, thus resulting in possible weight loss.” Mr. Stanek added that Linnea’s ginkgo biloba is a “truly pharmaceutical brand” in that it meets the European Commission monograph for ginkgo and is essentially similar to Schwabe EGB761, the worldwide standard for high quality ginkgo. “Ginkgo has been shown to improve memory and/or to lessen the decrease in cognitive impairment as we age,” he said.“As far as mood is concerned, with a better, fresher cognitive awareness the individual feels better, is more focused and more on task. A better memory makes the individual feel better.” Mr. Stanek continued,“Vinpocetine, another memory enhancer, is also beneficial in creating a more aware individual—one who is more focused due to increased cognitive quality.” January/February 2011

Mood Health

Another ingredient candidate is Kyowa Hakko’s Cognizin citicoline, which the company positions as a multifunctional brain health ingredient. “Cognizin not only has a role in enhancing cognitive function and neuroprotection, but also in modifying mood and response to stimuli via the dopamine system,” said Karen Todd, senior marketing manager, Kyowa Hakko, New York, NY. “A recently published study on Cognizin citicoline focused on one’s motivation to eat, since the response to appetite is regulated in part by dopamine. A significant decrease was seen in participants selfrated appetites after supplementation with Cognizin citicoline.” Ms. Todd added, “I like talking about the positive side effects of Cognizin relating to giving one a positive outlook or state of mind. We have seen this effect in studies used in drug dependence and now high fat/calorie foods. Participants generally felt better while taking Cognizin.” According to Lakshmi Prakash, PhD, vice president, Innovation & Business Development, Sabinsa, East Windsor, NJ, several plants inherently harbor“adaptogenic”properties, and the substances enabling these properties have been termed“adaptogens.” Adaptogens are well established in the traditional systems of medicine. Sabinsa says the ideal“adaptogen”should possess the following qualities: Be relatively innocuous and cause minimal disorder in the human body; and the action should be non-specific (i.e., it should increase resistance to adverse influences of several kinds including those of physical, chemical and biological nature). Along these lines, Dr. Prakash highlighted several mood health ingredients, including ashwagandha, bacopa and valerian. Ashwagandha has been traditionally used to stabilize mood in patients with behavioral disturbances. In fact, Dr. Prakash claims, bioactives isolated from the root of Withania somnifera have been shown to be effective in attenuating experimentally induced stress responses, including anxiety and depression. Dr. Prakash also hailed the anti-anxiety effects of Bacopa monniera as well as its beneficial role in memory and cognition. “Preclinical and clinical studies reveal that treatment with Bacopa monniera extract lowered the stress-related increased secretion of adrenal hormones,”she said. January/February 2011

Green tea reportedly induces relaxation due to the presence of the amino acid L-theanine.

Valerian has a history of use as a medicinal herb, and was used in ancient Greece and Rome. Hippocrates described its properties, and Galen later prescribed it as a remedy for insomnia. In a clinical study, both kava kava and valerian were found to moderate the effects of psychological stress induced under laboratory conditions in a group of healthy volunteers, according to Dr. Prakash. Drinking green tea reportedly induces relaxation. A pioneer in the science of green tea, Japan-based Taiyo International found this relaxation effect to be due to the presence of the amino acid L-theanine. Its branded L-theanine ingredient, Suntheanine, is produced via a fermentation process that mimics the natural process in green tea leaves resulting in a 100% pure L-isomer-theanine. Speaking of amino acids, gammaaminobutyric acid, also known as GABA, is one of four key neurotransmitters in the brain and is noted for its ability to induce relaxation, reduce stress and anxiety and increase focus. This ingredient, while popular in Japan, is just starting to make a large dent in the relaxation market in the U.S. Lactium, produced by France-based Ingredia International and distributed in the U.S. by Kearny, NJ-based Pharmachem, is a milk protein hydrolysate containing a bioactive peptide clinically shown to reduce stress-related symptoms and promote relaxation.“Extensive clinical research showed no www.nutraceuticalsworld.com

side effects or toxicity,” said Pharmachem’s Mr. Skop. “One study, conducted on 63 females, showed a significantly greater improvement in stress symptoms in five different areas in the group taking Lactium. “Lactium has helped people feel better overall, sleep better, awaken better and improve their mood, and reduce their blood pressure and cortisol levels,” Mr. Skop continued. “Most of all, Lactium is non-habit forming and does not produce a drowsy effect when taken.” Discussing its place in the product landscape, Mr. Skop said Lactium is becoming a popular ingredient for the next wave of relaxation beverages.“We also see more development with Lactium in chewing gum, mints and lozenges,”he added. Omega 3s have carved out a solid position among mood health ingredients. Although some recent studies have questioned their efficacy, particularly in the area of depression, the overall consensus regarding omega 3s is that they should be top-of-mind when considering the design of a mood health supplement, functional food or beverage. Most recently, a new study showed that the efficacy of omega 3s in depression might depend on the specific ratio of DHA (docosahexaenoic acid) and EPA (eicosapentaenoic acid). According to a recent article in HealthDay, researchers analyzed the results of 15 previous controlled clinical trials on the use of omega 3s—found in oily fish or in fish oil supplements—to treat depressed people. They found that when used by itself, DHA alone did not seem to offer any benefit. However, DHA combined with a rather high dose of EPA did improve depressive symptoms. The study, funded by the National Institutes of Health (NIH), was designed as a meta-analysis and presented at the American College of Neuropsychopharmacology meeting in Miami in December. The study’s lead researcher noted the next step should be to test the anti-depressant effect of the omega 3 fatty acid combination in a large population to establish a dose range. The Center for Integrative Medicine at the University of Maryland School of Medicine cites passionflower, kava kava and St. John’s Wort as having mood support properties. Passionflower (Passiflora incarnata) Nutraceuticals World • 37

Mood Health

was used traditionally in the Americas and later in Europe as a“calming”herb for anxiety, insomnia, seizures and hysteria. It is still used today to treat anxiety and insomnia. Although scientists aren’t sure, it is believed that passionflower works by increasing GABA levels in the brain. Kava kava (Piper methysticum) has been used as a ceremonial drink in the Pacific Islands for hundreds of years. The roots are chewed or ground into a pulp and added to cold water. Kava is best known for its relaxing qualities, especially its ability to elevate mood, well-being and contentment and produce a feeling of relaxation. Several studies have found that kava may be useful in the treatment of anxiety, insomnia and related nervous disorders. It is currently banned in Europe due to reports of liver failure. In the U.S., however, it is still on the market, although FDA issued a consumer advisory about it in March 2002. St. John’s Wort (Hypericum perforatum) is a long-living plant with yellow flowers whose medicinal uses were first recorded in ancient Greece. It contains many chem-

ical compounds. Some are believed to be the active ingredients that produce the herb’s effects, including the compounds hypericin and hyperforin. According to NIH, studies suggest that St. John’s Wort is of minimal benefit in treating major depression. A study co-funded by the National Center for Complementary and Alternative Medicine (NCCAM) found that St. John’s Wort was no more effective than placebo in treating major depression of moderate severity. There is some scientific evidence that St. John’s Wort is useful for milder forms of depression, however. Its use in treating anxiety is also questionable (see side bar below). Most recently, SAMe (S-adenosyl methionine) was studied and found to be helpful in subjects not responding to antidepressant treatment alone. The study, conducted by researchers at Harvard Medical School and Massachusetts General Hospital (MGH) in Boston, examined 73 adults who took SAMe or placebo for six weeks. All subjects continued on their anti-depressant medications, while more than half

Review Supports Use of Herbs in Treating Anxiety Nutritional and herbal supplementation is an effective method for treating anxiety and anxiety-related conditions without the risk of serious side effects, according to a systematic review of studies published in Nutrition Journal in October. Researchers said strong evidence exists for the use of passionflower or kava and combinations of L-lysine and L-arginine as treatments for anxiety symptoms and disorders. In addition, magnesium supplements and other herbal combinations may hold promise. Interestingly, they also said St. John’s Wort monotherapy “has insufficient evidence for use as an effective anxiolytic treatment.” “Over the past several decades, complementary and alternative medications (CAM) have increasingly become a part of everyday treatment,” the study authors wrote. “With the rising cost of prescription medications and their production of unStrong evidence exists for the use of passionflower as a treatment wanted side effects, patients for anxiety symptoms. are exploring herbal and other natural remedies for the management and treatment of psychological conditions.”

38 • Nutraceuticals World

added SAMe to their regimens. Thirty-six percent of those taking the SAMe/anti-depressant combination showed improvement, compared to 18% in the placebo group. Further, more than a quarter of those taking the SAMe/anti-depressant combination experienced a complete remission of symptoms. The study was published in the August 2010 issue of the American Journal of Psychiatry. George Papakostas, MD, associate professor of psychiatry at Harvard Medical School, director of treatment-resistant depression studies in the Department of Psychiatry at MGH, and lead author, commented on the study and what it means for the future of SAMe. “These findings provide preliminary support for the efficacy, safety and tolerability of SAMe as an additive therapy for patients with major depressive disorders who do not respond to anti-depressant treatment alone,” he said. “Continued research, however, is urgently needed to more definitively further our understanding of the role of SAMe in the treatment of adults diagnosed NW with depression.”

Nearly 7 million Americans suffer from generalized anxiety disorder. Many also suffer from side effects related to treatment. Researchers analyzed a total of 24 studies that investigated five different CAM monotherapies and eight different combination treatments involving 2619 participants. There were 21 randomized controlled trials and three open-label, uncontrolled observational studies. Most studies involved patients who had been diagnosed with either an anxiety disorder or depression (n = 1786). However, eight studies used healthy volunteers (n = 877) who had normal levels of anxiety, were undergoing surgery, tested at the upper limit of the normal range of a trait anxiety scale, had adverse premenstrual symptoms or were peri-menopausal, reported anxiety and insomnia, or had one month or more of elevated generalized anxiety. Heterogeneity and the small number of studies for each supplement or combination therapy prevented a formal meta-analysis, but of the randomized controlled trials reviewed, 71% (15 out of 21) showed a positive direction of evidence. Any reported side effects were mild to moderate. Researchers acknowledged that any positive effects seen could be due to a placebo effect, which may have a significant psychological impact on participants with mental disorders. However, based on the systematic review, “strong evidence exists for the use of herbal supplements containing extracts of passionflower or kava and combinations of L-lysine and L-arginine as treatments for anxiety symptoms and disorders.”

www.nutraceuticalsworld.com

January/February 2011

Delivery

Strategies

In Transit

The days of bulky, chalky ‘horse pills’ are virtually over, along with the notion that gummies, chews and other fun delivery formats are reserved for kids. By Sean Moloughney Associate Editor

As nutraceutical products compete for shelf space, new delivery systems can offer a point of differentiation while also improving a product’s efficacy and appealing to a broader group of consumers who can’t or won’t swallow tablets and capsules. With improved science and technology, delivery formats have evolved to meet the growing demands of people who want good-tasting, convenient products that coincide with their current lifestyles. As a result, manufacturers continue to launch a variety of foods and beverages fortified with health ingredients like omega 3s and probiotics, as well as dietary supplements available in formats that include chews, lozenges, gums, gummies, effervescent formulas, thin film strips, shots and gels, among others.

Omega 3s With sales of omega 3 products at an all-time high, alongside recognition that the Western diet is generally deficient in 40 • Nutraceuticals World

these essential fatty acids, consumers will continue to see new products in varying formats, beyond traditional soft gels. Manufacturers and product developers have faced numerous obstacles when fortifying products with omega 3s, including oxidation. “The primary challenge is delivering an innovative and high quality product that does not have inconsequential amounts of EPA, DHA or other nutrients,” said Tiffany Diehl, strategic projects manager, Nordic Naturals, Watsonville, CA. “It is important that unique dosage forms or combination products are not manufactured at the expense of concentration, taste, purity and freshness. Innovation in the manufacturing process becomes a critical part of addressing these challenges.” Perhaps exemplifying the progression of foods and beverages fortified with fish oil, in November of 2010 Renewal Laboratories, San Diego, CA, launched All Heart, an all-natural bottled tea that contains 250 mg of omega 3 fish oil. Available www.nutraceuticalsworld.com

in Sweetened and Unsweetened varieties, the beverage features the company’s NatureFormed technology. The patentpending process harnesses the natural power of molecular self-assembly to transform fish oil into stable, water-soluble microparticles without the use of chemical additives. The process eliminates the need for artificial emulsifiers or detergents, the company said. Ms. Diehl noted that omega 3 powders and emulsified products have gained popularity in recent years, allowing for more products that appeal to different consumer groups. “Gummies are popular with chil-

This article in a nutshell: • Omega 3s • Gummies & effervescent formulas • Probiotics & functional foods • Shots • Thin film strips • Gums & other formats

January/February 2011

Delivery Trends

dren and we even see a few adults with a passion for them,”she said.“With continuing education on the benefits of omega 3s, we will see a broader spectrum of consumers who are focused on the experience—taste, texture, convenience.” In 2010 Nordic Naturals introduced Nordic Omega 3 Gummy Worms—available in Strawberry flavor—which contain 56 mg of EPA + DHA per worm. The company has also looked to combine omega 3s with other nutrients, launching Omega 3 Effervescent, a water-soluble, Orangeflavor drink mix that contains 500 mg of EPA and DHA, as well as 1200 IU of vitamin D3 per serving. The company claims its new delivery system allows for faster absorption of omega 3s. Ms. Diehl said she believes new delivery technologies for omega 3s such as these are sustainable, but likely won’t overshadow the more traditional soft gel. “New delivery methods are moving away from the idea of ‘traditional’ dietary supplements,” she added. “Enjoying an orange drink is a much different concept than taking two to four soft gels per day.”

Gummies & Effervescent Formulas As research continues to underline the importance of omega 3s for children, gummies that contain omega 3 fatty acids, and other nutrients, have become an attractive alternative to hard-to-swallow pills or capsules. Olivia Sant’Angelo, market analyst with the Netherlands-based Innova Market Insights, noted that gummies offer “a more natural delivery system for children, whereby they can enjoy the taste of a gummy and the multivitamin boost of a supplement.” For example, Coromega, Vista, CA, expanded its line of omega 3 supplements in 2010 with Coromega Kids Omega 3 Gummy Fruits. Each serving of two gummies contains 50 mg of DHA and 10 mg of EPA. The product is available in Orange, Lemon and Strawberry Banana flavors. Also capitalizing on the growing popularity of vitamin D, the company has unveiled Coromega Omega 3 + Vitamin D. This uniquely emulsified supplement January/February 2011

offers the same amounts of 230 mg of DHA and 350 mg of EPA as the company’s traditional Omega 3 Squeeze, and also includes 1000 IU of vitamin D3 per pouch, available in Tropical Orange flavor. Natural Dynamix, Los Angeles, CA, released its Gummy Cuties line of children’s gummy vitamins in 2010. Gummy Cuties Multi Vitamin blends 11 essential nutrients and vitamins to help kids stay healthy. Gummy Cuties Calcium with Vitamin D helps to build strong bones and teeth and Gummy Cuties Omega 3 contains EPA and DHA. But gummies are no longer reserved for children. Natural Dynamix has also launched Fiber Adult Gummies, which contain 4 grams of fiber per serving, as well as Calcium Adult Gummies. In addition to a successful line of gummy products for children, Hero Nutritionals, San Clemente, CA, also offers Slice of Life Gummy Vitamins for Adults, available in a spectrum of formulas, including Multi-Vitamin + Lycopene, Vitamin C + Pomegranate, Vitamin B12 Energy, CoQ10, Omega 3-6-9 Fish Free and Vitamin D3. Made popular by products like Airborne and Emergen-C, effervescent formulas offer a quick and convenient means of obtaining nutrients by simply dropping a tablet or powder into water. Lisa Lent, CEO of Vitalah, Watsonville, CA, which created Oxylent, an effervescent multivitamin/mineral powder, said her company’s product offers numerous benefits to all types of consumers. “First and foremost, the powder form improves the bioavailability of vitamins and minerals because powder form supplements are produced with less processing of the ingredients (including avoiding excessive heat and binder ingredients such as cellulose); less time elapses between blending and processing, which reduces the exposure of the ingredients to air; and the powder form is better absorbed by the body because it does not need to be broken down by stomach acids to be absorbed in the small intestine—an advantage especially important for people with digestive difficulties.” Effervescent delivery systems are also a convenient way for children to obtain the www.nutraceuticalsworld.com

essential vitamins and minerals they need, she added, “as well as a useful option for an aging population that finds swallowing and absorption more challenging.”

Probiotics & Functional Foods Convenience is integral to a product’s success, according to Mike Bush, vice president of business development, Ganeden Biotech, Inc., Cleveland, OH, who said functional food companies are aiming to fortify products that people consume every day. “In our consumer research we found that people don’t want to add a new habit,” he said. “There are already enough things they have to do in order to be healthy that are intrusive on their lifestyle. Our primary goal is to improve the quality of life for the consumer while at the same time not making them add new habits.” While the lion’s share of probiotic products are drinkable and spoonable yogurts, these products don’t appeal to every consumer. “If you’re not a yogurt eater, it’s hard to add a once-a-day or twice-a-day yogurt habit to your general lifestyle,” Mr. Bush said. “But if you eat oatmeal every day, then we want to make sure there is a probiotic oatmeal available. We work hard at finding things that fit into the everyday, ordinary lifestyle of our consumers.” Ganeden has worked with companies such as Bigelow tea to offer a probiotic hot tea, as well as Raconto pasta and Heartland Sweeteners. The latter recently released Nevella, a low calorie sweetener with probiotics, which allows consumers to add probiotics to their own foods and beverages. “On the supplement side, we’re starting to see things like gummy bears coming out,” Mr. Bush said, also noting growth in combination products, such as omega 3s with probiotics.“That’s nice because they’re both products you have to take every day. By combining them and stabilizing the probiotic in the omega 3 you get twice the bang for your buck. And consumers seem to like that. We’re seeing a lot of neat things in the marketplace, from chocolate to Kombucha.” In the end, though, a delivery method Nutraceuticals World • 41

Delivery Trends

doesn’t mean much without an efficacious product. “The most important thing, no matter what you put it in, is the ability to have an efficacious dose at the time the consumer takes the product. We do a lot of work with our customers to test a product after the manufacturing process, including shelf-life testing to ensure the consumer is getting what they pay for.”

Shots Meeting consumer demand for convenient products that work, 5-Hour Energy, which offers an alternative to larger energy drinks in a 2-oz. bottle that contains only 4 calories, helped to catapult the shot market into mainstream stardom. Shot products, typically packaged in 24 oz. bottles (60-120 ml), are not limited to an energy platform, though many products have tried to capitalize on the success of 5-Hour Energy. For example, Innova’s Ms. Sant’Angelo said the Happy Planet line of shots in Canada is an innovative line of all-natural beverage shots that contain herbs and vitamins. “Happy Planet Shots, including Energy +, Immunity, Detox and Glow,

were formulated to address four specific occasions. The 75 ml Happy Planet Immunity Shot contains fucoidan, an algae that helps prevent the common cold and flu. Also added is echinacea, which has a long tradition as a cold fighter.” In the U.S., Lifeway Foods, Morton Grove, IL, launched BioKefir shots, which deliver probiotics in a 3.5-oz. package. Designed to support immunity, heart health and digestion, the product contains more than 20 billion units of live and active probiotic activity and is available in five varieties. BioKefir for Immunity is offered in Pomegranate/Blueberry and Kiwi/Passion fruit. It also contains acerola and delivers 100% of the recommended daily value for vitamin C. BioKefir for Heart Health is available in Blackberry and Black Cherry. It features grape concentrate as well as pomegranate, apple and green tea extracts that deliver antioxidants such as resveratrol. BioKefir for Digestion, available in Vanilla flavor, balances the digestive ecosystem with a Lifeway probiotic formula designed to soothe upset stomachs, alleviate diarrhea and help regulate the

‘Breathable Vitamins’ Set to Launch in the U.S. Unique delivery system enhances bioavailability Looking to revolutionize the delivery of micronutrients, Le Whif Vitamin has introduced a pill-free alternative to traditional vitamins utilizing a non-digestive process that enhances absorption through inhalation. Inventor David Edwards, a Harvard University professor who pioneered inhalable insulin, said the idea originated from work he has done related to delivering drugs and vaccines to the lungs. To develop Le Whif, London, U.K.-based Breathable Foods has worked in collaboration with Artscience Labs, an international network of laboratories founded by Dr. Edwards. “In 2007, during a lunch with a French chef, it occurred to me that the approach used until then to deliver drugs and vaccines to the lungs [could] be used to deliver food to the mouth,” Mr. Edwards recalled. “Everything that we’d worked on over the years to avoid depositing aerosol in the mouth might be rethought to precisely deliver aerosol to the mouth—a kind of inhalable fork.” The first product, Le Whif Chocolate, launched in the spring of 2009, and the second, Le Whif Coffee, launched in the win-

42 • Nutraceuticals World

symptoms of irritable bowel syndrome (IBS) and other digestive ailments. Vanilla BioKefir is also an “excellent source” of fiber.

Thin Film Strips Innova’s Ms. Sant’Angelo said oral thin strips have been an emerging category for breath freshening during the last three or four years, but are currently evolving into other health platforms. “The category now also features products claiming to contain hunger cravings,” she said, noting the U.K. product Slim Hunger Strips, from Healthmasters, which contains guarana seed extract. John Tobin, president and CEO of NutraFood Nutrients, Inc., Pleasantville, NJ, which specializes in thin film technology, said his company’s technology could be utilized in pharmaceutical, nutraceutical and cosmeceutical products, in oral strips and topical patches. “We developed a technology that allows us to put a higher level of active ingredients onto thin strips,” he said. “Most of the nutraceutical products on the market range from 5 mg to 30 mg of an active

ter of 2010. Both deliver food (chocolate and coffee) as tiny dry particles to the mouth, without the calories or the cup. Each Le Whif Vitamin inhaler contains a full daily dose of the particular vitamins indicated. “Le Whif Vitamin delivers vitamins to the mouth, very simply,” said Mr. Edwards. “There is no delivery to the lungs—assured by the size of the particles in Le Whif, which on average are in the 50-100 micron size range. Only particles less than 10 microns enter the lungs on respiration. There are decades of research demonstrating that powders of the kind delivered to consumers by Le Whif land in the mouth.” All ingredients are Generally Recognized As Safe (GRAS) for oral consumption, he added. Le Whif Vitamins are currently available in three flavors: Antioxidant Green Tea (vitamins C and E), Multivitamin Hibiscus Tea (vitamins A, B1, B2, B3 and B5) and Smart Wine Tea (vitamin D). “The goal of avoiding pills in vitamin delivery is well recognized—and achieved today through sprays, gums, strips and other oral dosage forms,” said Mr. Edwards. “It seemed to me that Le Whif might provide special benefits related to these existing approaches.” He discussed the general premise of “buccal” (or mouth) delivery of vitamins, alongside its advantages. “Delivery through the mouth, as opposed to through the gut, not only provides

www.nutraceuticalsworld.com

January/February 2011

Delivery Trends

ingredient. With our technology we can provide 250 mg of an active ingredient.” Mr. Tobin said this technology offers enormous appeal to the four out of 10 people around the world who are unable or unwilling to take pills or capsules. For example, small dosages of nutrients like vitamin D3 can be administered to infants. “We’re also investigating doing some products for the senior market. Many people in elder care simply can’t swallow pills,” he said. Overall, thin strips are“much more user friendly,” according to Mr. Tobin, as they are extremely portable and don’t need water. From a manufacturing standpoint, active ingredients on strips are also more bioavailable, as many nutrients are destroyed as they travel through the gastrointestinal tract.

Gums & Other Formats When thinking about delivery systems, “form follows function,” according to Joseph O’Neill, executive vice president of sales and marketing, BENEO Inc., Morris Plains, NJ. “In other words, one needs to consider the occasion of use and the ob-

jective. Is it a product that should be consumed several times during the day? On the go? Do you want a look that is not too medical? In such cases, gum is definitely a delivery system of choice.” Mr. O’Neill divided gums into two types: traditionally manufactured and compressed gums. “Traditionally manufactured gums allow a variety of forms and packages and the use of many functional/active ingredients. Compressed gums are useful with temperature-sensitive active ingredients as they are based on a simple, dry compressing method.” In the future, Mr. O’Neill predicted that “convenience of consumption” would drive delivery systems, as well as portion packs. “Since gum tends to be a product for younger generations, it may be able to now make the jump into being the supplement or better ‘added-value’ delivery system, in addition to being the delivery system for dental care benefits.” Many other delivery formats allow companies to diversify their product portfolio or enter new health categories. For example, CLIF Bar & Company, Emeryville, CA, has moved beyond the nutrition bar format to offer its SHOT

line of performance products. CLIF SHOT Bloks come in chewable, 33-calorie cubes that contain caffeine, carbohydrates and electrolytes. CLIF SHOT Energy Gel also provides quick energy to athletes while racing and training, according to the company. Dr. Sears Family Essentials, Irvine CA, added to its line of Immune Plus Fruit Chews, which contain vitamins C and D, zinc, selenium and Wellmune WGP, a natural ingredient shown to enhance immune health. The product is available in Citrus and Pom-Blueberry flavors. Mindful Products, LLC, launched Mindful Mints, which contain 50 mg of Suntheanine L-theanine per serving. The product was designed to focus on natural cognitive wellness. It is 100% sugar-free and uses all-natural xylitol. Demand for convenient products that deliver on taste and efficacy will continue to drive the evolution of nutritional products, in terms of food, beverages and dietary supplements. The variety of products available today reflects an expanding market that will reach more consumers looking to fill the nutritional gaps in their NW everyday lives.

consumers a non-pill apthey sometimes involve proach to vitamin delivnon-nutritional surfacery, but it also can lead tants and/or propellants to more effective delivery (i.e., in the case of to the body. This is essprays); and 3) they are pecially true for certain not necessarily enjoyvitamins, like B12, or able food experiences.” certain herbal suppleLe Whif Vitamins proments, like resveratrol— vide buccal delivery of which both substantially vitamins while dissolving degrade in the stomach rapidly, avoiding surfacand liver (i.e., upon ditants and propellants gestion in the form of and imparting an intrigupills or drinks).” ing food experience, he By absorbing subadded. “In the last reLe Whif products are currently available online in more than 40 countries. stances into the bloodgard, Le Whif Vitamin is They are set to launch in U.S. stores later this year. stream through the integrated into Japanese tissues of the mouth, teas and involves the fun delivery of these particular vitamins and supplements is more act of breathing food, which has been a good part of the exbioavailable, he continued. “Three potential drawbacks with citement around Le Whif over the past year-and-a-half since current buccal delivery systems are 1) they do not dissolve rapthe first launch.” idly in the mouth, therefore leading to some digestion on swalLe Whif products are currently available online in more than 40 lowing (i.e., in the case of gums, chewable vitamins, etc.); 2) countries. They are set to launch in U.S. stores later this year.

January/February 2011

www.nutraceuticalsworld.com

Nutraceuticals World • 43

“…supplementation with DHA compared with placebo did not slow the rate of cognitive and functional decline in patients with mild to moderate Alzheimer’s disease.”

Nutraceuticals Research

Nutraceutical: DHA Indication: Alzheimer’s disease Source: JAMA, November 2, 2010; 304(17):1903-1911. Research: In this study, researchers wanted to determine if supplementation with DHA could slow cognitive and functional decline in individuals with Alzheimer’s disease. In terms of study specifics, researchers followed 402 people with mild to moderate Alzheimer’s, who were randomly assigned to take 2 grams a day of omega 3 capsules containing DHA or a placebo. They continued their treatment regimens for 18 months. Cognitive function was measured upon entering the study, and again at 6 months, 12 months and 18 months. The subjects also had MRIs taken of their brains. Results: A total of 295 participants completed the trial while taking study medication (DHA: 171; placebo: 124). Supplementation with DHA had no beneficial effect on rate of change on ADAS-cog score, which increased by a mean of 7.98 points for the DHA group during 18 months vs. 8.27 points for the placebo group. In a subpopulation of participants (DHA: 53; placebo: 49), the rate of brain atrophy was not affected by treatment with DHA. Researchers concluded that supplementation with DHA compared with placebo did not slow the rate of cognitive and functional decline in patients with mild to moderate Alzheimer’s disease.

Nutraceutical: Omega 3s Indication: Atrial fibrillation (irregular heartbeat) Source: JAMA, November 15, 2010; [Epub ahead of print]. Research: Atrial fibrillation (AF) is common, yet there remains an unmet medical need for additional treatment options. Current pharmacological treatments have limited efficacy and significant adverse events. Limited data from small trials suggest omega 3 polyunsaturated fatty acids may provide a safe, effective treatment option for AF patients. Taking this into consideration, researchers set out to evaluate the safety and efficacy of prescription omega 3 fatty acids (prescription omega 3) for the prevention of recurrent symptomatic AF. To do this they conducted a prospective, randomized, double-blind, placebo-controlled, parallel-group multicenter trial involving 663 U.S. outpatient participants with confirmed symptomatic paroxysmal (n = 542) or persistent (n = 121) AF. Prescription omega 3s (8 g/d) or placebo were given to subjects for the first 7 days; prescription omega 3 (4 g/d) or placebo thereafter through week 24. Results: At 24 weeks, in the paroxysmal AF stratum, 129 of 269 participants (48%) in the placebo group and 135 of 258 participants (52%) in the prescription group had a recurrent symptomatic AF or flutter event. Researchers concluded that among participants with paroxysmal AF, 24-week treatment with

—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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prescription omega-3 compared with placebo did not reduce recurrent AF over 6 months. Nutraceutical: Vitamin B12 Indication: Alzheimer’s disease Source: Neurology, October 19, 2010; 75(16):1408-14. Research: The purpose of this study was to examine the relationship between serum levels of homocysteine (tHcy) and holotranscobalamin (holoTC), the active fraction of vitamin B12, and risk of incident Alzheimer’s disease (AD) in a sample of Finnish communitydwelling elderly. A dementia-free sample of 271 subjects aged 65-79 years derived from the Cardiovascular Risk Factors, Aging, and Dementia (CAIDE) study was followed up for 7 years to detect incident AD. Results: During follow-up, 17 cases of Alzheimer’s were identified. For each small increase in homocysteine the risk for Alzheimer’s rose 16%, but with each small increase in vitamin B12, the risk of Alzheimer’s dropped 2%, suggesting that both tHcy and holoTC may be involved in the development of AD. The tHcy-AD link may be partly explained by serum holoTC. As a result, researchers believe the role of holoTC in AD should be further investigated.

Log on, learn more @ nutraceuticalsworld.com Find out everything you wanted to know and more about Omega 3 EPA when you visit our online “Research” section and download the Natural Standard monograph from our “Monograph Center.”

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44 • Nutraceuticals World

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January/February 2011

Supply Source

Fluxome: Natural, Premium Ingredients for Life Utilizing unique fermentation processes, Fluxome A/S, Denmark, Copenhagen, delivers safe, natural, premium nutraceutical ingredients from secure, renewable sources. Founded in 2002 as an offshoot of a research group at the Technical University of Denmark, the company was formed to develop a technology platform for the production of nutrients in a controlled setting, according to Herbert Woolf, president and CEO of Fluxome Inc., the company’s U.S. commercial subsidiary, which recently relocated to Easton, PA. “Producing high value micronutrients in this way ensures product purity,” he noted. “We have a clean workplace environment

atrol and obesity, inflammation, cardiovascular diseases, cancer and longevity. Dr. Woolf said this conference was the first opportunity to assess the value and strength of current science and for colleagues to collaborate and set new directions. “There has been an unbelievable escalation in publication of articles and research findings on resveratrol,” he noted. “Many of these researchers never had the opportunity to be together to discuss their findings and to have a forum with peer interaction. This was an organized discussion to define new directions.” More than 150 participants from 25 different countries attended, discussing a range

“There has been an unbelievable escalation in publication of articles and research findings on resveratrol.” producing absolutely pure nutrients in a controlled setting. This is important because since 2001 bio-security has become a reality.” The company also emphasizes adherence to current Good Manufacturing Practices (GMPs). Its main product, trans-resveratrol, can be applied to dietary supplements, functional foods, cosmetics and cosmeceuticals. With so much hype surrounding resveratrol, a bioactive antioxidant compound found in red wine, Fluxome recently helped organize Resveratrol2010, an international scientific conference on resveratrol and health, which took place in Denmark in September. The conference allowed researchers from around the world to discuss their latest scientific findings, sharing research on resverJanuary/February 2011

of publications and developing recommendations for future resveratrol research. Another conference is planned for 2012. In addition to producing resveratrol, Fluxome has a partnership with Norway-based GlycaNova, a biotechnology company that developed a natural beta-glucan product through a unique fermentation process. The final product, Fluxome Beta Glucan, has been involved in several clinical trials confirming its immune-enhancing effects in humans, according to the company. The agreement gave Fluxome exclusive rights to market and sell the product in the U.S. dietary supplement market. The cooperation utilizes GlycaNova’s technology platform and the ability to develop and manufacture products with enwww.nutraceuticalsworld.com

hanced biological effect by using its patented fermentation and separation technology. “By using fermentation and very mild processing conditions they have optimized the efficacy of beta-glucan,” Dr. Woolf explained. In other ingredient developments, Fluxome will be offering a vegetarian, environmentally friendly and sustainable EPA (eicosapentaenoic acid) product that is free of toxins and contaminants. The company also has plans to develop a DHA (docosahexaenoic acid) product, as well as a single component arachidonic acid (ARA) product, which will be introduced to the global food and supplement market in the future. Overall, Dr. Woolf said he believes the nutraceuticals industry will continue to benefit from consumers’ desire for pure nutrients that will ensure health and nutrition, despite a shaky economy. “The growth in the industry is still buoyed by a strong driver, which is the concern or self-interest that gatekeepers, or any household manager, have in regard to the nutrition and well-being of their household.” While the company is doing more business in the cost-competitive, value market today because of the economy, Fluxome offers premium ingredients that mainly attract companies seeking products with a full regulatory profile in terms of safety and efficacy, as well as early-adopter companies looking for exclusively premium products that are highly pure and efficacious. With several clinical studies supporting its products, and more underway, Fluxome is positioned to offer safe ingredients that are proven to work for years to come. —S.M. Fluxome Inc. 400 Northampton Street, Suite 600 Easton, PA 18042 Telephone: 484-546-0321 Fax: 484-546-0323 E-mail: [email protected] Website: www.fluxome.com Nutraceuticals World • 45

New Products

Longevity Factors GNC, Pittsburgh, PA, has released Longevity Factors, a line of dietary supplements designed to help people age well. The seven product formulas feature clinically tested ingredients to support health and bioavailability enhancement technology to improve the absorption of key nutrients, according to the company. Healthy Aging Program is a complete daily pack with six key elements that support healthy aging, including a multivitamin, fish oil, memory formula and 500 mg of resveratrol for cell-aging defense. Heart Health contains phytosterols and is designed to maintain healthy cholesterol, blood pressure and circulation while supporting overall heart health. Cellular Antioxidant Defense contains a high-potency blend of antioxidants, including 500 mg of resveratrol, polyphenols and vitamin D3 to protect cells and DNA against free radicals and cell aging. Energy Enhancer contains antioxidants and an amino acid complex that supports natural energy levels. The product features polyphenols, which can help combat the free radicals associated with cell aging. Eye Health features a blend of potent carotenoids, including lutein, zeaxanthin and beta-carotene, to support healthy vision. Strength & Agility contains protein and fiber to maintain muscle tone. Memory Formula contains turmeric acid and huperzine.

contains 500 mg of the active ingredient alpha-glycerylphosphorylcholine (Alpha GPC), and is suitable for vegetarians/vegans. Jarrow has also unveiled five of its best-selling products in new Value Sizes: Alpha Lipoic Sustain 300, 120 tablets; Bone-Up, 360 capsules; Jarro-Dophilus + FOS, 300 capsules; Resveratrol 100, 120 vegetarian capsules; and Yum-Yum Dophilus, 120 tablets.

All Heart! Renewal Laboratories, San Diego, CA, has unveiled All Heart!, an all-natural bottled tea that contains 250 mg of omega 3 fish oil. Available in Sweetened and Unsweetened varieties, the beverage features Renewal Laboratories’NatureFormed technology. The patent-pending process harnesses the natural power of molecular self-assembly to transform fish oil into stable water-soluble microparticles without using any chemical additives. The process eliminates the need for artificial emulsifiers or detergents.

larProtect Complete capsule formulation. Two scoops mixed with water daily deliver nutrients at levels found to reduce the risk of AMD and its associated vision loss in the landmark Age-Related Eye Disease Study (AREDS), plus a comprehensive multinutrient to protect whole body health. MacularProtect Omega 3 Companion is based on the ongoing AREDS 2 clinical trial—a follow-up to the original AREDS trial that is studying if lutein (10 mg), zeaxanthin (2 mg) and/or 1000 mg of the omega 3 fats EPA and DHA will slow disease progression for those with at least moderate AMD. Two soft gels daily of MacularProtect Omega 3 Companion contain 1000 mg of fish oil. The formulation reflects the levels of EPA (650 mg) and DHA (350 mg) being studied in AREDS 2 and also includes zeaxanthin. The product is intended to be taken in combination with MacularProtect Complete, based on the original AREDS trial and inclusive of 10 mg of lutein and a multinutrient.

Caltrate Soft Chews MacularProtect Complete Drink Mix & Omega 3 Companion ScienceBased Health, Houston, TX, has launched two nutritional formulations to support people diagnosed with age-related macular degeneration (AMD). MacularPro-

Pfizer Consumer Healthcare, New York, NY, has launched Caltrate Soft Chews. Two daily Caltrate Soft Chews contain 1200 mg of calcium and 800 IU of vitamin D3. They are available in Chocolate Truffle and Vanilla Creme flavors.

Bite-amins Trident Vitality Cadbury North America, Parsippany, NJ, has added Trident Vitality to its gum portfolio. The product is available in three varieties: Vigorate, Rejuve and Awaken. Vigorate contains a “burst” of citrus and strawberry with vitamin C; Rejuve contains mint and white tea; and Awaken contains peppermint and ginseng.

Liquid Alpha GPC & Value Size Supplements Jarrow Formulas, Los Angeles, CA, has launched liquid Alpha GPC. Each serving 46 • Nutraceuticals World

tect Complete drink mix, available in Mango Lemonade flavor, contains the same ingredients in the company’s original Macuwww.nutraceuticalsworld.com

VitaPill LLC, Cheyenne, WY, has introduced Bite-amins, a dietary supplement that contains natural ingredients intended to deter mosquitoes from biting. The product also claims to boost the body’s defenses against allergic reaction from bites and itching. The anti-mosquito pill contains a proprietary blend of B vitamins, garlic, echinacea, vitamin C, quercetin, bromelain, curcumin and capsaicin. According to the company, the ingredients in Bite-amins deter mosquitoes from biting for up to 6 hours. The company suggests users take one tablet with water one hour prior to outdoor activity. January/February 2011

Suppliers Corner

Cran-Max PAC Content Proprietary Nutritionals, Inc. has improved Cran-Max, a proprietary cranberry concentrate, to provide a minimum of 7.2% PAC (proanthocyanidins) content per 500 mg. One 500 mg capsule of Cran-Max will now provide 36 mg of PAC, meeting the French Food Safety Authority, (AFSSA), function claim requirements for urinary tract health. For further information: www.cranmaxinfo.com

Retailer’s Staff Education Toolkit The Natural Products Association (NPA) has released its Retailer’s Staff Education Toolkit to help retailers stay within the legal limits of dietary supplement claims. The toolkit can be used to educate retail staff about what should and should not be discussed with customers. It also contains customer-friendly materials for stores. For further information: www.npainfo.org

krill that is designed for the cognitive health market. The exclusive PS grade contains both EPA and DHA conjugated to its backbone. For further information: www.enzymotec.com

antioxidant benefits. Exclusive sourcing from select tea cultivars, combined with Kemin’s proprietary formulation, make Enlivitea a unique tea ingredient. For further information: www.kemin.com

Lion’s Mane

Pur-Blue

Draco Natural Products has released Standardized Full-Spectrum Extract Lion’s Mane mushroom, a potent bioactive extract from a botanical that has been shown to contain cognitive, mood and healthy lipid normalizing benefits. Lion’s Mane contains beta-glucan polysaccharides, diterpenes, along with polypeptides and fatty acids. Clinical studies have shown that these polysaccharides, along with adenosine and oleanolic acids, stimulate induction of interferon and modulate the immune system, boosting the white blood cell count. For further information: www.dracoherbs.com

Valensa International and Parry Nutraceuticals have introduced Pur-Blue premium coated spirulina, which uses an all-natural phycocyanin extract coating to mask the flavor of the native spirulina. The blue color of the new superfood is also an element that can help differentiate it from other spirulina products on the market. For further information: www.usnutra.com

Enlivitea PS from Krill Enzymotec has introduced a new phosphatidylserine (PS) product derived from

Kemin Health has introduced Enlivitea, an all-natural, proprietary blend of green and black teas formulated to provide superior

Research Highlights geniVida Reduces Hot Flashes and Night Sweats A new study showed that geniVida genistein from DSM Nutritional Products reduced hot flashes and night sweats by 51% in postmenopausal women over three months. The study was presented by Dr. James Elliott at the 9th International Symposium on the Role of Soy in Health Promotion and Chronic Disease Prevention and Treatment meeting in Washington, D.C. The clinical study, conducted in collaboration with KGK Synergize Inc. London, Ontario Canada, was a randomized, placebocontrolled, double-blind trial in which 84 healthy postmenopausal women were enrolled and given either geniVida or a placebo. After 12 weeks the women on geniVida had a 51% reduction in hot flashes and night sweats compared to only 27% for the women in the placebo group. For further information: www.dsm.com

January/February 2011

Pet Ingredient Line Ecuadorian Rainforest, LLC, has introduced a line of ingredients tailored for pets. The ingredient categories include: aches & pain, allergies, anxiety, digestion, energy, joint care, reproductive health, uterine infections and more. The line will be promoted by spokes-dog Napoleon, a 6-year-old miniature poodle. For further information: www.intotherainforest.com

Phase 3 Sugar Controller Reduces Insulin and Glucose Impact to Sucrose Results of both pilot and clinical studies recently showed that Phase 3 Sugar Controller, a patent-pending, proprietary combination of a specific form of L-arabinose and a patented form of chromium, significantly reduced both blood glucose and insulin responses to sucrose challenges, according to Pharmachem Laboratories, developer of the ingredient. The pilot study of 20 healthy, non-diabetic subjects showed that taking Phase 3 Sugar Controller led to an average reduction in glucose of 31%, and an average reduction in insulin of 32% when presented with a 70-gram sucrose challenge. In the two-phase clinical trial of 50 healthy non-diabetic adults, subjects taking Phase 3 Sugar Controller had an average reduction in glucose of 24% and an average reduction in insulin of 28% when faced with the same sucrose challenge. The studies have been submitted for publication. For further information: www.pharmachemlabs.com

www.nutraceuticalsworld.com

Nutraceuticals World • 47

People in the News Bond

David Mackay announced that he plans to retire as president, CEO and director of Kellogg Company, Battle Creek, MI, effective January 2, 2011. According to its succession plan, the board of directors elected John Bryant, COO and current member of the board, as the new president and CEO. Mr. Mackay will work closely with Mr. Bryant to ensure a smooth transition. Mr. Bryant joined Kellogg in 1998 and has held numerous leadership roles. Most recently, in July 2010, he was elected to the company’s board of directors. C.K. Foods Inc., Toronto, Ontario, Canada, has promoted Jim Bornhold to vice president of sales. He joined the company in March 2009 as director of sales for the com-

48 • Nutraceuticals World

pany’s CK Nutritional Ingredients division. The company has also hired Nadine FarranGatti as director of business development for its specialty food and beverage ingredients business. She will oversee business development in Canada for the company’s range of functional and nutritional food and beverage raw materials. Heartland Sweeteners, Indianapolis, IN, has hired Amber Krueger as northeast sales director and Jerry Norris as vice president of foodservice. Ms. Kreuger previously served as a customer business manager with The Dannon Company. Mr. Norris previously served as vice president at Stratas Foods, managing all aspects of the company’s bakery business. Cyvex Nutrition, Irvine, CA, has appointed Katherine Bond director of business development. She will oversee all of Cyvex’s sales and marketing channels, determining growth opportunities and implementing appropriate strategies. Ms. Bond previously worked in the pharmaceutical industry in sales. Sterling Technology, Brookings, SD, has hired Angela Walter as business development manager. She will be responsible for guiding the marketing and sales promotion of Immunel and Tegricel in the dietary supplement industry. Comax Flavors, Melville, NY, has www.nutraceuticalsworld.com

named Jake Cohen sales associate. He will be responsible for new business development, market research, account management and account service. Mr. Cohen previously worked as a digital media specialist for Context Web in New York City. Kim Dresser has joined the Natural Products Association (NPA), Washington, D.C., as vice president of membership. She will be responsible for directing and administering NPA’s programs to attract new members and retain current members. In addition, she will implement membership marketing initiatives and identify, develop and oversee new and existing programs, services and benefits to meet member needs. She previously served as director of membership at the Home Builders Association of Maryland.

Classifieds

January/February 2011

2011 Calendar

JANUARY Jan. 13-14: GOED Exchange, Salt Lake City, UT: The Global Organization for EPA & DHA Omega-3s (GOED), Contact: Miranda Barnard, 801-538-0777; E-mail: [email protected]; Website: www.goedexchange.com

FEBRUARY Feb. 15: Health Claims Europe, Brussels, Belgium: Nutrition & Health Claims, 3251-31-12-74; E-mail: [email protected]; Website: www.healthclaims.eu

MARCH Mar. 3-4: Global Omega 3 Summit, Bruges, Belgium: Nutrition & Health Claims Europe, 32-51-31-12-74; E-mail: [email protected]; Website: www.omega3summit.org. Mar. 4-6: Integrative Healthcare Symposium, New York, NY: Diversified Business Communications, Contact: Carmella Perrone, 207-842-5423; E-mail: cperrone@di-

vcom.com; Website: www.ihsymposium.com Mar. 11-12: Nutracon, Anaheim, CA: New Hope Natural Media, 866-458-4935; Email: [email protected]; Website: www.nutraconference.com Mar. 11-13: Natural Products Expo West, Anaheim, CA: New Hope Natural Media, 866-458-4935; E-mail: [email protected]; Website: www.expowest.com Mar. 29-31: Interphex, New York, NY: Reed Exhibitions, 203-840-5314; E-mail: [email protected]; Website: www.interphex.com

APRIL Apr. 18-20: Pharma-Nutrition: Discussing the Interface Between Pharma and Medical Nutrition, Amsterdam, The Netherlands: Elsevier, Contact: Robyn Camilleri, 44-1865-843122; E-mail: [email protected]; Website: www.pharma-nutrition.com

MAY May 10-12: Vitafoods, Geneva, Switzerland: IIR Exhibitions, Contact: Phil Hawkins, 44-20-7240-2444; E-mail: [email protected]; Website: www.vitafoods.eu.com

JUNE Jun. 11-15: IFT Annual Meeting & Food Expo, New Orleans, LA: Institute of Food Technologists (IFT), 312-782-8424; E-mail: [email protected]; Website: www.ift.org

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

NOVEMBER Nov. 29-Dec. 1: Food Ingredients Europe, Paris, France: United Business Media, 31-20-40-99-544; E-mail: [email protected]; Website: www.ingredientsnetwork.com

Advertisers Index Advertiser

Page No.

Telephone

Fax

Website

Biothera. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27. . . . . . . . . . . . 877-699-5100 . . . . . . . . .651-675-0400 . . . . . . . . . . . . . . . . . . . . . . . . . .www.biothera.com Capsugel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CV3. . . . . . . . . . . 888-783-6361 . . . . . . . . .864-942-3079 . . . . . . . . . . . . . . . . . . . . . . . . .www.capsugel.com Cargill Health & Food Technology . . . . . . . . . . . . . 3 . . . . . . . . . . . . 866-456-8872 . . . . . . . . .952-742-7573 . . . . . . . . . . . . . . . . . . . . . . . . . . . .www.cargill.com Cognis Nutrition & Health . . . . . . . . . . . . . . . . . . CV2. . . . . . . . . . . 800-673-3702 . . . . . . . . .513-482-5516 . . . . . . . . . . . . . . . . . . . . . . . . . . . .www.cognis.com DSM Food Specialties. . . . . . . . . . . . . . . . . . . . . . . . 33 . . . . . . . . . 31-15-279-4136 . . . . . . .31-15-279-3480 . . . . . . . . . . . . . . .www.dsm-foodspecialties.com Ecuadorian Rainforest . . . . . . . . . . . . . . . . . . . . . . . . 7 . . . . . . . . . . . . 973-759-2002 . . . . . . . . .973-759-3002 . . . . . . . . . . . . . . . . . .www.intotherainforest.com Embria Health Sciences . . . . . . . . . . . . . . . . . . . . . CV4. . . . . . . . . . . 877-362-7421 . . . . . . . . .319-362-2557 . . . . . . . . . . . . . . . . . . . . .www.embriahealth.com Fluxome Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23. . . . . . . . . . . . 888-354-9998 . . . . . . . . .973-396-2116 . . . . . . . . . . . . . . . . . . . . . . . . . . . .www.fluxome.us HBA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 . . . . . . . . . . . . 212-600-3322 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .www.hbaexpo.com National Enzyme Co.. . . . . . . . . . . . . . . . . . . . . . . . . 5 . . . . . . . . . . . . 800-825-8545 . . . . . . . . .417-546-6433 . . . . . . . . . . . . . . . . . .www.nationalenzyme.com Pharmachem Laboratories. . . . . . . . . . . . . . . . . . 20-21 . . . . . . . . . . 800-526-0609 . . . . . . . . .201-246-8105 . . . . . . . . . . . . . . . . .www.pharmachemlabs.com Pharmachem Laboratories . . . . . . . . . . . . . . . . . . . 39. . . . . . . . . . . . 800-526-0609 . . . . . . . . .201-246-1000 . . . . . . . . . . . . . . . . . . . . . . .www.lactiumusa.com SanHerb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23. . . . . . . . . . . . 917-887-0262 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .www.sanherb.com Walter H. Jelly Ltd. . . . . . . . . . . . . . . . . . . . . . . . . . . . 48. . . . . . . . . . . . 847-455-4235 . . . . . . . . .847-455-4315 . . . . . . . . . . . . . . . . . . . . . . . .www.walterjelly.com

January/February 2011

www.nutraceuticalsworld.com

Nutraceuticals World • 49

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

Setting: All-Mart Mega Store, near Antinomos provincial capital, 30 March 2011. Nima Amin, Outer MVTV journalist: “Imagine going into a store—be it on shelf, online, in the cloud, or in the supra-solar stream—where EVERY advertisement, every claim of ‘Faster’, ‘Slower’, ‘or Greater’, on or

Ear-Relevant What if there were no regulations (and thus no enforcement) regarding nutrition product claims?

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. 50 • Nutraceuticals World

off label, might be a big fat lie. What appears to be a backward flight for consumer protectionism, the province of Antinomos enacted a law—Repeal and Exemption of Advertising Policies, or REAP—on January 1st of this year, rescinding all advertising and marketing regulations, and any related competitor claims and litigation. “Today we’re outside the multiverse’s largest retailer, checking the core temperature of consumers and their buying behavior and decision-making. [Nima, approaching a female consumer exiting the store] “Good morning. I’m Nima Amin with MVTV and I was wondering if we could ask you about the impact of REAP on how you approach shopping, and if it has changed your habits? What is your name and where do you live?” Shopper: “Hi. My name is Lolita Romo and I live in Antinomy.” Nima: “Lolita, I couldn’t help notice that you have a few nutrition products in your transporter. Do you evaluate nutrition products and are you making buying choices any differently than before REAP?” Lolita: “Historically, and throughout the universe, nutrition products have been publically and legally excoriated for being false, misleading and deceptive. I remember your network running an investigative hidden 4D video report on the nutrition industry a few years ago, probing how many of the actual www.nutraceuticalsworld.com

finished goods lived up to their claims. The report estimated that less than one out of a thousand were able to substantiate their claims—from arthritis to weight loss. For me, it’s business and buying as usual. In my transporter I even have two new nutrition products that I have never bought before.” Nima: “What was your buying decision process for the two new nutrition products you purchased today?” Lolita: “I was exposed to one of them—a new intestinal health beverage [Lolita points to a beverage bottle]—from an advertisement on 4D radio and multivision. After experiencing the ad for a few months, and enduring years of intestinal health issues, I decided to investigate. I went onto MeDidactica.evi and queried the evidence database for any human studies on the actual product. Two studies came up, one showing no substantial benefit. I then cyber-linked with the company and asked if they had any studies. They cyber-ported me three studies instantly, two of which I had already. I did my best to read and digest them, and here is the product! “The other product—for my psoriasis—I came across while doing some searches on MeDidactica about a medication my mother was taking. I heard two friends talking about it awhile back—every few months they are enchanted by a new nutrition or cosmetic product. I cyber-linked with this company and they cyber-ported me six studies on the actual product—the exact six on MeDidactica. I approach buying nutrition products the same way I do home appliances, transport vehicles and a home—deep research, independent confirmation and an informed choice. The evidence is out there but REAP has made it even easier to find. Either it exists or it doesn’t.” Nima: “Thank you so much, Lolita. I’m sure some of our viewers’ mouths are agape after your description of how you decide what nutrition products to buy. I know mine is, and yet you make it sound so simple!” NW January/February 2011

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Studies show consumers prefer liquid capsules. For a copy of this insightful market research and to find out how Capsugel’s innovative dosage forms can give your brand liquid appeal, order a free copy of the Licaps® Business Kit by emailing marketing.amer@pfizer.com or call 888-783-6361. You can visit us at capsugelsolutions.com.

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INNOVATIVE LIQUID DOSAGE FORMS

All-season performance, reliability and safety. We’re talking about immune health, not tires. Backed by science for year-round immune support. EpiCor®. For all-season traction, trust your immune product to EpiCor. EpiCor’s immune-balancing properties have been clinically shown to provide year-round support by helping the body boost or suppress immune response as needed.* EpiCor’s dual-function activity is unlike traditional, single-action immune ingredients, which may promote one response or the other, but not both. Taken year round, all-natural EpiCor helps support the body’s ability to handle seasonal challenges.* For safety and reliability your customers can count on year round, choose EpiCor. For more information visit www.embriahealth.com or call 877-362-7421. *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

EpiCor® is a registered trademark of Embria Health Sciences, LLC. ©2010