Nutraceuticals World Apr 2011

Newtrition -step up to healthy hearts. TM Add the cholesterol reducing protection of Heart Choice® and your new produc...

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Newtrition -step up to healthy hearts. TM

Add the cholesterol reducing protection of Heart Choice® and your new product will become the pulse of the market.

t #1 global supplier of plant sterols and sterol esters t Clinically proven to lower cholesterol up to 15% with FDA approved health claim t Branded ingredient with strong consumer awareness Newtrition - Eat. Feel. Live. TM

Cognis Corporation Nutrition & Health Phone: 1.800.673.3702, Fax: 513.482.3576 Email: [email protected] © 2010 All Rights Reserved. Heart Choice® is a registered trademark of the Cognis Group.

www.cognis.com www.heart-choice.com

Natural sweetness. Reduced sugar. Balanced energy.

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Table of Contents April 2011 • Volume 14, No. 3

36 Prebiotics & Probiotics: Partners in Health

The concept of healthy bacteria is beginning to leave a lasting impression on consumers and their well-being.

Cover design by: Jessica Carlin

44

44 Children of Convenience Today’s parents are so busy that the market is growing for fortified foods and beverages formulated for kids.

52

52 Getting the Joint Health Market Moving Again

Growth has been flat for more than a decade—a sign of maturity or a new beginning? Maybe both.

Columns 26 • Business Insights by Greg Stephens

32 • Quality Focus by Paula Brown

28 • Capitol Comments by Todd Harrison

34 • Research Process by Doug Kalman

30 • Eurotrends by Joerg Gruenwald 4 • Nutraceuticals World

www.nutraceuticalsworld.com

April 2011

The National Eye Institute is putting our best to the ultimate test. The National Eye Institute (NEI) is using DSM eye health nutrients in a major study. Scientific evidence suggests that nutrients such as lutein, zeaxanthin and omega-3 fatty acids can play a beneficial role in maintaining eye health. 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.optisharpandfloraglo.com or call 1-800-526-0189.

See our new website at www.optisharpandfloraglo.com

© 2011 DSM

®

FloraGLO is a registered trademark of Kemin Industries, Inc.

Table of Contents

14

66

68

Departments 8 • Top Of The News • Coca-Cola acquires Honest Tea; physicians take and recommend supplements 10 • Editorial • a word from the editor 12 • Nutraceuticals World In Print & Online • line-up of expanded coverage @ nutraceuticalsworld.com 14 • Industry News • Stevia market grew 30% in 2010; codex commission to develop fish oil standard 64 • Nutraceuticals Research • a recap of the latest clinical trials 66 • Supply Source • profiles on DSM Nutritional Products and OmniActive Health Technologies 68 • New Products • recent nutraceutical product introductions 74 • Suppliers Corner • new developments from industry suppliers 79 • People In The News • who’s who and who’s moving where 80 • Calendar • upcoming industry events 80 • Classified Section • classified advertising section 81 • Advertisers Index • cross reference of advertisers in this issue 82 • 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.

6 • Nutraceuticals World


April 2011

Top Of The News

Coca-Cola Completes Acquisition of Honest Tea


“We started Honest Tea 13 years ago with an ambitious mission to create a delicious, healthy beverage alternative produced with the health of our planet and our consumers in mind.” —Seth Goldman, co-founder, President & “TeaEO” In early March, The Coca-Cola Company, Atlanta, GA, exercised its option to acquire the remaining portion of Honest Tea. The move completes a transaction that began three years ago when Coca-Cola, led by the Venturing and Emerging Brands (VEB) unit of Coca-Cola North America, purchased a minority stake in the company. Financial terms of the transaction were not disclosed. Honest Tea, a leading organic bottled tea company, will continue to be based out of Bethesda, MD. In order to retain its entrepreneurial culture, it will operate as a standalone business under current “TeaEO” Seth Goldman, his management team and current Honest Tea employees. Mr. Goldman and VEB have developed a unique operating model that allows Honest Tea autonomy to continue to run its day-to-day operations while accessing the scale benefits of the Coca-Cola system in various areas, including manufacturing and distribution. As part of the VEB team, Honest Tea will also begin to sell current VEB brands to the natural channel. Under an innovative arrangement with The Coca-Cola Company, Mr. Goldman has chosen to reinvest most of his proceeds from the sale back into Honest Tea. Mr. Goldman’s co-founder, Barry Nalebuff and Gary Hirshberg,“CE-YO” of Stonyfield Farm, will continue to provide informal guidance to Honest Tea as part of the Advisory Council. “We started Honest Tea 13 years ago with an ambitious mission to create a delicious, healthy beverage alternative produced with the health of our planet and our consumers in mind,” said Mr. Goldman. “Over the past three years, it has been exciting to see the reach and impact of our mission expand as a result of our partnership with The Coca-Cola Company.” Since receiving an investment from Coca-Cola, Honest Tea has made rapid progress in a variety of areas, including the expansion of Honest Tea distribution from approximately 15,000 outlets in 2008 to more than 75,000 today, the introduction of a ground-breaking Honest Tea plastic bottle that uses 22% less material, and doubling the number of offerings as well as the sales of organic, zero-calorie drinks. Additionally, Honest Tea has committed to transitioning its entire tea line of Honest Teas to Fair Trade Certified by the end of March 2011. The consistently strong growth of Honest Tea, as well as its leadership in the natural foods channel, was among the many elements that attracted The Coca-Cola Company.“When we made the investment in Honest Tea, we did so because we saw that it had great potential to be a significant brand of the future. Three years after, the brand truly reflects where consumer demand is today and we are excited about being on the verge of still more growth,” said Deryck van Rensburg, president and general Manager, VEB, Coca-Cola North America.“Beyond growth, having the unique vantage point of a minority investee and watching Honest Tea has helped our company in many other ways, from encouraging Coca-Cola to obtain organic certification at three of our facilities, to establishing a state of the art tea brewing and filtration system at a bottling plant. Additionally, it enabled us to participate with Honest in a number of sustainability initiatives on recycling. All of these efforts reflect why VEB has chosen to invest in entrepreneurs like the team at Honest—they provide a source of innovative ideas and energy that enhance our own efforts.” www.nutraceuticalsworld.com

April 2011

Top Of The News

Physicians Take and Recommend Several Supplements for Overall Wellness

April 2011

For physicians within several medical specialties, including dermatology, cardiology and orthopedics, personal usage of and patient recommendations for dietary supplements are quite common, according to a study published in Nutrition Journal, a peer-reviewed, online journal that focuses on the field of human nutrition. The 2008 “Life…supplemented” Healthcare Professionals (HCP) Impact Study found that 75% of dermatologists personally use dietary supplements and 66% recommend supplements to their patients; 57% of cardiologists personally use dietary supplements and 72% recommend supplements to their patients; and 73% of orthopedic specialists personally use dietary supplements and 91% recommend supplements to their patients. “Health professionals including physicians have an interest in healthy lifestyles and in habits that may contribute to wellness, which may include the use of dietary supplements. Some surveys of physicians suggest that they are as likely as members of the general public to use dietary supplements,” the study authors state. The most commonly reported product taken by these specialists was the multivitamin—with 44% of all cardiologists, 61% of all dermatologists and 57% of all orthopedists indicating they had taken a multivitamin within the past year. Additionally, more than 25% of physicians in each specialty said they had used omega 3/fish oil supplements, and more than 20% of each of the three specialty groups said they had taken a botanical supplement in the past year, with green tea being the botanical most frequently mentioned. Overall health and wellness was the top reason these physicians reported for taking supplements, including 32% of cardiologists, 42% of dermatologists and 43% of orthopedists. Heart health was mentioned by more than a quarter of cardiologists and orthopedists, while bone health was mentioned by about a quarter of orthopedists and dermatologists. Lowering cholesterol was specifically cited by 20% of cardiologists, joint health by 29% of orthopedists, and skin, hair and nails by 16% of dermatologists. The survey also found that most of the physicians who reported supplement use were long-term users. About half of the supplement users in each specialty said they had taken supplements for four to 10 years, and about a third said they had taken supplements for more than 10 years. When it comes to why these specialists recommend supplements to patients, top reasons were often related to the physicians’ specialty: among cardiologists, lowering cholesterol, maintaining healthy cholesterol, and general heart health; among dermatologists, skin, hair, and nails; and among orthopedists, bone health, joint health and musculoskeletal pain. Findings from this survey add to the existing body of research on healthcare professionals’ use of/recommendations for dietary supplements. In 2009, Nutrition Journal published findings from a separate 2007 study from “Life…supplemented,” which found that physicians and nurses are as likely as members of the general public to use dietary supplements, and most physicians and nurses recommend supplements to their patients. www.nutraceuticalsworld.com

Nutraceuticals World • 9

From The Editor

Happy Kids = Happy Parents There is no harder job than raising a child. And now that I’m a parent I can certainly attest to that. It’s not just about changing diapers or finding the right toys or digging deep for that extra ounce of energy each day. Mostly it’s about making sure your child is happy. And when kids are happy, most moms and dads will tell you they’re happy too. Good nutrition plays a large role in a child’s well-being, setting a foundation they can feed off of for years to come. This month, guest author Amanda Baltazar (who happens to have a daughter a couple weeks younger than my son) does a fantastic job summing up the latest trends in the nutrition world as they pertain to children. As she rightly points out in her article (page 44),“Recent health crises among children and a demand for better, more sensible products from parents have pushed many companies to add health—and more—back into foods and beverages today. And there’s no one for whom that’s more important than children. Growing bodies and minds need fuel and it needs to be nutrient-packed.” Given the recent statistics surrounding kids’ health, it is no surprise that the market for children’s health products is booming. Driven by health-conscious parents who are tired of calorie-rich, nutrient-poor foods, companies are meeting their needs with a variety of products fortified with vitamins, minerals, omega 3s and probiotics. But it’s not just about foods; supplements are playing a part as well. According to Datamonitor, the percentage of new fortified kids’ beverages featuring DHA omega 3 rose to more than 16% in 2010 (up from just less than 3% in 2009) and expanded to more than 33% in supplements (up from 25% in 2009). Meanwhile, the percentage of new fortified children’s foods containing vitamin D rose to more than 12% in 2010 (up from just less than 3% in 2009), as the percentage of new supplements containing vitamin D hit 24% in 2010. On the other side of the age spectrum, there is the older crowd—the grandmas and grandpas out there, who are probably starting to experience the aches and pains that frequently accompany the aging process. The difference between this generation and those before it is that these consumers are not going to take those aches and pains lying down. Whatever it takes, they want to guarantee they can continue to chase their grandchildren well into their“golden years.”In this respect, the joint health category has served these consumers well. While the market (page 52) has been relatively flat for more than a decade, most experts believe it is a mainstay of condition-specific products that will continue to reinvent itself with new ingredients, applications and delivery technologies well into the future. With a strong mindset and some deep pockets, the Baby Boomer segment continues to offer a wealth of product opportunities, according to a recent report released by Packaged Facts.“As Boomers turn 50 and enter their 60s, they carry with them a firm belief that getting older means getting better. Many look at aging simply as another life stage filled with opportunities for reinventing themselves and experiencing new possibilities for personal growth rather than as a signal to wind down their lives,”explained Don Montuori, publisher of Packaged Facts. Most important, these consumers are far more willing to pay a premium when purchasing“better-for-you”grocery products compared to their peers. As parents and grandparents know, there is an enormous sense of pride that comes with raising a child. And my son, Tyler, makes me proud on a daily basis, which is why I just had to include his picture above.

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

Columnists Anthony Almada MSc GENr8, Inc.

Paul Altaffer RFI Ingredients, Inc.

Paula Brown British Columbia Institute of Technology

Jeff Crowther The Natural Products Association (NPA), China

Erik Goldman Holistic Primary Care

Joerg Gruenwald analyze & realize AG

Todd Harrison Venable LLP

Adam Ismail Global Organization for EPA & DHA (GOED)

Doug Kalman Miami Research Associates

Dr. A. Elizabeth Sloan Sloan Trends, Inc.

Grant Washington-Smith Alticor, Inc.

Editorial Advisory Board Steve Allen Nutrition Capital Network

Nancy Childs, PhD Saint Joseph’s University

Steven Dentali, PhD American Herbal Products Association (AHPA)

Loren Israelsen United Natural Products Alliance (UNPA)

Alex Merolli Nutri+Food Business Consultants

Paul Paslaski BioVittoria Limited

Ellen Schutt LaunchNatural

Scott Steinford ZMC USA

Gregory Stephens, RD (Business Insights Columnist) Windrose Partners

Rhonda Witwer National Starch Food Innovation



April 2011

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Stay connected with

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

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

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 Antioxidants: High Expectations for a High Quality of Life In a market filled with so many options for consumers, only the best will rise to the top—and stay there.

Supplement Curbs Breast Cancer Risk Researchers find promise in a combo supplement’s ability to improve breast health as it relates to estrogen-dependent breast cancer risk.

The New Dietary Guidelines Updated guidelines put stronger emphasis on calorie consumption and exercise but misses the mark on certain nutrients.

‘Naturally Filtered’ Blog Each month associate editor Sean Moloughney will offer his thoughts on emerging trends. Looks for his blog under the “Opinions” tab of our website.



April 2011

“The global market for stevia will reach 11,000 metric tons by 2014, equivalent to $825 million by value.” —Zenith International

Industry News

Stevia Market Grew Nearly 30% in 2010 Global sales of stevia reached 3500 metric tons in 2010, a 27% increase from 2009, taking its overall market value to $285 million, according to a new study from U.K.-

based food and drink consultancy Zenith International. Zenith also forecasts the global market for stevia will reach 11,000 metric tons by 2014, equivalent to $825 million by value.“As rising levels of obesity and diabetes continue to dominate head-

lines, there has never been so much emphasis on reducing our caloric intake as well as consuming healthier foods and beverages,” said Anya Hembrough, senior market analyst with Zenith.“After persistent efforts by key producers, legislators

CPG Industry Rebounding from ‘Great Recession’

0.8%, dollar sales grew more quickly than the industry average at 2.2%, largely driven by innovation that enticed consumers to trade up in key categories, such as eye and facial cosmetics. Industry report identifies new market opportunities Energy drinks led the way across the top 10 CPG categories, and strategies. with 13.5% unit sales growth in 2010. This category received a significant boost from energy shot sales in the convenience Consumers deserted shopping malls and car dealerships in droves channel. The wine category grew by 5.7%, followed by chocolate to spend wisely and save in 2009. While this conservative mindset candy at 4.9%, salty snacks at 2.9% and bottled water at 2.7%. has stuck with many consumers, others increased spending at On the other end of the spectrum, milk category unit sales slid by least somewhat during 2010. The consumer packaged goods 3% in 2010. (CPG) industry demonstrated signs of improvement, with unit sales Last year also marked the return of inflationary trends, with declines slowing markedly across channels, and some food prices increasing by an average of 0.5-1.5% for the departments and categories experiencing positive year. Some categories saw rather substantial price insales trends for the first time in five quarters. creases, with sugar leading the way at 12.5% folSymphonyIRI Group continued its analysis of the lowed by butter at 8.7% and breakfast meats at CPG industry’s performance throughout the past 8.6%. On average, though, packaged goods prices year and identified new market opportunities in its slid in 2010, down an average 1% versus 2009. latest report, “Times & Trends: CPG 2010 Year in Many of the price cuts last year were the result of Review: Out of Turmoil Rises Opportunity.” high promotional activity. Pricing trends are likely to “Although many are breathing a sigh of relief shift in 2011, with food-at-home prices expected to since the ‘Great Recession’ officially ended in climb by 2-3%. mid-2010, other consumers are still on the fence “More than ever, it is critical for CPG marketers and wondering if it’s a bit premature,” said John to heighten their understanding of the nuances beMcIndoe, senior vice president, Marketing, Symhind today’s trends and then communicate with Energy and sports drinks are shoppers on a very intimate level by complementing phonyIRI. “Make no mistake, the CPG industry will among the big winners in the continue to serve a very conservative consumer traditional online and print marketing strategies with U.S.’s economic recovery. base in 2011. Nonetheless, this is a time of great new communication mediums, such as social opportunity for marketers. The key is to act with a clear and premedia and smart phones/mobile devices,” added Mr. McIndoe. cise understanding of the changing attitudes, needs and behav“In doing so, savvy marketers will achieve new heights in dollar iors of your most important shoppers and target segments.” and unit share uplift, while fortifying relationships with an ever-inSeveral factors influence CPG growth, including home-based creasing number of shoppers.” eating and drinking and self-reliant health and beauty care rituals. To effectively compete in an unpredictable economy, SymphoAbove average unit sales growth of 1.6% across the center store nyIRI recommends that CPG and retail companies consider the department illustrates the power of these rituals. This department following action items: identify discreet microsegments; target is home to several of the fastest growing categories of 2010, inopportunities and risks of serving each; evaluate pricing, promocluding ready-to-drink coffee/tea, energy drinks and sports tion and merchandising strategies; explore opportunities to endrinks. While average beauty/personal care department unit sales hance product assortment; and create new strategies for lagged behind the industry average by a small amount, growing collaboration throughout the entire value chain.



April 2011

Industry News

worldwide are finally giving the green light to this new zero-calorie sweetener.” The turning point in stevia’s fortunes came in 2008, Zenith reports, when steviol glycosides, the sweetening components of the leaf, were deemed to be safe and Rebaudioside A, one particular steviol glycoside, was granted GRAS (Generally Recognized As Safe) status in the U.S. Since then, approval by legislators around the world has opened the door to new formulations and reformulations of foods and beverages with zero or reduced calorie content

Codex Commission to Develop Fish Oil Standard The Codex Committee on Fats and Oils has adopted a proposal from Switzerland to begin developing a standard for fish oils, according to the Global Organization for EPA and DHA Omega-3 (GOED), Salt Lake City, UT. The proposal will go to the Codex Alimentarius Commission for its endorsement at its July meeting. Several countries raised concerns that more technical detail on the processing of fish oils and trade data were needed in the Swiss proposal. The Codex member countries will be responsible for getting this data to

the Swiss delegation by the end of April. Oils from algae and marine mammals were excluded from the proposal. However, the scope of the standard will cover oils from both fish and shellfish, GOED said. Also, under Codex classifications, squid fall into the shellfish categories, so the standard will also cover oils from cephalopods.

Amino Acids Market to Exceed $11 Billion by 2015 The global market for amino acids is forecast to reach $11.6 billion by the year 2015, according to a new report from Global Industry Analysts, Inc. Growing demand for amino acids in various end-use markets, including animal feed, health foods, dietary supplements, artificial sweeteners and cosmetics is expected to fuel market growth in the coming years. The amino acids market witnessed a decline in demand during 2008 and 2009, primarily because of turmoil in the global economy. Slowdown in various end-use markets negatively impacted market growth during the period. However, the scenario is expected to improve in the near term following recovery in the economy and new demand emerging from end-use

Wilmar Honored for Creating Innovative Omega 3 Oil A new cooking oil fortified with omega 3s EPA and DHA aims to close nutrition gap among Chinese consumers. Ocean Nutrition Canada (ONC), Dartmouth, Nova Scotia, Canada, formally congratulated Wilmar on the launch of Arawana 3A+ premium cooking oil in a ceremony at the Natural Products Expo West show in March. Offering the added health benefits of omega 3 EPA/DHA from MEG-3 fish oil, this is the first Chinese cooking oil to exhibit such outstanding innovation, according to ONC. A national survey conducted by the Ministry of Health of the People’s Republic of China shows that the average daily intake of EPA/DHA of Chinese residents is only 37.6 mg per day. This daily intake is less than 25% of the EPA/DHA level accepted by the Institute of Medicine (IOM), and less than 10% of the intake recommended by the International Society for the Study of Fatty Acids and Lipids (ISSFAL). Due to this deficiency in the Chinese diet, Wilmar, in association with the Chinese Nutrition Society (CNS), launched Arawana blended oil enriched with MEG-3 fish oil.

April 2011

markets. Research activities are critical for the amino acids market, as they lead to the discovery and development of new products, as well as end-use applications. In the past, research has contributed to the growing application of amino acids in the healthcare and cosmetics markets. In addition, utilization of amino acids in nutritional food products and sports drinks has been made possible due to success of extensive research oriented programs. Though the pace of new product discovery has slowed down in recent years, the emergence of new applications holds immense potential for amino acids, the report said. Further, increased emphasis on specific benefits of amino acids, rather than focusing on overall wellness, is expected to open up new avenues for the market.

ADA Encourages Consumers to ‘Eat Right With Color’ As Americans look to improve their diets and lead healthier lifestyles, the American Dietetic Association (ADA), Chicago, IL, reminds consumers that an easy way to focus on eating better is to“Eat Right with Color.” “The American Dietetic Association is committed to improving the nation’s

ONC says Arawana 3A+ premium cooking oil is a technological breakthrough in terms of blended vegetable oil products, containing sufficient omega 3 (450 mg EPA/DHA per 100-gram serving) to help Chinese consumers meet IOM omega 3 intake recommendations. “Adding the goodness of EPA/DHA into a well-established Chinese household staple is a healthy step in the Arawana 3A+ cooking oil right direction,” the company provides 450 mg of EPA and said, adding, “This exciting DHA per 100-gram serving. product is making it easier for Chinese families to benefit from EPA/DHA, while consuming an already popular and essential product.” The Arawana 3A+ cooking oil is widely distributed in China and is available at supermarkets and traditional markets throughout the country. So far the company has spent about $100 million on promotions and advertising. To date, it has generated $230 million in sales.



Industry News

health, and one of the ways we do this is by providing science-based nutrition information to consumers in a way that’s easy to understand and apply to their everyday

lives,” said Judith Rodriguez, registered dietitian and ADA president. “Adding a splash of colorful seasonal foods to your plate makes for more than

just a festive meal. A rainbow of foods creates a palette of nutrients, each with a different bundle of potential benefits for a healthful eating plan,” said Karen Ansel,

sium and magnesium. (For a more detailed discussion of low sodium's market potential, see the March 2011 TrendSense column, pgs 16-17.) For supplement marketers, HBP represents a myriad of targeted opportunities. Uncontrolled blood pressure can result in stroke, heart, artery and kidney damage, vision/memory loss and erectile dysfunction. Smokers, diabetics, African Americans, oral contraceptive users, post-menopausal women, low-level estrogen users, women with high job strain, as well as those who have high cholesterol or are overweight/obese are at greatest risk, according to the American Heart Association (AHA). Nine in 10 (88%) consumers say they'll go to the doctor less and

Getting Ahead of the Curve: Blood Pressure & Stroke By Dr. A. Elizabeth Sloan With one in three adults already afflicted with high blood pressure (HBP)—and the incidence of stroke increasing in those under age 65 and in children—there will be unprecedented demand for products that help lower/manage blood pressure, improve artery health/circulation, prevent platelet aggregation and help cope with the various “side effects” of HBP (e.g., erectile dysfunction). According to SymphonyIRI's November 2010 “Over-the-Counter (OTC) Medication” report, 50 million U.S. households have a member treating HBP, representing a potential $7.8 billion annual market opportunity for OTC products, including supplements; the 27 million households with heart problems or stoke, $4.2 billion. Although IRI reports 87% of HBP sufferers rely on prescriptions to treat their condition, 50% also focus heavily on diet. While lower sodium, fat, calorie and high-fiber foods are “important,” sugar-free candy, ground decafe coffee and sugar substitutes are also popular with HBP consumers (IRI). Concern surrounding high sodium levels is also driving new concerns for adequate potas-

self-treat more even as the economy improves. Although 80% are aware of their high blood pressure and 71% are treating it, only 48% have it under control per AHA. Market Potential According to Sloan Trends' TrendSense Model, HBP and stroke are among the largest and fastest-moving nutraceutical markets, having reached “Mega Mass Market” status. Their enormous level of Medical Counts—approaching 100,000 new studies a year for HBP—have been accelerating rapidly during the last decade, propelling both these markets into Mega status around 2007-2008, when the CDC/NIH and the AHA moved center-stage with new data, media programs and the American Stroke Association on these growing public health issues. Even though Medical Counts appear to be flattening, HBP and stroke will continue their Mega status for years to come. Kid's high blood pressure is another virtually untapped segment, which has quickly and quietly reached mass-market status.

* 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.



April 2011

Industry News

registered dietitian and ADA spokeswoman. “Food variety supplies different nutrients, so to maximize the nutritional value of your meal include healthful

choices in a variety of colors.” Green produce indicates antioxidant potential and may help promote healthy vision. Orange and deep yellow fruits and

vegetables have nutrients that promote healthy vision and immunity. Purple and blue options may have antioxidant and anti-aging benefits and may help with

Growth Opportunities • More than 76 million U.S. adults >age 20 have HBP; 79 million pre-hypertension; HBP is a powerful determinant of risk for stroke (AHA, 2011). • On average, someone in the U.S. has a stroke every 40 seconds; 7 million Americans have had a stroke; 5 million a Transient Ischemic Attack or TIA (AHA, 2011). • Consumer concern is shifting to reduction of heart disease risk factors: 66% of Boomers are concerned about HBP, 48% Gen Xers and 46% Gen Yers; vs. 46%, 34% and 25% respectively for preventative heart health (Hartman, “Re-inventing Health & Nutrition 2010”). • More young people are having strokes; the percentage of people

A unique opportunity exists for basic foods that help offer the proper mineral balance to manage blood pressure in kids. Acute anemia has also been linked to silent strokes in children (AHA, 2011). Manufacturers must be aware of AHA communications associating coffee and soda/sugar sweetened beverages with higher blood pressure levels.

age 20-45 having a stroke was more than 7% in 2005 vs. 4.5% 1993-94 (AHA, 2011). • One-third of Americans are age 55+; those aged 55-64 are projected to grow 42% from 2008-18, the age when first heart attacks are most likely to occur; those 65-74 39%, the age when stokes come into play (Census, 2010). • Of the 42% of grocery shoppers who have HBP or feel they're at risk, 65% have changed their food buying behaviors (FMI, 2010). • Ethnic health is in the political spotlight. Blacks have a risk of firstever stroke twice that of Whites; the prevalence of stroke is nearly 4%, Whites 2.5%, Asians 1.3%. The incidence of stroke in Mexican Americans is expected to rise 350% by 2050 (Am. Stroke Assn. 2011). • Prevalence of HBP is highest in Black males 46%/females 43%; White males 34%/females 31%, Mexican Am. males 28%/females 29%; Asians 20% (AHA, 2011). • HBP in children has tripled in the past year; pediatricians are now monitoring blood pressure at age 3 (AHA/AAP). • 972 million people worldwide have HBP; two-thirds in developed countries; incidence will grow +60% to 1.56 billion by 2025 (WHO, 2010).

supplement marketers.

Functional Foods & Beverages More than half (52%) of consumers are looking for functional foods/drinks that help lower blood pressure (Mintel, “Functional Foods-US 2009”). Half (53%) are somewhat/very concerned about sodium (IFIC, 2010). Low sodium food topped $10 billion in sales in 2009 (Nielsen, 2010). Among those who have purchased lower/reduced sodium foods, 58% bought canned soup, 48% snacks and 41% canned vegetables; 43% say low sodium is an important snack attribute (IFIC, IRI, SnaxPo, 2010). Blood pressure-lowering foods touting dairy peptides, omega 3/DHA/EPA and potassium have been available in parts of Europe and Japan for the past five to 10 years. Magnesium ranks as the 3rd most popular ingredient in heart-healthy foods globally (Innova Market Insights, 2011).

April 2011

Dietary Supplements As detailed throughout this column, the physical ramifications of HBP, the many high-risk populations and rising demand for products that improve vascular health, circulation and help prevent clots offer a wide range of multi-functional and targeted products for

References furnished upon request. About the author: Dr. A. Elizabeth Sloan is president of Sloan Trends, Inc., Escondido, CA, which is a consulting firm that offers trend-tracking and predictions, strategic counsel and businessbuilding ideas for food, supplement and pharmaceutical marketers. Each month she will provide analysis and discuss opportunities of a particular market being covered in a given issue.

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



Industry News

memory and urinary tract health. Red produce may help maintain a healthy heart, vision and immunity. White, tan and brown foods sometimes contain nutrients that may promote heart health.

Food Safety Regulations Tightening Food safety is moving quickly to the top of agendas of food law regulators, as new and evolving regulations are adopted around the world, according to international food policy consultancy EAS. Xavier Lavigne, food law manager with EAS, said the European Union’s (EU) continued strengthening of its food safety regulation and the recent adoption of a new act on food safety in the U.S. demonstrate a trend toward heightened food safety awareness globally. “The EU, for example, has been further harmonizing rules on additives, enzymes and flavors, and is continuously revising the EU-harmonized authorized contaminants and pesticides levels,” said Mr. Lavigne.

“With the United States’ new act on food safety, one can see two different philosophies and legal frameworks towards the same goal. This will ultimately strengthen the trend towards food safety at the global and Codex Alimentarius level.” The changes triggered in Codex are important, he added. “As the WHO/FAO international monitoring body, its standards and guidelines have a significant impact on the 183 countries in the global arena that make up its membership. The Codex Committee on Food Import and Export Inspection and Certification Systems, for example, is currently developing guidelines on national food control systems. This discussion is still at an early stage, but developments in the EU, U.S. and the Association of South East Asian Nations will certainly speed up the rate at which it moves along.”

BCM-95 Curcumin Selected For Alzheimer’s Study Looking to determine the extent to which a

Almond Milk Emerging in Dairy-Free Market Fierce competition among major dairy alternative brands is raising mainstream awareness of almond milk. While soymilk continues to dominate the growing dairy-free market in most countries, there are signs that newer alternatives are emerging in the mainstream grocery sector, using alternative ingredients such as rice, oats and, more recently, almonds, according to Netherlands-based Innova Market Insights. Dairy alternative drink launches recorded on the Innova Database reached more than 600 in 2010, with almond milk and milk blends accounting for more than 8% of product launches. While the number of dairy alternative drinks launched was at a similar level to that in 2009, the share of almond lines was up from 6%, which in itself was double the 3% penetration of almond products five years previously in 2005. While non-dairy milk alternatives are still a relatively small market overall outside Asia, purchase levels are rising with growing awareness of allergy and intolerance issues and the low-fat, low-calorie and cholesterolfree positioning of many products. Soy is facing problems in some developed markets, particularly the U.S., with regard to health scares, and the result in some instances has been a move to non-soymilk alternatives, including those made with ingredients such as rice, hemp, oats and coconut, as well as almonds and other nuts. While almond milks have been available in health food stores for many years, their emergence in the mainstream market has


bioavailable form of curcumin (BCM-95) may prevent or delay the expected declines of Alzheimer’s disease, professor Ralph Martins, PhD, has initiated a one-year clinical study at the Centre of Excellence for Alzheimer’s Disease Research and Care, Edith Cowan University in Perth, Australia. Professor Martins is credited, in collaboration with Australian and German scientists, with isolating beta-amyloid protein, which forms amyloid plaque deposits in the brain, a characteristic diagnostic feature of Alzheimer’s disease. Professor Martins then went on to demonstrate that the Alzheimer’s brain is under oxidative stress, which is now recognized to mediate the action of beta-amyloid to cause Alzheimer’s. Dr. Martins is working to develop an early diagnostic blood test to prevent and/or treat this degenerative brain disease. Because of significant problems with curcumin absorption, clinical work with plain curcumin 95% has required very high dosing in previous studies. “I chose BCM-

been notable of late. The U.S. has led this trend, with nearly one-fifth of the 2010 dairy alternative drink launches recorded by Innova Market Insights being almond milk or almond milk blends. Dean Foods’ White Wave subsidiary launched PureAlmond, sold under its Silk brand, which is more usually associated with soymilk, while the California nut co-operative Blue Diamond Growers has its AlmondBreeze range, made using its own almonds. Both brands now have Dairy alternative drink launches several flavor variants, particureached more than 600 in 2010, with almond milk and milk larly Vanilla, as well as Original blends accounting for more and Unsweetened options. than 8% of product launches. “Competition in the sector has been ramped up as two mainstream brands have introduced chilled versions into grocery outlets alongside the original ambient products, previously found primarily in more specialist stores,” said Lu Ann Williams, head of research at Innova Market Insights. “The fight for dominance between the two players, both part of major companies, has not only grown their sales but also promoted overall awareness of the product, further encouraging development of smaller brands and retailer own-labels.”


April 2011

Industry News

95 curcumin for this human study because it has published human bioavailability data. Therefore, I can use a reasonable amount and expect that the serum levels will achieve a therapeutic range for a significant period of time,” said Dr. Martins. Curcumin studies in animal models of Alzheimer’s disease have demonstrated that it can play a significant role in the destruction of beta-amyloid plaque. It is also a potent antioxidant, with an ORAC value of 159,277 per 100 grams, as determined by USDA. Other studies have shown that curcumin plays a role in neuronal regeneration. All these properties contribute to its potential utility in addressing Alzheimer’s disease. EuroPharma is the sole distributor of BCM95 to health food retailers in the U.S.

Review Compares Plant Stanol Esters With Plant Sterols A new meta-analysis published in the scientific journal Prostaglandins, Leukotrienes, and Essential Fatty Acids shows the maximal LDL-cholesterol reduction achievable with

plant stanol ester is double that of plant sterol ester. Plant stanol ester is the cholesterol-lowering ingredient unique to Benecol products. Plant stanol ester produces additional and dose-dependent reductions in LDL-cholesterol with intakes above current recommendations (2 grams plant stanols/ sterols per day). For plant sterol ester, no such effect was evident. This meta-analysis was based on several scientific studies and included 182 data sets in total. It showed the estimated maximal LDL-cholesterol reduction was more than 18% for plant stanol ester versus 9% for plant sterol ester, with the difference between the two reaching statistical significance. The findings of the new meta-analysis are supported by two recently published independent clinical studies showing LDL-cholesterol reductions of approximately 17% with a daily consumption of 9 grams of plant stanols. “It is known that plant stanols and plant sterols have different structures and that they behave differently in the body, and so it was important to study the LDL-cholesterol-lowering effects of the two sub-

stances separately,” said Kathy MusaVeloso, PhD, the principle author of the article. “The results of the meta-analysis indicate that intakes of plant stanols in excess of 2 grams/day—in fact, up to 9 grams/day—are associated with further and dose-dependent reductions in LDLcholesterol. For plant sterols, however, we did not find a dose-response.” Several scientific and authoritative bodies recommend a daily consumption of plant stanols or plant sterols for improving blood cholesterol levels. The new data may have significant implications for current practices.

ShopSmart Reveals Unhealthy ‘Health’ Foods A new report in the April 2011 issue of ShopSmart magazine, from the publisher of Consumer Reports, unveils some foods that may seem healthy but aren’t necessarily, and offers advice on truly healthful foods to choose instead. A sampling of the magazine’s unhealthy health foods includes vegetable chips. “Their

Nurse Practitioners’ Role in Healthcare Unclear to Americans

betes, high blood pressure, infections and injuries; prescribe medications and other treatments; and manage a patient’s care. CRN also offered these facts about nurse practitioners: 97% CRN survey shows 60% of adults don’t know what nurse of nurse practitioners agree that in order for healthcare in the practitioners do. U.S. to improve, it’s important that all Americans take responsibility for their own health; 82% of nurse practitioners agree While research conducted by the American Academy of Nurse there are gaps in their patients’ diets that could effectively be Practitioners (AANP) shows that 81% of Ameriaddressed with dietary supplements; 59% of cans have had or know someone who has had a nurse practitioners believe in the next five direct experience with a nurse practitioner (NP), years Americans will take measurable steps to many are still not sure exactly what role these improve their wellness habits; 83% of nurse healthcare practitioners play in the healthcare practitioners agree it’s a good idea for patients paradigm, according to the Council for Responto take multivitamins; and 58% of nurse practisible Nutrition (CRN), Washington, D.C. In fact, tioners agree patients have a good under60% of U.S. adults admitted they have no idea standing of actionable steps they can take to what a nurse practitioner’s capabilities are, or improve their overall wellness. they could not articulate them. Nurse practitioners agree the following are Nurse practitioners practice in several setmajor barriers to Americans being healthy: A majority of nurse practitioners tings, including private physician or NP pracStress of daily lives caused by demanding believe the only way to improve tices, retail-based clinics (such as national chain jobs and hectic lifestyles (96%); not getting healthcare in the U.S. is for drugstores), hospitals, nursing homes, public enough rest (94%); staying indoors and not Americans to take responsibility for their own health. health departments and more. Among their getting enough physical activity due to many services, nurse practitioners: order, perweather (89%); overindulging during the holiform and interpret diagnostic tests such as lab work and X-rays; days or on vacation (76%); and not being able to find healthy diagnose and treat acute and chronic conditions such as diafood while on the road (72%).



April 2011

Industry News

colors may be mesmerizing, but they’re usually high in calories and fat and they don’t count as a serving of vegetables.” ShopSmart recommends air-popped popcorn or dried veggies instead. Regarding granola cereal, the magazine says: “It’s usually high in sugar, fat and calories and relatively low in vitamins and minerals…Have a bowl of an airy, oat-based cereal, like Cheerios, which topped ShopSmart’s tests of kid-friendly cereals. For extra crunch and sweetness, add just a sprinkling of granola on top.” The list also includes turkey hot dogs.“A lot of turkey hot dogs are surprisingly high in fat, and some are even higher in fat than regular hot dogs. They also might contain loads of sodium and nitrates…A turkey breast sandwich is a better choice.” For vitamin infused waters, the magazine says “they’re often loaded with sugar and sometimes caffeine. Have plain old H2O with a squeeze from a lemon, lime or orange slices.” Wrap sandwiches are often big enough for two people and may be high in calories and fat. ShopSmart recommended a sandwich on whole-grain or whole-wheat bread.“When shopping for bread, make sure whole grain is first on the ingredient list.” Lastly, couscous, just like white pasta, “is a processed, refined grain with little nutritional value. Buy whole-wheat couscous or opt for a whole grain like quinoa or brown rice.”

Dr. Jeffrey Bland Urges Focus on Health Instead of Disease New discoveries in science and medicine that make it possible to prevent chronic illnesses will transform healthcare from a disease-based to a health-focused delivery system, according to Jeffrey Bland, PhD, FACN, FACB, chief science officer for Metagenics, Inc., San Clemente, CA. Dr. Bland presented his address, “The End of the Term ‘Disease’ and the Future of Medicine,” at the Integrative Healthcare Symposium in New York, NY, in March. “We can now take a systems biology approach to diseases like type 2 diabetes, coronary heart disease, osteoporosis and cancers of the breast, colon and prostate,” said Dr. Bland, who is internationally known for his research into the science of nutrigenomics—how genes are effected by nutrition. ”We have the science to turn back the clock and prevent, even reverse, certain chronic illnesses with appropriate lifestyle changes. This capability will change the focus of medicine from treating acute illness to preventing chronic disease and promoting health.” His talk explored the convergence of recent discoveries in medicine from molecular and cellular biology, physiology, environmental science, clinical medicine, information science, systems biology, nutritional biochemistry, pharmacology and the traditional healing arts to shape an un-

derstanding of where medicine is going, who will be its practitioners, how it will be delivered and who will pay for it. As an example of the chronic illness epidemic in the U.S. today, nearly a third of adult Americans have metabolic syndrome, a cluster of conditions that increases the risk of developing cardiovascular disease, type 2 diabetes and many other chronic diseases. The Centers for Disease Control and Prevention (CDC) recently reported that two-thirds of adults with high cholesterol and half of those with high blood pressure are not being treated effectively for these conditions. Therefore, a new solution is needed to overcome America’s epidemic of chronic illness. That solution is a lifestyle medicine approach, helping people to change their lifestyles to lower their risk factors and to better manage or avoid chronic disease.

Most American Fail to Meet Vitamin D Recommendations Well-known for its role in keeping bones strong, vitamin D is now being hailed for much more—from normal muscle function to a healthy immune system. Yet despite the growing research on the power of vitamin D, seven out of 10 Americans still fall short of recommended amounts in their diets, according to the recent Dietary Guidelines Committee Advisory report. In fact, vitamin D is one of the four nutrients of concern identified in the 2010 Dietary

use of cyclodextrins to stabilize sulforaphane and its analogues.

Patents Sabinsa Corporation, East Windsor, NJ, has been granted a patent titled “Process for Preparing Water Soluble Diterpenes and Their Applications” from the State Intellectual Property Office of the People’s Republic of China. The innovation involves making the forskolin molecule water-soluble by approximately 6000 times. Forskolin is an extract prepared from the herb Coleus forskohlii, a member of the mint family of plants that grows wild in some parts of India. PharmAgra Labs, Brevard, NC, and Lalilab Inc., Durham, NC, have received a Notice of Allowance from the U.S. Patent Office regarding its Stabilized Sulforaphane patent application (2008-0176942). Patent applications in other major geographies are pending. The patent will contain method and compositional claims around the

April 2011

Cyvex Nutrition, Irvine, CA, has received a Notice of Allowance from the U.S. Patent and Trademark Office regarding a patent specific to methods of using Cognisetin, a fisetin-based ingredient, to enhance memory. The patent describes fisetin as a neuroprotector capable of generating neuron cells in the presence of damage, promoting antioxidant synthesis and reducing overactive brain- and spinal cord-specific immune defenses that contribute to age-related decline and/or conditions. Verdure Sciences, Noblesville, IN, has secured two Notices of Allowance from the U.S. Patent and Trademark Office for patent applications covering the composition and methodology of Pomella pomegranate extract brands. The company’s product is clinically researched and standardized to a patented composition, including the antioxidant-rich punicalagins.



Industry News

Guidelines for Americans, which means low intake is a public health concern for children and adults. Doctor of public health, registered dietitian and author Dr. Wendy Bazilian encouraged Americans to look to their diets for vitamin D. “Vitamin D is a true super nutrient and Americans can help close the vitamin D gap by taking simple steps like pouring one more serving of low-fat or fatfree milk each day for their families,” she said.“Milk is the leading source of vitamin D in our diets, supplying more than half of the nation’s vitamin D, along with a unique combination of key vitamins and minerals we all need each day.” A new research report titled“What America’s Missing,” which analyzed government food consumption survey data, identified a total of 11“gap nutrients,”including vitamin D, along with calcium and potassium, which make up three of the “nutrients of concern” identified in the 2010 Dietary Guidelines Advisory Committee’s report.

Kava Restrictions May Be Founded on Inadequate Information International trade and use restrictions on products containing the South Pacific herb kava (Piper methysticum G. Forster) due to several cases of liver disease linked to ingestion of the botanical may be founded

on inadequate information, according to a review article in the March 2011 issue of the AHPA Report, published by the American Herbal Products Association (AHPA), Silver Spring, MD. In the article, Rolf Teschke, MD, one of the world’s foremost experts on kava—a traditional botanical used in natural remedies and products— says the few cases of toxicity related to ingestion of kava products were “most probably a consequence of poor-quality raw kava material employed in the manufacture of a few kava extracts.” “Toxicity was associated with ingestion of traditional aqueous kava extracts, acetonic and ethanolic kava drugs, and kava dietary supplements in kava-herb mixtures,” he said. “These adverse reactions emerged unexpectedly in the face of the apparent safe traditional use of kava for thousands of years.” According to Steven Dentali, PhD, AHPA chief science officer: “Teschke’s article underscores the fact that there isn’t enough information to say that the safety issue with kava is likely supposed toxicity associated with its constituent kavalactones, a possible purported basis for many of the bans and restrictions on kava products.” Dr. Teschke reinforces the connection between the source and quality of the botanical and the safety and efficacy of the finished herbal product. Scientists and

Reports Available Revitalizing one’s physical well-being through diet rather than doctor prescribed medications or supplements has pushed foods fortified with health-boosting properties to the forefront of consumer culinary demands, according to “The Wellness Ingredients: Culinary Trend Mapping Report” from Packaged Facts and the Center for Culinary Development (CCD). Consumers are also driven by a quest for authentic products, for whole foods and for traditional food preparation methods. For further information: www.packagedfacts.com; www.ccdsf.com Food and beverage marketers know they need to understand social media, but many still have more questions than answers about how best to use this new technology and how to avoid the pitfalls, according to a new report from New Nutrition Business. The report outlines seven practical ways to make social media work, based on real life examples; provides practical insights and examples for any company (large or small) wanting to understand and better manage the risks and opportunities that social media and apps offer for marketing better-for-you foods and beverages; and explores the proliferation of apps for shopping, cooking and weight management. For further information: www.new-nutrition.com



April 2011

Industry News

manufacturers alike must carefully attend to the type of kava used as well as to other potentially influential factors stemming from harvest, handling and processing of the kava plant, the article notes. “To minimize hepatotoxic risks due to kava use, efforts have to be undertaken to improve kava quality standards and to establish strict regulations for kava cultivators, farmers, harvesters, manufacturers and physicians treating patients for anxiety, tension and restlessness,” Dr. Teschke said.

CoQ10 Supplements Pass Quality Tests, Some Curcumin Products Fail A new report by ConsumerLab.com,

White Plains, NY, highlights the difficulty consumers may have in selecting a supplement containing the antioxidant CoQ10 or its activated form, ubiquinol. CoQ10 is among the most popular dietary supplements in the U.S., with $450 million in sales in 2009, according to Nutrition Business Journal, Boulder, CO. Further, the recent “Supplement Users Survey” by ConsumerLab.com showed that 53% of serious supplement users purchased CoQ10 in 2010 and this rate was even higher among men and people over the age of 55. Across 31 products reviewed by ConsumerLab.com, the suggested daily serving size ranged from only 22 mg to 400 mg of CoQ10 or ubiquinol.

Recent Certifications & Approvals Cyanotech Corporation, Kailua Kona, HI, has self-affirmed that its BioAstin natural astaxanthin is Generally Recognized As Safe (GRAS) for use in food and beverages following review by a panel of experts. The European Food Safety Authority (EFSA) has issued a safety assessment supporting the use of chromium picolinate in foods intended for the general population in the European Union (EU). The approval is expected to extend the business expansion for Ingredia Nutritional’s (Arras, France) Chromax and Carblite weight management ingredients, which both contain chromium picolinate and have clinically proven efficacy on the regulation of carbohydrate metabolism. Prior to this assessment, in Europe, chromium picolinate was only allowed in nutritional supplements. Robinson Pharma Inc. (RPI), Santa Ana, CA, has received quality certification from STR following an audit that determined manufacturing facilities, production practices and staff qualifications are in compliance with 21 CFR Part 111. STR issued a certificate of conformance demonstrating that RPI has satisfied the standards for inclusion in the STR Retail Qualification Program (RQP). This is the third consecutive year that RPI has earned this confirmation of compliance with the STR RQP standard of manufacturing. Stratum Nutrition, St. Louis, MO, has self-affirmed that its Artinia chitin-glucan fiber ingredient is Generally Recognized As Safe (GRAS) following a comprehensive review of safety and toxicology by an independent panel of experts. GRAS designation will allow Artinia to expand into the food and beverage industry. Israel-based Algatechnologies has obtained Generally Recognized As Safe (GRAS) status for its AstaPure brand astaxanthin


The cost to obtain 100 mg of either ingredient from the products ranged from $.11 to more than $3. Some products contained “solubilized” forms of CoQ10 or ubiquinol, which may deliver more than twice as much CoQ10 into the blood as standard capsules. ConsumerLab.com’s supplement testing showed that all products contained their listed amounts of CoQ10 or ubiquinol, but four products violated FDA labeling requirements by depicting a heart symbol on their labels. The heart symbol is an implied health claim not permitted by FDA for CoQ10 or ubiquinol supplements. In a separate review, two of 10 turmeric products selected for quality testing were

from FDA, allowing for use in food and beverages applications. The company’s products are manufactured using super-critical CO2 technology, obtaining 10% astaxanthin in oleoresin form, with no solvent extractions. Aker BioMarine, Oslo, Norway, has self-affirmed that its Superba krill oil is safe for use as a human food ingredient following review by an independent panel of experts. It conducted a critical review of extensive safety, toxicology and clinical research data obtained from animal and human testing, based on scientific procedures and safety assessment criteria established by FDA. Nutrition Formulators, Inc., Miramar, FL, has received Good Manufacturing Practice (GMP) certification from NSF International. Requirements of the standard include label and formulation review, GMP plant audits, product testing, safety evaluation and ongoing monitoring to ensure continued conformance. Biothera, Eagan, MN, has received authorization from the Ministry of Health in China for the use of Wellmune WGP as a novel food ingredient. The new designation allows for the immediate use of Wellmune WGP in foods and beverages throughout China. The ingredient is derived from the cell walls of a proprietary strain of baker’s yeast (Saccharomyces cerevisiae). Biosecur Lab, Otterburn Park, Quebec, Canada, and P.L. Thomas, Morristown, NJ, have self-affirmed that the Biosecur product line is Generally Recognized As Safe (GRAS) for use in various food applications. AIBMR Life Sciences led the GRAS dossier and third party independent review. Biosecur is approved as a food ingredient in 40 food categories outlined by 21 CFR 170.3, including use as an antioxidant and preservation aid in all processed food applications, ready-to-eat and ready-to-bake products, fruits, vegetables, nuts, dairy products, condiments and beverages.


April 2011

Industry News

found to provide only 7.7% and 14.7%, respectively, of expected curcuminoid compounds. Unlike some turmeric supplements tested in the past, however, none of the recently tested products exceeded strict limits for lead and cadmium contamination.

plement NSF’s existing certification services in China and provide companies with a means to source safer products, raw materials and ingredients from Asia through independent, third-party testing and certification.

U.S.-China Health Products Association Receives Export Award

Survey Shows Dietitians Would Recommend a Carb-Control Supplement

The U.S.-China Health Products Association recently received an Export Appreciation Certificate from the U.S. Department of Commerce’s Commercial Service Health Team for the association’s work in promoting the export of U.S. products from Jarrow Formulas, All American Pharmaceutical, Pacific Health Labs, Forward Foods LLC and Chef Jays. The association worked closely with its retail member, World Health Store, which is the first foreign owned and managed health food store in China. The award was also presented for the association’s ongoing market intelligence reports to the U.S. Department of Commerce to ensure government-to-government dialogue continues toward the overall development of China’s dietary supplement and natural health products industry. The award was presented to executive director Jeff Crowther, who established the association along with its founding members Jarrow Formulas and NSF International. The association’s missions are to work toward a more open regulatory environment in China, to increase dietary supplement and other natural health product exports to China and to create a safer, more transparent supply chain through its work with NSF International.

A survey of 106 dietitians at the ADA Annual, Food & Nutrition Conference & Expo last year showed that more than 75% of them would recommend a carb-control supplement to their clients.“The response highlights the challenge of getting clients to adhere to a meal plan when it comes to consuming carbohydrates,” said Laura Garrett, MS, RD, CDE, who administered the survey on behalf of Pharmachem Laboratories, Inc., Kearny, NJ. “Normally, carbohydrates should make up 45-60 grams of a meal plan for adults trying to control their weight, or maintain healthy blood sugar levels. Our analysis showed that 28% of the dietitians believed their clients are consuming more than 76 grams of starch per meal. When asked if they would recommend a product like Phase 2 Carb Controller, which has been clinically shown to reduce the digestion of dietary starches, the vast majority said yes.” Consumers need carbohydrates, but often they eat too many of these comfort foods leading to weight and blood sugar issues, Ms. Garrett continued. “Consequently, a supplement that helps reduce starch digestion and absorption can be a valuable tool in helping consumers adhere to their meal plans.”

NSF Opens Shanghai Testing Laboratory Expanding its services in Asia to include testing in the areas of food equipment, dietary supplements and ingredients, and consumer products, NSF International, Ann Arbor, MI, has opened a new testing laboratory in Shanghai, China. The facility and staff will provide on-site training in the areas of food safety, pharmaceutical, medical device and dietary supplement manufacturing. NSF Shanghai Testing Technology Company will comApril 2011

NutrAwards Go to Fruitflow & Good Cacao DSM Nutritional Products, Parsippany, NJ, received the 2011 NutrAward for best new ingredient for its Fruitflow water-soluble tomato-based product. Fruitflow received approval for an Article 13.5 health claim in Europe, which says the ingredient helps reduce platelet aggregation and “contributes to a healthy blood flow.” The NutrAward for best finished product went to Good Cacao, a functional chocolate bar that contains several nutraceuticals, including the patented probiotic Ganeden BC30, Cognis’ www.nutraceuticalsworld.com

Heart Choice plant sterols, Fuji Health Science’s AstaREAL astaxanthin, Martek’s life’sDHA and Biothera’s Wellmune WGP immune support ingredient.

Lonza Signs Supply Agreement with EVA Pharma Egypt-based EVA Pharma and Lonza, Basel, Switzerland, have signed a multiyear supply agreement for Carnipure tartrate and Carnipure crystalline, two of Lonza’s L-carnitine products, as well as a Carnipure brand licensing agreement. EVA Pharma’s Carnivita Forte is an over-thecounter product intended for men looking to promote their fertility by increasing sperm count and sperm motility.

DSM Marks Transformation with New Brand Symbolic of the company’s transition from a chemical company into a life sciences and materials sciences company active in health, nutrition and materials, the Netherlands-based Royal DSM N.V. has introduced a new company brand: “Bright Science. Brighter Living.” The company said its new brand reflects its overall positioning. It stands for the DSM strategy, DSM culture and the way DSM wants its employees to work together. It represents the company’s sustainability value (working with a triple bottom line of people, planet and profit thereby creating value for all stakeholders), the One DSM philosophy (based on the realization that DSM can only fulfill its strategic goals if it operates as one united team across the globe) and it fits with the DSM mission to create brighter lives for people today and for generations to come.

Alpha Packaging Acquires Progressive Plastics Adding more than 160 stock items to its product offerings, Alpha Packaging, St. Louis, MO, has acquired Progressive Plastics, Inc., Cleveland, OH. Progressive is a manufacturer and decorator of plastic bottles and containers primarily for the personal care, auto care, house wares and food markets. Irving Place Capital, a middlemarket private equity firm, acquired Alpha in September 2010. Nutraceuticals World • 25

Business Insights

With the growing investment required for launching new products in the U.S. supplement market, it has become increasingly important that each product deliver on expectations. Whether launching new products, sustaining the lifecycle of maturing products or moving into a new distribution channel, a keen understanding of the targeted consumer is necessary. During the past few years, the behavior

Succeeding in Health & Wellness Today Product developers and marketers need to consider several key factors for their products to survive and thrive in today’s market.

By Gregory Stephens, RD

Greg Stephens is president of Windrose Partners, a company serving clients in the dietary supplement, functional food and natural product industries. Formerly vice president of strategic consulting with The Natural Marketing Institute (NMI) and Vice President of Sales and Marketing for Nurture, Inc. (OatVantage), he has 25 years of specialized expertise in the nutritional and pharmaceutical industries. His prior experience includes a progressive series of senior management positions with Abbott Nutrition (Ross Products Division of Abbott Laboratories), including development of global nutrition strategies for disease-specific growth platforms and business development for Abbott's medical foods portfolio. He can be reached at 215-860-5186; E-mail: [email protected]. 26 • Nutraceuticals World

of consumers has changed rather dramatically. Today’s population is driven by far more than just the state of the economy. With greater access to the Internet, consumers are more educated about supplements, have higher expectations and exhibit a renewed sense of environmental consciousness. These and other changes in the marketplace have impacted what can be identified as “key success factors” for health and wellness products. Clear & Compelling Benefit The product must provide a benefit that addresses an unmet consumer need. An unfortunate reality of health and wellness in the U.S. is that there is an ever-increasing incidence of health issues related to poor lifestyle and behavior choices. Certainly not easy to change, this has led to an epidemic of the comorbid conditions of obesity, diabetes, elevated serum lipids (like cholesterol) and possibly osteoarthritis. Additionally, with the growth of the Baby Boomer segment, the demand for solutions to issues associated with aging is on the upswing. Even though the concept of “beauty from within” is not new, the demand for anti-aging products is just taking off. In addition, other common health iswww.nutraceuticalsworld.com

sues that present with aging include declining cognition and memory, mental focus, eye health, energy and immunity. One of the many challenges facing marketers is the ability to communicate the benefit of an ingredient or product to the consumer. Consumer awareness of the benefits afforded by some more popular or common nutrients, such as glucosamine, omega 3s or antioxidants, are fairly well known. Awareness of some of these benefits has been facilitated by the approval of heath claims. Other emerging compounds like preand probiotics, peptides and newly introduced antioxidants often rely on more general structure-function claims. The benefit of these claims is increasingly important for ingredients with low consumer awareness. Unquestionable Safety Recent consumer surveys have shown that safety is the #1 product attribute affecting consumers’ purchase decisions for supplements. Consumer concern about the safety of dietary supplements is not new. However, it has intensified during the past few years through negative media coverage of products not delivering on label claims or poor quality of certain imported ingredients. Another upward trending concern for safety from the consumer perspective is increased awareness of the potential for interactions between supplements and Rx or OTC medications. This concern should be clearly addressed in product messaging, particularly when the risk exists. Demonstrated Efficacy Historically, the power of “the story” has played a significant role in the marketing of supplements. However, as marketers try to reach the emerging “mainstream” consumers, the importance of clinical substantiation becomes increasingly important. Consumers’ quest for substantiation is stronger for products offering preventative or long-term benefits. When conApril 2011

Business Insights

“In today’s competitive global environment, it is paramount to understand the rapidly changing consumer and market dynamics.” sumers “feel” a benefit, compliance and continued usage is more likely, for instance, after a course of glucosamine therapy for joint pain. Conversely, when the benefit is long-term, such as with preventative health products, consumers need to be assured, preferably through sound research, that the product is delivering the intended benefits. Believability of the benefit may be supported by such authoritative sources as a healthcare professional or trusted media sources. Lifestyle Fit This success factor contains a fairly broad group of elements that includes, for example, consumers’ eating and purchasing patterns, pill consumption, product applications, sustainability, preference for organic/natural/vegetarian and convenience. Sustainability has significant influence on the dietary supplement industry. Notably, in addition to focusing on post-consumption issues like recycling and reusable and biodegradable packaging, consumers are exhibiting increased interest in pre-consumption. Pre-consumption includes interest in locally grown foods and reducing “food miles” or otherwise addressing the environmental impact of getting food to consumer. Other trends affecting sustainability include the use of renewable power and pollution control in manufacturing, fair trade and a companies’ corporate social responsibility (CSR) commitment. While at present most U.S. supplement consumers prefer “capsule” forms for their dietary supplements, a growing number are looking for alternative formats. Certainly, some consumers prefer that the functional ingredients be formulated into foods they know and enjoy. It appears that young adults are more interested in functional food delivery forms compared with older generations. This may be influenced by their early April 2011

exposure to nutritional bars, shakes and other convenience foods during childhood. Convenience continues to play an important role in purchase behavior. From the proliferation of energy shots being sold in convenience stores to the growth of such value-priced online marketers as VitaCost, consumers are looking for convenient, one-stop shopping. One of the more notable conveniencedriven consumer behaviors is use of the Internet as a point of purchase with its potential for quick access to information on health issues as well. For example, the percentage of consumers shopping for health products over the Internet has increased quite dramatically during the past decade, according to some surveys, from less than 10% just 10 years ago to more than 50% of consumers today. One approach to attracting consumers in these emerging channels is providing valueadded services. For instance, consumers are often very confused when it comes to making their dietary supplement selections. So they often turn to the Internet as a source of unbiased information. However, most consumers feel commercial websites are biased and self-serving, and do not offer a balanced perspective. One way to address this issue is to provide accurate information through a reputable spokesperson. Good Value Based on several large consumer surveys it is clear the economic downturn has had a significant effect on dietary supplement usage. It appears consumers are buying fewer supplements. And if they are buying, they’re looking for less expensive and private label products. Only certain groups of consumers trust reputable brands and are willing to pay a premium for these products. Loyalty programs represent one way to hold on to the established consumer base today and expanding it for tomorrow. www.nutraceuticalsworld.com

There are several reasons for consumers’ preference for dietary supplements over the pharmaceutical alternatives. These reasons include, for instance, the absence of negative side effects. Also, when comparing the cost of dietary supplements, prescription medications have historically had the advantage of minimal co-pay supported by insurance companies. One way insurance companies are adapting their pricing to the new economy is increasing user contributions to prescription co-pays. In this case and with an increase in the uninsured population, the healthcare value proposition is beginning to shift toward the self-care model, at least when addressing minor health issues. Superior Sensory & Organoleptics One element of this success factor is taste but it more broadly encompasses texture, color and smell. For instance, organoleptics may include mouthfeel and the “throat catch” associated with high fiber products or the “aftertaste” often associated with consumption of some vitamins and fish oil products. In the past few years, food scientists have been quite successful at remedying these effects. Now more than ever, consumers are not willing to sacrifice taste for health benefits. This is especially true of products providing preventative health benefits. In addition to the high degree of trust in efficacy required of preventative health products, nutraceuticals must have superior sensory traits to ensure compliance and continued usage. Summary Product developers and marketers must take these key success factors into account when formulating and developing their marketing messages. In today’s competitive global environment, it is paramount to understand the rapidly changing consumer and market dynamics, particularly when moving to new channels of distribution or targeting a new consumer segment. With clear objectives and identification of white space in the market, all supported by appropriate research, companies can position themselves to provide superior consumerfocused solutions and benefit from a sucNW cessful product launch. Nutraceuticals World • 27

Capitol Comments

On February 23, 2011, FDA denied OVOS Natural Health, Inc.’s New Dietary Ingredient (NDI) application, permitting the use of homotaurine as a dietary ingredient in dietary supplements. FDA explained that it denied the petition because homotaurine is not considered a dietary ingredient within the meaning of Section 201(ff)(1) of the Food, Drug & Cosmetic Act (FD&C Act). The significance of this decision lies in the agency’s narrow interpretation of an“amino acid”

Narrowing the Field FDA’s recent decision to deny OVOS’ NDI request may be a sign of things to come.

By Todd Harrison

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]. 28 • Nutraceuticals World

as it applies to dietary supplements under the FD&C Act. According to FDA, for the purposes of Section 201(ff)(1)(D) of the FD&C Act, the term “amino acid”refers to an“alpha-amino carboxylic acid used as a constituent of proteins or peptides.” This means that if a substance is neither an alphaamino carboxylic acid nor a constituent of proteins or peptides, then it cannot be contained in a dietary supplement as an amino acid. As background, OVOS’ parent company previously instituted but discontinued an Investigational New Drug (IND) study of homotaurine in 2008 after completing a 78-week study. In 2009, the company decided to market homotaurine as an ingredient for use in dietary supplements. Under the FD&C Act, a dietary supplement may not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and existence of such investigation has been made public, unless it was marketed as a dietary supplement or as a food prior to such authorization. However, the FD&C Act does allow FDA to issue a regulation, after notice and comment, and waive this restriction with respect to a particular substance. It was reported on Nutraingredients.com—had the petition been granted—that OVOS would have become the first firm to have an ingredient switched from drug to dietary supplement status after its initial efforts to obtain drug approval for the ingredient were not satisfactory at the clinical trial stage. Based on the legislative history of the Dietary Supplement Health and Education Act of 1994 (DSHEA), FDA concluded that nutrition science www.nutraceuticalsworld.com

was the appropriate scientific context for analysis of what is an “amino acid” under Section 201(ff)(1)(D) and noted that amino acids recognized in nutrition science are alpha-amino carboxylic acids, which are constituents of proteins. FDA further stated that the “Amino Acids” Section of the Food and Nutrition Board of the Institute of Medicine (IOM) report discusses the 20 amino acids that are consistent with the agency’s definition and that these amino acids do not include homotaurine. FDA also noted that its food additive regulation for amino acids used as “nutrients added to foods” (21 C.F.R. § 172.320) lists the same 20 individual amino acids. According to FDA, more general definitions that include chemical or other non-nutritive properties are not appropriate for the purpose of defining the term“amino acid”in the context of the supplementation of the human diet. FDA thus concluded that homotaurine is not an “amino acid” under Section 201(ff)(1)(D) because it is a gamma-amino sulfonic acid, and not an alpha-amino carboxylic acid or a constituent of proteins. Another significant issue relates to FDA’s determination that synthetic substances that are not already part of the food supply do not qualify as a“botanical”(or extract thereof) within the meaning of Section 201(ff)(1)(C). Specifically, FDA says that although homotaurine naturally occurs in some plants, including the seaweed dulse, OVOS’ homotaurine is not a botanical (or extract thereof) because it is made synthetically (i.e., it was not extracted from the seaweed dulse or any other botanical). As FDA noted, the agency conclusion is consistent with its previous determination that synthetic compounds are not botanicals under Section 201(ff)(1). What Happens from Here? FDA’s narrow interpretation of the term “amino acid” in the context of dietary supplement regulation goes beyond this particular petition and will likely apply to the entire dietary supplement industry in the future. Not only is FDA expected to apply this definition when reviewing NDI notifications, but it may also make the marketing of many dietary supplement products impermissible under the FD&C Act. NW References furnished upon request. April 2011

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Eurotrends

The European Food Safety Authority (EFSA) is currently tasked with reviewing a multitude of health claim applications and giving its opinion to the European Commission, as per the new Health Claim Regulation that came into effect in 2007. The authority bases its opinions on the submitted substantiating evidence— the applicants’ tasks being to submit the entire body of evidence in literature,

More Issues with the European Health Claim Regulation EFSA makes some decisions that make companies go ‘huh?’

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. 30 • Nutraceuticals World

along with substantiating clinical trials done on the respective products. The points EFSA evaluates include: whether the product or substance in question is sufficiently characterized; whether the claimed effect is beneficial to human health; whether the submitted evidence is relevant; and whether a cause and effect relationship has been established between the evidence and the claim. Since EFSA has been reviewing applications, it has become apparent that it is using demanding criteria, comparably stringent to those used in evaluating drug claims. As a result, it has issued hundreds of rejections—some of which are being appealed by manufacturers—as well as some downright strange decisions. One such strange decision was made February 23, 2011, when EFSA rejected a claim for water and dehydration. The claim was submitted by two German professors as a test case, and not really meant in earnest, but EFSA treated it as earnest. It was an article 14 claim (a riskreduction claim), worded “regular consumption of significant amounts of www.nutraceuticalsworld.com

water can reduce the risk of development of dehydration and of concomitant decrease of performance,” which sounds pretty straightforward at first glance. The main point of a risk-reduction claim application is proving that using the product in question could reduce the risk of developing a disease. Again, no problem there, right? Drinking water certainly reduces the risk of becoming dehydrated. According to the regulation, risk-reduction claims are defined as claims, which state that the consumption of a food “significantly reduces a risk factor in the development of a human disease.” But what, precisely, are the risk factors for dehydration? And which factors must be reduced in order to prevent the disease “dehydration?” There was some back-and-forth between EFSA and the two professors, which led to the proposal that the risk factors for dehydration were “water loss in tissues” or “reduced water content in tissues.” EFSA disagreed, finding instead that these points were “measures of water depletion and thus are measures of the disease.” In other words, consuming water would reduce the disease, not the risk factor. The risk factors, according to the panel, include things such as “lack of water” or “heat” or other external factors facilitating dehydration. These, however, cannot be reduced by consuming water. EFSA then ruled that the water-dehydration claim is outside the scope of the EU nutrition and health claim regulation, and rejected the application. If the European Commission adopts EFSA’s opinion, it would basically mean that no company could make a claim linking water consumption and dehydration. This is yet another sign of how absurd this evaluation process has become. There is significant confusion that exists about the difference between “disease risk reduction” and “disease risk factor reApril 2011

Eurotrends

duction.” This confusion, according to claim applicants, may also be the reason why EFSA took almost 2.5 years to reach this decision. They say that they are likely to sue EFSA over the rejection of their application, but are not overly optimistic about the outcome. Other experts state that this decision illustrates the many inherent faults in EFSA’s evaluation framework. If dehydration is a disease because it does not fall within the scope of the health claim regulations for foodstuffs, does this mean that water is a drug because it is something that cures a disease?

changed decision. Many stakeholders believe EFSA is using a drug measuring stick on food claims. Or, to put it differently, it is applying drug standards to functional food claims. The discussion about risk factors is symptomatic for this need to measure acceptable markers. In a way, it is easier to prove drug efficacy, since the trials can

be conducted on patients, with the effect being the curing of a disease. In a food, the study population must be healthy volunteers, since the study population must be equal to the target population, which is assumed to be the general population. Proving a health effect in an already healthy study group is difficult and even more so if you’re working alone. NW

“In most cases, applications are rejected because of methodological flaws in substantiating clinical trials, or because of a complete lack of evidence.”

Rejections on the basis that the application in question does not fall within the scope of the regulation are rare. In most cases, applications are rejected because of methodological flaws in substantiating clinical trials, or because of a complete lack of evidence. However, the fact remains that the number of rejections far outweighs that of accepted claims, and occasionally, EFSA’s ruling is surprising and unacceptable for manufacturers and other stakeholders, who subsequently start lobbying for a April 2011



Quality Focus

“Quality has to be caused, not controlled.”—Philip Crosby, 1926-2001 As we transition into 2011 and look back over the last couple years of columns, I have decided it is time to take a break. No, I won’t stop writing just yet; rather I will steer away from the GMP for this one column to consider the very nature of the column’s subject matter: quality. The past few columns have

Waxing Philosophic About Quality Quality is not really about testing; it’s about the recipe.

By Paula Brown

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 be reached at [email protected]; Website: www.bcit.ca/appliedresearch/ibrc/. 32 • Nutraceuticals World

tended toward discussions of testing, but as any good quality assurance expert will tell you, you can’t test quality into a product. Establishing quality is a top-to-bottom process that assures that whatever goals you set for yourself in terms of making the product are met. Testing is only one part of the process. So if an HPLC chromatogram is the sole determinant of product quality, then I fear we are setting the bar pretty low. “Even though quality cannot be defined, you know what quality is.” —Robert M. Pirsig, b. 1928 When judging an apple, we as consumers might look at it and consider the color, shape, lack of blemishes and surface dirt. If those are acceptable, we’d take a bite out of it and evaluate crispness, flavor, maybe the feeling of satiation. We would then say either “Mmmm” or “Yuck.” As apple growers, we would be careful with harvest and transport, perhaps check for blemishes and divert those apples deemed unsuitable to further processing. As distributors or retailers, we would rotate our apple stock so that old apples were sold before they got mushy and rotted. Regulatory changes and even consumer demands of quality above freshness, appearance and taste, have moved to include a lack of pesticides and pathogens, as well www.nutraceuticalsworld.com

as labeling that designates the apple variety and even Country of Origin. Apple producers can manage these requirements by using approved pesticides as directed or not using pesticides at all, by only selling fruit that is picked directly from the tree and not off the ground where they may come in contact with animal waste, and by maintaining clean storage facilities and transport (these are elements of Good Agricultural Practice, perhaps another time). However, none of these controls involves analytical testing. My point is that the savvy consumer can tell a good apple from a bad when it’s presented as fresh whole fruit, just as they can distinguish fresh ground espresso and freeze-dried instant coffee. “Customers pay only for what is of use to them and gives them value. Nothing else constitutes quality.” —Peter F. Drucker, 1909-2005 In considering aspirin, there are superficial quality indicators that consumers can use to judge“quality”: Are the tablets all the same size, weight and color? Are they intact? Do they smell like vinegar? Those who remember the 1982 episode of poisoned acetaminophen will be concerned about packaging and more recent recalls may prompt concerns about over-potent products. Most important, perhaps, is the matter of whether or not the aspirin worked. Did your headache go away? Sensory evaluation coupled with easily discerned efficacy, are important hallmarks of aspirin quality. However, the health consequences of consuming poorly made drugs intended to work over long periods of time to reduce risk, such as statins, may not be observed for years. Your doctor may measure biomarkers of cardiovascular risk like cholesterol, but it’s difficult to collect evidence of “not having the heart attack that you might otherwise have had,” so efficacy is harder to judge than in the aspirin example. The U.S. Congress (with FDA oversight) requires that companies ensure that drugs “work” before they can be marketed, and April 2011

Quality Focus

drug GMP potency testing is built in to make sure there’s enough (but not too much) of the active substance in the product. How do manufacturers make sure the product will meet the specification for potency? Well, they take all the necessary steps to ensure the right ingredients in the right amounts are employed, and then test to make sure that everything went as planned. According to FDA’s MedWatch recall notice list-serve, most drug recalls result from GMP problems rather than from inherent safety issues. The former can cause therapeutic failure, while the latter can cause dangerous overdose. Drug GMP regulations don’t mention efficacy, because that is presupposed from the drug licensing process. However, controlling for and testing potency are vital to pharmaceutical manufacturing. For drugs the efficacy element is added to the general criteria for appearance, odor and taste that we cited in the apple example (i.e., there were no efficacy criteria in the food quality definition). “Quality is never an accident; it is always the result of intelligent effort.”— John Ruskin, 1819-1900 Although classified as a special category of food, consumers may be challenged to judge the quality of dietary supplements by their senses, so quality must be built in and evaluated by the manufacturer. In this respect, quality assurance for supplements is similar to drugs, although with most supplements intending to convey mild benefit over long periods of time, there is no instant efficacy feedback. With measures for shortand long-term efficacy harder to come by, defining and measuring quality in dietary supplements is more challenging. Interestingly, you can peruse the final GMP rule and its voluminous preamble without finding efficacy mentioned anywhere. Lacking information on the appropriate amount of active substance (herb, etc.) that should be contained in each product, FDA does not use the word “potency” in the GMP, but instead uses “strength” and mandates that experts (i.e., the manufacturers) set science-based specifications for strength as well as identity, purity and composition. The more prescriptive elements of the GMP deal with safety, such as the identity testing requirement that evolved from FDA’s concern from the substitution of foxglove April 2011

(poisonous) for plantain (not poisonous) in the 1990s. Rules about testing for “reasonably anticipated contaminants” came about from FDA reports of adulteration with pharmaceutical drugs and contamination with pesticides, microbials and heavy metals. Cases of manufacturers being less than punctilious about the exact locations of decimal places in formulating products led to the need for having Master Manufacturing Records and documentation that the recipes therein were followed. And so on. “It is easier to do a job right than to explain why you didn't.”—Martin Van Buren, 1782-1862 The intention of this column was to consider the nature of quality, but the process by which you assure quality is very much a part of GMP, so I might as well follow through with the FDA definition of quality: “the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under sections 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act” [referring to the Federal Food, Drug, and Cosmetic Act] (see 21 CFR 111.3).” There are many different approaches to manufacturing in the GMP environment, two of which I wouldn’t recommend if a quality product is the endgame. First, you can save money in the short-term by avoiding the time consuming and expensive controls, oversight, paperwork and testing, right up until the FDA shuts you down. Second, you can do the above, but test at the end to see if your specifications are met. While you may save money in the short-term, your chances of a product failing go way up and you are likely to reach the same endpoint with FDA. The third alternative is to have careful written processes and controls in place, and documentation to support they are being followed, and to test the finished product to make sure everything went as planned. In the long run the cost of production, without controls in place, is surely greater than carefully controlled production that results in the expected product. So, when all is said and done, ensuring quality within the context of the dietary supplement GMP comes down to three things: 1. Making sure you have the right compowww.nutraceuticalsworld.com

nent (whether ingredient, excipient or packaging) and it is clean; 2. You have a recipe and you can prove you followed it; and 3.You have the tools to prove your product is what you claim it to be. While“quality”for dietary ingredients is not easily defined, it is hopefully based on the substantiation information you have on file for your ingredients and your finished product. “Quality means doing it right when no one is looking.”—Henry Ford, 1863-1947 To the consumer, quality means the product is and does what it says. Most finished dietary supplement products can’t be evaluated by taste, appearance or smell, and many cannot be evaluated based on an immediate effect. Quality endpoints for drugs and foods are relatively simple compared to endpoints for supplements. For drugs, the endpoints are “no more dangerous than it has to be” and “it works.” For foods, quality endpoints are “it doesn’t make us sick” and “it tastes good.” Supplements don’t necessarily have to taste good, but they shouldn’t make us sick and they should do what they claim to do. The supplement GMPs take care of the “don’t make us sick”part but put most of the responsibility for“does what it claims to do” on the manufacturer. So outside the descriptors of quality required by the GMP rule, quality will be based on the rigor and integrity of your substantiation data and integration of that data into your recipes and testing protocols. “You can't fake quality any more than you can fake a good meal.”—William S. Burroughs, 1914-1997 GMP compliance can be verified by a lack of FDA warning letters to your company, but in the end consumers buy based on trust—trust that the manufacturer knows its business and takes pride in the connection of the products to nature and healing, not just the factory. Sort of like the farmer’s apples, quality is not really about testing; it is about the recipe. This is true for all good products from the apple to the drug. Just because Nana bakes her pie from memory, doesn’t mean there isn’t a recipe and if she screw’s up (sorry, Nana) the feedback will be pretty immediate when you take a bite. In industrial settings, your brand’s reputation can be worth millions to your bottom line, and that reputation hinges on conNW sumer perceptions of quality. Nutraceuticals World • 33

The Research Process

During the last 16 years, since the passage of the Dietary Supplement Health & Education Act (DSHEA), with many opportunities to create a “black and white” definition of substantiation, the regulatory bodies in this sector have been relatively quiet regarding this matter—until now. Indeed the recent FTC vs. POM as well as the Nestle, Iovate and Mark Dreher PhD

Are RCTs the Wave of the Future? If so, there are some basic things your company should know about study design.

By Douglas Kalman, PhD, MS, RD, CCRC, FACN

Douglas Kalman, PhD, MS, RD, FACN, is director of clinical nutrition at Miami Research Associates (MRA), Miami, FL, in the Nutrition and Endocrinology Division. MRA is a clinical service organization involved for over 10 years in phase II through post market trials for the pharmaceutical and nutraceutical industries. Mr. Kalman is also an active member of the American College of Sports Medicine, American College of Nutrition, the American Dietetic Association, the National Strength and Conditioning Association and the Association of Clinical Research Professionals. He is also the executive vice president and treasurer of the International Society of Sports Nutrition (ISSN). He can be reached at 305-666-2368; Fax: 305-669-8966; Email: [email protected]; Website: www.miamiresearch.com. 34 • Nutraceuticals World

cases may offer a clearer definition of substantiation going forward. Further, what FTC has said publicly about potential study designs may be an indication of the future for science-based products in the natural products industry. The ‘Nuts & Bolts’ of Study Design The FTC has stated that two well-designed randomized, double-blind, placebocontrolled trials (RCTs) represent the gold standard for substantiation. To gain a full understanding of RCTs it helps to run through some definitions. Understanding these common definitions represents a good first step in creating an original substantiated product. Randomized is defined as“to make random in arrangement, especially in order to control the variables in an experiment,” while double-blind is defined as “a testing procedure designed to eliminate biased results, in which the identity of those receiving a test treatment is concealed from both administrators and subjects until after the study is completed.” A placebo is considered “an inactive substance or preparation used as a control in an experiment or test to determine the effectiveness of a medicinal drug or other product.” The FTC also mentions terms such as“adwww.nutraceuticalsworld.com

equately powered” in the conversation regarding substantiation. Adequately powered means the study contains enough research volunteers (subjects) and controls so that the results are more likely accurate, rather than occurring by chance alone. For an adequately powered study to produce real results, one also has to look at the effect (effect size) of the intervention (as compared to placebo). Knowing the effect size or predicted effect size allows the study team to determine how many subjects will be needed for the study. Having the right amount of subjects calculated formally during the study design period allows for a cleaner study and clearer results. One reason FTC requires studies to contain a placebo is to help rule out a placebo effect. The placebo effect occurs when an inert or non-active substance is used and the person taking it gets the same or similar results as the intervention product. Placebo effects typically occur in psychological studies (i.e., forms of depression) as well as in some physical intervention trials (i.e., osteoarthritis trials where quality of life issues are prominent). Many studies have shown a real placebo effect and an improvement equal to or beyond that of the medical or nutritional intervention, posing a dilemma for researchers. But observing a placebo effect in a study does not necessarily mean that the interventional product did not have a real effect, either physiologically or psychologically. A commonly asked question regarding placebos is why use one if it has the potential to cloud the results. The answer is simple: using a placebo allows for more real results. There is a way to utilize a placebo in clinical trials without risking good data, by using a “placebo run-in.” In this case, just prior to administering the intervention, researchers will allow study participants to take a placebo for a specific amount of time. The placebo run-in is detailed in the “informed consent”as part of the study and study procedures, however subjects may not know April 2011

The Research Process

exactly when they are receiving placebo versus the real product. By using the placebo run-in you allow all subjects to experience a placebo response, which may diminish the placebo response during the actual intervention phase of the study (i.e., when the real product is given and placebo is also given in a controlled, randomized way). One could also argue that utilizing the right placebo run-in might enhance the FTC (and perhaps FDA) view and judgment about your study design and results (i.e., they are more believable, and there is a lower likelihood of placebo effect), especially if the results demonstrate an effect of the intervention. But perhaps your company isn’t quite ready for an RCT. In this case, it might be most logical, as part of your Product Master File— which is often used as a dossier for substantiation—to consider a “Proof of Concept” study (PoC). These studies typically use a preset amount of people, whereas the RCT will utilize a more formal sample size calculation. (The sample size calculation can be affected by many things, including the effect size expected—if known—of the intervention product being evaluated.) The PoC study allows researchers to obtain a rough idea of the effects of

“By using the placebo run-in you allow all subjects to experience a placebo response, which may diminish the placebo response during the actual intervention phase of the study.” the intervention. In other words, the results should be interpreted with some caution and not fully embraced as conclusive. Some PoC studies will utilize a design in which 90% or so of the subjects are on active product while only one or two people are on placebo. This type of study also gives researchers an indication of the degree of the placebo effect, while also making sure the lab test data are being analyzed correctly. Additionally, the results can help you determine the effect (effect size of your intervention) and thus how many subjects you would need for a larger trial. A new study design being employed in pharmaceutical research today is“adaptive design.”According to FDA,“There is great interest in the possibility that clinical trials can be designed with adaptive features (i.e., changes in design or analyses guided by examination of the accumulated data at an interim point in the trial) that may make the studies more efficient (e.g., shorter duration, fewer patients), more likely to demonstrate an effect of the drug if one exists, or more informative (e.g., by providing broader dose-response information).” This newer research design has gained popularity because it has the potential to answer multiple questions within the same study. Ultimately, it is in the best interest of all companies involved in the natural products sector to gather the most data on their products, especially if FTC and consumers are to believe the claims. NW April 2011



Prebiotics & Probiotics:

Partners in Health

The concept of healthy bacteria is beginning to leave a lasting impression on consumers and their well-being. By Sean Moloughney Associate Editor

A

s global demand for health products rises, the market for prebiotics and probiotics will grow stronger, in spite of regulatory challenges, thanks in part to broadening scientific research and increased consumer understanding, industry experts believe. Publication of clinical studies evaluating probiotics continues to accelerate and uncover new health indications—outside of the traditionally recognized digestive health benefits—to include immune sup-


port, anti-inflammation, oral and skin care and women’s health. However, to date, the European Food Safety Authority (EFSA) has rejected all applications for health claims related to probiotics, establishing a strict environment that has handcuffed marketers at times. Meanwhile, increased regulatory oversight in the U.S. led to false advertising charges from FTC against The Dannon Company for claims that its Activia product relieves irregularity and that DanActive www.nutraceuticalsworld.com

helps prevent colds and flu. Dannon agreed to a $21 million settlement in December, but admitted no wrongdoing.

This article in a nutshell: • Still selling • Awareness • Indications & research • Application issues • Regulations & differentiation

April 2011

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According to FTC, Dannon may not claim that Activia yogurt will relieve temporary irregularity or help with slow intestinal transit time, unless the ad conveys that three servings of Activia yogurt must be eaten each day to obtain those benefits. Dannon may claim that eating fewer than three servings a day provides these benefits only if the company is relying on two well-designed human clinical studies substantiating the claim. More recently, in February, FDA issued a warning letter to Lifeway Foods, Morton Grove, IL, for what the agency considered disease claims related to its Lifeway Kefir and other probiotic-containing products.

Still Selling Despite the tension between regulators and marketers, consumers’ buying habits speak for themselves. The global probiotics market, still in its infancy stage, could reach nearly $29 billion in revenue by 2015, according to a report from Global Industry Analysts, Inc. (GIA) titled “Probiotics: A Global Strategic Business Report.”The market is set to witness impressive growth as consumers become more conscious about their health and switch to preventative healthcare due to rising costs, the report said. Enhanced efficiency of ingredients and increasing scientific evidence on the benefits of probiotics are the other major factors facilitating market growth. GIA also predicts the market for prebiotics in Europe and the U.S. will reach nearly $1.2 billion and $225 million, respectively, by 2015. Popularity is rising within the functional food market due to various applications in dairy products, beverages, nutrition bars, breakfast cereals, bakery products, mineral supplements, weight loss products, infant formula and pet food. U.S. sales of prebiotic and probiotic food and dietary supplements exceeded $1.5 billion across natural supermarkets and Food, Drug and Mass channels for the 52-week period ending in February, representing an impressive 28% growth over the previous year, according to SPINS, a market research and consulting 38 • Nutraceuticals World

firm for the natural products industry based in Schaumburg, IL.

Awareness Consumers are accepting the concept that live microorganisms can offer health benefits when consumed in adequate amounts. “Over the last few years in the U.S., more consumers have become familiar with the word ‘probiotics,’ however, a deeper understanding of how probiotics actually work and the differences between specific strains and products are still needed,” said Lauren Weidelman, corporate communications manager, Yakult U.S.A, Torrance, CA, a subsidiary of Tokyo, Japan-based Yakult Honsha, Co., Ltd. “Our company focuses on educating healthcare professionals through annual scientific symposiums and regular probiotic seminars for dietitians. We believe that it is the role of the healthcare professional to educate and guide consumers as to the use of probiotics.” Increased awareness of probiotics and their health benefits has positioned the category alongside the most popular products on the market today, including vitamins and omega 3 fish oils, said Tim Gamble, senior vice president, Sales and Marketing, Nutraceutix, Redmond, WA. “Probiotics, with increased academic and scientific support, are now regularly recommended to consumers by practitioners in traditional medicine, not just integrative or alternative medicine.” Perhaps indicating the mainstream acceptance of probiotics, Ganeden Biotech, Inc., Cleveland, OH, recently launched its enLiven brand of all-natural yogurt exclusively in Wal-Mart stores. The low-fat yogurt contains GanedenBC30 probiotics and is available in four flavors: Vanilla, Blueberry, Strawberry and Peach. Mike Bush, vice president of business development, Ganeden, said the product has been selling very well and Ganeden’s website saw increased traffic, and more downloads of clinical trials, immediately after enLiven’s launch. The product doesn’t make any health claims, simply featuring “with Probiotics” and the Ganeden BC30 logo on the package. www.nutraceuticalsworld.com

It seems, then, a strict regulatory environment hasn’t been a barrier to engaging consumers, Mr. Bush noted, as consumers are taking the initiative to investigate products and research themselves. “I think consumers understand some of the benefits without shoving claims down their throat.” Yakult’s Ms. Weidelman agreed, saying,“I think once consumers experience the benefits of probiotics for themselves, they will understand how and why probiotics can be helpful and important in a healthy diet.”

Indications & Research Digestive health continues to represent one of the greatest needs among consumers and, in turn, one of the largest opportunities for companies in the health and wellness arena, according to New Nutrition Business, which ranked digestive health as the top heath and wellness trend for 2011. The overall digestive health market in the U.S. continues to show steady growth, due in part to increased awareness of prebiotics and probiotics, noted Sarah Staley, vice president of business development at FrieslandCampina Domo, Chicago, IL. “While consumer understanding of prebiotics has lagged behind the awareness of probiotics, market surveys show there is sustained interest in the benefits of prebiotic fermentation, particularly prebiotics that increase the level of beneficial probiotic bacteria, like Bifidobacteria,” she said. “In addition, these ingredients can now be found in everyday foods and beverages that fit into consumer’s lifestyles.” Neel Varde, Nutriose product manager, Roquette America, Keokuk, IA, said prebiotics are often bundled with fiber, and consumers recognize their deficiencies in that area. “The recommended daily value for fiber is 25 grams per day, and most adults only get half of this amount,” he said. “In general, a good prebiotic should increase the levels of good bacteria in the gut, decrease the levels of bad bacteria and provide some sort of physiological benefit.” Shaheen Majeed, marketing director, Sabinsa Corporation, East Windsor, NJ, April 2011

Pre-Probiotics

also discussed the unique relationship between pre- and probiotics, saying prebiotic (non-digestible) foods are vital to encourage probiotic organisms to survive and thrive in the human gut. “Probiotic bacteria taken together with prebiotics that support their growth are called ‘synbiotics.’ LactoWise is a synbiotic proprietary composition containing Bacillus

coagulans, a probiotic marketed by Sabinsa Corporation under the brand LactoSpore, and soluble Fenumannan from fenugreek seeds as the prebiotic component. Both work together in a synergistic way, more efficiently promoting the probiotic benefits.” Backed by sound scientific documentation, gut health remains the primary in-

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dication for pre- and probiotics, said Isabelle Champié, deputy manager and global marketing director for Institut Rosell-Lallemand, Montreal, Quebec, Canada.“Based on today’s clinical proofs, probiotics are particularly effective and recommended to help in the prevention and management of antibiotic-associated and acute diarrhea, lactose intolerance, gastroenteritis, intestinal infection, traveler’s diarrhea, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS) and transit regulation.” Recent years have witnessed a proliferation of published clinical studies involving probiotics.“According to the research database Pubmed.gov, the number of probiotic studies has significantly increased around the world in the last decade,” said Yakult’s Ms. Weidelman. “In the 1990s there were 456 published probiotic studies versus in the 2000s there were upward of 6260 published studies. The numbers are climbing significantly year over year.” For Yakult’s exclusive strain, Lactobacillus casei Shirota, the most compelling study in 2010 was a double-blind, randomized, controlled field trial conducted in the urban slums of India involving 3758 children, Ms. Weidelman noted. “These children were given one bottle of Yakult (65 ml) per day over a period of weeks. The study results indicated that Lactobacillus casei Shirota was significantly effective in reducing incidence of diarrhea in children. This is an important finding since there is a high rate of infectious diarrhea leading to mortality in children in developing countries or areas.” Ms. Champié said that other health indications beginning to emerge include immune support, based on the notion the gut is a primary immune site in the human body.“A growing number of studies show the effects of certain probiotic strains in the prevention of common infectious disease,” she said.“For example, ProbioKid, a synbiotic formula from Institut RosellLallemand has been shown to decrease the risks of common winter infections in children (Cazzola et al., Therapeutic Advances in Respiratory Disease 2010). These results were presented in September 2010 at the European Respiratory Society conApril 2011

Pre-Probiotics

gress in Barcelona.”She also noted potential benefits for women’s health with respect to the maintenance and protection of the urogenital microflora. Dr. S. K. Dash, president, UAS Laboratories, Eden Prairie, MN, agreed that probiotics have gained momentum from research that demonstrates clear health benefits. “Consumers are concerned about the antibiotic residues in milk, meat and eggs and are more concerned about antibiotic resistant bacteria,” he added. “This has made consumers prefer probiotics instead of antibiotics.” UAS Labs has completed a study on IBS that it expects will be published in June. Another clinical trial on urinary tract infections is underway and expected to be completed by the end of May, Dr. Dash added. Among other areas of research, Scott Bush, vice president of marketing, Health & Nutrition, Danisco, Madison, WI, said inflammation represents an interesting direction that probiotic research is starting to explore. “As medical science continues to better understand diseases and outcomes related to inflammation, the ability of probiotics to modulate inflammatory responses may be very significant. I expect we’ll see more research in that area.”

ation—better technologies have expanded potential applications to other food areas, including chocolate, juices and baked goods. For example, NextFoods, Boulder, CO, has added Probiotic Coconut Water to its GoodBelly line of probiotic fruit drinks, which contain the patented Lp299v strain. The new product contains 20 bil-

lion live and active probiotic cultures and 80 calories per serving. Michael Shahani, director of operations for Nebraska Cultures, Inc., Walnut Creek, CA, said that improvements in understanding how probiotics can be stabilized in food and beverage applications, has led to more successful product launches. “We are getting numerous in-

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Application Issues Logically, different probiotic strains behave differently. As a result, manufacturers must assess their needs before formulating, either with dietary supplements or functional foods and beverages. In the case of the latter, stability of probiotics in different food matrices depends on the specific strain, said Joanie Dion, technical representative, Lallemand Nutritional Food Ingredients. “Particular strains better resist acidic conditions, like in beverages, or osmolarity shock, like in chocolate, or even to heat treatment, like in bread and muffins. The challenge is to maintain adequate concentration through the shelf-life depending on storage conditions of the finished product.” While yogurt and dairy products have been the traditional vehicles for probiotic-fortified foods and beverages—due to a typically short shelf-life and refrigerApril 2011

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Pre-Probiotics

quiries about putting probiotics in dried meal replacement and energy beverage mixes, infant formula, frozen yogurt mixes, chocolate and other foods,” he said. “We expect quite a bit of new business for these applications.” Lorraine Niba, business development manager, Nutrition, National Starch, Bridgewater, NJ, said bars and other more trendy products like shots and chews are gaining popularity among consumers. “Ingredient suppliers who can offer functional ingredients that can be easily incorporated in multiple food, beverages and supplement categories will be at an advantage in this attractive market.” Sabinsa’s Mr. Majeed said his company’s LactoSpore could be used in powder form in ready-to-drink mixes suitable for use in room temperature liquids, dry suspensions, tablets, capsules, chewable tablets and dispersible tablets. Fenumannan can also be used in dry soup mixes. After some hesitancy to launch new products in an unstable economy, Ganeden’s Mr. Bush said he believes more companies have regained confidence. “Food companies have such long development cycles but we’re starting to see some acceleration now.” He also noted growth in the animal health and personal care markets.“On both fronts, we’re starting to see more aggressive research and development.” While improvements in food and beverage formulation have proffered growth for the category overall, dietary supplements continue to offer better viability and higher potency than other forms, according to Mr. Gamble, of Nutraceutix. “Probiotic chewables oral health products, probiotics in combination with vitamins and other top selling active ingredients are being formulated and produced at a heightened pace as brands seek ways to capture the attention of increasingly educated consumers.” Danisco’s Mr. Bush said the potency of probiotic supplements continues to increase. “It’s not a short-term trend. It’s been going on for some time, but the numbers are getting significantly higher. Ten years ago a lot of the counts were single digit billions—10-20 billion live bacteria would have been a very high 42 • Nutraceuticals World

count—now we’re seeing products with 40, 60, 80 and 100 billion counts.” He also noted VSL#3, marketed as a medical food for the dietary management of patients with ulcerative colitis (UC), an ileal pouch (IP) and irritable bowel syndrome (IBS), has a bacteria count of 450 billion. “While part of the drive to higher counts may be marketing driven, we have sponsored clinical studies in which a dose response is shown to exist with the higher count proving more efficacious.” In order to preserve viability of probiotic counts, Capsugel, Peapack, NJ, has developed a series of capsules that provide for flexible and targeted delivery of probiotics. All the capsules use hydroxypropyl methylcellulose (HPMC), which is lower in moisture (4-6% in 50% relative humidity) than regular gelatin (12-14%) and thus protects the moisture-sensitive probiotics from activating in the package and/or before it reaches the intestines, where they are most effective for digestive health. Recently, the company introduced DRcaps, vegetarian capsules with properties that slow down capsule opening after swallowing and are particularly suited for probiotics. In vitro studies show the capsule contents are protected for at least 30 minutes at a gastric pH of 1.2 and release fully at an intestinal pH of 6.8. Capsugel also offers Pre-Pro Combo, which is designed to contain a combination of prebiotic and probiotic ingredients. It utilizes the company’s Moisture Defense System (MDS), which includes the use of capsule-in-a-capsule technology. The inner capsule of the Pre-Pro Combo contains L. acidophilus, which is then suspended in a liquid-based prebiotic formula containing fructo-oligosaccharide (FOS). “Prebiotics and probiotics can work together to improve the ultimate nutritional effectiveness of probiotic ingredients,” said Mark Vieceli, director of sales, marketing and business development for Capsugel, Americas Region. “However, prebiotic regimens are less common because they are new to the market and more difficult to find on store shelves. The Pre-Pro Combo gives manufacturers a distinctive way to efficiently offer consumers additional benefits within one www.nutraceuticalsworld.com

unique product.” Pre-Pro Combo is designed so that the inner capsule containing the probiotic culture takes longer to fully dissolve, helping to improve its ability to reach the digestive system where it is most effective. “The natural-delayed dissolution properties of Pre-Pro Combo reduce the need for enteric coatings,” said Mr. Vieceli. “Such coating processes add an extra step in manufacturing, and the heat and moisture involved can affect the viability of the live bacteria.”

Regulations & Differentiation While the pre- and probiotics market seems to be thriving in spite of a restrictive regulatory environment, Danisco’s Mr. Bush noted a lack of approvals has negated a significant point of differentiation for companies that have invested in research. “The types of claims we see on products with science behind them are often no different than the statements made on products with no science,” he said. “It’s really hard to differentiate a documented product from an undocumented product at the consumer level. Researchers and physicians can spend the time to read the literature and see what is supported by good science. But the consumer walks into a health food store, picks up 10 products and reads the labels, and they can all sound remarkably similar.” Nebraska Culture’s Mr. Shahani said that as the market progresses, it’s important to educate both manufacturers and consumers about the benefits and limitations of probiotics.“We have already seen that some manufacturers making unsubstantiated claims about the efficacy or stability of their probiotic products has tarnished the reputation of the industry as a whole. As a result, regulatory agencies such as the FDA and the FTC are beginning to take a closer look at the probiotics industry.” Nebraska Cultures supports efforts of organizations like the International Probiotic Association to work with companies and regulatory agencies to ensure that probiotics are promoted and regulated in a responsible and effective manNW ner, he added. April 2011

Children of Convenience

Today’s parents are so busy that the market is growing for dietary supplements, fortified foods and nutritional beverages for kids. By Amanda Baltazar Contributing Editor Busy, busy, busy. It’s almost a mantra these days and it’s ubiquitous. As a result, the diets of Americans have changed. Commonplace foods are processed, with the nutrients taken out of them. But recent health crises among children and a demand for better, more sensible products from parents have pushed many companies to add health—and more— back into foods and beverages today. And there’s no one for whom that’s more important than children. Growing bodies and minds need fuel and it needs to be nutrient-packed. Currently, the hot ingredients are omega 3 fatty acids (i.e., DHA), pre- and probiotics, vitamin D and calcium, and manufacturers are putting these into all types of foods, beverages and supplements to try to enhance the diets of kids of all ages.

Boosting the Health of a Calorie-Rich, NutrientPoor Generation What is this doing for our children? On 44 • Nutraceuticals World

the one hand, it’s boosting the health of a generation that eats poorly. A recent report from the U.S. government, published in the October 2010 issue of the Journal of the American Dietetic Association, showed that American kids are filling up on empty calories. Equally worrying, the report showed that almost 40% of children’s calories come from solid fat and added sugars and half came from just six foods/beverages: soda, fruit drinks, dairy desserts, grain desserts, pizza and whole milk. On the other hand, nutritionists are concerned that fortified foods are leading parents to believe their offspring are obtaining all the nutrition they need. “Parents are going for this lesser-thanevil,” said Melissa Abbott, trends and culinary insights director, The Hartman Group, Seattle, WA.“They give their child Pirate’s Booty instead of a proper meal, or if they won’t eat a proper meal. They feel that at least the child is getting some nutrition and these foods are largely to make the parents feel better. It lessens www.nutraceuticalsworld.com

the guilt of the parents.” But there’s no proof these foods are actually safe. According to Christen Cooper, MS, RD and founder of Cooper Nutrition in Pleasantville, NY: “The average child can survive quite well eating normal food. That is, of course, if the child is eating a healthy, well-rounded diet. “Scientists do not know enough about what happens when we remove one component of a food, such as omega 3 fatty acids, or certain vitamins and minerals, then isolate them and add them to other foods. Furthermore, companies can charge extra for what may actually prove to have little value for the consumer.” On the other side of this debate sits

This article in a nutshell: • Boosting the health of a calorie-rich, nutrient-poor generation • Ingredient headliners • The supplement side • What about tweens and teens?

April 2011

Children’s Nutrition

Elizabeth Somer, RD, author of Eat Your Way to Happiness, who is a big advocate for supplementation. “There are few people in the U.S. who are eating perfectly. An FDA study found only one in 100 people was eating perfectly. Especially little children don’t eat well—they go on food jags.”

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Parents tend to fall into the same camp as Ms. Somer, prompting a huge demand for fortified foods and beverages specially formulated for children. According to New York, NY-based Datamonitor, the percentage of new fortified kids’ beverages featuring DHA rose to more than 16% in 2010 (up from just less than 3% in 2009) and expanded to more than 33% in supplements (up from 25% in 2009). The percentage of new fortified children’s foods containing vitamin D rose to more than 12% in 2010 (up from just less than 3% in 2009), while the percentage of new supplements containing vitamin D hit 24% in 2010. By and large, the products making these claims, explained Tom Vierhile, director of Datamonitor’s Product Launch Analytics, were yogurt, cereal bars, pasta and poultry/poultry products. Martek Biosciences, Columbia, MD, is the manufacturer of life’sDHA, a vegetarian, sustainable source of the omega 3 fatty acid DHA. Martek’s DHA can be found in more than 99% of infant formulas on the U.S. market. It’s also used in foods and beverages targeted directly at children, such as Horizon Organic Milk and Pediasure. This spring it will also be in a new line of toddler vitamins called Brain Strong. These will be in the form of a sachet of flavorless powder for the very young (ages one through three) and gummies containing 100 mg of DHA per serving for kids aged three plus. Martek’s DHA is different from others, according to company spokeswoman Cassie France-Kelly, because it’s made from algae. Its DHA ends up in children’s Martek’s life’sDHA is used in foods and beverages targeted directly at products, she said, because children, such as Horizon Organic kids are a really vulnerable Milk and Pediasure. population. “It’s in breast milk and formula but when they are weaned, unfortunately in the western diet, DHA intake falls off because it’s found mainly in fatty fish. DHA is very important to brain development and brain health.”


April 2011


A new product enjoying recent success is Mojo Milk. Launched in November 2010, it delivers 10 times the probiotics of yogurt and comes in powder form, in individual stick packs. Peter Leighton, a partner in Natural Discoveries, owner of Mojo Milk, was one of the people behind the product’s creation. “Seeing the chocolate milk on the market, none of them were healthy, so I started doing some research,” he said. In the course of this he discovered the probiotic GanedenBC30, which, said Mr. Leighton, is the only probiotic that has been clinically shown to survive the application of heat and the acidity of digestion. “This one expands or grows in the gut so the good flora proliferate,” he added. Each of the stick packs delivers 2 billion CFU (colonizing units, which support enhanced immune function and digestive health benefits. Half of this would be sufficient, but the company put in more to ensure children get all they need. “We wanted a better version than Nesquik,” said Mr. Leighton. “So we looked at nutritionally what children are lacking that would make the biggest impact on their health.” Although, of course, Mojo Milk is providing kids with calcium, the company can’t make any claims about that since they don’t supply the milk. One company that is proud of how it helps get calcium into little bodies is FrieslandCampina Domo. This Paramus, NJbased company develops and produces Vivinal GOS—a prebiotic galacto-oligosaccharide that has been shown to improve calcium and mineral absorption, primarily through its action in the large intestine. Unlike other prebiotics, it’s fermented in the colon to produce short chain fatty acids, which help to lower the pH of the colon, thus creating a more acidic environment, making it easier for bound calcium to become soluble and pass into the blood stream. In addition, Vivinal GOS helps to increase secretion of the calcium transporter protein Calbindin, which also facilitates calcium uptake and absorption. Vivinal GOS has only been in infant formulas since 2008, but in just three years has grown to capture almost the entire April 2011




U.S. market. “It was not so much a case of one manufacturer following another but an industry recognition of the importance of prebiotics for immunity,” said Sarah Staley, vice president of business development for the Americas. Infant formula is an ideal application for Vivinal GOS, she explained.“Manufacturers realize that for consumers to get the benefits of prebiotics, they need to consume them every day.” But, she added, these manufacturers are starting to get more adventurous in where they put them, such as chocolates and snack bars. “Manufacturers recognize that dairy products are not widely used by some demographic groups so other vehicles for delivery of this important component are becoming more prevalent. Offering different product options gives people more opportunities to consume prebiotics in efficacious amounts on a daily basis.” And awareness of calcium’s importance is growing, too.

“For older children, particularly girls, it is important to get adequate calcium intake. Optimal calcium absorption occurs up to the end of the teenage years. Vivinal GOS can assist with calcium absorption for this age group, helping ensure adequate calcium is available for healthy bone development.” On the other side of the product spectrum, Soothie Suckers makes popsicles that are infused with herbs to treat children’s colds, sore throats and boost immunity. The Grape-flavored Cold Fighter, for example, contains mullein leaves, saw palmetto, eyebright, horehound and cayenne fruit. Together, these herbs help expel and reduce mucus and boost the body’s immune system, while anti-inflammatory agents reduce swelling and pain. Soothie Suckers’ CEO Marietta Harrison devised the products alongside a master herbalist who has more than 40 years of experience. The products were launched last summer. Soothie Suckers are aimed at children

aged two through 12. “Kids seem to love the distraction of a delicious tasting pop,” explained Ms. Harrison, adding that the popsicles soothe, especially sore throats. Parents love them, too: They’re hydrating so they know their child is getting liquids. And there’s no sugar, artificial colors, flavors or preservatives. “Herbs are supportive to the body’s natural systems rather than invasive, as are most of our Western medicines,” said Ms. Harrison. “This is especially important for kids: To ingest products that stimulate their immune system rather than override it.” Fairlight Bakery, Vancouver, WA, launched its products four years ago and now, the Zac O Mega Bars and Zac Attack Snack Bars are going gangbusters in schools, where they’re dished up for breakfast and snack times. These refrigerated bars contain 1.3 grams (Zac O Mega Bars) and 500 mg (Zac Attack Bars) of ALA omega 3 fatty acids. There are no FDA requirements for omega

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3s, explained president Tom Fitzgerald, but recommendations from various sources suggest 1.3 grams and 1.6. “So even with 1.3 grams we’re giving kids 85% of an adult’s daily requirement.”

The Supplement Side Along with foods and beverages, supplements designed specifically for children are also enjoying a measure of success. Nordic Naturals, Watsonville, CA, has several products for kids, including Children’s DHA, Baby’s DHA, Omega-3.6.9 Junior and Omega-3 Effervescent. “Pre-birth through age two and three represents the most critical time for children because it’s when the brain is developing,” said Corinna Bellizzi, division manager. “If they’re not getting enough omega 3 and DHA in those years it could negatively impact brain development.” Children need supplements of these foods now, she added, because they eat a lot more saturated fats and different oils

April 2011

Pre-birth through age two and three represents the most critical time for children because it’s when the brain is developing...If they’re not getting enough omega 3 and DHA in those years it could negatively impact brain development.


than 30 or 40 years ago, “so they’re not getting the fatty acids they need.” Nordic Naturals does have omega 3 gummi products for children and while Ms. Bellizzi said she realizes that this isn’t the healthiest choice for a child, she concedes that it’s “a necessary product that helps us reach the almost unreachable consumer. With our young and most discerning crowd, taste is always king.” Even better, there’s a liquid omega 3 supplement, which actually contains more omega 3 than the gummies, and is one of the most popular supplements in the company’s line. Sales of these products are growing, as parents become more aware of the need for omega 3s and they move into the mainstream. “It’s a supplement that everyone has a need for because our diets have changed a lot in the past 50 years,” pointed out Ms. Bellizzi. “It’s never too late to start your children on omega 3s.” At the end of the day, there’s a place



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for all of these products in a child’s diet, and that diet is preferably one that also contains healthy proteins, vegetables and dairy. Americans aren’t going to become less busy—unless they’re very lucky—so expect to see more supplements, fortified foods and beverages that are designed to keep our soon-to-be busy kids as healthy as they can be.

What About Tweens & Teens?

WHAT DO YOU WANT TO MASK?

While many of the fortified foods on the market are designed for young children, with fun graphics and cute names, there’s another market segment that’s almost untapped: Tweens and teens. A key nutrient for tween girls in this age group is calcium for bone density, according to Jared Reynolds, chief innovation officer, Nutraceuticals Research Innovations, Miami, FL. “A pre-pubescent woman is not menstruating so her bone density is similar to a boy’s. But as she enters adulthood, that changes and there’s a need for iron, calcium and vitamin D, especially before she starts to menstruate.” Mr. Reynolds said in the future he expects to see powdered add-ins for beverages that are loaded with bone density-focused nutraceuticals, such as vitamin D and calcium. “I think it is hard to get tweens to take vitamins. It’s harder even than kids, who you can give chewy ones to. But drinks are more convenient, especially for the more active tweens and teens. Plus,

“...it is hard to get tweens to take vitamins. It’s harder even than kids, who you can give chewy ones to. But drinks are more convenient, especially for the more active tweens and teens.”

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if their mom tells them to do something, they probably won’t do it. So it needs to be in something they already like. I think you’ll start to see these things on the market in the next year.” And for tween boys, we’ll see bulking up in a different form— for them it’s muscle rather than bone. This used to be the domain of teen males but younger boys are starting to take an interest in weight lifting, too, Mr. Reynolds explained. “The key products for these tween and teen boys will be nutraceuticals that promote athletic performance, size and strength. This includes supplements and compounds found useful in muscle growth such as whey protein. An increasing area of nutraceutical research among this class of consumers is brain and mental health, a trend we see continuing.” For boys, Mr. Reynolds said he expects to see powdered mix-ins, as well as power/protein bars and beverages.“They probably won’t promote them for the tweens but you may see some tween-friendly advertising/packaging.” Offering one final prediction, Mr. Reynolds said,“The question will be how do we deliver the nutrients we know these kids need? Food is difficult because if you cook or alter the food you are probably hurting the chemical bond in the compound. Drinks NW are where I see the future.”


April 2011

Getting the Joint Health Market

Moving Again

Growth has been flat for more than a decade— a sign of maturity or a new beginning? Maybe both.

By Rebecca Wright Editor Adult joint health supplement use has been relatively flat since 1996, according to the Natural Marketing Institute’s (NMI) 2010 Health and Wellness Trends Database. And Larry Kolb, president, TSI Health Sciences, Missoula, MT, believes category crowding is to blame. “The mass market continues to increase the quantity of product offerings at the same or even lower pricing at retail,” he explained. “This has placed significant pressure on the costs and overall supply chain integrity.” Nonetheless, Christian Artaria, marketing director and head of functional food development for Italy-based Indena S.p.A., said the category continues to be a top priority for companies, especially with Baby Boomers and the elderly experiencing joint problems in growing numbers. “Sales of products in the joint health category are very important for most manufacturers,”he said. “Therefore, each manufacturer wants to maintain its market share or increase it by further differentiating its products through new ingredients and technologies.” Further, he said, it’s the ideal time for other joint health ingredients to play a bigger part in the market, especially since glu52 • Nutraceuticals World

cosamine has matured. Eric Anderson, vice president of sales and marketing for Aker BioMarine Antarctic US, Inc., which is wholly owned by Norway-based Aker BioMarine ASA, agreed. “We are seeing expanded formulations and new offerings as the market for glucosamine and chondroitin is softening and consumers are looking for alternative products with demonstrated efficacy,” he said. “Also, consumers don’t just want products that relieve pain; they are looking for nutrients that improve their health and have positive benefits not only on symptoms, but also on function.” As for where other pockets of growth might lie, Holly Harmon, marketing director, Bergstrom Nutrition, Vancouver, WA, said while consumers believe strongly that reducing inflammation is critical to their body’s well-being, NMI reports they are dissatisfied with the lack of supplements in forms other than pills and capsules. As a result, she said,“Alternative-form methods of delivery, like quick dissolve strips, are showing the most growth.” Describing the impact of joint-related illnesses on quality of life, Paul Dijkstra, preswww.nutraceuticalsworld.com

ident and CEO, InterHealth Nutraceuticals, Benicia, CA, offered some sobering statistics.“According to an October 2010 CDC report, data analyzed from the 2007-2009 National Health Interview Survey showed that more than 22% (nearly 50 million) of adults had self-reported doctor-diagnosed arthritis and 9% (21 million or 42% of those with arthritis) had arthritis-attributable activity limitation (AAAL),” he explained. “Among those with arthritis, the age-adjusted prevalence of AAAL also increased significantly with increasing BMI, from nearly 35% for those who are underweight/normal weight to almost 45% for those considered obese.” With up to 40 million Americans suffering from arthritis, 16 million of whom have been diagnosed with osteoarthritis, Olaf Weitz, head of business development—Supplements Group, Martin Bauer Inc., Secau-

This article in a nutshell: • Reinvigorating the category • Educational opportunities • Leaving GAIT in the past

April 2011

Joint Health

cus, NJ, said the need for anti-inflammatory supplements as well as chondroprotective supplements to stimulate the production of cartilage tissue is growing. And just in time, as many end users are relying on painkillers and/or strong anti-inflammatory compounds to deal with dysfunctional joints, according to Vladimir Badmaev, MD, PhD, director of medical and scientific affairs, PL Thomas, Morristown, NJ. As a consequence, he said this practice might deter proper diagnosis of the condition and postpone intervention, including appropriate nutritional help. “In fact, a diet lowering potential inflammatory factors should be considered as beneficial to overall skeletal health,”he asserted. Chris Haynes, director of marketing, ESM Technologies, Carthage, MO, says being a success in the joint health market is all about messaging—pain and flexibility relief and speed of results are critical elements at the consumer level. He said simply: “Consumers need cost-conscious products that deliver results.”

Taking this into consideration, Dean Mosca, president, Proprietary Nutritionals Inc., Kearny, NJ, believes messaging has become more assertive and dynamic, as well as more niche oriented. As an example of the former, he said the maker of a branded liquid joint-support supplement recently contracted with a widely known endurance athlete who is participating in a cross-country run and will appear on the “Live with Regis and Kelly” morning show, where his joints will be monitored by the physician who created the product. Throughout his run, which commenced in February, viewers will be able to track his progress through the show as well as through the athlete’s Twitter and Facebook pages. “Because the joint-health category is so crowded—reflecting now both Gen-X and Boomer consumers’ desires to maintain active lifestyles—marketers need to follow examples like this,”Mr. Mosca said, adding, “You can no longer act upon the assumption that one joint health product will en-

gender loyalty from all consumers seeking joint support supplements.”

Reinvigorating the Category Glucosamine, chondroitin and MSM continue to capture most of the market share in the joint health category. But as these ingredient segments continue to mature, newer entrants offering similar safety and efficacy profiles and consumer-friendly delivery formats are moving in. One such ingredient is UC-II from InterHealth. Mr. Dijkstra discussed its benefits. “Arthritis-attributable activity limitation can severely affect quality of life. In a peerreviewed published, randomized, doubleblind, clinical study, UC-II was shown to improve quality of life—significantly improving comfort during daily activities. The improvements in joint comfort and function seen in the clinical study demonstrate that increased quality of life is possible with just 40 mg of UC-II.” Mr. Dijkstra went on to note that 40 mg

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April 2011

Joint Health

of UC-II a day is also more effective than 1500 mg of glucosamine + 1200 mg of chondroitin in promoting joint health. Kevin Ruff, PhD, MBA, director of scientific and regulatory affairs, ESM, said while consumers still recognize glucosamine and chondroitin as the “go-to” joint health ingredients, the Glucosamine Arthritis Intervention Trial (GAIT) study and others show that there is definitely room for improvement with respect to efficacy and the time needed to see any effect. “Manufacturers of joint health products are searching for new ingredients that are both safe and effective and that can improve on what glucosamine and chondroitin can do,”Mr. Ruff explained.“That’s where NEM (Natural Eggshell Membrane) comes in. It is clinically proven to reduce pain and stiffness associated with osteoarthritis in as little as seven to 10 days. It’s also about five times more clinically effective than glucosamine and chondroitin, alone or in combination, according to a 2009 study published in Clinical Rheumatology.”

Another relative newcomer to the joint health market is Indena’s Meriva, which is comprised of curcumin and soy phospholipids. “The joint health benefits of Meriva were proven in two long-term studies published in 2010. These studies included 150 participants and demonstrated the effectiveness of Meriva for pain relief and increased mobility in patients with osteoarthritis,”Mr. Artaria offered. “The results of both studies showed that the Meriva-treated group had a statistically significant reduction in all primary clinical endpoints—the Western Ontario and McMaster Universities (WOMAC) score, the Karnofsky Performance Scale, and the treadmill walking performance test,” he added. “These results were complemented by the evaluation of a series of inflammatory markers that also showed a marked reduction in the Meriva-treated group, while no significant variation was observed in the ‘best available treatment’ group.” In order to bring new consumers to the category, PL Thomas’ Dr. Badmaev sug-

gested manufacturers address joint and bone health together, since mobility and performance associated with joint health depends on healthy bone structures. “The research on the health of the skeletal system, while recognizing the important role of calcium and vitamin D3, goes beyond these nutritional standards in maintaining bone health,” he said.“Preclinical and clinical studies indicate that essential fatty acids (especially docosahexaenoic acid, DHA), carotenoids (such as lycopene) and most significantly vitamin K2 (menaquinone) may contribute independently and collectively to bone health.” For joint health in particular, Dr. Badmaev said Boswellia serrata (boswellic acids) is a favorite among botanicals for its anti-inflammatory benefits, as well as its safety. In a 2010 published clinical study, a composition including Boswellia serrata gum resin, known as Aflapin (Indian Patent Application No. 2229/CHE/2008), was evaluated in patients with osteoarthritis of the knee. In this 90-day, double-blind, ran-

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April 2011

Joint Health

domized, placebo-controlled study, the efficacy and tolerability of Aflapin was evaluated along with 5-Loxin (another Boswellia preparation). The subjects received either 100 mg of 5-Loxin or 100 mg of Aflapin or a placebo for 90 days. At the end of the study, both 5-Loxin and Aflapin produced statistically significant improvements in pain scores and physical function scores in osteoarthritis subjects. “Importantly,” Dr. Badmaev pointed out,“the significant improvements in pain score and joint functionality were recorded as early as seven days after initiation of the study supplements. Another botanical worth discussing, according to Mr. Weitz of Martin Bauer, is rose hips, along with its role as an inflammation reducer. During the past few years, he claims several human studies have demonstrated its pain-reducing properties as well as its ability to reduce symptoms such as joint stiffness—even the need for additional medication. But because herbal powders are typically not as stable and uniform as extracts, scientists at the Martin Bauer Group investigated the effect of transferring the active principal into an extract. “From these investigations came the Nutrifin Motion Plus Concept, which is based on a (patent-pending) combination of cartilage protective compounds—collagen hydrolysate—with a special purified extract of rose hip peels cultivated by the Martin Bauer Group,” Mr. Weitz explained. “It is processed and concentrated in multiple stages, including aqueous extraction, special purification and spray-drying. This purified rose hip extract differs from other rose hip preparations due to its anti-inflammatory, pain-reducing and cartilage protective functionality.” Mr. Weitz offered more details on the combination’s functional value.“A special type 1 hydrolyzed collagen matrix used in Nutrifin Motion Plus stimulates the biosynthesis of the extracellular matrix of chondrocytes and enhances the production of cartilage tissue,” he said. “It was found that in comparison to the use of the hydrolyzed collagen matrix alone, the cartilage protective and regenerative effects were significantly improved in the Nutrifin Motion Plus concept.” Speaking of collagen, in September 2010, BioCell Technology, Newport Beach, CA, announced the successful completion of a clinical trial of BioCell Collagen II in subjects suffering from osteoarthritis.“This multi-center, double-blind, placebo-controlled trial demonstrated the ingredient’s safety and efficacy in reducing the disease-associated symptoms such as pain and in improving various physical activities, confirming results from a previous pilot study,” said BioCell’s Joosang Park, vice president of scientific affairs. Further, he said, a more recent study including 80 subjects showed that a majority experienced substantial improvement of their joint conditions as measured by VAS pain and WOMAC scores. This study outcome is in the process of being published. “Together with other independent studies on collagen-derived peptides and hyaluronic acid, these two trials raise a very interesting hypothesis that BioCell Collagen II containing both bioactive molecules may facilitate the re-growth of degraded cartilage via stimulation of the chondrocytes, the only resident cells in the cartilage, as well as stimulate the synovium cells surrounding the joint,” Mr. Park added. 58 • Nutraceuticals World


April 2011

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Joint Health

Clinical substantiation is a priority for Ben Winters, director, Aroma New Zealand, Christchurch, New Zealand, who discussed the most recent research developments with his company’s joint health ingredient, GlycOmega-PLUS. “We carried out a human clinical on our GlycOmega-PLUS green-lipped mussel extract on patients with osteoarthritis of the knee. Patients experienced a significant increase in joint mobility, reduced pain and overall improvement in gut health as a result of stopping their previous drug medications for arthritis,”he said.“GlycOmega-PLUS is a new generation mussel extract that is cold processed and has significant anti-inflammatory activity over steamed opened mussel powders.” At India-based Sami Labs Limited, a company associated with Sabinsa Corporation, East Windsor, NJ, formulators have been busy focusing on dosage, delivery and bioavailability. “Joint health products usually require large doses (generally above 1

gram). And if it is a multi-ingredient product, it becomes even more challenging for the formulator to address the product’s mode and means of delivery to derive its maximum benefits,” said Dr. Ria Biswas, senior manager, Technical Marketing. “Nilitis or NilPain SR is a sustained release bi-layered tablet containing a proprietary composition from Sabinsa that includes Curcumin C3 Complex (95% curcuminoids), Boswellin (40% AKBA) and ginger extract (35% gingerols), which naturally supports the management of pain and discomfort without undesirable side effects,”she said.“The sustained release delivery ensures that the nutrients are released and absorbed in efficacious amounts over a period of eight hours, to support the management of inflammation and pain throughout the day.” During the last year, Dr. Biswas added, the thrust in research activities in the joint health category at Sabinsa Corporation has been on Boswellin PS. “A considerable

The Outlook for Joint Health Supplements Sales are down 3% to $746 million due to negative efficacy reports and increasing competition, but liquid supplements may hold key to future growth. By Chris Allan Editor Nicholas Hall’s INSIGHT North America Dollar sales of joint health supplements—comprising mainly glucosamine/chondroitin options—continued to fall in 2010. Industry sources suggest a number of contributing factors to the decline, including price competition between brands and private label, wellpublicized reports questioning the efficacy of glucosamine/chondroitin and encroachment from other joint health options, such as fish oil and topical analgesics/heat pads. The Council for Responsible Nutrition (CRN), Washington, D.C., defended glucosamine/chondroitin supplements in September 2010 after a meta-analysis (conducted by the University of Bern and published in British Medical Journal) concluded that the ingredients, taken individually or together, provided no clinical benefit for joint pain or joint space narrowing. The industry association questioned the depth and scope of the study and referred to the “large body of scientific research that demonstrates glucosamine and chondroitin provide benefits for consumers coping with certain types of joint pain or immobility.” Despite the overall declining trend, demographic factors—espe-


amount of research muscle was spent on developing this product to elicit its underlying mechanisms of action by which it shows its healthful effects. Boswellin PS— PS for PolySal—contains the active boswellic acids along with Polysal, a polysaccharide with proven anti-inflammatory activity.” Sabinsa’s answer to the GAIT controversy was its registered and patent pending ingredient Boswellin PS, which was developed in early 2009 and marketed in 2010. Sabinsa was able to replace glucosamine in existing formulations and offer Boswellin PS, which has shown advantages in three areas, over conventional Boswellia serrata extracts that are standardized for one or more boswellic acids alone: enhanced water solubility; unique two-stage release profile for actives that support immediate and sustained action; and enhanced activity against pro-inflammatory cytokines, which translates to added benefits in supporting joint health and mobility.

cially the aging Baby Boomer population and rising obesity levels— provide a strong growth opportunity for joint health supplements in the U.S. Education, which marketers can drive through advertising and promotional activities, will be essential to raise awareness about the importance of joint health and the natural solutions that are available. Osteo Bi-Flex Leads the Market Leading brand Osteo Bi-Flex (Rexall Sundown/NBTY, recently acquired by The Carlyle Group) managed to buck the overall negative sales trend, advancing nearly 4% to $117 million in sales. Line extensions and advertising investment were key factors behind the brand’s success. Joint Aid liquid, positioned as an on-the-go product ideal for consumers who don’t like swallowing pills, rolled out in late 2009. Meanwhile, the most recent version is One Per Day glucosamine + vitamin D3, which is claimed to provide full joint health support in just one caplet. NBTY uses strong efficacy claims on packaging and in advertising to gain consumer confidence. Its position as the No.1 doctor & pharmacist recommended glucosamine/chondroitin branded supplement features heavily, while its 5-Loxin Advanced patent-pending formula is claimed to improve joint comfort within seven days. TV ads feature middle-aged people happily conducting their favorite outdoor hobbies helped by Osteo Bi-Flex. NBTY also markets Flex-A-Min under its Nature’s Bounty long-line range, although it struggled in the competitive environment and sales slipped to $21 million. Move Free Advanced (Schiff) fell further behind Osteo Bi-Flex in sales terms, declining by around 10% to $38 million. In his sum-


April 2011

Joint Health

As a producer of established joint health ingredients like chondroitin and glucosamine, TSI is focusing on value in today’s market. “Since we are a fully integrated manufacturer, our customers are benefiting from our value services, which allow us to incorporate these ingredients into a drum-to-hopper blend or granulation that is either encapsulated or pressed into tablets,”said Mr. Kolb.“This appears to add significant value for companies that want to achieve manufacturing efficiencies through easy-to-use granulations, with a closed-down supply chain in which the ingredients are tested and quality-verified.

Educational Opportunities Dr. Badmaev of PL Thomas said one of the most important issues in today’s joint health market is educating end users and product formulators that only a total approach to skeletal health will effectively address joint mobility and flexibility.“The total

approach starts with proper care and ageappropriate prevention of deteriorating of bone health,” he explained.“Sometimes an obvious sign(s) of deteriorating bone health can be missed if we do not recognize it.” He went on to discuss the interesting correlation between oral bone and tooth loss and bone loss at non-oral sites in the body. In one study, Dr. Badmaev recalled, tooth loss was examined in 145 healthy subjects aged 65 years and older who completed a three-year, randomized, placebo-controlled trial of the effect of calcium and vitamin D supplementation on bone loss from the hips. “During the two-year follow-up period, 40% of subjects with a total calcium intake of at least 1000 mg per day lost one or more teeth compared with 59% who consumed less calcium,” Dr. Badmaev stated. “These findings suggest that dental health is indicative of skeletal health and that intake levels of calcium and vitamin D aimed at preventing osteoporosis also have a beneficial effect on tooth retention.”

mary of the company’s fiscal Q2 2011 results, Schiff president and CEO Bruce Wood noted the overall negative glucosamine/chondroitin category trend as a factor but pointed out that the brand still outperformed several rivals. TV ads in support of Move Free Advanced claim that millions of people use the brand because “it works!”, while packaging claims it can start comforting sore joints within seven days. Cosamin (Nutramax) recorded a relatively strong performance in the difficult environment, with sales remaining steady at around $14 million. Cosamin ASU, marketed as an advanced formula combining avocado/soybean unsaponifiable with glucosamine/chondroitin, grew strongly but may have cannibalized sales of stable mate Cosamin DS. Cosamin is positioned as a premium brand—No.1 recommended by orthopedic specialists—and Nutramax backs it with consistent advertising and promotional support. The Start Cosamin ASU campaign, which began in April 2010, gave consumers the opportunity to receive a free sample bottle through their doctor. Spokespersons for the brand include retired baseball star Jim Palmer and world champion figure skater Kimmie Meissner. Relying on Innovation for Future Growth Industry sources believe that innovation can help brands fight low-cost rivals, with delivery format a common theme. Liquid supplements are becoming increasingly popular, largely in response to consumer feedback expressing difficulty or a dislike of swallowing pills. One liquid joint care brand performing well is

April 2011

Switching gears, TSI’s Mr. Kolb offered some words of caution regarding adulteration. “Economic adulteration of chondroitin continues throughout the ingredient supply chain. Fillers and adulterants that fly under the most sophisticated radar remain common and undetected,” he said. “There have been strides with new analytical tests, however, there remains a lack of industry-wide validation methods and the industry continues to suffer—with low cost, inferior quality ingredients winning the price battles.” Eric Brown, sales director, Bergstrom Nutrition, offered a similar point of view. “An issue in our industry is the influx of low-cost and inferior product. There are big differences in the source material and processes used between MSM manufacturers and we need to continue to educate and demonstrate those differences to brand manufacturers,” he said.“Our own OptiMSM offers ease of formulation, stability and other production benefits that others can’t match,

glucosamine/chondroitin supplement Joint Juice (Joint Juice Inc.). The original supplement drink was joined on shelves by line extensions On-The-Go drink mix in summer 2010 and Easy Shot in January 2011. The brand was supported by a national ad campaign in 2010 targeting active adults looking for joint support to keep doing the things they love. The company is keen to educate consumers about the importance of joint health and uses in-store displays and informative takeaways to pass on joint health advice. Meanwhile, Botanical Labs gave consumers a chance to win up to one year’s supply of Wellesse Joint Movement glucosamine and vitamin D3 fast-absorbing liquid formula as part of its Discover the Liquid Advantage online sweepstakes campaign, which ran between September-December 2010. It is possible that we will see more liquid supplement launches during the coming years, which may provide some of the innovation necessary to return the glucosamine/chondroitin-led joint health category to growth. Editor’s Note: All data in this report 12 months to November 2010 (MSP), sourced to Nicholas Hall’s INSIGHT based on industry estimates and Nicholas Hall’s DB6 2010 OTC database, in partnership with Nielsen in specific countries. DB6 is an important strategic planning tool for the OTC industry, going far beyond traditional audits to provide astute market intelligence covering all channels of retail distribution. About the author: Chris Allan is the editor of Nicholas Hall’s INSIGHT North America. He can be reached at 44-1702-220-226; E-mail: [email protected]; Website: www.nicholashall.com



Joint Health

and there’s still a lot of communication to do around the dangers of contaminants in cheap, commodity products."

Leaving GAIT in the Past While the results from GAIT in general were disappointing, especially given the size, duration and wide publication of the study, most experts believe the players in the joint health market have moved on. “The GAIT results did nothing to help the joint health market. If the results had been positive, the market could have publicized the results to take the market to an even higher level for several more years. This did not happen. And the fact that the findings were not positive resulted in the overall maturation of the category,”said Indena’s Mr. Artaria.“Now manufacturers are looking for new ingredients to revitalize their joint health product lines.” In other cases, the GAIT results may have helped companies.“The results of GAIT have had little, if any, impact on MSM sales. If any-


thing, it may have helped. The work published in Clinical Drug Investigation in 2004 by Usha and Naidu showed that combination therapy with MSM and glucosamine demonstrated higher efficacy than either of the compounds alone,” said Rod Benjamin, technical director, Bergstrom Nutrition. “Although the mechanism of the body’s sulfur cycle is still poorly understood, MSM may play a pivotal role in helping the body utilize both glucosamine and chondroitin. “In a 2008 pharmacokinetic study, it was shown that urinary sulfate levels decreased in an inversely dose-dependent manner with MSM supplementation. Although further research is needed, that does suggest MSM may play a positive synergistic role with other compounds to support joint health.” Mr. Dijkstra of InterHealth said regardless of the GAIT findings joint health would continue to be an important category for consumers who are looking for new ingredients that are more effective than existing products.“Joint-care ingredients backed by research should be extremely successful as


consumers are increasingly concerned about efficacy and safety of the ingredients in their dietary supplements,”he said.“Even though glucosamine and chondroitin have become household names at the consumer level, they seem to lack a level of long-term efficacy consumers seek.” Still, according to BioCell’s Mr. Park, clinical substantiation will always be an evolutionary process. “Continuous studies on existing ingredients enrolling more subjects in higher quality clinical trials have made market players, healthcare professionals and consumers better understand not only which ingredients actually provide clinically relevant benefits, but also which mechanisms may be behind the efficacy.” Modern medicine has not quite hit the mark when it comes to finding the onesize-fits-all approach to joint health, but it seems supplements are doing a good job picking up where pharmaceuticals left off. Growth might be flat, but the market remains wide open for innovative ingredient NW combinations and delivery formats.

April 2011

“Intake of B vitamins from food [not supplements] was associated with a lower risk of PMS.”

Nutraceuticals Research

Nutraceutical: B vitamin-rich food Indication: PMS Source: Am J Clin Nutr, February 23, 2011;[Epub ahead of print] Research: Thiamine, riboflavin, niacin, vitamin B-6, folate and vitamin B-12 are required to synthesize neurotransmitters that are potentially involved in the pathophysiology of premenstrual syndrome (PMS). In this study, researchers set out to evaluate whether B vitamin intake—from food sources and supplements—is associated with the initial development of PMS. They conducted a case-control study nested within the Nurses’ Health Study II cohort among participants who were free of PMS at baseline (1991). After 10 years of follow up, 1057 women were confirmed as cases and 1968 were confirmed as controls. Dietary information was collected in 1991, 1995 and 1999 by using food-frequency questionnaires. Results: Intakes of thiamine and riboflavin from food sources were each inversely associated with incident PMS. For example, women in the highest quintile of riboflavin intake 2-4 years before the diagnosis year had a 35% lower risk of developing PMS than did those in the lowest quintile. However, there were no significant associations between incident PMS and dietary intakes of niacin, vitamin B-6, folate, and vitamin B12. Additionally, intake of B vitamins from supplements was not associated with a lower risk of PMS.

ically anthocyanins) Indication: Parkinson’s disease Source: American Academy of Neurology’s annual meeting, Honolulu, HI, April 10-17. Research: In an effort to better understand the role of flavonoids in the development and diagnosis of Parkinson’s disease, researchers gathered data on more than 49,000 men who took part in the Health Professionals Follow-Up Study and more than 80,000 women from the Nurses’Health Study. Participants filled out detailed questionnaires about their diets. Using information compiled from detailed diet questionnaires, the researchers calculated the amount of flavonoids people consumed. In addition, they also looked at the consumption of tea, berries, apples, red wine and oranges and orange juice. Results: Over 22 years of follow-up, 805 people developed Parkinson’s disease. Among men, those who consumed the most flavonoids were 40% less likely to develop the neurodegenerative illness compared with men who consumed the least amount of flavonoids. However, there wasn’t any relationship between total flavonoid intake and the risk of developing Parkinson’s when researchers studied the women. Further, anthocyanins specifically were associated with a lower risk of Parkinson’s in both men and women. The researchers hypothesized that this protective effect probably resulted from the antioxidant effect of berries and their ability to thwart oxidative stress.

Nutraceutical: Berries (flavonoids, specif-

Nutraceutical: Broccoli sprouts

—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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Indication: Cancer Source: Nutr Cancer, February 2011;63(2):196-201. Research: Sulforaphane (SF) is a chemopreventive isothiocyanate (ITC) derived from the myrosinase-catalyzed hydrolysis of glucoraphanin, a thioglucoside present in broccoli. Broccoli supplements often contain glucoraphanin but lack myrosinase, putting in question their ability to provide dietary SF. This study compared the relative absorption of SF from airdried broccoli sprouts rich in myrosinase and a glucoraphanin-rich broccoli powder lacking myrosinase, individually and in combination. Subjects (n = 4) each consumed 4 meals consisting of dry cereal and yogurt with 2 g sprouts, 2 g powder, both or neither. Blood and urine were analyzed for SF metabolites. Results: The 24-hour urinary SF recovery was 74%, 49% and 19% of the dose ingested from broccoli sprouts, combination and broccoli powder meals, respectively. Urinary and plasma ITC appearance was delayed from the broccoli powder compared to the sprouts and combination. A liver function panel indicated no toxicity from any treatment at 24 hours. These data indicate a delayed appearance in plasma and urine of SF from the broccoli powder relative to SF from myrosinase-rich sprouts. Combining broccoli sprouts with the broccoli powder enhanced SF absorption from broccoli powder, offering the potential for development of foods that modify the health impact of broccoli products. Nutraceutical: Cocoa flavanols Indication: Prebiotic potential Source: Am J Clin Nutr, January 2011;93(1):62-72. Research: Researchers assessed the prebiotic potential of cocoa flavanols in a randomized, double-blind, crossover, controlled intervention study. Participants included 22 healthy human volunteers April 2011

Nutraceuticals Research

who were randomly assigned to either a high-cocoa flavanol (HCF) group (494 mg cocoa flavanols/day) or a low-cocoa flavanol (LCF) group (23 mg cocoa flavanols/day) for 4 weeks. This was followed by a 4-week washout period before volunteers crossed to the alternant arm. Fecal samples were recovered before and after each intervention, and bacterial numbers were measured by fluorescence in situ hybridization. Results: Compared with the consumption of the LCF drink, the daily consumption of the HCF drink for 4 weeks significantly increased the bifidobacterial and lactobacilli populations but significantly decreased clostridia counts. These microbial changes were paralleled by significant reductions in plasma triacylglycerol and C-reactive protein concentrations. Furthermore, changes in Creactive protein concentrations were linked to changes in lactobacilli counts. These in vivo changes were closely paralleled by cocoa flavanol-induced bacterial changes in mixedbatch culture experiments. According to researchers, this study shows that consumption of cocoa flavanols can significantly affect the growth of select gut microflora in humans, which suggests the potential prebiotic benefits associated with the dietary inclusion of flavanol-rich foods. Nutraceutical: Creatine Indication: Cognitive function (in vegetarians) Source: Br J Nutr, December 2010;1:1-6. Research: Creatine supplementation influences brain functioning as indicated by imaging studies. Given the key role played by creatine in the provision of energy, the influence of its supplementation on cognitive functioning was examined, contrasting the effect in omnivores and vegetarians. Young adult females (n=128) were separated into those who were and were not vegetarian. Randomly and under a double-blind procedure, subjects consumed either a placebo or 20 grams of creatine for 5 days. Results: Creatine supplementation did not influence measures of verbal fluency and vigilance. However, in vegetarians rather than in those who consume meat, creatine supplementation resulted in better memory. Irrespective of dietary style, researchers said the supplementation of creatine decreased April 2011

the variability in the responses to a choice reaction-time task. Nutraceutical: Echinacea Indication: Common cold Source: Ann Intern Med, Dec 21, 2010;153(12):769-77. Research: In a randomized controlled trial, 719 patients were assigned to one of four parallel groups: no pills, placebo pills (blinded), echinacea pills (blinded), or echinacea pills (unblinded, open-label). Echinacea groups received the equivalent of 10.2 grams of dried echinacea root during the first 24 hours and 5.1 grams during each of the next 4 days. The primary outcome was the area under the curve for global severity, with severity assessed twice daily by self-report using the Wisconsin Upper Respiratory Symptom Survey, short version. Secondary outcomes included interleukin-8 levels and neutrophil counts from nasal wash, assessed at intake and 2 days later. Results: Of the 719 patients enrolled, 713 completed the protocol. A comparison of the two blinded groups showed a 28-point trend toward benefit for echinacea. Mean illness duration in the blinded and unblinded echinacea groups was 6.34 and 6.76 days, respectively, compared with 6.87 days in the blinded placebo group and 7.03 days in the no-pill group. Median change in interleukin-8 levels and neutrophil counts were not statistically significant. Nutraceutical: Fiber Indication: All-cause mortality Source: Arch Intern Med, February 14, 2011;[Epub ahead of print]. Research: Dietary fiber has been hypothesized to lower the risk of coronary heart disease, diabetes and some cancers. However, little is known of the effect of dietary fiber intake on total death and cause-specific deaths. Investigators examined dietary fiber intake in relation to total mortality and death from specific causes in the NIH (National Institutes of Health)-AARP Diet and Health Study, a prospective cohort study. Diet was assessed using a food-frequency questionnaire at baseline. Cause of death was identified using the National Death Index. Results: During an average of 9 years of follow-up, researchers identified 20,126 deaths in men and 11,330 deaths in www.nutraceuticalsworld.com

women. Dietary fiber intake was associated with a significantly lowered risk of total death in both men and women. Dietary fiber intake also lowered the risk of death from cardiovascular, infectious and respiratory diseases by 24% to 56% in men and by 34% to 59% in women. Inverse association between dietary fiber intake and cancer death was observed in men but not in women. Dietary fiber from grains, but not from other sources, was significantly inversely related to total and cause-specific death in both men and women. Nutraceutical: Omega 3s and fish Indication: Age-related macular degeneration (AMD) Source: Arch Ophthalmol, March 14, 2011;[Epub ahead of print]. Research: Researchers conducted a study among 38,022 females enrolled in the Women’s Health Study, who completed a food frequency questionnaire and were free of diagnosis of AMD at baseline. The goal of the study was to determine whether omega 3 fatty acids and fish affects the incidence of AMD in women. Results: A total of 235 cases of AMD, most characterized by some combination of drusen and retinal pigment epithelial changes, were confirmed during an average of 10 years of follow-up. Women in the highest tertile of intake for DHA, compared with those in the lowest, had a multivariate-adjusted relative risk of AMD of 0.62. For EPA, women in the highest tertile of intake had a relative risk of 0.66. Consistent with the findings for DHA and EPA, women who consumed one or more servings of fish per week, compared with those who consumed less than one serving per month, had a relative risk of AMD of 0.58.

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


Supply Source

DSM Nutritional Products: Bright Science. Brighter Living. As a leading producer of bulk vitamins, carotenoids, custom nutrient blends, nutritional lipids and other nutraceuticals, DSM Nutritional Products, Inc., Parsippany, NJ, a business unit of The Netherlands-based Royal DSM N.V., has made and retained a commitment to developing innovative, science-based products that benefit the health and wellness of consumers around the world. The core of DSM’s nutrition business stems from the acquisition of Roche Vitamins nearly a decade ago. Since that time, DSM has invested heavily in nutritional research, working with major universities, and partnered with innovative companies in the health and wellness industry to develop and deliver quality products to the marketplace. “Through science we ultimately impact the health and well-being of people around the world,” said Jim Hamilton, president of DSM Nutritional Products USA. “No firm spends more on nutrition science and innovation than we do.”Innovation can come through in-house development, as well as through partnerships, alliances and acquisitions, he added. Most recently, DSM acquired Martek Biosciences, Columbia, MD, for more than $1 billion. The deal is expected to provide DSM new opportunities in the infant nutrition market, as well as the omega 3 and 6 markets, given Martek’s microbial DHA and ARA ingredients. Martek also recently acquired Amerifit, a consumer business for branded dietary supplements. DSM’s global network will help extend Martek’s products to other regions, nations and market segments, according to Mr. Hamilton. “Discussions are going on now about the best way to integrate the organizations.” 66 • Nutraceuticals World

Martek represents a “highly complementary business,” to DSM, Mr. Hamilton noted. “It’s a piece to the puzzle that you can connect, rather than overlap. The benefit for us is not through classic synergies, but rather complementary values.”

Quality for Life seal, which assures that ingredients are safe in terms of quality, reliability and traceability, and are manufactured in a safe and sustainable way. As the recently elected chairman of the Board of Directors at the Council for Responsible Nutrition (CRN), Washington, D.C.—a post he will hold through 2012— Mr. Hamilton said one of the primary goals for the association will be to continue fos-

“The core of DSM’s nutrition business stems from the acquisition of Roche Vitamins nearly a decade ago. Since that time, DSM has invested heavily in nutritional research...and partnered with innovative companies in the health and wellness industry to develop and deliver quality products to the marketplace.” Looking to express its values as a company, DSM also recently introduced its new company brand: Bright Science. Brighter Living.—complete with a new, colorful logo. The brand represents DSM’s sustainability value, overall philosophy and mission to create brighter lives for people today and in the future. A pioneer in the synthesis and production of fine chemicals, starting as early as 1935 with the first industrial production of vitamin C, today DSM offers a range of health products, including its Quali-Blends pre-mix formulations, resVida resveratrol, geniVida genistein and Teavigo green tea extract, as well as Fruitflow, a water-soluble, tomato-based ingredient with aspirinlike properties. Originally developed by Provexis, Fruitflow has received approval for an Article 13.5 health claim in Europe, allowing marketers to claim the ingredient helps reduce platelet aggregation and “contributes to a healthy blood flow.” DSM’s overall commitment to quality products is perhaps best symbolized by its www.nutraceuticalsworld.com

tering and supporting consumer confidence in the industry. “For example, we believe in GMP (Good Manufacturing Practice) regulations that help ensure the industry is delivering quality and regulated products,” he said. Overall, while companies and consumers around the world have felt pressure from a struggling economy, Mr. Hamilton said he believes the nutraceuticals industry is in unique position to prosper.“The health and nutrition business is economically agnostic. Consumers aren’t prepared to sacrifice their health and well-being, regardless of the economy. We will continue to deliver on the promise we’ve made to consumers, especially in tough times.” —S.M. DSM Nutritional Products, Inc. 45 Waterview Boulevard Parsippany, NJ 07054 Telephone: 800-526-0189 Fax: 973-257-8420 E-mail: [email protected] Website: www.unlimitednutritionna.dsm.com April 2011

Supply Source

OmniActive Health Technologies: There’s No Substitute for Quality OmniActive Health Technologies, Short of only having to do what excites us,” Mr. Hills, NJ, is perfectly positioned to carry out Doshi said.” OmniActive spends a lot of time develits mission of providing unique, quality ingredients that help its customers differen- oping and evolving a handful of ingreditiate their products in the marketplace. ents, including Lutemax, Lutemax 20/20 Applying a combination of innovation, ed- and Capsimax. As its name implies, Omni ucation and determination to the develop- Active makes sure it perfects all aspects of OmniActive's Capsimax ingredient is based on ment of its ingredients, the company has an ingredient before bringing it to market. capsaicin from red peppers. won the confidence of some of the top It also prides itself on being active on all players in the dietary supplement, food fronts—food, nutrition and health—as producing. OmniActive on the other hand well as applying a pharmaceutical mindset has developed a way to safely and effecand personal care industries. tively encapsulate the ingredient so that OmniActive’s parent company Kancor, to each ingredient it produces. its pungency doesn’t affect the has been a manufacturer of finished product or the person premium ingredients, flavors consuming it. Capsimax is and colors for more than three touted for its benefits for weight decades, with a business hismanagement, sport performtory since 1865. Further, Kancor ance and overall wellness. has been serving leading comSome of the company’s other panies in the food, health and key products and technologies personal care industries in include: OmniBead vegetarian nearly 50 countries. beadletting technology and UlOmniActive has experienced trasol Dry Nutrient and Liquid much success since its incepNutrient systems for lipophilic tion, growing from four to 145 and unstable compounds, as employees in the span of six well as proprietary ingredients, years, according to Hiren such as Curcumax turmeric Doshi, business development OmniActive decided early on to grow its own Marigold flowers in order to control its lutein supply chain. (curcumin) and CateKan green director. This is because the tea extract. company set its goals, follows “The nutraceuticals industry is in fantasGoing into more detail on the developthem and only pursues ingredients it believes in. “We are in the fortunate position ment of its lutein ingredient, Mr. Doshi ex- tic shape,”Mr. Doshi said, adding,“And we plained, “We realized early on that we are doing well because we are forming reneeded to control the supply. So we decided lationships with like-minded companies to grow our own (Marigold) flowers. As a and offering the versatility and services —R.W. result, we believe we know more about they are looking for.” lutein than most others and we want to share that experience with our customers.” OmniActive Health Technologies Capsimax, which is based on capsaicin 51 JFK Pkwy, 1st Floor West from red peppers, is another “hot” ingre- Short Hills, NJ, 07078-2704 dient in the company’s arsenal. Given the Telephone: 866-588-3629 inherent difficulties surrounding the en- Fax: 877-588-3629 OmniActive has experienced much success capsulation of this ingredient, many com- E-mail: [email protected] since its inception, growing from four to 145 employees in six years. panies have been unsuccessful in Website: www.omniactvies.com April 2011



New Products

Fruit & Veggie Smoothies Jamba Juice, Emeryville, CA, has launched Fruit & Veggie Smoothies, which contain three servings of fruits and vegetables in each 16-oz. offering. Products are available in three flavors: Berry

90 calories per serving, respectively. The company has also launched Horizon Organic Fat-Free Milk Plus DHA Omega 3, which contains the vegetarian, algal oil life’sDHA.

GoodBelly Probiotic Coconut Water, SuperGreen Live & StraightShot NextFoods, Boulder, CO, has added Probiotic Coconut Water, SuperGreen Live and StraightShot to its GoodBelly line of probiotic fruit drinks, which contain the patented Lp299v strain. GoodBelly Probiotic Coconut Water contains 20 billion live and active probiotic cultures and 80 calories per serving. GoodBelly SuperGreen Live contains a blend of antioxidants, vitamins and mineral-rich organic ingredients like spinach, spirulina, chlorella, parsley, alfalfa grass and oat grass. GoodBelly StraightShot contains 20 billion live and active probiotic cultures per 2.7-oz. shot. UpBEET, Apple ‘n Greens and Orange Carrot Karma. Each contains less than 250 calories and represents an “excellent source” of vitamins A and C. Berry UpBEET contains strawberries, blueberries, carrots, beets, broccoli and lettuce. Apple ‘n Greens blends apple-strawberry juice with dark leafy green vegetables, carrots and lettuce, as well as spirulina, peaches, mangos and bananas. Orange Carrot Karma contains carrot juice, orange juice, mangos, bananas and ice.

Silk Pure Coconut Milk & Fat-Free Milk Plus DHA WhiteWave Foods, Broomfield, CO, has introduced Silk Pure Coconut milk, which contains no dairy, lactose or cholesterol. Silk Pure Coconut is calciumfortified, and is an “excellent source” of vitamin D and vegetarian-friendly vitamin B12. It is available in two low-calorie flavors: Original and Vanilla, with 80 and 68 • Nutraceuticals World

Canton Soup with Wellmune WGP Lassonde Specialties, Saint-Damase, Quebec, Canada, has added to its Canton line of ready-to-serve soups with three new products that contain Wellmune WGP, an immune-supporting ingredient. The soups include Vegetable, Chicken Noodle and Chicken with Rice.

of quercetin, 85 mg of green tea catechins, seven essential vitamins and 90 calories. They are offered in Cherry Limeade and Wild Berry flavors, which are formulated with organic sugar and stevia. Peach Mango, a low-calorie flavor option at 20calories, is available with sucralose.

Daytime Restore & Nighttime Repose Xigo Health, Key Biscayne, FL, has released Daytime Restore, a dietary supple-

ment designed to provide sustained energy and focus. The product contains green tea, Siberian ginseng (eleuthero), ginkgo biloba, curcumin and vitamin D3. The company has also launched a companion product, Nighttime Repose, which is intended to promote restful sleep. This synergistic formulation contains melatonin, ashwagandha and L-theanine.

AriZona Sports FRS Healthy Protein & Healthy Energy The FRS Company, Foster City, CA, has added Healthy Protein and Healthy Energy formulas to its FRS line of ready-todrink products. Both products contain the patented FRS quercetin formula. Healthy Protein debuts in two flavors: Orange Cream and Blackberry Acai. Each contains 25 grams of whey protein, 7 grams of dietary fiber and essential vitamins. FRS Healthy Energy products contain 325 mg www.nutraceuticalsworld.com

AriZona Beverages USA LLC, Woodbury, NY, has launched AriZona Sports, a line of 100% natural isotonic sports drinks. Products include a proprietary formula that contains pure cane sugar and a balanced concentration of salts and minerals designed for rapid absorption. Each flavor, Fruit Punch, Lemon-Lime and Orange, contains electrolytes, including sodium, potassium chloride and sodium citrate. The Sports line contains no artificial colors or flavors and no preservatives. April 2011

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Products also contain 50 calories per 8oz. serving.

enLiven Yogurt Ganeden Biotech, Cleveland, OH, has released enLiven all-natural yogurt exclusively in Walmart stores. The low-fat yogurt contains GanedenBC30 probiotics and is available in four flavors: Vanilla, Blueberry, Strawberry and Peach.

CocoaNova Honest Tea, Bethesda, MD, has launched Honest CocoaNova, a line of low-calorie, brewed cocoa beverages. Honest CocoaNova is a brewed cacao infusion that

added sugar. Available in Cranberry and Pomegranate Blueberry, the beverages contain 90 calories per serving. One can is a “good source” of vitamin C and equals a full serving of fruit, according to the company. Diet Ocean Spray Sparkling Juice Drinks contain 10 calories per serving.

wagandha plant. I AM Healthy contains essential vitamins and minerals along with an antioxidant blend of organic goji berry, hibiscus and beta-glucan. I AM Energized contains yerba mate, black tea and natural coffee extract. I AM Sleepy contains melatonin.

Thorne Vet

Cognitex Basics

Thorne Research, Sandpoint, ID, has introduced its Thorne Vet line of more than 40 integrative and holistic animal health products, which includes advanced specialty formulations of antioxidants, products to support metabolic, cardiovascular, neurological, dietary, bone, joint, gastrointestinal and eye health, and products to reduce stress and anxiety, improve sleep and support general animal health.

Life Extension, Ft. Lauderdale, FL, has launched Cognitex Basics. This brain health supplement contains phosphatidylserine and Sharp-GPC Active alpha-glycerylphosphoryl choline.

New Chapter Supplements

ZeaVision, LLC, Chesterfield, MO, has re-formulated its zeaxanthin-based EyePromise Restore nutraceutical by adding vitamin D and 25% more omega 3s. The ocular health formula is designed to increase macular pigment density in the eye, according to the company.

New Chapter, Brattleboro, VT, has launched several new products. On the fish oil front, the company offers its line of Wholemega products, which combine full-spectrum herbs with 100% wild Alaskan salmon fish oil. In addition, Wholemega Cardio contains hibiscus, artichoke and turmeric; Wholemega Flex contains rose hips, turmeric and ginger; and Wholemega Focus blends lemon balm, sage and holy basil. The company has also released Perfect Calm and Perfect Energy multivitamins, which contain targeted, organic herbal blends that enhance energy, endurance and recovery, or support calm and overall well-being, according to the company. Perfect Calm contains holy basil, chamomile and lemon balm, while Perfect Energy contains organic maca, ginseng and rhodiola.

CogniSure

Omega-7 Complete

Optimal Plant Proteins

Metagenics Inc., San Clemente, CA, has released CogniSure, a dietary supplement designed to support healthy aging of the brain. The product contains Colostrinin, a colostrum-derived, protein-rich polypeptide complex shown to influence mechanisms associated with brain aging and to support adult cognitive function, according to the company. Each Chocolate-flavored chewable tablet contains a daily dose of 100 mcg of Colostrinin.

SeabuckWonders, Chicago, IL, has added Omega-7 Complete to its line of sea buckthorn products. The dietary supplement contains certified organic sea buckthorn as well as omega 3, 6 and 9, vitamins C, E, B1, B6 and beta-carotene in each soft gel.

Jarrow Formulas, Los Angeles, CA, has launched Optimal Plant Proteins, a vegan

Acti-Joint Swanson Health Products, Fargo, ND, has launched Acti-Joint, a dietary supplement that contains glucosamine, chondroitin and hyaluronic acid. The product is designed to support primary joint structures and functions, including subchondral bone, synovial fluid and cartilage. contains antioxidants and theobromine naturally found in dark chocolate. Made with certified organic and fair trade certified cacao beans, the main ingredient in chocolate, the products contain 50 calories per 10-oz. bottle, as well as 50 mg of theobromine. Honest CocoaNova is available in three varieties: Mint Cacao, Mocha Cacao and Cherry Cacao.

Sparkling Juice Drinks Ocean Spray, Lakeville-Middleboro, MA, has launched Sparkling Juice Drinks, which contain 70% real fruit juice and no 70 • Nutraceuticals World

EyePromise Restore

I AM I AM enlightened nutrition has unveiled its I AM liquid nutritional supplements, available in four condition-specific, single-dose formulations: I AM Happy, I AM Healthy, I AM Energized and I AM Sleepy. I AM Happy contains Sensoril, a patented standardized extract of the ashwww.nutraceuticalsworld.com

April 2011

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