Nutraceuticals World Jun 2011

Stop by the BASF & Cognis IFT booth #5829

Newtrition -the perfect balance. TM

Tonalin® CLA’s fat-fighting and body shaping benefits can bring your body composition and well-being into balance.

t Reduces up to 10% body fat and prevents fat regain t Effectiveness and safety proven by 18 clinical studies t Multiple forms for easy addition to functional foods and beverages Newtrition - Eat. Feel. Live. TM

For reducing body fat

Cognis Corporation Nutrition & Health Phone: 1.888.866.2546, Fax: 513.482.5516 Email: [email protected] © 2011 All Rights Reserved. TONALIN® conjugated linoleic acid (CLA) is an exclusively licensed product of Cognis Group.

www.cognis.com www.tonalin.com

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 June 2011 • Volume 14, No. 5

36 Soy Story Soy has had a wild ride during the past decade, and it’s not over yet.

Cover design by: Sara Downing

44 (R)evolution in Flavors & Colors

44

Balancing flavor with healthfulness while keeping costs low may prove to be the magic formula.

50

50 A Bright Outlook for Oral Care As research develops, more companies will be sinking their teeth into fresh opportunities.

Columns 26 • Business Insights by Greg Stephens & Sheila Campbell

30 • Eurotrends by Joerg Gruenwald 32 • Quality Focus by Paula Brown

28 • Capitol Comments by Todd Harrison & Seung-Hyun Ryu 4 • Nutraceuticals World

34 • Research Process by Doug Kalman

www.nutraceuticalsworld.com

June 2011

Capsugel gives you more than one way to grow.

Our full range of capsule solutions can become your seeds for success.

We can c custom-color any capsule to your company’s ca specification, with either one- or two-color capsules. o Differentiate your brand. D

LIQUID FORMULATION SUPPORT We offer custom liquid formulation support pport port to speed your product launches and to o optimize bioavailability. It’s a formula for success.

PRINTING CAPABILITIES IN-STOCK COLOR PROGRAM For time-sensitive color capsule needs, we offer an in-stock color program with quick shipping, HGC and plant-based capsules available. What’s your color?

We can imprint any capsule with your company’s logo or product identification compan any type style or ink color. See your in an name in lights. n

Capsugel offers more than just beautiful capsules. We offer a comprehensive portfolio of products, services and innovative dosage solutions designed to help you attract new markets and drive sales growth here and around the world. Call 888-783-6361, contact us at marketing.amer@pfizer.com or visit us at capsugelsolutions.com.

CLEAN LABEL CAPSULES We off offer vegetarian, plant-based capsules with no preservatives, cap ps no allergens, no plasticizers n and no GMOs for the natural products market. Would you like a healthy portfolio?

TECHNICAL SUPPORT We offer technical expertise and hands-on support to prevent production crises. Go ahead and whistle while you work.

10CAPS2523

CUSTOM COLOR

Table of Contents

15

58

59

Departments 8 • Top Of The News • Pharmacists recommend and take dietary supplements 10 • Editorial • a word from the editor 12 • Nutraceuticals World In Print & Online • line-up of expanded coverage @ nutraceuticalsworld.com 14 • Industry News • Helsinn & Thorne to provide supplements to cancer patients 56 • Nutraceuticals Research • a recap of the latest clinical trials 58 • Supply Source • profile on Consumer Product Testing Co. 59 • New Products • recent nutraceutical product introductions 61 • Suppliers Corner • new developments from industry suppliers 64 • People In The News • who’s who and who’s moving where 64 • Classified Section • classified advertising section 65 • Calendar • upcoming industry events 65 • Advertisers Index • cross reference of advertisers in this issue 66 • 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

www.nutraceuticalsworld.com

June 2011

Top Of The News

“Pharmacists are able to help consumers choose the types of supplements that are right for their individual wellness plan.” —Douglas MacKay, ND, CRN

Pharmacists Recommend and Take Dietary Supplements

Pharmacists have become an influential information source for consumers, answering questions about dietary supplements and offering recommendations to their customers. Additionally, pharmacists themselves are incorporating dietary supplements into their lives as a means of increasing their overall health and wellness. According to research from the“Life…Supplemented”Healthcare Professionals (HCP) Impact Study, 93% of pharmacists recommend supplements to their customers, while 87% believe supplements can play an important role in improving or maintaining the health of their customers. “Pharmacists are able to help consumers choose the types of supplements that are right for their individual wellness plan,”said Douglas MacKay, ND, vice president, Scientific & Regulatory Affairs, Council for Responsible Nutrition (CRN), Washington, D.C., and a consultant to the “Life…supplemented” consumer wellness initiative. “A pharmacist’s training specifically qualifies him or her to take a comprehensive look at an individual’s current prescribed medications and determine if any potential drug-dietary supplement interactions or drug-induced nutrient depletions may need to be addressed. To maximize benefits and safety it is important to talk to a pharmacist or other qualified healthcare practitioner about all the things you are taking for your health.” Eighty four percent of pharmacists said they believe it is a good idea for customers to take supplements, citing joint health (65%), bone health (61%) and flu/colds (51%) as the top three reasons they have recommended supplements to their customers. Pharmacists also noted in the survey that when they did speak to customers about supplements, two thirds reported customers had initiated the conversation. With regard to which supplements pharmacists were most often asked about, the top three mentioned by respondents were omega 3/fish oil (mentioned by 73%), calcium (73%) and glucosamine/chondroitin (70%). Pharmacists, like many other healthcare populations, also were willing to take their own counsel when it comes to supplements. Nearly nine in 10 pharmacists said they use dietary supplements (86%), citing “overall health and wellness”(44%) and“filling in nutrient gaps”(40%) as the top two reasons they personally take them. Seventy six percent of those surveyed indicated they take a multivitamin; other popular supplements taken by pharmacists include omega 3/fish oil (35%), calcium (35%), vitamin C (32%), B vitamins (25%), vitamin D (23%) and fiber (19%).

Researchers Share Puzzling Findings on Omega 3s and Prostate Cancer Risk

The largest study ever to examine the association of dietary fats and prostate cancer risk has found what’s good for the heart may not be good for the prostate. Analyzing data from a nationwide study involving more than 3400 men, researchers at Fred Hutchinson Cancer Research Center found that men with the highest blood percentages of DHA had two-and-a-half-times the risk of developing aggressive, high-grade prostate cancer compared to men with the lowest DHA levels. Conversely, the study also found that men with the highest blood ratios of trans-fatty acids—which are linked to inflammation and heart disease and abundant in processed foods that contain partially hydrogenated vegetable oils—had a 50% reduction in the risk of high-grade prostate cancer. In addition, neither of these fats was associated with the risk of low-grade prostate cancer risk. The researchers also found that omega 6 fatty acids,

8 • Nutraceuticals World

www.nutraceuticalsworld.com

June 2011

Top Of The News

which are found in most vegetable oils and are linked to inflammation and heart disease, were not associated with prostate cancer risk. These findings by Theodore Brasky, PhD, and colleagues in the Hutchinson Center’s Public Health Sciences Division were published online April 25 in the American Journal of Epidemiology. “We were stunned to see these results and we spent a lot of time making sure the analyses were correct,”said Dr. Brasky, a postdoctoral research fellow in the Hutchinson Center’s Cancer Prevention Program. “Our findings turn what we know—or rather what we think we know—about diet, inflammation and the development of prostate cancer on its head and shine a light on the complexity of studying the association between nutrition and the risk of various chronic diseases.” The researchers undertook the study because chronic inflammation is known to increase the risk of several cancers, and the omega 3 fatty acids found primarily in fish and fish oil supplements have anti-inflammatory effects. In contrast, other fats, such as the omega 6 fats in vegetable oil and trans-fats found in fast foods, may promote inflammation. “We wanted to test the hypothesis that the concentrations of these fats in blood would be associated with prostate cancer risk,”Dr. Brasky said.“Specifically, we thought that omega 3 fatty acids would reduce and omega 6 and trans-fatty acids would increase prostate cancer risk.” The mechanisms behind the impact of omega 3s on risk of high-grade prostate cancer are unknown.“Besides inflammation, omega 3 fats affect other biologic processes. It may be that these mechanisms play a greater role in the development of certain prostate cancers,”Dr. Brasky said.“This is certainly an area that needs more research.” Currently, there is no official Recommended Daily Allowance (RDA) for omega 3 fats for adults or children, although many nutrition experts and physicians recommend 450 mg of omega 3 DHA per day as part of a healthy diet. The study was based on data from the Prostate Cancer Prevention Trial, a nationwide randomized clinical trial that tested the efficacy of the drug finasteride to prevent prostate cancer. While the trial involved nearly 19,000 men age 55 and older, the data in this analysis came from a subset of more than 3000 of the study participants, half of whom developed prostate cancer during the course of the study and half of whom did not. The clinical trial was unique in that prostate biopsy was used to confirm the presence or absence of prostate cancer in all study participants. Among the study participants, very few took fish oil supplements—the most common non-food source of omega 3 fatty acids, which are known to prevent heart disease and other inflammatory conditions. The majority got omega 3s from eating fish. So based on these findings, should men concerned about heart disease eschew fish oil supplements or grilled salmon in the interest of reducing their risk of aggressive prostate cancer? Dr. Brasky and colleagues don’t think so. “Overall, the beneficial effects of eating fish to prevent heart disease outweigh any harm related to prostate cancer risk,” Dr. Brasky said.“What this study shows is the complexity of nutrition and its impact on disease risk, and that we should study such associations rigorously rather than make assumptions.” The National Cancer Institute (NCI) funded this study, which also involved researchers from the University of Texas Health Science Center at San Antonio and the NCI. June 2011

www.nutraceuticalsworld.com

Nutraceuticals World • 9

From The Editor

Nestlé Has Seen the Light—Have You? People have been buzzing about personalized nutrition for years, with little or nothing to show for it in terms of big market introductions or widespread consumer acceptance. Well, Nestlé hopes to change that. On May 24, Nestlé Health Science acquired Prometheus Labs, a California maker of medical devices and pharmaceuticals for the gastrointestinal market. This is the business unit’s third purchase in less than eight months, according to a Dow Jones article. Analysts speculate Nestlé paid between $500 million and $1 billion for the company. To recap, Nestlé Health Science was formed to create nutritional solutions for people with specific dietary needs related to illnesses, disease states or the special challenges of different life stages. To further these efforts, in late March it acquired CM&D Pharma, a small Switzerlandbased drug company specializing in kidney disease, IBD and colon cancer. The company’s leading product, Fostrap, is a “medical food” in the form of a chewing gum fortified with chitosan for kidney patients who have an elevated level of phosphate in the blood (i.e., hyperphosphataemia). While this condition is rare in the general population, it commonly affects patients with kidney failure or renal insufficiency. Prior to the CM&D deal, Nestlé Health Science purchased Vitaflo, a U.K.-based clinical nutrition company, which develops products for infants, children and adults with genetic disorders that affect how food is processed by the body—e.g., phenylketonuria (PKU), maple syrup urine disease (MSUD) and homocystinuria (HCU). From specially formulated omega 3 supplements to protein shots, the company produces a wide range of products that offer nutritional and metabolic support. About the latest buy, Luis Cantarell, Nestlé Health Science president and CEO, said, “This acquisition is a strategic move into gastrointestinal diagnostics. Prometheus’s leading edge diagnostics and highly experienced medical sales representatives together constitute a robust platform for Nestlé Health Science to accelerate its current and future healthcare business. It will enable new personalized healthcare solutions based on diagnostics, pharma and nutrition.” This means Nestlé Health Science will have the capability to offer both diagnosis and treatment with pharmaceuticals and nutrition products. Finally, we have a company with a strong interest in linking food, pharmaceuticals, medical devices and dietary supplements—a company that believes consumers deserve more than pharmaceuticals when it comes to their medical needs. Is this the wave of the future? And are other companies likely to follow suit? Datamonitor analyst Mark Whalley thinks so.“The current market’s personalized food and beverage offerings are likely only a small representation of what’s to come. As interest amongst consumers increases, we expect to see a surge in the number of food and drink companies launching products with DNA/genetic influences over the next few years, probably originating from smaller niche companies looking to find gaps in the market.” Mr. Whalley also said the concept of personalized nutrition is lucrative if approached effectively. “Most of the big food and beverage players will be identifying this as something interesting to consider for the long term.”Certainly Nestlé wouldn’t spend upward of $1 billion if it didn’t believe in the future of personalized nutrition. According to Greek mythology, the god Prometheus bestowed the gift of fire to mortals on earth, bringing them warmth and light to relieve their suffering in the darkness. Obviously Nestlé has seen the light. I hope the healthcare world will too.

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

10 • Nutraceuticals World

www.nutraceuticalsworld.com

June 2011

Stay connected with

nutraceuticalsworld.com

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

Knowledge Center In an effort to help you access more than 10,000 articles from the past 12 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 What is Pterostilbene? The berry-derived ingredient is proving to be a potent antioxidant and cardiovascular system supporter.

The Rising of the Green Sun Defying the economic downturn, greenfoods are stronger than ever.

Minerals: The Next Generation The market continues to evolve in light of consumer demands, new applications and emerging technologies.

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

12 • Nutraceuticals World

www.nutraceuticalsworld.com

June 2011

Industry News

Helsinn & Thorne to Provide Supplements to Cancer Patients Looking to develop, acquire and market a range of dietary supplements and other products specifically formulated to meet the unique requirements of cancer patients, Helsinn Group, Lugano, Switzerland, has completed a minority investment in Thorne Research, Inc., which develops and manufactures nutritional supplements marketed through licensed healthcare practitioners. In addition to nutritional supplement products, Helsinn and Thorne will pursue the development of medical information and supportive services for healthcare professionals and their patients. The venture will initially be directed at cancer supportive care, cancer pain management and other areas of oncology, and may ultimately be broadened to other disease areas. The deal will create a dedicated natural products division in cancer supportive care within Thorne Research.

Dr. Sears Blames Obesity Crisis on Omega 3-6 Imbalance Disproportionately high levels of omega 6 fatty acids in U.S. diets and the need for more omega 3 oils are at the heart of the country’s obesity crisis, according to Dr. Barry Sears, best-selling author of The Zone, creator of the Zone Diet and founder of ZoneDiet.com. “Relying simply on eating less and exercising more is not enough because the obesity problem is far more intricate,” Dr. Sears said. “Too many omega 6 fatty acids in the diet promote inflammation, while omega 3 fatty acids decrease inflammation. People need a one-to-one balance of omega 6 to omega 3 in the diet, just like it was a century ago, rather than today’s approximate 20:1 ratio.” Omega 3 is found in fish oils, walnuts and spinach. Omega 6 is in low-cost vegetable oils, such as corn oil and soybean oil.“Cutting omega 6 is not easy since, as taxpayers, 14 • Nutraceuticals World

“Cutting omega 6 is not easy since, as taxpayers, we spend about $20 billion a year subsidizing agribusiness to produce food ingredients that make us more inflamed.” —Dr. Barry Sears, Zone Diet Creator we spend about $20 billion a year subsidizing agribusiness to produce food ingredients that make us more inflamed. These are some of the most common ingredients in the foods today, as virtually all processed food in supermarket aisles contains omega 6 fatty acids,” Dr. Sears said. The nation’s obesity crisis has resulted in significantly higher incidences of weight-related health issues, from diabetes to heart problems, he noted. “When parents stopped giving their children fish oil, such as a tablespoon of codliver oil a day, as they did a generation or two ago, America started to get fatter. It tastes terrible, but a tablespoon of cod-liver oil has about 2.5 grams of omega 3 fatty acids, and that is enough to turn back the inflammatory tide that is at the base of so many health issues,”he said.

Survey Identifies Communication Gap on Child Nutrition New findings from the NOURISH (KNOwledge, UndeRstanding & InsightS Into CHild Nutrition) survey reveal that nearly half (47%) of healthcare professionals (HCPs) surveyed globally believe most parents of children they see still do not fully understand the long-term impact of early nutrition. Despite regular dialogue with parents about an optimal balance of nutrients during their child’s first five years of life, HCPs reported that when it comes to feeding and nutrition, less than one-fifth (17%) of parents are “very concerned” about ensuring their child is getting the right balance of nutrients they need. The NOURISH survey also revealed an opportunity to provide parents with additional guidance and education about healthy growth and appropriate feeding practices for infants and young children. Globally, in 2010, around 43 million children under the age of five were overweight. Proper nutrition means getting an optimal balance of nutrients; however, too much of certain nutrients—even those www.nutraceuticalsworld.com

that are important for a child’s development—can negatively affect long-term health outcomes. Over-nutrition, or the over-consumption of certain foods or food components, may contribute to heart disease, stroke, diabetes and cancer.

Nestlé Waters to Acquire Sweet Leaf Nestlé Waters North America, Stamford, CT, has signed an agreement to acquire the Sweet Leaf Tea Company, Austin, TX, including its Sweet Leaf and Tradewinds beverage brands. The acquisition, which remains subject to regulatory approval and satisfaction of other customary closing conditions, will expand Nestlé Waters’portfolio of bottled water to include high quality iced teas, lemonades and juices. It follows an initial investment by Nestlé Waters in the Sweet Leaf brand in March 2009. The acquisition will bring Nestlé Waters’ increased capabilities to the company’s operations, allowing it to make Sweet Leaf and Tradewinds beverages available to more people across the U.S.

European Commission Authorizes Three DHA Claims, Rejects One In early May, the EU Commission approved three Article 14 DHA claims related to children’s development and rejected one claim related to ARA/DHA and brain development in infants and young children. As of May 26, the following three claims can be made on foods on the EU market: 1. Docosahexaenoic acid (DHA) intake contributes to the normal visual development of infants up to 12 months of age. (This is the claim that received so much attention in recent months, which the Global Organization for EPA and DHA Omega-3s, GOED, Salt Lake City, UT, reported on three separate times: March 16, April 1 and most recently, April 6.) Conditions of use: Information shall be given to the consumer that the benefiJune 2011

Industry News

cial effect is obtained with a daily intake of 100 mg of DHA. When the claim is used on follow-on formula, the food shall contain at least 0.3% of the total fatty acids as DHA. 2. Docosahexaenoic acid (DHA) maternal intake contributes to the normal de-

velopment of the eye of the fetus and breastfed infants. Conditions of use: Information shall be given to pregnant and lactating women that the beneficial effect is obtained with a daily intake of 200 mg of DHA in addition to the recommended

Price Rivals Taste as Top Influencer for American Buying Habits

daily intake for omega 3 fatty acids for adults, i.e. 250 mg DHA and eicosapentaenoic acid (EPA). The claim can be used only for food, which provides a daily intake of at least 200 mg DHA. 3. Docosahexaenoic acid (DHA) maternal intake contributes to the normal brain de-

Increasingly for Americans, the cost of food is becoming almost as important as the taste of it, according to the International Food Information Council (IFIC) Foundation “2011 Food & Health

director of Trends and Consumer Insights at the IFIC Foundation. “This would be consistent with current trends toward small indulgences and a shift in perception about food in which consumers are seeking to be empowered rather than educated about food, health and food safety practices.”

Survey.” Although taste remains the top consideration (87%), 79% of consumers say price impacts their decision when deciding which foods and beverages to purchase, a 6% increase from 2010 and a noteworthy 15% increase since 2006. While healthfulness (66%), convenience (58%) and sustainability (52%) play roles in consumer decision-making, no other motivator rose at the same rate as price during the past five years. Interestingly, these trends are consistent with what drives Americans’ menu decisions at restaurants: taste (69%) and price (61%) are ranked as the top two motivators. Americans also say lower prices are the top driver that would lead them to make more healthful choices when shopping for food. “The economy seems to be having a significant effect on what people look for when buying food,” said Marianne Smith Edge, MS, RD, senior vice president of Food Safety and Nutrition at the IFIC Foundation. “While Americans will almost always choose foods that taste good first, they’re certainly looking for affordable, healthful foods as well.” The IFIC Foundation “2011 Food and Health Survey” also found significantly fewer Americans are concerned about their weight status when compared to last year; 50% of Americans described themselves as overweight in 2011 compared to 57% in 2010. More Americans perceived their diet as extremely or somewhat healthful (62%) when compared to 2010 (53%). At the same time, fewer Americans report making dietary changes (59% in 2011 compared to 64% in 2010) and more Americans report their physical activity levels are sedentary (43%)—a significant increase from 2010 (37%). These contradictions are further evidenced by the fact that the number of people trying to lose or maintain weight (69%) has significantly decreased since 2010 (77%). “This contradiction may indicate that Americans are being less hard on themselves and less critical of their health and wellbeing than in past years, despite an environment in which improved health and wellness is increasingly discussed from the media to government to the dinner table,” said Carrie Dooher,

The IFIC Foundation “2011 Food & Health Survey” captured the thoughts, perceptions, and behaviors of 1000 American adults over a Americans are being less hard on themselves and less critical two and a half-week period in of their health and well-being March and April of 2011. than in past years. Additional findings from the International Food Information Council Foundation “2011 Food & Health Survey” include: • Americans’ awareness of the Dietary Guidelines for Americans has increased (81% in 2011 compared to 71% in 2010). Still, 95% of Americans could not name another “healthy living” initiative beyond the Dietary Guidelines for Americans or MyPyramid, such as First Lady Michelle Obama’s Let’s Move! campaign. • Despite significant attention on sodium, Americans’ concern about sodium remains stable. A little more than half of Americans (53%) say they are very or somewhat concerned about their sodium intake, equal to last year (53%). • Sixty-one percent of Americans believe that imported food is less safe than foods produced in the U.S., citing less regulation as the top reason. Trust in the safety of the U.S. food supply, however, remains stable. Half of Americans are extremely or somewhat confident in the safety of the U.S. food supply, similar to previous years. The top U.S. food safety concern continues to be foodborne illness (50% in 2011). • Only 9% of Americans can accurately estimate the number of calories they should consume in a day for a person of their age, height, weight and physical activity. The majority of Americans do not keep track of calories consumed or burned, citing numerous barriers, including extreme difficulty and a lack of interest, knowledge and focus. • Despite the popularity of some “food rules” that suggest certain foods to avoid, Americans say they would rather hear what to eat (63%) instead of what not to eat. The interest in positive messaging rose 7% since 2009 when the survey last polled Americans on this sentiment.

Survey reveals economic impact of consumer purchases and perceptions.

June 2011

www.nutraceuticalsworld.com

Nutraceuticals World • 15

Industry News

velopment of the fetus and breastfed infants. Conditions of use: Information shall be given to pregnant and lactating women that the beneficial effect is obtained with a daily intake of 200 mg of DHA in addition

to the recommended daily intake for omega 3 fatty acids for adults, i.e. 250 mg DHA and EPA. The claim can be used only for food, which provides a daily intake of at least 200 mg DHA.

The health claim rejected by the Commission, “Docosahexaenoic acid (DHA) and arachidonic acid (ARA) contribute to the optimal brain development of infants and young children,” may be used for

foods/drinks and videos, according to Marketdata Enterprises’ “The U.S. Weight Loss & Diet Control Market, May 2011.” Marketdata Enterprises reports sales of the top eight commercial weight loss chains reached $3.14 billion in 2010, online dieting sales $238 million and diet home delivery sales $924 million.

Getting Ahead of the Curve: Protein & Weight Loss By Dr. A. Elizabeth Sloan While low carb may have been one of the hottest diet fads of all time, it’s high protein that’s long been the winner in the war on weight. Among adults trying to lose weight, 55% made a strong effort to increase their protein intake, up from 50% in 2007, according to the “2010 Gallup Study of Weight Management.” Those making a strong effort to limit carbs declined among current dieters from 39% to 33%. Moreover, with consumers associating protein with other important weight loss needs—including feeling full, building muscle/body toning, increased energy and lowering cholesterol for those on condition-directed weight loss plans—the future potential for high protein products is awesome indeed. And, the timing is right. While the economy kept growth in the $61 billion U.S. weight loss industry—which includes foods, supplements, Bariatric surgery, videos, etc.—to less than 1%, it caused “dieters” to further shift to low cost do-it-yourself diet plans, e.g., diet websites, OTC diet pills, meal replacements, low calorie

Market Potential According to Sloan Trends’ TrendSense Model, protein and weight is a very large, strong and stable Level 2 mass-market opportunity on par with vitamin D and omega 3s. Medical Counts have continued to accelerate throughout most of the decade, indicating very strong scientific support and a wide variety of new newsworthy research findings. Although medical and research activity has flattened since 2006, this very high level of Medical Counts will easily sustain growth for the next three to five years. Mass marketers should be capitalizing on the widespread association of protein and weight, which is still a virtually untapped opportunity. Perhaps, most compelling is the fact that protein and weight have been a highly marketable association throughout the decade and particularly before and after the low carb movement between 2003 and 2004, when low carb entered the mass-market phase temporarily at Level 1. After several years of fad-like behavior earlier in the decade, low carb and weight has once again returned to its rightful position in the Popularization Phase, important to trendy specialty/health food channel shoppers and to very health and condition-specific shoppers. Low carb has never crossed the Medical Threshold, indicating the beginning of a long-term sustainable trend and thus, continues to remain among the trendy diet fads. Specialty retailers should continue to capitalize on low carb and weight with creative new approaches recognizing its fad-like behavior.

* 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.

16 • Nutraceuticals World

www.nutraceuticalsworld.com

June 2011

Industry News

only the first 6 months after the entry into force (May 26, 2011) of this Regulation. This means by the end of November this year it will be illegal to use this health claim.

Tate & Lyle Forms Monk Fruit Partnership with BioVittoria U.K.-based Tate & Lyle has entered into a five-year strategic partnership agreement with New Zealand-based BioVittoria Ltd. for

Growth Opportunities • 54% of adults tried to lose weight in 2010 (Calorie Control Council Consumer Survey). • The typical dieter now makes four weight loss attempts per year, the highest number in 15 years (Marketdata Enterprises). • 80% of “dieters” and 69% of the general population believe it is important to consume more protein when trying to lose weight (Gallup). • 68% of consumers believe protein helps build muscle, 40% helps you to feel full, and 37% helps with general weight loss (International Food Information Council, “2010 Food & Health Survey”). • Among the 13% of food shoppers who were on a specific diet program, 11% were on the Atkins diet in 2010, 14% a low carb diet of their own (FMI, “US Grocery Shopper Trends,” 2010). • 38% of consumers chose foods/beverages because they’re high in protein; 31% said they maintained a high protein/low carb diet in 2010 (HealthFocus). • Only 2% of consumers believe calories from protein are most likely to cause weight gain. • Weight control and cholesterol tie for the most desirable benefits of functional foods; one-third of consumers bought a functional food for weight loss in 2009 (Mintel “US-Functional Food Report, 2009”). Functional Foods More than half of dieters—and 39% of the general population—are making a strong effort to increase their protein intake, according to Gallup. Of the 80% of weight watchers in 2010 on a do-it-yourself program, 60% want to use regular grocery store foods to help control their weight, reports Marketdata Enterprises. With breakfast considered the most important meal by dieters, ready-to-eat cereals, smoothies and other traditional fare are strong candidates for higher protein options. Snacks and combination products for those concerned about heart health and weight are other important options. With the American Heart Association and other organizations still negative on high protein diets, manufacturers must pay strict attention to a product’s fat content and should fortify these products to stem challenges that high protein products prevent the delivery of certain nutrients. Dietary Supplements With nearly 28 million U.S. households having a member that is obese, SymphonyIRI’s November 2010 “OTC Medication Report” estimates their annual market potential alone for OTC and supplement weight related products at $4 billion per year.

June 2011

the exclusive global marketing and distribution rights of BioVittoria’s monk fruit. Tate & Lyle will be marketing the products in the U.S. under the brand name Purefruit. According to terms of the agreement, BioVit-

Weight loss meal replacements remain a strong direction, posting sales gains for the last six years in a row to $2.4 billion in 2010 (NBJ, Feb. 2011). Cross marketing these products with energy, satiety, fortification with nutrients lost when trying to lose weight or a toning/flab fighting program are other big ideas more specific to the supplement market. Lastly, with pill form supplement sales unchanged since 2003 at $1.57 billion, designer and unique blends of protein may well be a bright light as the pill form supplement market moves away from thermogenic weight loss. 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 trendtracking and predictions, strategic counsel and business-building 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.

www.nutraceuticalsworld.com

Nutraceuticals World • 17

Industry News

toria will award exclusive global sales and distribution rights to Tate & Lyle for its monk fruit extract. Tate & Lyle will support the development of the Purefruit line with sales, research, marketing and product development. Using proprietary, natural methods, the Tate & Lyle research team has further refined and improved the taste of its Purefruit products for a wide array of commercial uses. BioVittoria will continue management of the monk fruit extract supply chain, including seedling cultivation, the grower network and natural processing.

Lonza Set to Enter Probiotic Market Lonza, Basel, Switzerland, has signed an exclusive license agreement with Berlin, Germany-based OrganoBalance for the global development, production and commercialization of products containing a probiotic Lactobacillus strain. Developed by OrganoBalance GmbH via a fermentation process, the probiotic strain acts against Helicobacter pylori (H. pylori). Research shows that H. pylori has been implicated as a common cause of peptic ulcers and gastritis. Utilizing a unique patent-protected mode of action, Lactobacillus anti-H. pylori binds to H. pylori in the stomach, thus creating large aggregates, which are subsequently flushed out of the stomach and excreted.

Ocean Spray Partners with Artemis Lakeville-Middleboro, MA-based Ocean Spray Ingredient Technology Group (ITG) and Artemis International, Fort Wayne, IN, have formed a strategic partnership through which Artemis will provide sales and mar-

keting support to Ocean Spray’s sale of cranberry powder and extract to nutraceutical manufacturers. “We are thrilled that Artemis has agreed to team with Ocean Spray to combine product expertise and industry acumen to compete in the nutraceutical market,” said Tom Jones, senior manager, Business Development, Ocean Spray ITG. “Artemis will play an essential role in supporting our existing customers and driving Ocean Spray’s continued growth in this segment.”

SIDI Working Group Comments on FSMA The Standardized Information on Dietary Ingredients (SIDI) Working Group, composed of dietary supplement firms and industry trade associations, recently submitted comments to FDA regarding the Food Safety Modernization Act (FSMA): “Title III—A New Paradigm for Importers.”SIDI supports establishing a strong program for qualifying raw material suppliers, testing incoming ingredients and verifying the contents of finished products in order to reduce the risks of contamination, adulteration and other supply chain failures. “As the global supply chain becomes more complex, proper supply chain management is critical,”the group said.“A robust testing program must be balanced with knowledge of the ingredient suppliers’quality practices. The Working Group’s guidelines emphasize a science- and risk-based approach to supplier qualification and ingredient testing. Those developing the guidelines trust that science- and risk-based principles will also be the foundation for future guidance and rulemaking related to the

Patents

T IF 6 t a 4 s 69 u # t si oth i V o B 18 • Nutraceuticals World

India-based Natural Remedies Pvt. Ltd. has obtained Australian patent (No. 2007257480) for its brain health ingredient, BacoMind, a standardized extract of bacopa. Published clinical research indicates efficacy and safety of BacoMind, which is designed to promote attention and memory in elders and enhance learning performance in children. Verdure Sciences, Noblesville, IN, has obtained two new patents from the U.S. Patent and Trademark Office covering the composition and methodology of its POMELLA pomegranate extract. U.S. Patents #7,897,791 and #7,919,636, granted in 2011, are in addition to U.S. Patent #7,638,640 secured by Verdure Sciences in 2009.

www.nutraceuticalsworld.com

June 2011

Industry News

Food Safety Modernization Act.” SIDI offered documents it has developed related to guidelines for supplier qualification, including the SIDI Protocol—a volun-

tary guideline to standardize exchange of relevant and required information between dietary component suppliers and dietary supplement manufacturers—as well as a

NIH Unveils New CAM Resource for Healthcare Providers Dialogue between providers and patients lacking despite widespread use. A new online resource designed to give healthcare providers easy access to evidence-based information on complementary and alternative medicine (CAM), has been revealed by the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (NIH). With this new resource, providers can learn about various CAM practices and products and be better

Certificate of Analysis Guideline for Dietary Supplement Components. “We feel that the science- and riskbased principles that underpin the Work-

The NIH resource comes at a time when a survey from AARP and NCCAM indicates Americans over the age of 50 often do not discuss CAM use with their healthcare providers, despite growing frequency of use. Overall, 53% of respondents reported they had used CAM at some point in their lives. Among those, 58% said they had discussed CAM with a healthcare provider. This dialogue is important because, while CAM is a part of health and wellness for many Americans, some CAM products can interact with conventional medicine. Use of CAM among the 50 and older population is widespread. The 2007 National Health Interview Survey found that 44% of people age 50-59 use some form of CAM, compared to the average

able to discuss the safety and effectiveness of complementary and adult use rate of 38%. “Older Americans want to lead healthy, acalternative medicine with their patients. tive lives, and that means using healthcare safely,” said Elinor GinThe portal on the NCCAM website, nccam.nih.gov, is tailored to zler, AARP vice president. “For many people, CAM is an important fit the needs of all healthcare providers, inpart of staying healthy, but some CAM prodcluding physicians, nurses and nurse practiucts may make conventional medicines less tioners, physician assistants and CAM effective or lead to potentially dangerous inproviders. It includes information on the teractions. Healthcare providers and patients safety and efficacy of a range of common need to start talking together to ensure you health practices that lie outside mainstream get the full benefit of both CAM and your medicine—natural products, such as dietary medications.” supplements, herbs and probiotics, as well as Other findings from the AARP/NCCAM surmind-body practices such as meditation, chivey suggest that if CAM is discussed at a ropractic, acupuncture and massage. medical appointment, it is most likely to be Patients often don’t discuss CAM with their This resource was developed based on a brought up by the patient. Respondents were healthcare providers because (1) the provider series of NCCAM-sponsored focus groups twice as likely to say they raised the topic never asks (42%) and (2) the patients did not where healthcare providers identified the rather than their healthcare provider. Accordknow they should bring it up (30%). need for an evidence-based, one-stop place ing to the survey, the two main reasons that to answer their patients’ questions on CAM. the patients gave for a lack of discussion with With this need in mind, NCCAM developed a resource that provides their healthcare providers are that the provider never asks (42%) reliable, objective and evidenced-based information on CAM, inand the patients did not know they should bring it up (30%). In the cluding: links to relevant clinical practice guidelines; safety and efsurvey, the most frequently cited reasons for using CAM are for fectiveness information; links to systematic reviews; summaries of general wellness (77%), to help reduce pain or treat a painful condiresearch studies; scientific literature searches; programs for contintion (73%), to treat a specific health condition (59%) and to suppleuing education credit; and patient fact sheets. ment conventional medicine (53%). Those surveyed were allowed Annually, Americans spend nearly $34 billion out-of-pocket on to provide more than one reason for using CAM. CAM products and practices. Surveys show that nearly 40% of “In this survey, we found that 37% of respondents have used an American adults and 12% of American children use some form of herbal product or dietary supplement in the past 12 months. Some CAM. Other surveys show that patients do not regularly discuss of these natural products can interact with conventional treatthese practices with their healthcare providers. “NCCAM is charged ments,” said Dr. Briggs. “As we’ve learned from NCCAM-funded reto study and provide evidence-based information on the safety and search into herbal and dietary supplements, natural does not efficacy of CAM health practices that are readily available and alalways mean safe. Thus, an open dialogue about CAM use, particuready used by a great number of people,” said Josephine Briggs, larly herbals and dietary supplements, is vital to ensuring safe and MD, director of NCCAM. “As a physician, I understand the need to coordinated care.” have easily accessible and accurate information on all health pracThe AARP/NCCAM survey was conducted by telephone intertices. This web resource is a way for NCCAM to share this valuable view in October 2010, with a random sample of 1013 people age 50 information with all providers.” and older.

20 • Nutraceuticals World

www.nutraceuticalsworld.com

June 2011

Industry News

ing Group voluntary guidelines should serve as a basis for guidelines and regulations that arise from the FSMA,”the group said. “In addition, given that dietary supplements are addressed in other regulations and legislation, the Working Group encourages FDA to exempt dietary supplements from import certification. We support the agency’s effort to establish accredited third party auditors, which will further the Working Group’s efforts to ensure supply chain integrity.”

New Book Offers Natural Strategies to Reverse Food Allergies Food allergies and food intolerances are increasing dramatically throughout the world, especially among developed countries. For example, peanut and tree nut allergies among American children more than tripled between 1997 and 2008. In Britain, hospitalizations for food allergies have increased five times in the 15 years between 1990 and 2005. Furthermore, hos-

Most Women Need Help Achieving Wellness Studies indicate women require more support to stay healthy and cope with arthritis. More than 25% of American women are focused on and proactive about their health and well-being, according to the “Life…supplemented” My Wellness Scorecard National Study. In addition, nearly three-quarters of American women try to live a healthy lifestyle, but often miss the mark. Ranked on a scale from “AlphaWELL” (those who are extremely proactive and meticulous about their health) to “OhWELL” (those who do little to nothing about maintaining their health), participants were evaluated on their overall wellness regimen—maintaining a healthy diet, taking supplements, getting routine exercise and other general lifestyle habits. Only 1% of women are AlphaWELLs and 26% are WELLs, while 42% and 31% are WannabeWELLs and OhWELLs, respectively. The study suggests that while women want to be well, they need help to achieve their goals. “The average woman wears so many ‘hats’ that she often neglects taking adequate time for herself,” said Cheryl Forberg, RD, registered dietitian for “The Biggest Loser” and consultant to the “Life…supplemented” campaign. “Women need to invest in themselves. If they spend just a little time evaluating their overall well-being, it is easy to develop healthy habits that can last a lifetime.” According to the My Wellness Scorecard National Study, 58% of women report doing a fairly good job of avoiding processed foods, watching what they eat when it comes to cholesterol-rich dishes and avoiding fatty foods like whole milk and fatty meat. However, nearly 35% admit they eat more cholesterol-rich and fatty foods than they should. When it comes to vitamins and other dietary supplements, 61% of women take a multivitamin. However, only 46% of women say they take a multivitamin daily. Regular exercise is extremely important, and 48% of women say they “enjoy cardiovascular exercise like running, walking, aerobics, dancing, tennis and basketball.” However, 41% of women say they don’t have a regular exercise regimen.

June 2011

pitalizations for anaphylaxis due to food allergies have risen nearly 9% per year in recent years among developed countries. What is causing this dramatic increase in food allergies? What can be done to prevent them? More importantly, can a person with food allergies or food intolerances do anything to reverse them? Drawing from more than 1000 peer-reviewed studies, including hundreds of clinical studies, as well as clinical experience in traditional medicine, Natural Solutions for Food Allergies

Another recent survey found that women are also struggling to cope with arthritis and often feel they receive less support than their spouses. In addition, co-workers offer more support than family members. These findings came from Flexcin International, Inc., Fort Myers, FL, manufacturer of degenerative joint supplements for people and pets. A proceeds sponsor of the Arthritis Foundation, Flexcin sought to understand the level of The average woman wears so awareness and support from the many ‘hats’ that she often network of friends and family of neglects taking adequate someone living with arthritis. time for herself. The company’s research division conducted a national online survey throughout April and received responses from 1350 people who all have some form of arthritis—e.g., osteoarthritis, psoriatic arthritis, rheumatoid arthritis, gout, lupus—or other joint-related pain, illness or disability. Information and feedback from the survey will be used to develop future communications and outreach programs for people with a form of arthritis. In households where only one spouse has a form of arthritis, more than 78% of women feel they receive little or no support; nearly 66% of men said they are satisfied with support. More than half of respondents still working (56%) said they feel co-workers offer a higher level of support and overall awareness compared to that of family members. About 67% of respondents said other members of the household are never or only occasionally aware of their arthritis, while about 64% of respondents said others in the household never or rarely take an interest in their daily issues with arthritis. A majority of respondents (58%) said their arthritis hurts the most when cleaning and doing household chores. “Flexcin believes a strong support network can significantly help a person coping with degenerative joints,” said Tamer Elsafy, CEO and founder of Flexcin International. “It’s important for other people to be aware of certain issues arthritis sufferers deal with on a day-to-day basis to increase the amount of support offered.”

www.nutraceuticalsworld.com

Nutraceuticals World • 21

Industry News

and Food Intolerances by Casey Adams, PhD, provides clear and proven strategies to reverse food allergies and intolerances using inexpensive and natural methods.

Next Proteins Acquired California-based Designer Protein, LLC, has purchased certain operating assets of Next Proteins, Inc., Carlsbad, CA, including the Designer Whey Protein sports nutrition brand and line of products, according to Partnership Capital Growth, a full-service boutique investment bank that focuses on the healthy, active and sustainable living marketplace. Designer Protein is a subsidiary of Athena Wellness Brands, LLC, a newly formed company that is backed by GarMark Partners, Northwood Ventures and Stockton Road Capital. Partnership Capital Growth acted as the exclusive financial advisor to Next Proteins in the deal.

Testing Reveals Issues with Vitamin D Supplements Among 28 vitamin D supplements recently selected for independent testing, problems were found with eight products (29% of those reviewed), according to

ConsumerLab.com, White Plains, NY. Vitamin D has become one of the most popular supplements in the U.S., with sales rising from $72 million in 2006 to $429 million in 2009, according to Nutrition Business Journal, Boulder, CO. It was the fourth most popular supplement in a ConsumerLab.com survey of its readers in 2010, used by 56% of respondents. In the recent tests, ConsumerLab.com evaluated vitamin D supplements as well as those containing calcium and/or vitamin K. Results were released in three separate Product Review reports. The most common problem found by ConsumerLab.com with supplements containing vitamin D was the wrong amount of vitamins. A popular supplement for children listed 200 IU of vitamin D per two gummy bears, but actually contained 501 IU, 251% of the listed amount. A gummy product for adults listed 1000 IU of vitamin D, but contained only 317 IU, 32% of the listed amount. A liquid product listing 42 IU of vitamin D contained only 18 IU, 44% of the listed amount. A tablet listing 800 IU of vitamin D contained only 664 IU, 83% of the listed amount. And a vitamin D/vitamin K

supplement contained its listed amount of vitamin D but provided only 36.8 mcg of its listed 50 mcg of vitamin K per capsule, 74% of the listed amount. Two other products containing combinations of vitamins D and K and calcium were contaminated with lead, according to test results. Further, a vegan vitamin D product that passed laboratory tests was not approved by ConsumerLab.com because it listed potential benefits of vitamin D but failed to provide the required FDA disclaimer for such claims.

CRN Comments on Phytosterol Health Claim The Council for Responsible Nutrition (CRN), Washington, D.C., recently submitted comments to FDA regarding the agency’s proposed rule for the health claim on phytosterols and risk of coronary heart disease. Douglas MacKay, ND, vice president, Scientific & Regulatory Affairs, said CRN has concerns that FDA’s proposed action to exclude all dietary supplement products that contain free phytosterols from bearing the approved health claim does not reflect full consideration of the impact of all

Energy Drinks with Alcohol Riskier Than Alcohol Alone

tion of AmED alters neurocognitive and subjective measures of intoxication compared with the consumption of alcohol alone. Participants (n = 56) attended one session where they were ranResearchers investigate subjects ‘under the influence’ domly assigned to receive one of four doses (0.65 g/kg alcohol; and draw some important conclusions. 3.57 ml/kg energy drink, AmED; or a placebo beverage). Performance on a cued go/no-go task was used to measure the reEnergy drinks appear to alter some of the objective and subjecsponse of inhibitory and activational mechanisms of behavioral tive impairing effects of alcohol and may contribute control following dose administration. Subjective to a high-risk scenario for the drinker, according to ratings of stimulation, sedation, impairment and research published in Alcoholism: Clinical & Experilevel of intoxication were recorded. mental Research. The mix of impaired behavioral Alcohol alone impaired both inhibitory and activainhibition and enhanced stimulation is a combinational mechanisms of behavioral control, as evition that may make alcohol mixed with energy denced by increased inhibitory failures and drinks riskier than alcohol consumption alone. increased response times compared to baseline There has been a dramatic rise in the consumption performance. Coadministration of the energy drink of alcohol mixed with energy drinks (AmED) in with alcohol counteracted some of the alcohol-inyoung people, according to researchers. AmED has duced impairment of response activation, but not Mixing alcohol and energy been implicated in risky drinking practices and response inhibition. For subjective effects, alcohol drinks is a risky practice. greater accidents and injuries have been associincreased ratings of stimulation, feeling the drink, ated with consumption. Despite the increased popliking the drink, impairment and level of intoxication, ularity of these beverages (e.g., Red Bull and vodka), there is little and alcohol decreased the rating of ability to drive. Coadministralaboratory research examining how the effects of AmED differ tion of the energy drink with alcohol increased self-reported stimfrom alcohol alone. ulation, but resulted in similar ratings of the other subjective This experiment was designed to investigate if the consumpeffects as when alcohol was administered alone.

22 • Nutraceuticals World

www.nutraceuticalsworld.com

June 2011

Industry News

delivery matrices on the efficacy of dietary supplements containing free phytosterols. “In addition to tablets, soft gels and capsules, dietary supplements can be formulated as dry powders that are intended to be blended into a food or beverage prior to consumption,” he noted.“A free phytosterol powdered dietary supplement that is reconstituted into a food or liquid beverage will overcome dissolution and distribution limitations that may occur with the tablet or capsule form of free phytosterols. Spilburg, et al., 2003, demonstrated that 4-weeks’ supplementation with a powdered phytosterol that was mechanically blended into a lemonadeflavored beverage prior to consumption significantly reduced LDL cholesterol as compared to placebo. “Furthermore, Kassis, et al., 2008, demonstrated that supplementation with a free phytosterol powder that was mixed into margarine and served as a single dose with breakfast significantly lowered plasma total cholesterol and LDL cholesterol. These data suggest that the delivery matrix used for free phytosterol-containing dietary supplements influences the efficacy of the formulation and that some dietary supplements should be able to bear the health claim relating phytosterols and risk of coronary heart disease.” A closer look at disintegration time and efficacy data reveals that disintegration of the specific dietary supplement delivery matrix is an important variable that needs con-

sideration when evaluating the effect of free phytosterols, he added, noting that disintegration time has been an important variable for other FDA approved nutrition-related health claims.

DSM Acquires Carotenoids Producer Strengthening the natural carotenoids offerings of its nutrition business, The Netherlands-based Royal DSM N.V. has signed an agreement with P&R Group (Italy) to acquire Vitatene S.A.U., León, Spain, a producer of natural carotenoids. Founded in 2004, Vitatene is a leader in the production and sale of a range of high-value natural carotenoid products derived from fermentation of the fungus Blakeslea trispora. The products are sold under the brand names Betanat and Lyconat.

Standards for TCM Addressed at ISO Meeting The second plenary meeting of the International Organization for Standardization (ISO) Technical Committee (TC) 249 on Traditional Chinese Medicine (TCM) met recently in The Hague, Switzerland, with representatives from 14 countries in attendance. Michael McGuffin, president of the American Herbal Products Association (AHPA), Silver Spring, MD, served as the U.S. head of delegation. The formation of this TC 249 came about as a result of a re-

Reports Available Driven by rising consumer concerns about weight management, health related issues and the importance of healthy, functional foods, the global market for L-carnitine is forecast to reach nearly $128 million by the year 2017, according to a new report from Global Industry Analysts, Inc. (GIA). Growth in the market is also powered by other factors, such as an aging population, greater spending power and the need to look youthful and attractive through safe and natural methods. For further information: www.strategyr.com Energy drinks—the “bad boys” of the beverage world—have become a driving force behind a resurgence in the beverage market, according to market research publisher Packaged Facts. Sales of energy drinks—along with the performance of ready-todrink (RTD) teas and sports drinks—have helped the functional and natural RTD beverage market grow to $23 billion. Packaged

24 • Nutraceuticals World

quest in 2009 by the Standardization Administration of China (SAC) for ISO to address a scope described as “standardization in the field of TCM, in terms of basis, application, administration and the related technical fields, such as terminology, diagnosis and treatment methods, manipulation standards, training standards, quality standards of appliance and equipment, and production and usage standards of Chinese herbal medicines and their test methods, etc.” An initial focus of the meeting was on structural issues. Consideration was therefore given to the formation of several working groups that will be made up of experts in key areas of interest that fall under the TC 249 scope of work. Over the course of the meeting, the committee resolved to establish working groups on raw materials, manufactured products, medical equipment and informatics. Several proposals for specific areas for standardization were also considered, including projects on ginseng seeds and seedlings, on acupuncture needles and on a coding system for herbal ingredients, among others. Additional ideas for specific areas of activity will continue to be identified.

Central American & Caribbean Regulators Discuss Supplements Twenty regulators from across Central America and the Caribbean met in Costa

Facts’ “Functional and Natural Ready-to-Drink Beverages in the U.S.” report reveals that sales growth of energy drinks isn’t conjured up by counterculture or cool-hunting marketing, but instead is due to offering consumers a distinctive benefit they want and need (i.e., more energy). For further information: www.packagedfacts.com Overall sales of clinical nutrition products are rising with an aging population in the U.S. and EU as well as rising incidence of illnesses and conditions that require clinical nutrition. But sales of clinical nutrition products containing probiotics and prebiotics are outpacing sales of conventional clinical nutrition products, opening up a new market that is dominated by a handful of players, according to a recent report from Business Insights. Nearly all of the major manufacturers of enteral nutrition products—Abbott Nutrition, Danone, Fresenius Kabi and Nestlé—are currently working to expand their offerings of products containing probiotics and prebiotics. For further information: www.business-insights.com

www.nutraceuticalsworld.com

June 2011

Industry News

Rica recently to debate evolving food supplement regulations globally, regionally and nationally. Officials, from Costa Rica, El Salvador, Guatemala, Honduras, Jamaica, Mexico, Panama, Paraguay and the Central American Economic Integration System (SIECA), many of which are in the process of developing food supplement regulations, discussed regulatory issues such as the classification, definition and safety of food supplements. Organized by the International Alliance of Dietary/Food Supplement Associations (IADSA), the workshop was an opportunity for regulators to share the challenges they face when evaluating food supplement products, according to Peter Zambetti, IADSA chair. “Many countries in the region do not have specific laws in place for food supplements, or are in the process of developing their regulations. At the workshop there was strong emphasis on the need to ensure the safety and quality of food supplements and the establishment of a system to control food supplement products on their respective markets.”

PR*Bar to Develop Team USA Performance Nutrition Bars In consultation with U.S. Olympic Committee (USOC) sports dietitians, PR Nutrition, Inc., (PR*Bar), Carlsbad, CA, will create, develop and sell a line of Team USA performance nutrition bars through

a multi-year licensing agreement. A portion of the proceeds from sales will support the training of U.S. Olympic and Paralympic athletes and hopefuls. The agreement runs through June of 2017. PR*Bar’s line of Team USA performance nutrition bars, as well as PR*Bar’s U.S. Olympic-branded nutrition bars, will be available at retail in mid-2011. This licensing agreement augments the USOC’s strategy to build a long-term, competitive licensing platform.

Fuji Expands AstaREAL Production Responding to increased demand worldwide, Fuji Chemical Industry Co., Ltd., Toyama, Japan, has expanded production capacity for AstaREAL natural astaxanthin at its wholly owned subsidiary, BioReal (Sweden) AB, in Gustavsberg, Sweden. The expansion at BioReal is in line with Fuji´s decision to focus its astaxanthin production in Sweden. The process is modular and can be expanded rapidly to accommodate the continued growth of the natural astaxanthin market. The expansion at the Swedish facility will double current production capacity.

Domino Sugar Enters Stevia Market Domino Foods, Inc., Iselin, NJ, has formed a collaborative agreement with Germany-

Recent Certifications & Approvals

World Health Store Opens New Location in Shanghai U.S.-China Health Products Association member World Health Store (WHS) has expanded its presence in China, opening its seventh location. The company celebrated the grand opening with a visit from the U.S. Embassy’s Minister of Commercial Affairs William Zarit, along with U.S. Foreign Commercial Service and Agricultural Trade Office. WHS is the first true health food store in China, offering more than 500 individual natural health products, such as dietary supplements, sports nutrition, pre-packaged organics, aromatherapy, hand-made soaps, air/water filtration systems and exercise equipment.

EPAX received Friend of the Sea certification in 2009 for its sustainable and traceable marine sourcing and production methods.

A+ Secure Packaging, LLC, LaVergne, TN, has received confirmation that its manufacturing facility is in compliance with current Good Manufacturing Practices (GMP) following completion of a two-day FDA inspection. A+ Secure Packaging is a custom contract packaging service provider for the manufacturers of pharmaceutical, OTC, nutraceutical, dietary supplement, animal health and medical device products. EPAX AS, Aalesund, Norway, has received this year’s Friend of the Sea (FOS) Award in the omega 3 category. The recognition is largely the result of EPAX’s commitment to source from approved, sustainable fisheries and its marketing and communications efforts informing customers about the importance of sustainable and traceable certification. Additionally, as part of its internal environmental initiative, EcoVision, EPAX manufactures and distributes its marine-derived oils with minimal environmental impact.

June 2011

based WILD Flavors GmbH and Chinabased Sunwin International to offer allnatural sweetener products, such as cane sugar, rice, malt and stevia, in addition to sweetening systems that can include both natural and artificial sweeteners plus sophisticated flavor modifiers. Domino Sugar and its affiliates produce and market sugar and other sweetener products through technical, engineering and manufacturing knowledge. In addition to refined cane sugar products, Domino Sugar provides brown rice syrup, evaporated cane juice, fondants, honey, invert sugar, malt, molasses, as well as flavor and texture modifiers.

Amway North America has received sports certification for three of its NUTRILITE brand products (NUTRILITE Daily Multivitamin, Concentrated Fruits and Vegetables and DOUBLE X Vitamin/Mineral/Phytonutrient) through NSF International’s Certified for Sport program. To earn certification, the three NUTRILITE products were evaluated by NSF International to verify that the information appearing on the label matched the content of the product and that no banned substances were present. Biothera, Eagan, MN, has obtained a positive scientific opinion from the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies for Wellmune WGP as a novel food following a review of clinical and safety data. Novel food designation allows for use in foods, beverages and supplements in Europe.

www.nutraceuticalsworld.com

Nutraceuticals World • 25

Business Insights

Spices have served several purposes throughout history. In addition to their use in flavoring food, spices have been used in cosmetics, to embalm the dead and to mask the taste of food past its prime prior to the availability of refrigeration. Ancient Egyptian papyri from 1555 BC record the use of coriander, fennel, juniper, cumin, garlic and thyme. It is reported that the Sumerians were using thyme for its health

Spices That Belong in the Medicine Chest Today’s manufacturers and suppliers are taking an interest in spices because of their health benefits. By Gregory Stephens, RD & Sheila Campbell, PhD, RD Greg Stephens, RD, is president of Windrose Partners, a company serving clients in the 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; Email: [email protected]. Sheila Campbell, PhD, RD, has practiced in the field of clinical nutrition for 30 years, including 17 years with Ross Products Division of Abbott Laboratories. She has authored more than 70 publications on scientific, clinical and medical topics and has presented 60 domestic and international lectures on health-related topics. She can be reached at [email protected]. 26 • Nutraceuticals World

properties as early as 5000 BC, and the farmers of Mesopotamia were growing garlic as early as 3000 BC. In the 1700s and 1800s, pirates valued spices just as much as the other booty they ruthlessly plundered from trading ships on the high seas. Today, the health benefits of spices are not going unnoticed by manufacturers and suppliers. According to a report published by Research and Markets, today’s U.S. spice and extract market is estimated at $8.5 billion, with significant growth projected in the U.S. and abroad. Many see this as an opportunity to enter or further capitalize on the booming nutraceutical market. As an example, the McCormick Science Institute was formed as a research-driven organization with a mission to support scientific research and disseminate information on the health benefits of culinary spices and herbs to both consumers and healthcare professionals. From the end-user perspective, most consumers do not differentiate between spices and herbs. Though there are many similarities between the two, there are some important differences too. Probably the most significant is where they come from on a plant. Herbs usually come from the leafy part of a plant, while spices are www.nutraceuticalsworld.com

most often obtained from seeds, fruits, roots, bark or some other vegetative substance. Interestingly, some plants yield both an herb and a spice. For instance, cilantro is the leafy herb of the same plant that gives us the coriander seed, a popular spice. Though herbs have been used more frequently than spices in the medical field, many spices do more than impart flavor. Spices are increasingly taking on more value as science and technology reveals their medicinal qualities, many of which are already well known and appreciated in Traditional Chinese Medicine, Ayurvedic food practices and other disciplines. Fortunately, spices don’t add much weight to the dinner plate aside from evocative and exotic flavors. However, in terms of therapeutic quality, mounting evidence shows that many pack a powerful punch. Spices Primarily Function as Antioxidants The healthful effects of antioxidants in reducing inflammation are recognized by experts and the public. By way of a quick review, here is a summary of what an antioxidant is, chemically speaking, and how it helps reduce inflammation. Antioxidants help neutralize or eliminate free radicals, which are unstable molecules that arise normally during metabolism, as well as from environmental influences such as pollution, radiation, cigarette smoke, herbicides and even physical exercise. To be clear, not all free radicals are bad. For example, the body’s immune cells purposefully create them to destroy viruses and bacteria. Harmful effects arise because free radicals lack an electron. They “steal” an electron from a neighboring atom, causing it in turn to become unstable. The resulting chain reaction wreaks havoc in cells and tissues. June 2011

Business Insights

As shown in Figure 1, antioxidants neutralize free radicals by donating an electron without becoming unstable themselves. Normally the body adequately defends itself against these free radicals, except when its supply of antioxidants is inadequate, or when free radical production is excessive. The negative effects of free radicals result in cell damage, dysfunction and death, impaired immunity, and contribute to chronic diseases such as heart disease, diabetes and cancer. The damage caused by free radicals also figures heavily in theories explaining the physical effects of aging. The oxygen radical absorbance capacity (ORAC) assay is a well-known method for assessing antioxidant capacity. However, measuring the antioxidant capacity of compounds is challenging. For example, there are at least three other methods besides the ORAC assay for assessing antioxidant capacity—and unfortunately results derived from using these do not always agree with one another. Spices and herbs grown in different geographies have differing antioxidant capacities. There can even be seasonal variations within the same plant. Furthermore, different parts of the plant and whether the herb or spice is dried or fresh affects its antioxidant capacity. These confounders make establishing a standard value for the antioxidant capacity of a given herb or spice difficult. Nonetheless, it is possible to provide

Figure 1: Antioxidant Behavior examples of herbs and spices that studies have identified as being particularly high in antioxidant capacity (see Table 1). Spices have been found to reduce inflammation via mechanisms in addition to their function as antioxidants. Some spices contain bioactive compounds that regulate the inflammatory and immune response. Reducing inflammation is as-

Table 1: Selected Spices & Herbs with High Antioxidant Capacity Spice

Herb (fresh)

Cinnamon

Dill

Cloves

Marforam

Cumin

Oregano

Ginger

Peppermint

Oregano

Rosemary

Turmeric

Sage

Source: Carlson MH, et al. Nutr J. 2010;9:3-11. Dragland S, et al. J Nutr. 2003;133:12861289. Halvorsen BL, et al. Am J Clin Nutr. 2006;84:95-135. Ninfali P, et al. Br J Nutr. 2005;93:257-266. June 2011

www.nutraceuticalsworld.com

sociated with cancers of the breast, colon, lung, pancreas and the head and neck. Spices, herbs and their bioactive compounds can also affect metabolic pathways that regulate cell division, cell proliferation and detoxification—actions important to cancer prevention. Spices also have antimicrobial and antifungal qualities. These qualities may potentially reduce cancer risk and help prevent food borne illnesses. More research is needed to support these theories; however, it is noteworthy that countries with warmer climates regularly feature the use of multiple spices in their cuisine that may act in concert or singly as antibacterial agents. Such condiments include chili peppers, garlic, onion, anise, cinnamon, coriander, cumin, ginger, lemongrass and turmeric. Each day scientists are uncovering more health effects and elucidating the mechanisms of action of several spices from around the world. Previously exotic spices are becoming commonplace as well-read consumers expect them in the marketplace. This opportunity should not go unnoticed NW by the savvy business professional. Nutraceuticals World • 27

Capitol Comments

With the world’s sixth largest economy, California is a huge market for food, drugs, dietary supplements, medical devices and cosmetics. At the same time, it is where manufacturers and sellers of such products face a formidable source of litigation known as California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (“Proposition 65”), which requires companies to provide “clear and

Prop 65 Primer Knowing all the details surrounding Prop 65 could help your business avoid the pitfalls of non-compliance.

By Todd Harrison & Seung-Hyun Ryu

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

reasonable” warnings to consumers if a product exposes them to a chemical known to the state of California to cause cancer, birth defects or other reproductive harm in excess of the maximum daily exposure level (a “safe harbor” level) established by California’s Office of Environmental Health Hazard Assessment (OEHHA). Proposition 65 applies to all products distributed in California and covers both in-state and out-of-state businesses that sell products or provide services to California consumers. As such, its reach extends well beyond California. Proposition 65 Warning Requirement Proposition 65 does not restrict the amount of the listed chemicals in consumer products. Instead, it only requires that a product containing any of these chemicals be accompanied by a “clear and reasonable warning.” The standard language reads: “WARNING: This product contains a chemical known to the State of California to cause cancer and birth defects or other reproductive harm.” Proposition 65 Incentives for Plaintiffs & Dilemma for Food And Drug Manufacturers Proposition 65 allows for both injuncwww.nutraceuticalsworld.com

tive relief and civil penalties of up to $2500 per violation per day. Its significance is reinforced by the fact that Proposition 65 allows any individual acting in the public interest to file lawsuits to enforce its provisions and provides 25% of the civil penalties assessed to be paid to the plaintiff, with the rest going to the State of California. Successful plaintiffs can also recover attorneys’ fees. As a California Appellate Court has noted, bringing a Proposition 65 lawsuit is “so absurdly easy.” Proposition 65 does not require a plaintiff to allege that anyone has been harmed by the product in question or that the product is defective. Instead, a plaintiff simply needs to show that one of more than 900 listed chemicals is present—in any amount—in a product, and the burden of proof is on the defendant to establish that the exposure at issue did not require a warning. There is strong pressure for defendants to settle because proving an exemption is often difficult and cost prohibitive. Not surprisingly, there are many bounty hunters who have aggressively filed thousands of Proposition 65 claims against manufacturers, distributors and retailers sometimes only for the settlement value. In fact, between 1988 and 2006 more than 25,000 businesses faced claims under Proposition 65. And in 2010 alone, 187 settlements generated roughly $13.6 million, of which approximately $7.8 million went to plaintiff’s lawyers. Questions of liability may arise between various companies in the supply chain. Under Proposition 65, any listed chemical present in the product—regardless of its ultimate origin—may trigger a warning requirement, if the amount is above its “safe harbor” level. Consequently, Proposition 65 liability may arise regardless of whether the chemical was added by the manufacturer or was present in the environment as a result of pollution. June 2011

Capitol Comments

Almost all Proposition 65 claims are settled before trial. After the settlement, products must be reformulated to remove the chemical at issue or bear Proposition 65 warnings. Where the chemical at issue is difficult to eliminate, however, food, drug and dietary supplement manufacturers/distributors face a dilemma, as the other alternative—posting a Proposition 65 warning on their food/drug/dietary supplement product—may, frankly, not be a commercially feasible option. Proposition 65 Possible Defenses & Recommendations A mere presence of one or more of the listed chemicals does not necessarily mean there is Proposition 65 liability, and there are several exemptions/defenses available to defendants who bear the burden of proof. For example, no warning is required (1) when a business has less than 10 employees; (2) when exposure to a chemical occurs at or below the “safe harbor” level, or the exposures are so low as to create no significant risk of cancer or birth defects or other reproductive harm; (3) when the listed chemical occurs naturally in food; (4) when an exposure takes place less than 12 months subsequent to the listing of the chemical by the OEHHA; and (5) when federal warning law preempts state law.

CREATING TOMORROW’S SOLUTIONS

WHAT DO YOU WANT TO STABILIZE?

“Almost all Proposition 65 claims are settled before trial. After the settlement, products must be reformulated to remove the chemical at issue or bear Proposition 65 warnings.” Proposition 65 defenses, however, are often difficult to establish. For example, to establish a “naturally occurring” defense, a defendant must prove that the chemical is, in fact, “naturally occurring” and does “not result from any known human activity” such as soil pollution or the use of pesticides. Many plaintiffs have targeted the dietary supplement industry because they know the cost of establishing “naturally occurring” levels of chemicals in soil, botanicals and minerals is extremely high and the task is quite difficult under the court cases that have addressed this issue. Nevertheless, some defendants have successfully made this argument and prevailed against Proposition 65 claims. Manufacturers and sellers of food, drug and dietary supplement products should consult with an attorney before deciding whether and how to provide Proposition 65 warnings in California. When companies receive a Proposition 65 60-day Notice of Violation, they should immediately contact an experienced deNW fense lawyer to strategize their options. June 2011

NEW ORLEANS, LA, USA Visit us at Booth 8147

Is your ingredient of choice prone to degradation? Talk to us. We have the solution. With our technology and know-how we can help you stabilize sensitive ingredients. We offer you the controlled encapsulation of a large variety of molecules. In many cases, we can encapsulate the desired ingredient for you and supply you with ready-to-use complexes. Our technology of choice is encapsulation via ring-shaped sugar molecules, known as cyclodextrins. With 15 years of experience in manufacturing and formulating _-, `- and a-cyclodextrins we are the innovative partner for the nutrition industry. Find out more about us and our other products and services at www.wacker.com/food Wacker Chemical Corp., +1 517 264 8794, [email protected]

www.nutraceuticalsworld.com

Nutraceuticals World • 29

Eurotrends

Inflammation is a process that periodically occurs in the body, usually connected to some sort of infection that needs to be fought. This makes shortterm inflammation, by and large, a good thing, which is typically over with once the job is done. Chronic inflammation, however, is another story.

Chronic Inflammation Pursuing biomarkers of inflammation might create new stories for old nutrients.

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

In 2004, Italian researchers published a review that stated: “Obesity, insulin resistance, and diabetes are associated with a pro-inflammatory state, which in turn is associated with increased cardiovascular risk.”This pro-inflammatory state is more popularly referred to as “chronic inflammation”—and it has since been linked to a range of conditions promoting heart disease, osteoporosis, cognitive decline (up to and including dementia), Type 2 diabetes and arthritis. Researchers believe that chronic inflammation is a modern condition, brought about—like many other ailments—by unhealthy diets combined with physical inactivity, sending the usually-temporary inflammation process into an endless loop. Several biomarkers connected to inflammation have been identified, clearing the path toward the detection of, and clinical research into, chronic inflammation. Obesity, for example, has been shown to increase inflammatory markers, indicating higher risk for heart disease and other conditions. Indeed, being overweight is not just a cosmetic issue; rather it promotes serious biochemical changes www.nutraceuticalsworld.com

that can lead to other, more serious health issues. A Potential Solution? Meanwhile, scientists in the Netherlands recently formulated a test supplement designed to counteract chronic inflammation by initiating metabolic changes in overweight people. The test supplement—consisting of fish oil, green tea extract, resveratrol, vitamins C and E and a lycopene-rich tomato extract—produced changes in genes associated with inflammation, counteracting some of the effects of obesity. The underlying mechanism is called nutrigenomics, or the effect certain nutrients can have on an individual’s gene expression. Inflammation is a cascading process that involves pro-inflammatory mRNA and cytokines/chemokines, and the expression of their underlying genes can be affected by certain nutrients. Thus, consuming anti-inflammatory nutrients can, in fact, reduce the severity of the inflammatory cascade. Another interesting aspect of chronic inflammation and the fact that it may be at the center of several serious health conditions is this: What if heart disease, Alzheimer’s, colon cancer and many other conditions are merely symptoms of inflammation? Wouldn’t it be nice, by “curing” the chronic inflammation, to cure all those diseases along with it? One cure for multiple illnesses! A theory like this might even be intriguing enough to make the healthcare profession, which is traditionally skeptical of healthy foods, take notice of the ever-growing number of ingredients targeting inflammation. In fact, the consumption of antioxidants as anti-inflammatory ingredients is already being considered a potential strategy for the reversal of disease progression for many June 2011

Eurotrends

conditions where inflammatory markers play a starring role. Not surprisingly, most anti-inflammatory nutrients have antioxidant properties—because free radicals are linked to inflammatory states—and are fairly well known as such to the consumer. Among them are herbal extracts, such as ginger, turmeric, boswellia and green tea, as well as Pycnogenol, astaxanthin, resveratrol, omega 3 fatty acids, vitamins C and D, folic acid, CoQ10, chromium and L-carnitine. And coincidentally, all of these ingredients could use new stories. In addition, the so-called superfruits (specifically açai and pomegranate) are also being discussed as having potential anti-inflammatory power, with studies already published. Some questions to consider: How easily can consumers understand inflammation, as well as the connection between inflammation and, say, Alzheimer’s? Will they believe that an anti-inflammatory nutrient (e.g., a lycopene-rich tomato extract) can help?

June 2011

“…the consumption of antioxidants and anti-inflammatory ingredients is already being considered a potential strategy for the reversal of disease progression for many conditions where inflammatory markers play a starring role.” At first glance, the connection between chronic inflammation and several serious health conditions is a better selling argument than merely being an antioxidant, which, to the consumer, amounts to nothing more than “good for you” at this time. However, time will tell if this bears out. According to industry insiders, it all depends on how the next generation of dietary supplements or functional/med-

www.nutraceuticalsworld.com

ical foods is marketed. All of this is good news for the functional/medical food and dietary supplement industries, which continue to struggle in Europe in the wake of the new Health Claim Directive. Now all that remains is a successful health claim application using an anti-inflammatory ingredient and a study with inflammatory NW markers to send a signal.

Nutraceuticals World • 31

Quality Focus

My last column (April 2011) was a tough one to write, however the process of stepping back shook cobwebs off some interdisciplinary synapses and got me thinking about aspects of quality beyond those involving analytical chemistry—in particular, the roles of knowledge and ignorance in supply chain management and how these pertain to quality. I’ll con-

Supply Chain Management: Like Laundry, It Never Ends... Supply chain management needs to be more than a laundry list of what you should know and what you should control.

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

centrate on the three P’s for now: Provenance, Processing & Production. Take a minute and think about everything these three terms imply—all movement and storage of raw materials, in-process materials and finished products from manufacture through to the consumer. Consider the level of knowledge and detail you actually need to have about all of these elements to ensure a high quality product is delivered. In analytical science, we know that every measure or variable (such as weighing, pipetting, loss during transfer, etc.) has uncertainty associated with it, and these errors propagate. Add enough steps to any process and even very small errors associated with each can accumulate in a hurry. In a previous column, the SIDI protocol (Standardized Information on Dietary Ingredients) was introduced (“Quality Focus,” November 2009). To recap, it provides a checklist for purchasers to use when sourcing raw materials. The template for botanicals includes a section called “Botanical Manufacturing Information” with places to enter the name and address of the manwww.nutraceuticalsworld.com

ufacturer, the mode of manufacturing, agricultural process, manufacturing process, GMP compliance sterilization or fumigation method, and known or potential sources of impurities and/or contaminants. The agricultural process section gives guidance on what sorts of information to enter, such as method(s) of cultivation (e.g., sustainably-wildcrafted or cultivation method), identification, harvest, handling and post-harvest processing. In order to manage the supply chain, the SIDI checklist would have to be filled out each time the material changes hands. The provenance of the material would be tracked by a form from the collector or farmer and a form from for the purchasing center that buys and compiles material from small farms/collectors. Throughout the processing there would be forms—from the facility that processes material, ships the material, extracts material, the bulk packager, maybe another shipper. After all these stages the dietary supplement ingredient goes into production and there could be more forms for the finished product manufacturer, packager, labeler and distributor. While there may be fewer or more steps, the point is there are numerous steps requiring documents to trace materials from field to finished product. As a manufacturer, perhaps you will see a single checklist from the raw material supplier and one would hope it reflects the information from all the other checklists that have been accumulating. The intent here isn’t to suggest we print redundant certificates but rather to point out the level of detail that can exist for every stage of every component in a finished product, despite whether the information is known or not. Rather than blather on about forms and how “what we don’t know may in fact hurt us,” let’s consider an example or two... June 2011

Quality Focus

Provenance The SIDI form gives the supplier the opportunity to determine whether the material was wild collected or cultivated, as well as the place (country, farm, GPS coordinates) from which it was collected. The geographic origins of a material can provide volumes of information over and above simply knowing where something was grown. There can be tremendous implications to quality through informing manufacturers about the likelihood of a particular contaminant, such as the use of DDT to combat malaria in some countries. USDA’s Animal and Plant Health Inspection Service (APHIS) can and will stop botanical raw material at the border if it comes from a country that is known to harbor a plant pathogen, while the same material from a non-infested country is allowed. Processing Processing and preservation techniques vary from supplier to supplier. Simple drying of materials can range from lying out in the sun, wood or charcoal fires to a temperature-controlled vacuum oven. Knowing how a material was dried is critical information when considering potential risk associated with that material. For example, sun-dried materials in warm climates may be at risk for mold growth on wet biomass. Molding of root materials, such as ginseng, can lead to unacceptable levels of mycotoxins. Biomass dried with the assistance of open fire may cause the material to be high in potentially cancer-causing polyaromatic hydrocarbons (PAH). Production Botanicals (and other dietary supplement ingredients) can be contaminated or otherwise sullied by the manufacturing process just as easily as in any other part of the supply chain. Many sensory and/or pharmacologically relevant compounds can be degraded with light, heat or even changes in pH. Spray-drying an extract for too long or at too high a temperature could turn a nice, aromatic, light-gray green material into a charred mess. Even an over zealous tablet compression could generate enough heat to decrease the quality of a finished product. The selection of the excipients could also lead to contamination and impact quality. Summary This column was not intended to be a laundry list of areas that can introduce risk and potentially decrease product quality. Obviously we cannot know everything and we cannot control everything. But making decisions throughout the supply chain to allocate resources based on potential risk is just good business management. That being said, just identifying risks seems to lead back to a massive laundry list that gets longer and longer with the number of components, ingredients and products a company deals with in manufacture. Perhaps more significant than all the potential sources of risk in a supply chain are the consequences of failures. I believe FDA has made it clear where it feels the consequence of failure poses too great a risk through NW enactment of the 100% Identity Rule. June 2011

www.nutraceuticalsworld.com

Nutraceuticals World • 33

The Research Process

Can a company design a study for a condition-specific product and still be in compliance with the Dietary Supplement Health & Education Act (DSHEA) and subsequent laws? By law, as most people know, dietary supplements cannot be marketed to treat, prevent or cure any disease, which is why FDA requires that the following statement be listed on all dietary

Research At Your Own Risk Navigating the complex world of dietary supplement research can be challenging for even the most seasoned professionals.

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; E-mail: [email protected]; Website: www.miamiresearch.com. 34 • Nutraceuticals World

supplement products: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Claims The label of a dietary supplement or food product may contain one of three types of claims: a health claim, nutrient content claim or a structure/function claim. Health claims describe a relationship between a food, food component or dietary supplement ingredient, and reducing risk of a disease or health-related condition. Nutrient content claims describe the relative amount of a nutrient or dietary substance in a product. A structure/function claim is a statement describing how a product may affect the organs or systems of the body—but it cannot mention any specific disease. Remember that to be fully DSHEA-compliant one must also submit to the FDA any structure/function claims that are going to be made within 30 days of going to market (it does not need approval; it just needs to be submitted). While one does not need FDA approval on a structure/function claim, one does www.nutraceuticalsworld.com

need substantiation for any claim that is being made. Most important, the marketing related to a supplement cannot state that it prevents or reduces the risk of a disease or health-related condition unless the claim has been approved by FDA. Conditions As Diseases If you accept the notion that conditions are related to diseases, then let’s consider that Metabolic Syndrome (“MetSyn”)—a combination of abdominal obesity, elevated blood pressure, high triglycerides, low HDL (the “good” cholesterol) and/or high blood sugar—might also be a disease. While this condition (MetSyn) is not formally recognized by FDA as a disease, many health organizations have definitions for it. Recently, two studies published in peerreviewed journals detailed the effects of a dietary supplement on bone metabolism in postmenopausal women with MetSyn. The dietary supplement contained 200 mg hop rho iso-alpha acids, 100 mg berberine sulfate trihydrate, 500 IU vitamin D(3) and 500 mcg vitamin K(1), and was taken twice daily for 14 weeks. The purpose of these studies was to evaluate the impact of a dietary supplement (“targeted phytochemicals and nutrients”) on bone turnover markers in healthy postmenopausal women and postmenopausal women with MetSyn. These studies found this specific dietary supplement produced a more favorable bone biomarker profile indicative of healthy bone metabolism (i.e., positive changes in osteocalcin, 25-hydroxyvitamin D and with type-I collagen) in healthy postmenopausal women as well as those with MetSyn. Here’s the tricky part. FDA has indicated that in order to conduct a human interventional clinical trial with a dietary supplement on a “diseased” population, an June 2011

The Research Process

“FDA has indicated that in order to conduct a human interventional clinical trial with a dietary supplement on a ‘diseased’ population an Investigational New Drug (IND) application must be filed.” Investigational New Drug (IND) application must be filed. INDs require a lot of paperwork, are laborious, and might affect opportunities to market the product as a dietary supplement. In other words, FDA says any product being studied for anything that is not quality-of-life related and where the primary endpoint is disease related (e.g., change in lipids in a group of people with elevated cholesterol outside the normal range) you need an IND. This is all well and good unless you want to take that study product to market as a supplement. A perfect case in point is the recent New Dietary Ingredient (NDI) rejection of homotaurine. FDA rejected homotaurine as a dietary ingredient because it once was submitted

June 2011

as part of an IND package for potential development as a drug. Going forward, it will be an uphill battle for the company to argue that this ingredient be considered a supplement and not a drug. In fact, it appears from the February 2011 FDA ruling on homotaurine that once an ingredient gets the FDA stamp of approval for research under the IND program, then the agency has the power to remove the product or ingredient from the supplement marketplace. The studies mentioned previously by Drs. Holick and Lamb provide some evidence that their unique intervention aids in healthy bone metabolism and has potential in those who are at increased

www.nutraceuticalsworld.com

osteoporotic risk. But there are still some unanswered questions: 1. Did the researchers or sponsor know they needed an IND application for their 2011 study (since it was in women with MetSyn)? 2. If they did file an IND application, can the studies be used as part of product substantiation, since the group studied had a “condition”? These are important issues to consider in designing clinical trials. While research is certainly important, one must be cognizant of the subtle details that might affect the product’s target population and marketability in NW the future. References furnished upon request.

Nutraceuticals World • 35

Soy

Story

Soy has had a wild ride during the past decade, and it’s not over. By Rebecca Wright Editor

hen Nutraceuticals World first covered the soy market in January 1999 (in only our second issue), most experts painted a pretty rosy picture. For several reasons—e.g., health appeal, formulation benefits, rising consumer awareness—soy became a media darling and a hot target for product developers and marketers. And once FDA approved a health claim linking soy to a reduction in coronary heart disease risk, it was soy’s time to shine. But like most health trends, the good times couldn’t go on forever. “Soy’s role in the marketplace has changed in recent years,” said Peter Golbitz, director of business development,

W

36 • Nutraceuticals World

Canada-based SunOpta Grains and Food Group. “Originally, it was a macro trend and a driver—every large company wanted soy as an ingredient. It wasn’t about health and wellness; it was just about soy.” “But every trend has its cycle, and now soy is becoming a mature category and is a micro trend,” Mr. Golbitz added. “Few foods created a flurry like soy did, but now the attractiveness of soy is competing with other trends under the health and wellness category—e.g., whole grains, protein, antioxidants, etc.”

The U.S. Market

soy market reached more than $4 billion in sales in the U.S. by 2004, a point at which the market started to turn. Fast forward to 2011 and it is very clear the soy market has matured. Growth has slowed or declined completely in most

This article in a nutshell: • The U.S. market • A polarizing ingredient • Soy isoflavones • The global outlook • Despite the health benefits… • Soy’s future

Buoyed by incredible momentum, the www.nutraceuticalsworld.com

June 2011

Soy

categories, leaving small pockets of opportunity in others. Focusing on the bright side, Joe Jordan, content director, Soyatech, Southwest Harbor, ME, pointed out, “While the overall industry has been stuck in neutral since 2004, it has become increasingly clear that soy foods are not monolithic. Convenient, delicious foods containing soy protein continue to find success in the marketplace. Meat alternatives and energy bars, in particular, have experienced sustained sales growth even while the larger industry has slumped.” Proving problematic for the category, recent research has not only questioned the efficacy of soy in relation to certain health issues, but also its safety, especially in relation to increasing the risk of cancer. While some experts claim these study results are unfounded, based on poorly designed trials, the negative aura surrounding soy continued to grow during the last several years. “Negative information about soyfoods, mostly in the form of vague, poorly substantiated Internet rumors, have experienced a resurgence in the last couple of years, impacting the soyfoods market strongly in 2009,” Mr. Jordan said. “More positive news in 2010, including new scientific research, has seemed to turn the tide for the time being.” Furthermore, soy is facing some stiff competition. Ironically, just as it offered consumers an alternative to dairy and meat, now other options like almond milk and fungus-based meat are moving in on soy’s territory and stealing market share. According to a new report from Chicago, IL-based Mintel (“Soy Food & Beverages U.S., March 2011”), while some of soy’s plunge can be blamed on the recession and consumers cutting back on premium-priced soy items, competition from other heart healthy foods and good-tasting, soy-free milk alternatives June 2011

kets benefit from their full range of shelfstable, frozen and refrigerated soy foods and beverages,” the market researcher said.“Furthermore, major retailers in both supermarket and mass merchandisers carry their own private label brands of soy food and beverages.” On the other side of the spectrum, natural supermarkets captured $192 million, or 7% of the soy market, after stealing one percentage point of sales from FDM stores in 2008-10. While relatively small, Mintel said it is important to keep in mind that this channel is central to the soy market, as it’s a launching pad for a broad array of soy products that, once successful, gain distribution in FDM and other outlets. Another point Mr. Browne wanted to drive home: Mintel’s latest report covered food and beverage products where soy is the primary ingredient. So he said this would exclude supplements as well as meal replacements. The latter segment, he said, is doing fairly well, so if that had been factored into the analysis the overall picture might have been affected. Still, most experts agree that soy’s best days might be behind it. “A decade ago, the soy foods market was in a period of rapid growth, featuring constant innovation from nimble, entrepreneurial companies as consumer awareness of soy exploded and as soy foods became more convenient, familiar and accessible,” said Mr. Jordan. “However, by 2004 the market of consumers willing to eat soy had become

are also challenging the industry and hampering soy sales. “Aside from the depressed economy, consumers are experiencing soy burnout,” said David Browne, senior analyst, Mintel.“Not too long ago, American consumers were told soy is a ‘superfood’ they can’t get enough of, but now they’re hearing they may be getting too much. With soy aversion now a relevant concern, there are tons of competitive products available that have made it easy to switch to something new.” Mintel/SPINS data show the soy food and beverage market declined 16% between 2008 and 2010 to $2.6 billion. And the market researcher predicts another 17% decline between 2010 and 2012 (see Table 1). While these numbers are somewhat shocking, Mr. Browne said they need some context.“When we put this most recent report out a couple of soy organizations said we were painting a poor picture of the market. But it is important to realize that these numbers don’t reflect sales from Trader Joe’s, Whole Foods or Wal-Mart, and a lot of consumers shop for soy products at the these stores,” he explained. Given this variable, he said the picture could be different if those numbers were available. Further, he said, the soy market stands to perform better in the coming years when factoring them in. Mintel/SPINS data point to the FDM (food, drug and mass) channel as holding the largest share of soy sales, accounting for 93% of total soy food and beverage sales, or $2.4 billion in 2010. “Supermar-

Table 1: Sales of Soy Foods and Beverages in FDMx and Natural Supermarkets, at Current Prices, 2008-12

Year

$ million

% change

Index (2008 = 100)

Index (2010 = 100)

2008*

2,995

-

100

116

2009*

2,835

-5.3

95

110

2010*

2,588

-8.7

86

100

2011 (fore)

2,372

-8.4

79

92

2012 (fore)

2,153

-9.2

72

83

* 52 weeks ending Dec. 27, 2008; Dec. 26, 2009; and Dec. 25, 2010 Source: Mintel/SPINS/Nielsen www.nutraceuticalsworld.com

Nutraceuticals World • 37

Soy

saturated—and nearly all of the independent companies who had zealously spearheaded innovation in the category were swallowed up by large food manufacturers—and growth quickly cooled,” he continued.“Since then, the market has grown very slowly—even declining in 2009 for the first time since we began tracking the category.” Contrary to Mintel’s analysis, Soyatech’s data showed that 2010 was a year of mild recovery for the soy foods market, as overall sales grew by about 2%.

A Polarizing Ingredient Like many hot ingredient trends, there is a certain period of exploration from companies in terms of product development. When soy was the “it” ingredient companies spent a lot of time perfecting formulations, specifically trying to tackle one of its most notable attributes: the taste. Apparently, the taste issue is a polarizing one. For soy lovers, taste is the main reason they consume these products, while soy haters avoid it for the same reason. “At least half of survey respondents use soy because they like the taste. Interestingly, taste is also the main reason non-soy users steer clear of soy (45%),” Mintel said in its report. Soyatech’s Mr. Jordan offered a similar view. “U.S. consumers generally identify soy as a healthful food. However, taste issues and concerns over the possibility of negative health implications continue to depress market growth, and we believe they will continue to do so in the near term,” he commented. Regardless of the sensory issues, dedicated soy companies will continue to work out the formulation kinks. “There is ongoing work to improve the flavor and color of soy protein, making it possible to use in a wide variety of products,” said David Krause, global applications manager for Israel-based Solbar, suggesting that consumers, especially Westerners, are looking for an invisible ingredient.“Soy is not something that is traditional to them; it is quite new and sometimes they are not happy with that. It seems people want the benefits of an ingredient that—in terms of taste and appearance—is not there.” 38 • Nutraceuticals World

Just as soy offered consumers an alternative to dairy and meat, now other options like almond milk and fungus-based meat are moving in on soy’s territory and stealing market share.

Perhaps ADM, Decatur, IL, has the answer. The company recently unveiled Clarisoy, an isolated soy protein that allows formulators to provide protein fortification in transparent, low pH beverage systems. “ADM’S Clarisoy is the world’s first vegetable-based protein that offers clarity and complete protein nutrition for low pH beverage systems,” commented Courtney Kingery, marketing and customer development manager, ADM Oilseed-Specialty Products. As background, in March 2011, ADM signed an agreement with Canada-based Burcon NutraScience to commercialize Clarisoy isolated soy protein. This ingredient, Ms. Kingery said, will come in handy for sports and energy beverages. “Mintel projects double-digit growth in the sport and energy markets and the fruit and vegetable drink market through 2015,” she added. Keith Parle, vice president of commercial cereal, bars & confectionery end-use markets, Kerry Ingredients & Flavours, Beloit, WI, agreed that taste is the number one consumer acceptance issue when it comes to soy. But he said the improvements on this front during the last several years have been very positive.“There has been continual development of soy masking technology and definite improvement in the last three or four years,”he said.“Just think: bars www.nutraceuticalsworld.com

were terrible 10 years ago and I think they are definitely in a different place today.” “I think flavor houses and formulators have done a great job improving products that were pretty awful and making them, from a sensory point of view, mainstream,” he added. Another positive, according to Mintel, is that soy still has health benefits compared to meat, and many more innovations currently on the market compared to other non-soy meat and dairy alternatives, so it will likely remain a household presence among many health-conscious consumers. In this vein, Mintel said, while the total market dropped more than 13% between 2008 and 2010, seven of the top 10 segments (energy bars and gels; frozen meat alternatives; condiments, dressings and marinades; refrigerated meat alternatives; cold cereals; refrigerated juices and functional drinks; and tofu) saw moderate growth, driven by demand for health and convenience, and fueled by innovation to meet these. (See Table 2, page 40.) “Soyfoods: The U.S. Market 2011,” published in April by Soyatech, also highlighted the growth in the meat alternatives and energy bar categories. The latter, it said, witnessed 18% growth in 2010 vs. 2009, while the former posted 4% growth during the same period. “Energy/nutritional bars and meat alternatives are also relatively large segments of the market that we expect to experience consistent growth over the next few years,”said Soyatech’s Mr. Jordan. “New blends of vegetable proteins that include soy are providing a basis for further flexibility and innovation in the category.” According to Mintel’s report, soy-based energy bars and gels generated $522 million in sales, representing 20% market share in 2010 in FDM and natural supermarkets. “From 2008-10, the segment grew 21% benefitting from product innovations from leading companies, including Clif Bar, which offer good tasting products targeted to specific consumer segments.” Mr. Jordan also discussed emerging opportunities for soy. “Smaller subcategories that have shown promise recently include soy-based condiments as well as frozen entrees, pizzas and convenience foods,” he said. “Soyfoods, if marketed June 2011

What’ss y So oy your Soy

Solbar'ss wide range of Isolated Isolatted Soy Proteinss is suitable for dry blend blend beveraages and for ready to drink beverages appliccations. Our proteins offer applications. Z\W WLYPVYWLYMVYTHUJLPUÅH]VY Z\WLYPVYWLYMVYTHUJLPUÅH]VY T TV\[OMLLSKPZWLYZPVUU TV\[OMLLSKPZWLYZPVU and suspension.

www.solbar.com m

Solbar USA , 680 Hale Ave., St. Paul, MN 55128 ,phone: 651 493 4 0250 fax: 651 528 672 6728, 28, [email protected]

Soy

properly, may gain some ground by leveraging the current success of ‘gluten-free’ foods where possible, but that will not be a long-term growth trend.” Once considered a leader in the soy segment, Mintel said baby food (18% of the soy market) sales fell 48% to $477 million between 2008 and 2010, well behind energy bars in sales. Mr. Browne cited recalls of infant formula and the aggressive encouragement of breastfeeding as major causes of the sharp decline. Refrigerated non-dairy beverages, which comprise nearly 15% of sales at $380 million, experienced a sales decline of more than 14% between 2008 and 2010. As far as other trends go, SunOpta’s Mr. Golbitz offered, “There is continued growth in fermented soy products. In the future, we believe there will be more soy products with new flavors, additional benefits and new products like soy/juice blends. The tofu market has grown, and

will continue to grow as it is made more convenient and available for consumers.” Mr. Browne believes formulators will eventually move away from using soy as the main attraction. “Product developers may be able to gain new users by blending soy ingredients with nuts and grains to create innovative, better tasting and possibly more affordable food and beverages.”

Soy Isoflavones According to Aparna Parikh, MBA, RD, senior marketing manager (for geniVida and Women’s health platform), DSM Nutritional Products, Parsippany, NJ, the isoflavone market has fluctuated over the years, even though consumer awareness of soy isoflavones and their health benefits is at 37% (Multisponsor surveys, 2010). However, she said if you look at the market for condition-specific supplements (growing as a whole), such as

menopause supplements (predominantly soy isoflavones and black cohosh) and bone health supplements, the categories have continued to grow (NBJ, 2010). “Soy isoflavones (either as a total or their individual components) are to a large extent positioned for menopausal health and increasingly for bone health— the idea being that calcium and vitamin D by themselves are not enough,” Ms. Parikh explained. “This positioning is based on sound scientific evidence that soy isoflavones and their individual components play a key role in imparting health benefits for both these areas.” Laurent Leduc, vice president, Health Division, Frutarom Americas, North Bergen, NJ, believes some of the struggles soy isoflavones have encountered during the last 10 years can be attributed to unfounded research. “The soy isoflavone market grew very rapidly to mid-2000, then saw steep decline during the past decade,” he said.

Table 2: Sales of top 10 soy food and beverages segments in FDMx and natural markets, 2008-10

2008*

2009*

2010*

Sales growth 2008-10

Share change 2008-10

$m

% market share

$m

%market share

$m

% market share

%

% points

Energy bars and gels

432.9

14.5

444.7

15.7

522.0

20.2

20.6

5.7

Baby food

921.7

30.8

801.0

28.3

477.2

18.4

-48.2

-12.3

Refrigerated non-dairy beverages

443.1

14.8

420.8

14.8

380.6

14.7

-14.1

-0.1

Frozen meat alternatives

249.7

8.3

252.8

8.9

260.0

10.0

4.1

1.7

Condiments, dressings, and marinades

118.6

4.0

124.6

4.4

130.5

5.0

10.0

1.1

Cookies and snack bars

146.8

4.9

115.9

4.1

100.1

3.9

-31.8

-1.0

Refrigerated meat alternatives

71.4

2.4

76.9

2.7

83.4

3.2

16.8

0.8

Cold cereals

77.8

2.6

67.5

2.4

78.8

3.0

1.3

0.4

Refrigerated juices and functional drinks

46.7

1.6

53.1

1.9

69.3

2.7

48.4

1.1

Tofu

61.2

2.0

61.4

2.2

62.4

2.4

2.0

0.4

2,569.9

85.8

2,418.7

85.3

2,164.3

83.6

-15.8

-2.2

425.1

14.2

415.8

14.7

423.9

16.4

-0.3

2.2

2,995.0

100.0

2,834.8

100.0

2,588.3

100.0

-13.6

-

Top 10 Segments

Subtotal All other food/beverage segments Total

* 52 weeks ending Dec. 27, 2008; Dec. 26, 2009; and Dec. 25, 2010; Source: Mintel/SPINS/Nielsen 40 • Nutraceuticals World

www.nutraceuticalsworld.com

June 2011

Soy

Mr. Leduc blamed the drop on tenuous research resulting in the negative portrayal of soy. For the future, Mr. Leduc believes greater care needs to go into designing clinical trials on soy and soy isoflavones, with a particular focus on bioavailability. “You need to test to make sure subjects are actually getting isoflavones in the bloodstream,” Mr. Leduc said.“Today researchers are doing a better job understanding the differences in absorption but there is still a long way to go.” Mr. Leduc mentioned this as a point of concern because the negative studies that impacted the market years ago did not test for the bioavailability of isoflavones. Yet, these studies still made broad (negative) conclusions about isoflavones. Fortunately, Mr. Leduc said he has noticed increased interest in soy isoflavones during the past 12 months. “We are seeing interest in soy isoflavones for both supplement and functional food applications.” As for health benefits, he said, “Menopause is still the primary use for isoflavones; secondary would be bone health (synergy with calcium); and incontinence would be the third.” In terms of the latter, Frutarom carries a product substantiated by clinical studies on bladder control. The propriety blend, called Go-Less, combines pumpkin seed extract and SoyLife.“This is a new indication area for the U.S. market,” Mr. Leduc said. “We strongly believe in the synergy of these extracts for bladder health.” Mr. Leduc also highlighted the important differences between natural and synthetic materials, especially in relation to Frutarom’s soy germ ingredient, SoyLife. SoyLife is rich in isoflavones. But more than just an isoflavone concentrate, SoyLife offers the complete spectrum of natural soy compounds. This soy matrix, Mr. Leduc said, enhances the bioavailability of the isoflavones. “You need all the components of the matrix to benefit the body. You don’t have the same synergy when you are creating synthetic isoflavones. The soy matrix is there for a reason.” Sharing his opinion on isoflavones, SunOpta’s Mr. Golbitz commented,“While I understand that isoflavones are in soyJune 2011

beans and they may be responsible for some of the health benefits, isoflavone supplements are not really a soy food, nor do I think they should be classified as a soy food per se. These are highly refined compounds that may or may not be very effective without all of the other healthful components of the soybean, particularly the protein.” Offering another view, Ms. Parikh said isoflavones in soybeans can be broken down into three principal components: genistein, daidzein and glycitein, representing approximately 50%, 40% and 10% of the total soybean isoflavone content, respectively. “Genistein, the primary isoflavone in soy foods is the main circulating isoflavone in humans and has been the most thoroughly researched of the three— in humans and animals it has been experimentally the most efficacious,” she said. “geniVida, pure genistein, is an isoflavone that has been developed by DSM for use in dietary supplements and functional foods. It is a nature-identical, non-allergenic (and hormone-free) form of genistein that was created in the laboratory, thereby guaranteeing purity and consistency.” “Studies indicate that geniVida can effectively relieve menopausal symptoms while helping to improve bone mineral composition,” Ms. Parikh continued. “In a randomized, placebo-controlled, doubleblind clinical study, geniVida supplementation resulted in a 51% reduction in hot flashes and night sweats compared to only 27% for women in a placebo group.” This new evidence, Ms. Parikh said, complements research showing that geniVida Bone Blend significantly increased bone mineral composition by up to 3.4% in postmenopausal women in comparison with women taking a calcium placebo who actually experienced bone loss.

The Global Outlook While the U.S. soy market has had its struggles, the global outlook seems a bit more upbeat, according to estimates from Global Industry Analysts (GIA), San Jose, CA, and its new report, “Soy Foods: A Global Strategic Business Report.” “Global demand for soy foods witnessed a significant increase during the past few years. Although the market witwww.nutraceuticalsworld.com

nessed 6% growth from 2006-2007, the market for soy supplements was adversely impacted by the anti-soy allegations that surfaced during that time,”the report said. “However, subsequent research and investigations rendered the allegations vague on grounds of incorrect research methodology used to come to such inferences. The soyfoods industry, thereafter, recovered from the controversies and has since been marching forward.” GIA claims the worldwide soy foods market continues to be driven by increasing consumer awareness about the health benefits, including heart health, bone health and protection from cancer. “In addition to its high protein and fiber content, soyfoods provide low concentration of saturated fat, and are completely without cholesterol,” the report said. “Soyfoods have now emerged as a healthier and convenient dietary alternative in developed nations. Even in developing markets, soyfoods have found a place in the mainstream market and are provided as packaged foods in several varieties.” Asia-Pacific represents the largest regional market for soy foods worldwide, according to GIA, with the U.S. trailing behind, followed by the European market. “Future market growth is expected to be driven by developing regional markets such as Asia-Pacific and Latin America,” the market research firm said. “The shift of soy foods from small-sized natural food outlets to mainstream markets in developing countries could be attributed to market liberalization and improved supply network,”GIA reported.“The market for soy-based products expanded considerably with innovative and continuous launch of various soy products. Formerly, soy products found in retail stores were limited to tofu, bitter-tasting soymilk and poorly textured meat analogues. With advanced technology, development of tasty soy products has become easier. Several types of tasty soy beverages and snacks continue to hit the market every year.”

Despite the Health Benefits… In large part, said Mr. Parle of Kerry, the soy industry reaped the benefits of governNutraceuticals World • 41

Soy

“Soy prices are at an all-time high. This makes less expensive heart health products like whole grains more attractive.” ment-funded research on soy during the past several years. But soy isn’t the only health ingredient backed by science these days. “A decade ago, if you wanted to pursue health benefits, soy was your only choice. But now there are many more choices,” he said. Further, as the health food industry evolved, more companies realized that consumers were not prepared to wait to see if they could prevent heart disease or cancer, Mr. Parle explained. “As a result, there has been a move away from products that offer benefits years down the road toward those that offer more immediate benefits.” While soy spent many years enjoying a solid healthy halo, recent years have not been as kind. Soy and breast cancer and soy and infant health are two areas that have been impacted recently. Setting the record straight on the former, the Soyfoods Association of North America said, “Conflicting results from studies on soy’s connection to breast cancer often leave consumers confused. As more research is published, there is stronger support for the role of soy foods in reducing the risk of breast cancer—especially when soy is consumed during childhood and adolescence. More and more research also suggests that women who are at risk for developing breast cancer or who are breast cancer survivors can safely consume moderate amounts of soy foods—anywhere from a few servings a week to three servings a day.” Despite its health benefits, high prices for soy motivated consumers to exchange soy foods for products based on less expensive ingredients such as whole grains, including wheat, barley and oats. Based on Mintel’s consumer survey, 22% of non-soy users say they do not buy soy because it is too expensive.“Soy prices are at an all-time high. This makes less expensive heart health products like whole grains more attractive,” Mintel explained. “This competitive set of products had a particularly negative impact on segments like cookies and snack bars, chips and pretzels, which each lost sales during 2008-10.” 42 • Nutraceuticals World

Meanwhile, instead of focusing on specific benefits like reducing the risk of heart disease, many companies are stepping back to concentrate on soy’s generic attributes. In keeping with soy’s reputation as a health food, purity claims like “natural,” “organic” or “no additives and preservatives” rank in the top 10 claims soy food and beverages made during 2006-10, as monitored by Mintel’s Global New Products Database (GNPD). Such claims, the market researcher said, help brands stand out in meeting consumers’ desires for foods that promote wellness. For others, promoting the health benefits of soy sometimes comes down to regulations.“Eating soy for its health benefits is a geographic issue. Companies are always trying to look for health claims but the reality is there are a lot of differences in regulations—especially in Europe, which has only approved one claim related to soy and cholesterol reduction,” said Solbar’s Mr. Krause. “Regardless, people want to become healthier as they eat and soy is playing a nice role as a healthier alternative to unhealthy options.” To address some of today’s broader issues, Mr. Parle said Kerry is adjusting its focus on consumer groups.“One part of the soy business is following a cost-yield path, sometimes using GMOs to make more affordable, more nutritious products,”he said. “The other part of the market is focusing more on affluent consumers, who are moving away from GMOs and buying organic as a safer alternative.” As for those in the middle, Mr. Parle said, this has become a dead space. “This segment of the market is not doing well.” “We’re interested in connecting with more educated, more affluent consumers and aggressively developing higher-end soy ingredients to appease their concerns,” Mr. Parle added.“These consumers are concerned less with price, and more with safety, environmental footprint and health. We are trying to do what we can on the soy side to attract these consumers.” For example, he said Kerry has develwww.nutraceuticalsworld.com

oped a 99.95% GMO-free soy product.“We hope to be at 99.99% very soon, meaning there will be virtually no GMOs in the material. Some folks are weary of GMOs, so this would address those issues.” At the same time, the company is making the harvesting of its soybeans more environmentally friendly. “The whole idea is to completely avoid hexane in the production of soy,”Mr. Parle said.“We have developed a range of isolates produced without the use of hexane. Functionally and nutritionally they are almost identical to our other isolates.”

Soy’s Future Soyatech’s Mr. Jordan predicted the soyfoods industry would continue to grow at a relatively slow rate (1-2% per year), which he said is typical of a mature food category. “The lines between soyfoods and other healthful, vegetarian food options will become blurred as consumers will care more about convenient, delicious nutrition than about the source of protein,” he explained. “The impact of negative health stories will be largely blunted by the weight of scientific evidence finding soy to be a healthful component to a balanced diet. Taste concerns will be mitigated—though not erased—by further breakthroughs in processing technology.” SunOpta’s Mr. Golbitz offered a similar perspective.“We believe the soy market will see slow, steady growth and be strong a decade from now. With rising food prices, soy will be an increasingly significant part of how we feed mankind,” he commented. “The developing world needs more protein, and with the high cost of food many will need to turn to vegetable protein.” In the developed world, Mr. Golbitz believes soy will fare differently than in the developing world and be based on other factors, such as trends and demographics. “Soy will have its cycles, but we do think it will see growth in the future, especially if there are issues with dairy or meat safety,” NW he concluded. June 2011

=76