rebecca wright nutraceuticals world sep 2011

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46 Fat Fighting StrategiesThe collective weight of the world has becomeunbearably burdensome, and the ripple effect couldbe felt for another generation.

58 Nutricosmetics:Creating Solutions for TodaysBeauty Consumer

Global potential of this burgeoning marketremains largely untapped.

Cover design by: Jessica Carlin

4 Nutraceuticals World www.nutraceuticalsworld.com September 2011

26 Business Insights by Greg Stephens

28 Capitol Comments by Todd Harrison

32 Eurotrends by Joerg Gruenwald

34 Quality Focus by Joseph Betz

36 Research Process by Doug Kalman

Columns

September 2011 Volume 14, No. 7

38 Up & Coming Markets:Mining the Mega-Market Re-DirectionIts anything but business as usual in the market thesedays, so understanding the new rules, roles and marketboundaries consumers are imposing on supplements,functional foods/beverages and natural remedies will bethe key to future success.

Table of Contents

46

58

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Table of Contents


8 Top Of The News Nutraceuticals Market to Generate $207 Billion; Pfizer to Sell Nutrition Business

10 Editorial a word from the editor

12 Nutraceuticals World In Print & Online line-up of expanded coverage @ nutraceuticalsworld.com

14 Industry News ConsumersValue Functional Foods; Associations Oppose Supplement Labeling Bill

62 Nutraceuticals Research a recap of the latest clinical trials

64 Supply Source profiles on Gnosis and Nutra3 Complex

66 New Products recent nutraceutical product introductions

68 Suppliers Corner new developments from industry suppliers

71 People In The News whos who and whos moving where

72 Classified Section classified advertising section

73 Calendar upcoming industry events

73 Advertisers Index cross reference of advertisers in this issue

74 The Nutraceuticals Multiverse a quirky look at nutraceuticals in a parallel universe

Departments

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Top OfThe News

The functional foods segment isexpected to attain a value of$49 billion by the end of 2011, andanalysts indicate the market will beworth more than $67 billion by 2016.

CompaniesandMarkets.com

The nutraceuticals market is growing rapidly, with a 2016 forecast value of $207billion, according to a new report available on companiesandmarkets.com.Thereare distinct opportunities for growth in the functional food, beverages and sup-plements market.Demand for healthy food and drink has increased in recent years, particularly

for multi-tasking products, which provide additional heath and well-being ben-efits. The termnutraceuticals is used to describe products of this nature, in-cluding foods, beverages and supplements.The functional foods segment is expected to attain a value of $49 billion by the

end of 2011, and analysts indicate the market will be worth more than $67 bil-lion by 2016, representing a growth rate of more than 6%.Food companies are using functional foods and beverages for differentiation

in the highly competitive food market. Currently, they are focused on vegetar-ian and food-allergy products, but a key future trend is the creation of functionalfood and drinks for childrencapitalizing on parental concern.Growth in the functional food and drink market has been encouraged by con-

sumer interest in healthy living, particularly from the younger demographic, al-though the aging population has also prompted sector expansion. Factorsrestraining growth in the nutraceutical segment include the time taken betweenconcept and product launch, as well as the impact of false product claims, whichhave affected consumer confidence.

In early July, Pfizer,NewYork,NY, announced plans to spin off its animal and nu-trition units. At the time, the company said it was considering options includ-ing, among others, a full or partial separation of each of these businesses fromPfizer through a spin-off, sale or other transaction. Given the separate and dis-tinct nature of Animal Health and Nutrition, the company said it might pursuea different strategic alternative for each business.Pfizer Nutrition is a leader in infant and pediatric nutrition, which it acquired

as part of its $68 billion takeover of Wyeth less than two years ago. It also pro-duces vitamins for pregnant women.This Nutrition business has operations on six continents, products available in

more than 60 countries, and a focused presence in key markets throughoutAsia,the Middle East, Europe and LatinAmerica, with China, Philippines, U.K.,Mex-ico andAustralia being among its top markets. Nutrition generated revenues ofnearly $2 billion in 2010.The Pfizer sale would be the largest of a vitamin or nutrition company in more

than a decade, according to data compiled by Bloomberg. The biggest deal inthat sector was Carlyle Groups $3.8 billion acquisition of vitamin maker NBTYInc. last year, the data show.Bloomberg says a successful bidderwhich analysts speculate could include

companies like Nestle, Danone, Abbott, Mead Johnson or Unileverwouldgain operations with sales approaching $2 billion annually and baby-formulabrands, including SMA Gold and Promil Gold. If Pfizer fails to fetch the priceits seeking for the infant-nutrition unit, it could spin out the business into aseparate company.

Nutraceuticals Market toGenerate $207 Billion by 2016

Pzer to SellNutrition Business

8-9TopNews0911.qxd:NUTWORLD 2009 Top of the News 8/23/11 2:33 PM Page 8

September 2011 www.nutraceuticalsworld.com Nutraceuticals World 9

Top Of The News

Smart Balance, Inc. has acquired Importations DE-RO-MA, which ownsGlutino Food Group (Glutino), for more than $66 million, from Claridge, aMontreal-based investment firm. Based in Laval, Quebec, Glutino is a leadingmanufacturer and marketer of premium-priced gluten-free foods sold underthe Glutino and Gluten Free Pantry brands. Glutino offers a wide range of shelf-stable and frozen gluten-free products, including snack foods, frozen bakedgoods, frozen entrees and baking mixes throughout North America and on itswebsite. Glutino had annual sales of nearly $54 million during its fiscal yearended March 31, 2011.Smart Balance paid $66.3 million in cash.The transaction was funded by Smart

Balances existing credit facility. As of the close of the acquisition, Smart Bal-ances long-term debt is estimated to be $115 million. The addition of Glutinoto Smart Balances portfolio of brands is expected to be accretive to earnings inthe next 12 months.Commenting on the announcement, chairman and CEO Stephen Hughes

stated,We are truly excited about adding the Glutino Food Group to our port-folio of health and wellness brands. Glutino has increased its sales approxi-mately 30% annually over the past three years, and we are confident about itsgrowth prospects and contribution to Smart Balance. The demand for gluten-free products is significant, and is now a category of over $2 billion in retail sales.We are bullish on the continuation of the categorys 10% compound annualgrowth rate due to increased awareness and diagnosis of gluten-induced ail-ments, including celiac disease, gluten intolerance and wheat allergies.Furthermore,Mr.Hughes stated,The gluten-free segment is complementary

with our corporate vision of creating a health and wellness innovation platformthat builds brands targeted at highly motivated consumer need states. Just asour Smart Balance, Earth Balance and Bestlife brands address the health andwellness needs of consumers, Glutino addresses a specific dietary need by elim-inating gluten in foods that consumers have to avoid for health reasons.I know I speak for the Glutino team when I say we are enthusiastic about

joining the Smart Balance organization,stated Terence Dalton, general man-ager.We are impressed with the companys leadership and vision and look for-ward to working together to grow its health and wellness platform. We areexcited to be part of a strategically focused organization, committed to meetingconsumer needs.

Minneapolis,MN-basedGeneralMills has completed its acquisition of a 51% con-trolling interest inYoplait S.A.S., and a 50% interest in a related entity that holds theworldwideYoplait brands, from PAI Partners and Sodiaal in a transaction valued atapproximately $1.2 billion. The remaining ownership stakes in both entities willcontinue to be held by Sodiaal, Frances leading dairy cooperative. Headquarteredin Boulogne-Billancourt, France,Yoplait is the second-largest brand in the global yo-gurt market.The business will be governed by a supervisory board with represen-tation fromGeneral Mills and Sodiaal. Chris OLeary,General Millsexecutive vicepresident and COO, International, will havemanagement oversight responsibilityfor General Mills, with Lucien Fa continuing asYoplaits executive chairman.

Smart Balance AcquiresGlutino for More Than$66 Million

General Mills Completes$1.2 Billion Acquisitionof Yoplait

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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 USATel: 201-825-2552; Fax: 201-825-0553E-mail: [email protected]: www.nutraceuticalsworld.com

Subscription Information:To renew/subscribe/update subscription

information, please visitwww.nutraceuticalsworld.com

and click on subscription services or [email protected]; 201-825-2552 x356

ColumnistsAnthony Almada MSc

GENr8, Inc.Paul Altaffer

RFI Ingredients, Inc.Paula Brown

British Columbia Institute of TechnologyJeff Crowther

The Natural Products Association (NPA),ChinaErik Goldman

Holistic Primary CareJoerg Gruenwaldanalyze & realize AGTodd HarrisonVenable LLPAdam Ismail

Global Organization for EPA & DHA (GOED)Doug Kalman

Miami Research AssociatesDr.A. Elizabeth Sloan

Sloan Trends, Inc.Grant Washington-Smith

Alticor, Inc.

Editorial Advisory BoardSteve Allen

Nutrition Capital NetworkNancy Childs, PhD

Saint Josephs UniversitySteven Dentali, PhD

American Herbal Products Association (AHPA)Loren Israelsen

United Natural Products Alliance (UNPA)Alex Merolli

Nutri+Food Business ConsultantsPaul Paslaski

BioVittoria LimitedEllen SchuttLaunchNaturalScott Steinford

ZMC USAGregory Stephens,RD

(Business Insights Columnist)Windrose PartnersRhonda Witwer

National Starch Food Innovation


All Shook Up

As I sat down to write my editorial for this issue, a 5.9 magnitude earth-quake hit the East Coast. Earthquakes are rare in this neck of the woodsbut they do happen. Anyway, it got me thinking about the nutraceuticalsmarket and how it has experienced a shake-up of its own during the lastseveral years.To put it all into perspective, trends expert Dr. A. Elizabeth Sloan takes

an in-depth look at the state of the nutraceuticals market by the numbersin this issue (page 38). She discusses a wide range of trends, from ingredi-ents to products to health issues to demographics. Dr. Sloan contends thatalthough consumers have been shaken by the economy and a healthcarecrisis, they are incorporating dietary supplements and functional foods intothe changes theyre making in their liveschanges that will likely remainpermanent for years to come. She believes this resetting of market priori-ties and product criteria will create numerous opportunities for companiesin this sector.A shift in thinking has also occurred in supermarket aisles across the

country, according toShopping for Health 2011,an annual study releasedby the Food Marketing Institute (FMI) and Preventionmagazine (page 18).While shoppers used to care most about undesirable characteristics theirfoods were devoid ofe.g., fat, sugar, salt, calories, etc.they are increas-ingly more interested in fortification and the inclusion of key health in-gredients, with fiber (44%) being the most sought-after component; wholegrain (36%), protein (27%), omega 3s (23%) and antioxidants (16%) follow.While the main criteria for healthy foods was previously determined

by ingredients it did not contain, todays shoppers are now instead won-dering whats in their food, seeking to better understand the nutritionalcomponents of what they eat,said Cary Silvers, director of consumer in-sights for Prevention.To take advantage of this, industry companies must take the lead in ed-

ucating consumers about these products and ingredients. Ignoring this re-sponsibility could potentially add up to billions in lost sales.Speaking of lost sales, FDAs release of its New Dietary Ingredient (NDI)

Guidance in July has some pundits claiming the industry will have to re-move several of its products from the market if finalized in its current form.Several trade associations (e.g., AHPA, CRN, UNPA, NPA, etc.) are work-ing tirelessly to make sense of it all. In the meantime, two stories in thisissue (pages 14 and 28) will help to paint a picture of the current situation.To avoid the worst-case scenario, companies must remain tuned into thisissuethe future depends on it.

From The Editor

10Editorial0911.qxd:NUTWORLD 2009 Editorial 8/24/11 2:02 PM Page 10

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Knowledge CenterIn an effort to help you access more than 10,000 articles from the past 12years of Nutraceuticals Worlds coverage, we have created aKnowledgeCenter,which contains a growing base of information designed to offer youthe most relevant news and articles associated with specific categories in thenutraceuticals industry. We have divided the Knowledge Center into twosub-categoriesNutraceuticals Markets and Health Conditions, which aredivided further into nearly 50 unique sections, such as Antioxidants, BabyBoomers, Cardiovascular Health, Immune Function and Sports Nutrition.

TrendSenseIndustry expert Liz Sloan is flexing her marketing muscles, offering analysison different segments each month using Sloan TrendsTrendSense models.You can find her analysis, complete with downloadable TrendSense DataCharts, under theResearchtab of our website.

Top Online Stories @ nutraceuticalsworld.com

Dissecting FDAs NDI GuidanceDiscussing the highlights of the new guidance and what it means for thesupplement business.

Fresh Opportunities in Functional FoodsSuccess in todays functional foods market can be found at the crossroads ofprice, taste, awareness and efficacy.

Great News for the Omega 3 MarketDouble-digit growth predicted thanks to ongoing demand for productscontaining omega 3 fatty acids.

The New NutraceuticalsWorld.comNutraceuticals 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.

Naturally Filtered BlogEach month associate editor Sean Moloughney will offer his thoughts on emerging trends.

Look for his blog under the Opinions tab of our website.


Stay connected withnutraceuticalsworld.com

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Most Consumers SeeValuein Functional FoodsMaintaining health and reducing risk ofdisease is at the forefront of many con-sumers minds as they age. New researchfrom the International Food InformationCouncil (IFIC) shows that Americans citecardiovascular disease (46%),weight (32%)and cancer (22%) as their top health con-

cerns. Along with these issues that can af-fect people as they age, almost one in fiveAmericans (19%) cite healthy aging as a tophealth concern.

The2011 IFIC Functional Foods/Foodsfor Health Surveyalso shows that peopleoften look to food for its health benefits.Ninety percent of Americans can name atleast one food and its associated benefit and

76% say functional foods, or foods that canpromote health, can have a meaningful im-pact on their health when they consumethem. The foods and food componentsAmericans look to themost to help improveor maintain their health are: fruits and veg-etables, fish/fish oil, dairy, whole grains andherbs and spices.The top components withbenefits mentioned in the survey include

Industry News

Maintaining health and reducing riskof disease is at the forefront of manyconsumersminds as they age.IFICs 2011 Foods for Health Survey

FDA Releases NDI Draft Guidance

Trade associations respond, requesting an extendedcomment period.

Potentially affecting consumer access to dietary supplements,

FDA released its much-anticipated draft guidance for New Di-

etary Ingredient (NDI) notications in July.

The Natural Products Association (NPA), Washington, D.C.,

voiced concern that FDA might be overstepping Congresss in-

tent as expressed in the Dietary Supplement Health and Educa-

tion Act (DSHEA), ultimately limiting the number of products in

the marketplace.

The draft guidance answers a lot of questions for the industry,

but it also raises concerns about its overall impact, said Cara

Welch, PhD, vice president of scientic and regulatory affairs with

NPA. It could profoundly affect the ability of Americans to get

the supplements they want and need.

In terms of proving that an ingredient was on the market be-

fore 99, FDA is asking for much more from the industry than

most companies can probably produce, she added. These re-

quirements will reduce ingredients meeting the established

grandfathered status to a regrettably small number.

NDI notications are required for: components of food mar-

keted after 99; a change in solvent when processing an ingre-

dient; a change in manufacturing that produces nanoscale

particles; and each manufacturer of each supplement containing

an NDI. The agency further claried that synthetic versions of di-

etary ingredients require an NDI notication, with the exception of

synthetic botanical constituents, FDA has declared are not con-

sidered dietary ingredients. These situations, experts contend,

have the potential to impact dietary supplement manufacturers

far and wide.

Today, half of all Americans trust dietary supplements and use

them as part of a healthy lifestyle, noted Dr. Welch. For them and

for our industry, its

vital that we make

sure consumers con-

tinue to have access

to popular, safe di-

etary supplements.

In a joint state-

ment, NPA, the

American Herbal

Products Associa-

tion (AHPA), the Con-

sumer Healthcare

Products Association (CHPA), the Council for Responsible Nutrition

(CRN) and the United Natural Products Alliance (UNPA) requested

an extension for submitting comments on the document.

Members of our respective organizations believe additional

time is needed to adequately prepare meaningful feedback for

the agencys consideration. Therefore, on behalf of AHPA, CHPA,

CRN, NPA and UNPA members, we are requesting that FDA ex-

tend the submission deadline by an additional 5 days (i.e., No-

vember 7, 20).

Steve Mister, president and CEO of CRN, said the draft guid-

ance is simply that; it is not a new regulation and does not create

new rights or responsibilities for the industry. Nevertheless, this

draft guidance does represent an important step for the dietary

supplement industryand for the agencyas it demonstrates

further implementation of the requirements of DSHEA and will

give companies clearer understanding of FDAs expectations

under the law.

He added, This guidance has potential for short- and long-

term implications for our industry and for our consumers ability

to have access to in-demand products and we want to be sure

the guidance is appropriate, reasonable and practical for industry

and the more than 50 million consumers who use dietary sup-

plements year after year.

FDAs new NDI Guidance could have a seriousimpact on the dietary supplement industry

and ultimately consumers.

Nutraceuticals World www.nutraceuticalsworld.com September 20

14-24IndustryNews0911.qxd:NUTWORLD 2009 Industry News 8/23/11 2:54 PM Page 14

Industry News

calcium (92%) and vitamin D (90%) forbone health, protein (87%) and B vitamins(86%) for overall well-being, omega 3 fattyacids (85%) for heart health and probiotics(81%) and fiber (79%) for digestive health.

Associations OpposeSupplement Labeling BillThe Natural Products Association (NPA),Washington, D.C., has launched a grass-roots campaign to oppose the DietarySupplement Labeling Actrecently intro-duced in Congress by Senator RichardDurbin (D-IL).NPA is urging its more than1900members to ask their legislators to op-pose the bill by sending them a letter atwww.npainfo.org/Durbin. Among otherprovisions, the bill would direct the De-partment of Health and Human Services(and presumably FDA) to create a list of in-gredients and proprietary blends of ingre-dients thatcould cause potentially seriousadverse events. According to NPA, thisoverly broad language (e.g., no definition isoffered ofcould cause) takes the regula-tion of supplements well beyond the cur-rent, effective rules governing the industry.Sen. Durbin cited the issue of energy

drinks and foods masquerading as dietarysupplements when introducing the legisla-tion. The most controversial part of the Di-

etary Supplement LabelingActmay be its re-quirement for product registration, a changethat Sen. Durbin has sought in the past.TheNPA supports actions by the FDA to

hold accountable those who violate the law,and weve done our part through self-regu-latory activities to ensure accuracy, qualityand safety in the dietary supplement indus-try, said John Gay, NPA executive directorandCEO.We believe, however, that currentregulations are sufficient. The U.S. supple-ment industry has an excellent safety record,and burdensome, duplicative new regula-tions are not needed.It may appear that this proposal has an

uphill climb in this Congress,he added,butit is important that we do not let bad bills getany traction. If we do not make our positionknown,we could find ourselves facing a billwith 30 co-sponsors.Things change in Con-gress, and when and if this bill moves wewant it to start from the one yard line, notfrom the 50.The Council for Responsible Nutrition

(CRN), Washington, D.C., also said it op-poses the bill. Steve Mister, president andCEO, CRN, called itmisguided.The bill contains duplicative require-

ments that already exist under current lawthat gives FDA the proper legal authority totake action to protect consumers andmain-

tain safety standards,he said.FDA needsto continue working toward becoming amore efficient steward of its resources, andwe continuously call on the agency to use itspower under the law.We urge Sen. Durbinto join us in that effort.

Novel Antioxidant Foundin Tomato PlantsA team of researchers from the Institute ofMolecular and Cell Biology (IBMCP)ajoint center of the Universitat Politcnica deValncia (UPV) and CSIC, the Spanish Na-tional Research Councilhave identified anovel and potent natural antioxidant occur-ring in tomato plants. The phenolic sub-stance is synthesized by the tomato plantwhen it is subjected to biotic stress.TheUPVand CSIC have registered the national andinternational patents of the new antioxidantand the laboratory procedures used to iso-late and synthesize it chemically. The find-ing was recently published in the journalEnvironmental and Experimental Botany.IBMCP researchers point out that the an-tioxidant potency of the new compound ishigher (about 14 times higher) than resver-atrol. In addition, it is 4.5 times more potentthan vitamin E and 10 times more potentthan vitamin C. This substance could havemultiple applications. It could be used as a

Reports Available

Awareness of omega 3 fatty acids, among the most important

nutrients for physical and mental health, has reached critical

mass, according to a new Packaged Facts report titled Omega-

3: Global Product Trends and Opportunities. Correspondingly,

the number of consumers who are seeking high-omega products

has increased dramatically over the past few years. In the U.S.

market, for example, 9% of grocery shoppers buy high omega 3

food or beverage products in a typical grocery shopping trip, and

the percentage of adults who take sh oil supplements has

jumped from 8% in 2006 to 17% in 2011. Packaged Facts esti-

mates that global consumer spending on omega 3 food and bev-

erage products (excluding sh), health and beauty care products

(including supplements), and pet products will reach $13 billion in

2011. For further information: www.packagedfacts.com

The omega 3 category is expected to witness considerable

growth, as it continues penetrating the functional food and di-

etary supplement markes, according to a new report from Mar-

kets and Markets titled Omega 3 & 6 Market by Source,

Applications, Geography Trends & Global Forecasts (2011-

2016). This market research study provides individual forecasts

for marine, algal and flaxseed oils. The study also analyzes the

supply chain, raw material supply, regulatory issues and com-

petitive structure of the market. It provides qualitative analysis

of the omega 6 ingredients market as well. For further informa-

tion: www.marketsandmarkets.com

A small number of products for specic diseases have been in-

troduced over the years, but companies have only recently

started to focus on the specic nutritional requirements of pa-

tients with different diseases in depth. A new report from Busi-

ness Insights examines the potential of this burgeoning market

by identifying areas of unmet need and the companies looking to

cater to this demand with new product development. The grow-

ing aging population and the fact that healthcare systems across

the globe are under nancial pressure are driving interest in this

emerging area. Research is, for example, investigating the possi-

bility that integrating nutrition in therapeutic schedules for cancer

might improve treatment outcomes. For further information:

www.business-insights.com



Industry News

preservative in food for human consump-tion, or in animal fodder, because of its ac-tion as a retarder of lipid oxidation. Thecompound could also have major applica-tions in the pharmaceutical industry.

Codex Decides on KeySupplement IssuesThe Codex Alimentarius Commission(CAC) has agreed on a way forward for keyissues in the food supplement sector, in-cluding steviol glycosides, nutrient refer-

ence values, genetically modified organ-isms and fish oils, according to the Interna-tional Alliance of Dietary/Food SupplementAssociations (IADSA). At its July meetingin Geneva, CAC, the highest decision-mak-ing body in Codex, adopted theGeneralPrinciples for Establishing Nutrient Refer-enceValues (NRVs) ofVitamins and Miner-als for the General Population. It alsoadopted aCompilation of CodexTexts Rel-evant to the Labeling of Foods Derivedfrom Modern Biotechnology, following a

decision from its food labeling committeeto discontinue work on definitions and la-beling conditions for genetically modifiedorganisms (GMOs) following no agree-ment, and to develop the compilation ofexisting Codex texts instead. Thirdly, theCAC endorsed the decision of its CodexCommittee on Fats and Oils (CCFO) to de-velop aStandard for Fish Oils,which willcover oil from fish and shellfish; and on theadditives front, it agreed to a maximumlevel for the use of steviol glycosides (INS

EFSA Finalizes Review ofGeneral Function Claims

Panel approves about one in five of the 2758claims evaluated.

This summer the European Food Safety Authority (EFSA) issued its

nal evaluations regarding Article 3. general function health

claims, excluding those related to botanical substances, culminat-

ing more than three years of work by experts.

Since 2008, the panel has assessed 2758 food-related general

function health claims to determine whether they were supported

by sound scientic evidence, thereby assisting the European Com-

mission and Member States in the establishment of a list of claims

authorized for food. These approved

claims will enable European consumers to

make informed choices about their diet.

This very challenging task was com-

pleted thanks to the dedication and com-

mitment of the experts on the NDA Panel

in collaboration with EFSA staff, who have

had to cope with an unprecedented and

unforeseen workload, coupled with very

tight deadlines and often poor information,

said Professor Albert Flynn, chair of

EFSAs NDA Panel. Despite these chal-

lenges our experts have assessed the

claims consistently and fairly to the highest possible scientic

standards. All this was achieved within the deadline agreed with

the Commission.

The outcomes of evaluations were favorable when there was

sufcient evidence to support the claims. This was the case in

about one in ve claims, which related mainly to: vitamins and min-

erals; specic dietary bers related to blood glucose control, blood

cholesterol or weight management; live yogurt cultures and lactose

digestion; antioxidant effects of polyphenols in olive oil; walnuts

and improved function of blood vessels; meal replacement and

weight control; fatty acids and function of the heart; the role of a

range of sugar replacers (such as xylitol and sorbitol) in maintain-

ing tooth mineralization or lowering the increase of blood glucose

levels after meals; and carbohydrate-electrolyte drinks/creatine

and sports performance.

Experts issued unfavorable opinions in cases where the informa-

tion provided did not allow a relationship between the food and the

claimed effect to be established. Reasons included: lack of informa-

tion to identify the substance on which the claim is based (e.g.,

claims on probiotics, or on dietary ber without specifying the

particular ber); lack of evidence that the claimed effect is indeed

benecial to the maintenance or improvement of the functions of

the body (e.g., food with antioxidant properties and renal claims

related to water elimination); lack of precision regarding the health

claim being made (e.g., claims referring to terms such as energy

and vitality, or claims on womens health or mental energy); lack

of human studies with reliable measures of the claimed health ben-

et; claims referring to food categories

which were considered to be too broad,

such as fruits and vegetables and dairy

products to be linked to specic effects.

EFSAs work on general function health

claims has highlighted the importance of

constructive dialogue between risk asses-

sors, scientists, decision-makers and

stakeholders and has contributed to our

thinking on the future shape of our organi-

zation, said Catherine Geslain-Lanelle,

EFSAs executive director. As a result,

EFSA plans to launch an applications help

desk to facilitate dialogue with applicants. By ensuring there is a

shared understanding of the scientic evidence required, the work

we have undertaken will, we trust, support the work of industry by

helping to establish future directions for research and innovation.

The NDA Panel will continue to assess health claims, such as

those submitted by individual applicants concerning claims based

on childrens development or health. Following a meeting with

stakeholders last year, EFSA has nalized a guidance document

for health claims related to gut and immune function and has

launched online consultations on guidance for health claims re-

lated to: bone, joint and oral health; oxidative damage and cardio-

vascular health; and satiety, weight management and blood

glucose concentrations.

EFSA has issued a positive opinion on liveyogurt cultures and lactose digestion.




Industry News

960) as an additive in food supplements, atthe level of 2500 mg/kg as proposed byIADSA. This level and use applies only tochewable food supplements.

India NutraceuticalsMarket RisingMore than 200 experts from the fields ofnutrition science, pharmacy and health-care attended a conference in India inJune to discuss the future of the countrysfood supplement and nutraceuticals mar-ket as it continues to display fast growth,with new regulation on the horizon. Theconference, co-organized by IndiasHealth Foods and Dietary SupplementsAssociation (HADSA) and the Federationof Indian Chambers of Commerce and In-dustry (FICCI), was the third InternationalConference on Nutraceuticals, DietarySupplements and Functional Foods. Par-ticipants at the conference highlightedconsumer trust through the provision ofsafe and sustainable products as a key fac-tor for the nutraceuticals market, and ad-dressed the challenges at play, such as therapidly growing market and customiza-tion issues.The market in India has good potential

both locally and internationally as consumerdemand for products grows across theworld,saidAjit Singh, chairman ofHADSA.Last year it was estimated to be worth $2billion.Therefore it is important that we ad-dress the emerging opportunities in regula-tion and in customizing nutraceuticals.According to a Frost & Sullivan-FICCI

knowledge paper launched at the event, theIndian nutraceuticals market is expected togrow 16% year-on-year for the next fiveyears, reaching roughly $5 billion.Speaking at the event, Simon Pettman,

executive director of the International Al-liance of Dietary/Food Supplement Asso-ciations (IADSA), said: The market inIndia is growing fast and with as much po-tential as many of the fastest growing tech-nology sectors. Increasingly, productconcepts that once would have been onlylocal are now starting to have a regionaland global distribution.Mr. Pettman saidIndias food supplement sector was still inthe early stages of achieving its potentialand stressed the importance of investing inproduct quality.

NPA Endorses ExpandingHSA and FSA Coverageof SupplementsThe Natural Products Association (NPA),Washington,D.C., said it supports legislationrecently introduced in Congress that wouldallowAmericans to use their Health Spend-ing Account (HSA) and Flex SpendingArrangement (FSA) dollars on dietary sup-plements and meal replacement products.TheFamily and Retirement Health Invest-ment Act of 2011was recently introducedin the U.S. Senate by Senator Orrin Hatchand in the U.S. House by RepresentativeErik Paulsen.John Gay, executive director and CEO of

NPA said the bill would be an importantstep in promoting preventative health andwellness, and reducing overall healthcarecosts.Current law allows these dollars to bespent on prescription drugs but not supple-ments. NPA supports increased access tosupplements as part of our healthcare sys-tem so that it is truly a healthcare system andnot simply a disease treatment system. Let-ting HSA and FSA funds apply to supple-ments would bring us closer to that goal.Mr.Gay encouragedNPAmembers and theindustry to ask their senators and represen-tative to support the legislation as it worksits way through Congress.

Stevia AwarenessOutpaces SucraloseAwareness of stevia has grown rapidlyalongside a positive perception in the mar-ketplace, according to findings from a newconsumer study from PureCircle InsightsGroup. The study also identifies a starkcontrast between stevia development andother high intensity sweeteners.As of May2011, stevia awareness reached 62%, from46% just a year earlier in the general U.S.population. According to the study, steviahas now surpassed sucralose, which had42% recognition, since its launch in 1998.The study, based on a survey of consumersacross the U.S. in May 2011, covered suchareas as awareness, perception and pur-chase interest of branded and unbrandedsweeteners in the U.S. market, includinginterest in their use across a broad set offood and beverage categories.We had a hypothesis in early 2009 that

the stevia market needed to be looked at

very differently from earlier high intensitysweeteners,said Jason Hecker, vice presi-dent of global marketing and innovation,PureCircle.Traditionally, branded sweet-eners have had much greater awarenessand positive impression than their un-branded counterparts. Overall, the trendswith stevia are the reverse. The data indi-cates that consumers find the unbrandedmessage, in fact, to be the most natural.Perhaps this shouldnt be completely sur-prising as the commonly used term for thesweetener is also the name of the plant.

Provexis to StrengthenHeart Health PortfolioU.K.-based Provexis plc has entered a de-velopment agreement with DSM Nutri-tional Products, Parsippany,NJ, to develop anew ingredient based on DSM-owned in-tellectual property. Provexis plans to developthe naturally-derived casein, progressthrough clinical trials and gain the necessaryregulatory approvals.The partners will iden-tify themost appropriate commercializationarrangements before the product islaunched.Thismarks a second collaborationfor the two companies, after Provexis pro-prietary heart health technology, Fruitflow,was licensed to DSM in 2010. The acquisi-tion serves to strengthen Provexis pipelineof technologies for the functional and med-ical foods sectors, which now includes aplantain-derived extract for the treatment ofCrohns disease and work on an ingredientderived from cruciferous vegetables for car-diovascular inflammation.

Nestl Health SciencePartners with Vital FoodsFocused on digestive health issues, Switzer-land-based Nestl Health Science has be-come a strategic investor in NewZealand-basedVital Foods, taking a minor-ity stake in the company. The terms of thetransaction were not disclosed. NestlHealth Science was established in January2011 to pioneer personalized nutritional so-lutions to address chronic medical condi-tions, such as gastrointestinal disorders,metabolic conditions and cognitive decline.Nestl Health Science said it is interested inVital Foodsportfolio of dietary supplementsfor digestive health, particularly constipa-tion. The dietary supplementsKiwi Crush


Industry News

and Phloeare already widely used andrecommended inNewZealand and are sup-ported by clinical trials. Founded in 1991with strong agricultural science credentials,Vital Foods has captured a strong marketposition in theNewZealandmarket with itskiwifruit-based digestive health products.The range is being expanded to focus onmaintaining consumersdigestive health andwell-being.

GanedenBC30Crosses the PondBringing its probiotic ingredient Gane-denBC30 to the U.K., India, Poland andFrance, Ganeden Biotech, Cleveland, OH,has partnered with U.K.-based CorneliusHealth and Food. Cornelius will promoteand raise awareness for the Ganeden brandin various food industries, such as bakery,confectionery and dairy.Ganedens vision todevelop new, innovative and patented tech-

nologies and applications will translate toCornelius goal of providing products thatare leading todays functional food and bev-erage markets.

AHPA Approves DMAALabeling RequirementThe American Herbal Products Association(AHPA), Silver Spring, MD, has approved atrade requirement for the labeling of prod-ucts containing the ingredient 1,3-dimethy-lamylamine (DMAA). The traderequirement, which becomes effective onJanuary 13, 2012, requires thatAHPAmem-bers do not label 1,3-dimethylamylamine,whether identified by this name or any syn-onym, as geranium oil or as any part of thegeranium plantwhether by the commonname of geranium or by the botanical nameof any plant known as geranium.Nothing inthe new requirement prevents labeling ofany compound that is in fact derived from

geranium plant materials by that com-pounds common or usual name.

Cott Licenses pTeroPure fromChromaDexCott Beverages Inc., Dunkirk, NY, a sub-sidiary of Cott Corporation, and Chro-maDex, Irvine, CA, have entered a licensingand supply agreement for the joint develop-ment of a clinically-backed, proprietary in-gredient blend to serve the food andbeverage, nutraceutical and cosmetic mar-kets. The agreement provides Cott access toChromaDexs pTeroPure pterostilbene plat-form. For ChromaDex, the agreement rep-resents an opportunity to license its growingportfolio of intellectual property.

JISSN Highest Rated SportsNutrition JournalThe Journal of the International Society ofSports Nutrition (JISSN), an open-access,

Heart Health & Fiber Drive Consumers toHealth Products

More consumers are being proactive and looking forhealthy ingredients.

A shift in thinking has occurred in supermarket aisles across

the country, according to Shopping for Health 20, a yearly

study released by the Food Marketing Institute (FMI) and Pre-

vention magazine, and published by Rodale Inc. Shoppers

used to care most about undesirable characteristics their

foods were devoid of: fat, sugar, salt, calories, etc. Now, how-

ever, fortification and the inclusion of key health ingredients are

on the rise, with fiber (44%) being the most sought-after com-

ponent; whole grain (36%), protein (27%), omega 3 (23%) and

antioxidants (6%) follow.

While the main criteria for healthy foods was previously deter-

mined by ingredients it did not contain, todays shoppers are now

instead wondering whats in their food, seeking to better under-

stand the nutritional components of what they eat, said Cary Sil-

vers, director of consumer insights for Prevention.

About half of shoppers have bought cranberry juice, dark

chocolate or almonds in the past year, due in part to marketing

campaigns and news coverage touting the health benets of

these so-called superfoodsdubbed as such because they

contain large quantities of specic nutrients. Shoppers are also

purchasing green tea (43%), pomegranate juice (25%) and Greek

yogurt (2%).

Certain health claims are also proving to be attractive to cus-

tomers. When purchasing food, heart health (73%) is the top

health claim on packaging that matters to con-

sumers. More energy (7%), digestive health

(66%) and improving mind health (65%) follow

closely behind.

But despite this attention to

healthy foods, lack of planning is

trumping health in the decision-mak-

ing process at the American dinner

table, as 72% of shoppers decide

what to have for dinner that day.

When same-day decisions for dinner

are made, health (52%) falls well be-

hind taste (73%), quickness of prepa-

ration (60%) and craving (52%). Lack

of meal planning is so pervasive that

one-in-four shoppers (24%) decide

what to have for dinner within one

hour before eating.

Shoppers can take many routes to

healthy eating, including how they

shop, how they prepare food and how they eat. Substantial num-

bers make an effort in each of these areas: 44% use a list when

shopping for healthy food most of the time; 54% have tried a

new healthy recipe in the past year.

Half of shoppers say they dont actively monitor their calorie

intake on a daily basis but do make an effort not to consume too

many calories at a time. About half say they are paying more at-

tention to consuming fewer calories than they did two years ago;

the same share say they are paying the same amount of atten-

tion; and just 6% say they are paying less attention.

Todays shoppers areinterested in whats intheir food (i.e., vitamins,fiber, etc.) instead ofwhats not (i.e., salt,sugar, calories, etc.).




Industry News

peer-reviewed journal published by BioMedCentral, has received an official Impact Fac-tor score of 2.68, according to a Journal Cita-tion Report (JCR), placing the JISSN as thehighest rated sports nutrition related jour-nal. A journals Impact Factor is often usedas a means of assessing the quality of arti-cles publishedwithin the journal and impactthe journal ismaking on the field. JISSN alsoplaced among the top 12%of journals in theSports Sciences category (ninth of 79 jour-nals) and among the top 32% of journals intheNutrition&Dietetics category (22nd outof 70 journals).

ERSP EvaluatesLuraLean ClaimsThe Electronic Retailing Self-RegulationProgram (ERSP) has determined that clini-cal studies on a key ingredient, LuraLean,provide adequate support for performanceclaims made by DR-Hos for its SlimmiesWeight Loss Chocolates. The marketeragreed to voluntarily modify other claims asrecommended by ERSP.ERSP, the electronic

direct-response industrys self-regulatoryforum, is administered by the Council ofBetter Business Bureaus (CBBB) with policyoversight by the National Advertising Re-view Council (NARC). The marketers ad-vertising came to ERSPs attention pursuantto its ongoing monitoring program. ERSPreviewed online advertising for Slimmiesand identified several claims for review.As support for performance claims,

DR-Hos submitted various studies relat-ing to LuraLean, a form of glucomannan,and its effect on feelings of fullness andsatiety. The marketer explained that glu-comannan is a water-soluble dietary fiberderived from the konjac root. These stud-ies demonstrated that participants whoconsumed LuraLean prior to meals wereable to achieve greater weight loss thanwhile on a control treatment. Other stud-ies submitted showed that LuraLean ef-fectively reduced glucose levels.Regarding the claim that Slimmies canabsorb fat, DR-Hos informed ERSP that itwill modify the language to more accu-

rately reflect LuraLeans effect on meta-bolic activity.

Norway Company EntersSalmon Oil MarketHofseth Biocare (HBC), the Oslo, Norway-based division of Hofseth International AS,is entering the global salmon oil market.Thecompany enjoys global patent protection onitsmethod for processingmarine biomass ina low temperature, enzyme-driven process.This approach yields ingredients like salmonoil that are fresh,pure and 100% sustainable,with no impact onwild salmon populations,according to the company. The companystarts with fresh salmon and extracts virginsalmon oil within 24 hours. Rapid process-ing time and unmatched capacity and trace-ability make the companys offerings a newand interesting option for soft gel and liquidsupplement marketers and manufacturers.

Thorne Research AcquiresRights to CoQ10 FormulationSandpoint, ID-basedThorne Research, Inc.,

GELITA USA Sioux City, IA www.gelita.com [email protected]

GELITA Collagen Proteins. Innovative and Healthy Ideas.

The VITARCAL concept consists of a holistic range of collagen proteins, specifi cally optimized for reducing energy density in calorie management products.

The collagen peptides comprising FORTIGEL are scientifi cally proven to stimulate joint cartilage regeneration.

Geliko Kosher gelatine products are certifi ed Kosher pareve by the Orthodox Union. Health-concious consumers know the OU logo stands for quality beyond question.


Industry News

has acquired the exclusive global rights tomarket Q-Cell, an advanced CoQ10 formu-lation previously marketed under the brandname Q-Best. Q-Cell has a unique, tri-lipidgel-based formulation that has been shownto increase absorption rates by up to 10-foldin comparison to dry powder supplements.The proprietaryQ-Cell formulation preventscrystallization, an after effect of someCoQ10formulas that can disrupt the absorptionprocess when metabolized in humans.To-gether with our recent alignment withHelsinn Pharmaceuticals, the addition ofQ-Cell to our portfolio represents anothermajor milestone in our efforts to developand market the finest supplements for arange of health needs, including supportivecare in the oncology market,said Paul Ja-cobson, CEO,Thorne Research.

FutureCeuticals TeamsUp with BioBoronResearch InstituteLooking to advance the scientific study

and global commercialization of FruiteX-B calcium fructoborate, a patented, nature-identical plant mineral complex,FutureCeuticals, Inc., Momence, IL, hasformed a strategic alliance with theBioBoron Research Institute and its direc-tor, the renowned chemist Dr. Ion Romu-lus Scorei. The collaboration creates apotent discovery engine for FutureCeuti-cals proprietary product.As part of the co-operative research, Dr. Scorei and his teamwill contribute to the chemical and bio-logical differentiation of calcium fructob-orate from other boron-based compoundsand borate complexes.

Sunsweet PurchasesFunction DrinksYuba City, CA-based Sunsweet Growers hasacquired FunctionDrinks,which is known forits line of dietary supplement beverages.Theacquisition is part of Sunsweets ongoing ini-tiative to leverage its resources to help emerg-ing beverage brands break through to

mainstream success. In conjunction with thetransaction, Sunsweet formed a whollyowned subsidiary named Disruptive Bever-ages Inc (DBI). DBI has been formed to helpdrive the growth of developing beveragecompanieswith strong products and ideas intodays increasingly competitive and capital-constrained landscape. Function is the firstfull acquisition as part of this plan and stronginterest remains in finding additional emerg-ing brands to add to its portfolio.Function co-foundersDaytonMiller, Josh Simon andAlexHughes will continue tomaintain leadershippositions in the company. While Sunsweetwill leverage its resourceswherever synergiesexist, the Function business will continue tooperate on afairly standalone basis.

Emerson to DistributeMetagenics ProductsNationallyEmerson Ecologics, LLC, Bedford, NH,has expanded its partnership with Meta-genics San Clemente, CA, becoming a

FDA Seeks Comment on Gluten-Free Labeling

Agency believes its proposed rule published in 2007remains valid.

As awareness of gluten intolerance and sensitivity increases, FDA

is looking to dene gluten-free for labeling food products, in-

cluding dietary supplements. The agency reopened the public

comment period on its proposed gluten-free labeling rule pub-

lished on January 3, 7. FDA is also seeking comments on a

report regarding the health effects of gluten in people with celiac

disease. The report includes a safety assessment on levels of

gluten sensitivity in people with the disease.

Technically, gluten represents specic proteins that occur nat-

urally in wheat. However, the term gluten is commonly used to

refer to certain proteins that occur naturally not only in wheat, but

also in rye, barley and crossbreeds of these grains and that can

harm people who have celiac disease.

Eating gluten doesnt bother most consumers, but some peo-

ple with celiac disease have health-threatening reactions, and

they need to know whether a food contains gluten. According to

the National Institutes of Health (NIH), celiac disease affects as

many as 1% of the U.S. population. Currently the only treatment

for this disorder is a life-long gluten-free diet.

Having a federal denition of gluten-free is critically impor-

tant, said Andrea Levario, executive director of the American

Celiac Disease Alliance. If we have one national standard, the in-

dividual will know that all products labeled gluten-free will have

no more than a minimal

amount of gluten.

FDA has been working to

dene gluten-free in an ef-

fort to: eliminate uncertainty

about how food producers

may label their products and

to assure consumers who

must avoid gluten that foods

labeled gluten-free meet a

clear standard established

and enforced by FDA.

In 7, FDA proposed to

allow manufacturers to label

a food gluten-free if the

food does not contain any of

the following: an ingredient

that is any type of wheat,

rye, barley or crossbreeds of these grains; an ingredient derived

from these grains and that has not been processed to remove

gluten; an ingredient derived from these grains and that has been

processed to remove gluten, if it results in the food containing

or more parts per million (ppm) gluten.

In the notice reopening the comment period, FDA stated that it

continues to believe the proposed denition of gluten-free is

the correct one. FDAs notice also describes current analytical

methods that can reliably and consistently detect gluten at levels

of ppm or more in a variety of foods.

Having a federal definition ofgluten-free is critically important,

so people know that all products la-beled gluten-free will have no more

than a minimal amount of gluten.



Industry News

national distributor for its full productline of nutritional supplements. For morethan 25 years, Emerson Ecologics hasbeen a West Coast distributor for Meta-genics. The expanded agreement enableshealthcare practitioners throughout theU.S. to order all Metagenics products di-rectly from Emerson. Metagenics has alsoqualified as an Emerson Quality ProgramGold Partner.The program is an exclusivequality assurance program that verifiesquality manufacturing procedures andstandards, as well as the potency,bioavailability and certainty of raw mate-rials used in nutritional supplements.Metagenics maintains triple Good Manu-facturing Practices (GMP) certification

from the three leading independent qual-ity organizations.

PureCircle & Firmenich InkDistribution AgreementAccelerating the commercialization of itsnew NSF-02 natural flavor, PureCircle, OakBrook, IL, has signed a global, multi-yeardistribution agreement with Switzerland-based Firmenich. PureCircle recentlylaunched its PureCircle Flavors product line,including NSF-02, which is designed towork in combination with the companyshigh purity stevia sweeteners, Reb A andSG-95, and sugar or high fructose cornsyrup, enhancing flavor, sweetness and tasteof food and beverages. Under the agree-

ment, Firmenichwill have exclusive rights tocommercializeNSF-02 both as a standaloneingredient and within the companys flavorsystems. PureCircle will retain rights to dis-tribute directly in select accounts. Also, aspart of the agreement, the two companieswill further collaborate on marketing andregulatory activities that will accelerate theadoption of the new flavor modifier acrossglobalmarkets beyond theU.S.,whereNSF-02 has Generally Recognized As Safe(GRAS) status.

ConsumerLab.com TestsCoconut Water Brands,Menopause SupplementsCoconut waterthe natural juice from

Stage Set for New Superfruit Stars

Strong supply chains and effective marketing of healthbenefits will lead to success.

Growing consumer awareness regarding the health benets as-

sociated with the high antioxidant content of superfruits has

helped to drive activity, bringing many little known fruits into the

mainstream market, according to The Netherlands-based Innova

Market Insights. Activity has been reected in growing use of su-

perfruits as ingredients and avorings in a

wide range of food and drink products.

Innova recorded a 10% rise in the number of

product launches marketed on a superfruit plat-

form in the year to the end of May 2011 over

the previous 12-month period. The soft drinks

category saw the greatest number of launches,

equivalent to nearly 40% of the total, primarily

in the fruit drinks and wellness drink arenas. But

there were products with superfruit ingredients

launched across most other sectors, led by

confectionery, dairy products, fruit and veg-

etable products and desserts and ice cream.

In terms of types of fruit, pomegranate ap-

pears to have emerged as the leader, accounting for more than

40% of the launches tracked containing a superfruit during the

June 2010 to May 2011 period. Other fruits are also continuing to

grow in popularity, including acai, goji and other berries. In the U.S.,

Innova Market Insights recorded highest levels of product activity in

pomegranate, ahead of blueberry, although interest in acerola also

appeared to be increasing, and there was ongoing interest in goji.

U.K. launches were focused strongly on pomegranate and berries,

particularly cranberries, blueberries and acai, while Germany has

seen rising levels of interest in Sanddorn (sea buckthorn).

New fruits are emerging on the superfruit bandwagon, all focus-

ing on high levels of antioxidants, often by comparison with levels in

more established superfruits, and often moving into food and drinks

following a period of launches in supplement form. The Maqui berry

from Chile (Aristotelia chilensis), also known as the Chilean

Wineberry, is one example of this trend.

Lu Ann Williams, head of research for Innova Market Insights,

noted that with so many different types of tropical and exotic

fruits, it is difcult to predict where the new success stories will

come from. But what is almost inescapable is that there will con-

tinue to be new varieties put forward as the market develops and

these will have to compete alongside more

established and familiar varieties. The ability

to supply the quantities needed and market

their multiple benets successfully will be key

to their future, as well as the willingness of

mainstream food and drinks companies to

take them up as ingredients in their products,

she concluded.

In other developments, ConsumerLab.com,

White Plains, NY, recently issued a review arti-

cle on baobab (Adansonia digitata) fruit pulp,

which is native to West Africa, saying the su-

perfruit has become an attractive ingredient

thanks to its tangy taste, high ber content and

antioxidant properties.

Dried baobab fruit pulp was approved for use as a food additive

in Europe in 2008. In 2009, FDA determined it was Generally Rec-

ognized As Safe (GRAS) for use as an ingredient in blended fruit

drinks at a level of up to 10% and up to 15% in fruit cereal bars. Oil

from baobab seed is used in various cosmetic products.

Baobab fruit pulp demonstrates signicant antioxidant activity in

the laboratory. Marketers claim its ORAC (oxygen radical ab-

sorbance capacity) value is double that of pomegranate and cran-

berries, and signicantly greater than fruits such as blueberries,

raspberries and blackberries.

Pomegranate has been leading productlaunches during the last year, accountingfor more than 40% of the introductions.



Industry News

green coconutsis often touted as a natu-ral alternative to sports drinks. But does itreally deliver?It depends on the brand,according to ConsumerLab.com president,Tod Cooperman, MD. ConsumerLab.comrecently purchased and tested three of themost popular brands of coconut water:O.N.E. Coconut Water, Vita Coco 100%Pure CoconutWater and Zico Natural PurePremium Coconut Water. Test resultsshowed that two of the products had farfewer electrolytes than claimed. One hadonly 18% of the listed amount of sodium,the key electrolyte for rehydration. The

other had only 59% of its promised level ofsodium.Magnesium levels were also lowerthan claimed (77% and 64% of the listedamounts). Only one of the three popularcoconut water products delivered itsclaimed electrolytes.Coconut waters have become a big

business.The company behindVita Coco,All Market Inc, predicts $100 million insales this year for its product alone.Among the coconut waters tested byConsumerLab.com, all contained signifi-cant amounts of potassium (about 570mg to 670 mg per serving), which is about

25% more than in a banana. However,this amount of potassium is not essentialfor efficient rehydration. Sodium, whichaccounts for the vast majority of mineralloss during exercise, is much more im-portant. Amounts of sodium in the co-conut waters ranged from just 11 mg (ina 330 mL suggested serving) to 160 mg(in a 414 mL suggested serving). Typicalsports drinks such as original Gatoradeprovide about 110 mg of sodium per cup(8 fluid ounces or 240 mL).In a separate review, Consumer-

Lab.com provided quality ratings for

Recent Certifications & Approvals

Robinson Pharma Inc. (RPI), Santa Ana, CA, has obtained conrma-

tion that its Omega-3 30% Fish Oil Softgels have been veried

through the USP Dietary Supplement Verication Program (DSVP),

earning the right to use the USP Veried Mark on its product label.

USP DSVP uses a rigorous standard that exceeds the federally man-

dated Good Manufacturing Practices (GMP) regulation. USP con-

ducted audits of Robinson Pharmas facility and quality systems,

including a review of staff training, manufacturing operations, supply

chain qualication for all ingredients used in the manufacture of the

product, and the stability studies for the product post manufacturing.

RPI has also received conrmation that four of its joint health for-

mulas manufactured in tablet form have been approved through the

USP DSVP. The products include Glucosamine HCL, Glucosamine

HCL with MSM, Glucosamine with Chondroitin and Glucosamine,

Chondroitin, MSM, with Vitamin D.

Aker BioMarine Antarctic, Oslo, Norway, has received conrmation

from FDA that the agency has no objections to the companys New

Dietary Ingredient (NDI) notication for Superba Kill Oil. FDA re-

viewed extensive toxicology and clinical research data obtained

from animal and human testing, which provides support for evi-

dence of safety. Aker BioMarine further provided detailed composi-

tion of krill oil, including the most extensive elucidation to date

showing 69 distinct choline-containing phospholipids, believed to

be responsible for the unique benets of krill.

FDA has also accepted with no objections the notication of the

companys independent Generally Recognized As Safe (GRAS) de-

termination for Superba Krill Oil for use as a food ingredient.

Nordic Naturals, Watsonville, CA, has earned certication from NSF

International, verifying that the companys new LEED-designed cor-

porate headquarters complies with Good Manufacturing Practices

(GMP) as set forth in NSF/ANSI Standard 173-008, Dietary Sup-

plements, Section 8. Nordic Naturals former facility was also GMP

certied, however, new certication was required when the com-

pany moved its headquarters in February of this year.

Marlyn Nutraceuticals, Inc., Phoenix, AZ, has received Good Manu-

facturing Practices (GMP) certication following a successful audit

of the companys facility by NSF International. The certication veri-

es that Marlyn Nutraceuticals is compliant with federal standards

outlined in 1 CFR Part 111.

GMP Laboratories of America, Anaheim, CA, has received certica-

tion that its facility meets Good Manufacturing Practice (GMP) stan-

dards following a successful audit conducted by Silliker, Inc. The

companys facilities have also been independently audited and cer-

tied GMP compliant by NSF and NPA.

HealthCo, a division of NOW Health Group, Bloomingdale, IL, has

received a letter of no objection from FDA regarding the Generally

Recognized As Safe (GRAS) status of its Stevia FSE. The company

self-afrmed this natural sweetener is GRAS in May 010 following

a comprehensive review of chemistry, safety and toxicology data by

an independent panel of scientists. Healthco sells Stevia FSE as a

bulk powder food ingredient, in private label consumer sizes and

food-service bulk packets.

The Wright Group, Crowley, LA, has obtained FSSC/ISO 000 cer-

tication. The Foundation for Food Safety Certication (FSSC) de-

veloped the certication of food safety systems for food

manufacturers that process or manufacture animal products, per-

ishable vegetable products, products with a long shelf-life and

(other) food ingredients like additives, vitamins and bio-cultures.

With more than 50,000 custom nutrient premixes, The Wright Group

continues to adhere to stringent quality and safety standards in the

food and beverage industries.

Ayush Herbs, Redmond, WA, recently received designation as an

Emerson Quality Program (EQP) Gold partner. The EQP, a quality

assurance program for the nutritional supplements industry, identi-

es and veries manufacturers with a commitment to quality manu-

facturing practices. Companies must meet several standards,

including compliance with Good Manufacturing Practices.




Industry News

more than 20 menopause supplementsthat contain estrogen-like isoflavones(from soy or red clover), the herbal rem-edy black cohosh or creams containingprogesterone. Most products evaluatedpassed the review, however, one supple-ment contained only 32% of its listedisoflavones and another black cohoshsupplement was contaminated with asmall amount of lead.

Alternative therapies can help somewomen cope with menopause, said Dr.Cooperman.However, not every productcan be expected to work. And it is diffi-cult, if not impossible, to really knowwhats in a product and make meaningfulcomparisons without laboratory testing.With soy products, for example, as muchas half of the isoflavones listed on thelabel are actually just sugar moleculesthat are naturally linked to the phytoe-strogens, he added. Experts at Con-sumerLab.com, such as pharmacognosistWilliam Obermeyer, PhD, calculated theamount of active isoflavones in each

product, making it possible for con-sumers to compare products to one an-other and to clinical standards.

GLG Life Tech EstablishesNew Stevia FormulationCompanyFocused on providing naturally sweetenedzero- and reduced-calorie food and beverageformulations to customers outsidemainlandChina, GLG Life Tech Corporation,Vancou-ver, British Columbia, Canada, has created anew subsidiary, AN0C Stevia SolutionsCompany Limited.The new companywill beheaded by James Chen, who has more than30 years of consumer beverage and food for-mulation experience and is responsible fordevelopingmany leading food and beverageproducts inAsian markets.

All solutions and formulations providedto customers will be natural basednaturalsweeteners, natural flavors and natural col-ors.The company is alreadyworking on cus-tomer opportunities in the Middle East andIndia, and expects to be working on oppor-

tunities in other parts of the world withGLGs existing stevia distributors or throughdirect customer inquiries.

BioExx Signs DevelopmentAgreement with HormelBioExx Specialty Proteins Ltd., Toronto,Ontario, Canada, has signed a product de-velopment and sales license agreementwith Hormel Foods Corporation and itsCentury Foods International division,Sparta, WI. Under the agreement, whichcovers the U.S. and Canada, the companieswill co-develop BioExx proteins in variousnew products, which will be manufacturedandmarketed by Century to the sports nu-trition industry. Example products wouldinclude meal replacements, dietary supple-ments, weight-loss aids, powdered proteinsupplements, nutritional beverages andcustom formulations.

Nutrawise Debuts withHealth & Beauty ProductsA manufacturer and distributor of nu-


Industry News

traceuticals looking to expand the definitionof health and beauty, Nutrawise recentlyopened its new headquarters in Tustin, CA.The company is led by founder and CEO,Darren Rude, who said:My talented lead-ership group is far from being a stranger tothis industry.Our lifes work has brought ushere, and our focus is to put our principlesand people first,while providing the highestquality products, service and value to ourcustomers.The Nutrawise facility exceedsGood Manufacturing Practice (GMP) stan-dards, he added.Prior to startingNutrawise,Mr. Rude served for a decade as executivevice president for the NeoCell Corporation.Nutrawise is developing, manufacturingand by late this year,will distribute a varietyof beauty and wellness supplements underits own brand,Youtheory.

Sensient ExpandsPharmaceuticalsBusiness in CanadaSt.Louis,MO-based Sensient Pharmaceuti-cal Coating Systems,which is a part of Sen-

sient Colors LLC, a business unit of SensientTechnologies Corporation, has expanded itspharmaceutical operations into Canada.This growth is a result of increasing indus-try demand for Sensients innovative phar-maceutical and nutraceutical coatingswithinthe United States and globally,said SteveStrickland, general manager of SensientPharmaceutical Coating Systems.

Biovelop Signs DistributionAgreement with BrenntagSweden-based Biovelop AB has signed anexclusive distribution agreement in the U.S.with Brenntag North America for its Pro-mOat product. BrenntagNorthAmerica, Inc.will distribute PromOat, a naturally-sepa-rated, oat beta-glucan-rich, soluble fiber,throughout the U.S.

SFS Grants Exclusive Licensefor ComfortezeScientific Food Solutions, LLC (SFS), Fair-field, CA, has entered into an exclusive li-censing agreementwith IntraFem for the use

ofComfortezewith a probiotic.Theproduct iscalled FloraFem. Comforteze is formulatedusing natural, low lead, USP grade calciumcarbonate, vitamin C and other alkalizingagents, utilizing a unique patent-pendingprocess.This acid-reducingproduct combinesnatural ingredients to deliver neutralizationof acids and increased bio-absorption of nu-trients, comforting the digestive system andassisting inmaintaining a proper body pH. Ithas a pHof 9.5 andnot only reduces stomachacid, but also increases the pH of the blood,which reduces overall body acidity.

Metabolic Technologies &TSI PartnerLooking to develop and commercializenew, innovative ingredients, MetabolicTechnologies, Inc. (MTI), Ames, IA, haspartnered with TSI Health Sciences, Mis-soula, MT.MTI develops safe and effectivenutritional products while TSI Health Sci-ences has evolved throughout the lastdecade to excel in manufacturing processesand assurances.

Patents

Nutra Products Inc., Faireld, CA, the parent company of Scientic

Food Solutions (SFS) has received U.S. Patent 7901717 B1 for an

alkalizing compound, which SFS is using to make nutritional ingre-

dients more palatable for consumers. The patent, dated March 8,

011, is for an Alkalizing Composition and Methods for Using The

Same. The patent covers several applications for products offered

by SFS including Garli-Eze, Comforteze, FAST-C and Aqua-Lyte.

Ethical Naturals Inc. (ENI), San Anselmo, CA, has obtained a patent

from the U.S. Patent and Trademark Ofce covering the companys

method for manufacturing high antioxidant extracts from grapes.

The process broadly covers extracts from any part of the grape that

exceed an ORAC (Oxygen Radical Absorbance Capacity) value of

10,000 mol TE/gram. ENIs antioxidant ingredient, ORAC-15M, is a

highly concentrated extract that is especially rich in polyphenols

and other naturally occurring grape antioxidant compounds. The

extract is also a key ingredient in ENIs multi-fruit extract, Standard-

ized Fruit Blend (SFB), which incorporates the same patented tech-

nology during the manufacturing process.

Pivotal Therapeutics Inc., Toronto, Ontario, Canada, has led ve

provisional patent applications with the U.S. Patent and Trademark

Ofce. The patent applications represent the initial lings contem-

plated by Pivotal Therapeutics in the development of a comprehen-

sive patent portfolio to protect its lead product Vascazen, a

prescription-grade omega 3 formula. Vascazens unique EPA to

DHA ratio contains sh oils produced exclusively for Pivotal Thera-

peutics by a unique patented manufacturing process, which en-

sures these oils are of the highest purity.

Lonza, Basel, Switzerland, has announced the World Intellectual

Property Organization (WIPO) published its International Patent Ap-

plication WO 011/038898 for Larch Arabinogalactan (LAG), the key

component in the immune ingredient ResistAid. The application ti-

tled Arabinogalactan for Enhancing the Adaptive Immune Re-

sponse contains patent claims relating to LAGs positive effect on

the adaptive arm of the immune system prior to, during and after

exposure to foreign antigens. Furthermore, the application claims

potential use in a vaccination kit comprising a composition with

Arabinogalactan and a vaccine.

Guiding Stars Licensing Co., Scarborough, ME, has received U.S.

patent No. 797881 for its Guiding Stars nutrition rating algorithm.

The Guiding Stars algorithm is grounded in evidence-based science

and the most current guidelines and recommendations of leading

national and international health organizations, such as FDA and

USDA. The system credits all edible foods based on the presence

of vitamins, minerals, dietary ber and whole grains, and debits for

the presence of trans fat, saturated fats, cholesterol, added sugars

and added sodium. Food items are then awarded zero, one, two or

three stars. One star means good nutritional value; two stars, better

nutritional value; and three stars, the best nutritional value.



Project8:Layout 1 7/22/11 9:40 AM Page 1


Earlier this year inBusiness Insights,I re-viewedKey Success Factors for Nutraceu-tical Products. These criteriaincludingsensory, efficacy, safetyare the critical fac-tors to be considered in the innovationprocess to help assure success of new prod-uct launches.This month, Ill reflect on howmarket dynamics over the past decade havechanged the relative importance and char-acteristics of the success factors.

Growth of Mainstream ConsumersNotably, in the evolution of the dietary

supplement market, the growth of main-stream consumers has significantly af-fected product development. Significantgrowth has been seen in thefood/drug/mass/club (FDMC) distribu-tion channel where consumers needsand desires are often quite different fromthe traditionalhealth foodconsumerin this case,health foodbroadly encom-passing the natural products, multi-levelmarketing and catalogue channels. Forstarter,s lets consider the importance oftaste and other sensory factors.

The success factor of sensory andorganoleptic characteristics encompassestaste as well as texture, color and smell.Not too long ago, there was a widely heldnotion that if a dietary supplement orhealth foodDIDNT taste bad, it prob-ably WOULDNT work. Given the pas-sionate belief of health food consumersin their products and the fact that pro-cessing technologies had not been fo-cused on this industry, many productslived up to the reputation.

For instance, omega 3s from fish sourceswere not as refined and encapsulationtechnologies were not widely utilized, thus

a strong fishy taste and aftertaste was oftenthe norm. Botanicals, amino acids, pep-tides and proteins and even fibers pre-sented substantive product developmentchallenges in terms of improving sensoryand organoleptic characteristics.

Over the years, however, food scien-tists have been quite successful at reme-dying many of these issues. And thatsgreat news, especially considering thattodays mainstream consumers are notwilling to sacrifice taste for health bene-fits. This is particularly true of productsproviding preventative health benefits,i.e., those that may be realized in the fu-ture. Therefore, to succeed in todays di-etary supplement and functional foodmarket, products must deliver on con-sumers high sensory expectations.

Clear & Compelling BenefitsAnd Therefore Efficacy

Driven by educated consumers withspecific lifestyle and life stage needs,products must provide clear and com-pelling benefits that address unmetneeds. These needs have evolved overtime driven by, for instance, the aging ofthe U.S. population.

Health issues faced by Baby Boomersare quite specific, ranging from joint pain,mental acuity, heart health and vision, tomore general categories such as health,energy and wellness. Further, BabyBoomers are not accepting aging as aninevitable decline in activity and per-formance, as their parents may have.

The proliferation of quality medical in-formation on the Internet, more knowl-edgeable healthcare professionals andconsumer expectation for clinical substan-tiation highlights the increasing need fordemonstrated efficacy. Historically, thestory behind a new dietary supplementwas often relied on to drive consumer pur-chase decision or belief.That story could bebased on anything from significance in

Greg Stephens, RD, is president of WindrosePartners, a company serving clients in the thedietary supplement, functional food and natu-ral product industries. Formerly vice presidentof strategic consulting withThe Natural Mar-keting Institute (NMI) and Vice President ofSales and Marketing for Nurture, Inc (Oat-Vantage), he has 25 years of specialized ex-pertise in the nutritional and pharmaceuticalindustries.His prior experience includes a pro-gressive series of senior management positionswith Abbott Nutrition (Ross Products Divisionof Abbott Laboratories), including developmentof global nutrition strategies for disease-spe-cific growth platforms and business develop-ment for Abbott's medical foods portfolio. Hecan be reached at 215-860-5186; E-mail:[email protected].

Business Insights

The last 10 years have hada sizable impact onproduct development.

By Gregory Stephens, RD

What a Difference aDecade Makes

26-27BusinessInsight0911.qxd:NUTWORLD 2009 Business Insights 8/23/11 2:57 PM Page 26


Business Insights

clinical research to cultural beliefs andpractices from a faraway land.Interestingly, the need for a good story

is still effective in generating consumerinterest, however, todays consumer hasalso grown to expect solid clinical sub-stantiation as areason to believe.Prod-ucts targeting mainstream distributionwill always be held to a higher standard.As an executive from a major club storechain stated at the recent NBJ Summit,Our products must be on trend but willnever be trendy.

Safety is #1The safety of dietary supplements has

always been important to consumers;however, several recent surveys haveshown it is now the #1 product attributeaffecting consumer purchase decision.Negative media coverage of products notdelivering on label claim, poor quality ofsome imported ingredients or evendeaths associated with adulterated prod-ucts have elevated safety to a new level.Another change in consumersexpecta-

tion of safety is increased awareness of po-tential interactions between supplementsand Rx or OTC medications. Continuededucation of healthcare professionals, es-pecially pharmacists and primary carephysicians, will help to alleviate this con-cern. Unquestionable safety in consumersminds has become an ante for new prod-ucts entering the market.

Lifestyle FitLifestyle fit includes a fairly broad

group of characteristics, including, for ex-ample, convenience, eating and purchas-ing patterns, pill consumption, productforms and applications, sustainability andother environmental issues, as well aspreference for organic, natural and vege-tarian/vegan products.

Convenience. The demand for conven-ience has changed quite dramatically

over the years. No longer are customerswilling to

rebecca wright nutraceuticals world sep 2011

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