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FUNCTIONAL FOODS

Health benefits may be key for foods of the future

Inorder to gain wide acceptance,functional foods must offer healthbenefits consumers can under-

stand, speakers emphasized at aninternational conference entitled"Global Developments and Opportu-nities in Functional Foods andNutraceuticals," held Oct. 29-30 inCopenhagen. Denmark.

The terms "functional food" and"nutraceuticals" themselves are con-fusing, participants said, and theyseemed to agree that the primary goalshould be to develop foods with addedhealth benefits, rather than to rely onsupplements.

Food regulations will need to bechanged 10allow more claims on foodlabels and in advertising based onclear scientific evidence linking anutrient or food component to reducedrisk of a specific disease or condition.However, speakers reiterated thatcompanies must stress that such com-ponents have the potential only toreduce the risk of disease and not toprevent disease.

A key unresolved point of discus-sion centered on what terminology touse for products that confer healthbenefits. Some favored using distinctdesignations such as functional foods,fortified foods, and supplements. Gen-erally, participants argued againstusing the term "mnraceuticals," atleast in reaching consumers.

The conference was attended byapproximately 160 persons from 23nations on five continents.

Europe in generalAn expert committee organized byILSI (International Life ScienceInstitute) Europe met Oct. 13-15 inMadrid, Spain, to develop a consen-sus report concerning functionalfoods, according to Marcel Rober-froid of the Universite Catholique deLouvain, Brussels, Belgium. Thatgroup eventually endorsed the fol-

This article was written byINFORM senior editor/writerBarbara Fitch Haumann.

Speeker Suunne FenMlau of Germany (right) answers ql$Stlons poNd by Pater Davisof Semlnls Vegetable Seeds In the United States.

lowing statement that offers a defini-tion for functional foods: "A foodcan be regarded as functional if it isadequately demonstrated to benefi-cially affect one or more target func-tions in the body, beyond normalnutritional effects, in a way which isrelevant to either the state of wellbeing and health and/or the reductionof the risk of a disease."

The committee described twotypes of claims: one linked toenhanced function, such as improvedcalcium absorption, and one linkedto a reduced risk of disease. A keywill be the discovery and validationof relevant biomarkers to measurehealthy physiological functions inhuman intervention trials, Roberfroidsaid.

Proposed research programs forfood and health in the EuropeanUnion's 5th Framework Program,expected to be launched in early 1999,will focus on health, food, and envi-ronmental factors, according to Lau-rent Bochereau of the European Com-mission, the administrative division ofthe European Union. Key projectgoals include improving the food pro-cessing chain, ensuring food safetythrough improved detection methods,

studying the role of food in promotinghealth, assessing the effect of environ-mental factors on food, and investigat-ing links between foods and diseases,and foods and allergies.

United KingdomFunctional foods have had mixed suc-cess in the United Kingdom. Failurerates have been highest for productsassociated with health benefits poorlyunderstood by consumers, accordingto John Young, who manages theFunctional Foods Working Group ofLeatherhead Food R.A. Young citedproducts containing long-chain n-3fatty acids as a prime example offoods that have met little success.

Young predicted it may take 10-15years for the functional food market totruly catch on in the United Kingdom.

Currently, supplements, enrichedfoods and drink products, and func-tional foods compete for market share.In order for a food to qualify as afunctional food rather than a fortifiedfood, it must bear a health claim, suchas "can help reduce cholesterol as partof a low-fat diet," "boosts naturaldefenses," or "aids digestion," Youngsaid.

"Consumers are becoming increas-

INFORM, Vol. 10. no. 1 (January 1999)

19

ingly confident about self-medicationand willing to maintain health througha broad mix of products, includingenriched foods, reduced- and no-sugarproducts, reduced-fat foods, supple-ments, functional foods, and organicfoods:' he added.

The U.K. retail market is estimatedat £3.2 billion (approximately $5.25billion), of which enriched foods anddrinks account for 87%. supplements10%, and functional foods 3%.

The most successful functionalfoods in the United Kingdom thus farare bioactive yogurts containing pro-biotic bacteria, most of which arebased on the use of bifidus cultures.Probiotic bacteria are defined as livemicrobial food supplements that main-tain or restore the balance of gutmicroflora.

Recent announcements by Unileverand Raisic 10 launch plant sterol-con-taining cholesterol-lowering spreadsinto the U.K. market during 1999 arebright prospects for this segment.However, the British Heart Founda-tion already has warned that the dailyamount of the new spreads necessaryto reduce serum cholesterol would addto consumer fat intake and "mightlead down the road to obesity."

David Richardson, group chief sci-entist at Nestle UK, said the JointHealth Claim Initiative Code of Prac-tice of June 1997 describes three pos-sible food health claims: maintainsnormal health, improves performanceand well-being, and reduces risk ofdisease.

"The development of functionalfoods requires careful attention to safe-ty, labeling and claims as well as to thenutritional and physiological rationale,cost and sensory qualities. Develop-ments will depend heavily on scientificsubstantiation," Richardson said.

F.. neeFrance has not yet determined whatclaims to allow, according to VincentDuvillier, general manager of BeghinMeiji Industries of France.

"The scientific committee is stilldiscussing definitions. Also, the min-istries are proposing risk reductionclaims. but I do not know what willhappen:' he said.

Functional foods and nutraceuticals

combined represent a market of about$1.5 billion a year in France. Current-ly, foods are available in France thatcontain n-3 fatty acids, or added min-erals and vitamins, as well as probi-oucs and prebicdcs.

Eric Postaire of the Danone Groupestimated that tbe process to gain ahealth claim for a functional foodtakes about five years.

Current functional food researchtopics in France include:

• infant growth and development,including maternal adaptations duringpregnancy and lactation. and fetaldevelopment;

• substrate metabolism, includingthe long-term effects of fat replacerson energy and fat balance and onweight control;

• defense against free radicals,including optimal levels of antioxi-dants;

• target functions concerning car-diovascular health, including lipopro-tein homeostasis, endothelial and arte-rial integrity, thrombogenic control.homocysteine levels, and hyperten-sion;

• effect of selected dietary compo-nents such as fatty acids and bioactiveamines on nitric oxide metabolismand free radicals;

• effects of n-3 and n-6 fatty acids,antioxidants, and fiber on arterialthrombus fonnation;

• intestinal physiology and long-term effects of changing the composi-tion of colon microflora; and

• human intervention studies con-cerning such behavioral and psycho-logical functions as appetite and satia-tion.

GennanyJurgen Brand of Dehler GmbH, whosaid that the first successful launchesof functional foods in Germany were"wellness" drinks, predicted this cate-gory will continue to succeed owingto consumers' awareness of healthissues.

Functional foods, Brand noted,are targeted for the general popula-tion, while the term "nuuaceuricals"is used for products aimed at specificage categories and "medical foods"are designed for patients. Prebioricand probiotic dairy products lead the

market. Products include breakfastdrinks, anticholesterol drinks, free-radical scavengers, sports fitnessdrinks. antisunburn drinks, and evenbeverages aimed at the elderly. How-ever, current regulations generallyban health claims. Under discussion,however, is a plan which, ifapproved, would allow food for spe-cial health use, as is permitted inJapan.

Outlining research initiatives inGermany, Suzanne Fenselau of theFederal Dairy Research Centre saidprojects of interest to the fats and oilsindustry include milk products offer-ing enhanced health benefits,flavonoid-rich foods, conjugated fanyacid isomers. and food from genetical-ly engineered rapeseed. There also areprojects to investigate the metabolismof fat replacers and the effects of fatsand their isomers on nutrition-relateddiseases.

ScandinaviaDespite a general trend toward health-ier eating in Scandinavia. consumersdo not recognize functional foods as aconceptalthoughthey doshow astrong pref-erence fornatural andorganicfoods,accordingto TageAffertsholtof Food-Group Den-mark. Consumers also want the gov-ernment to control health claims, hesaid.

In Denmark, one of the first func-tional food products was Gaio yogurtmarketed by MD Foods with theclaim, "for the natural balance ofyour body." The functional foodmarket is small, with dairy productsrepresenting the lion's share, andspreads having only about a 3%share.

The market in Sweden is doublethat of Denmark, with dairy productsleading. and spreads with a 3% share.In Norway, spreads have a larger

T. Attert.hotI

INFORM. \til. 10. no. I (January 1999)

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FUNCTIONAL FOODS

Grev KItzmiller of Indiana University gives examples of some functional food. on the mar-ket In the United States to conference participants from around the world.

share, at 12%. Also available are eggscontaining 0-3 fatty acids.

In Finland, spreads dominate thefunctional foods market, due toRaisio's Benecol spread that containsstanol esters. This success is prompt-ing further launch of Benecol,licensed to the U.S. company McNeilConsumer Products Co" in the UnitedStates and the marketing of a similarstano l ester spread developed byUnilever in the United Kingdom andUnited States during 1999. Benecol'sprice is four times higher than mar-garine and four times that of butter onthe Finnish market, Affertsholt said.

Regulations vary among the fourcountries, although all are influencedby Codex Alimentarius provisions andthe European Union labeling directivefor health claims. Under Codex, nutri-ent content claims, comparativeclaims, and nutrient function claimsare allowed. There are no provisionsconcerning physiological claims, dis-ease prevention claims for a food, ordisease prevention claims for diets.

In Denmark, nutrient contentclaims and comparative claims areallowed. In Sweden and Finland,nutrient function claims and physio-logical claims also are allowed. InSweden, Aria's Gaio spread, forinstance, is labeled as providing ahealthy balance between different

fatty acids. In Finland, Raisio'sBenecol is labeled with a claim oflowering cholesterol.

In Norway, nutrient content claims,comparative claims, and nutrient func-tion claims are allowed. No claim ismade for Fjordland's Omega mar-garine, but it is marketed in a heart-shaped tub. Mills' Vita margarine ismarketed as a way to reduce serumcholesterol.

Finn Holm, also of FoodGroupDenmark, said the Nordic region his-torically has high rates of diet-relatedcardiovascular disease (CVD) andcancer.

"That may be the reason why a lotof research with functional foods ishappening here," he said. Relevantresearch falls into four main scientificareas: phyrochemicals and antioxi-dants, plant fibers, probiotics. andlipids.

The Nelherlands"Consumer trust is crucial for the suc-cessful development of the functionalfoods market," according to Geert vanPoppe I of TNO Nutrition and FoodResearch Institute, The Netherlands.

For health claims or to prove effi-cacy, human trials demonstratingeffects or biomarkers are a prerequi-site. van Poppel said. TNO, forinstance. has conducted human trials

concerning cholesterol-loweringyogurt; oligofructoses for enhancedcalcium absorption; lactulose as afood supplement to enhance calciumabsorption: and phytosterol-enrichedmargarines for cholesterol reduction.

Lactobacilli. cligofructose, and lac-rulose are not considered novel foodsunder the European Novel Foods leg-islation, van Poppel said. Unilever'sphytosterol, however, is partiallybecause of the higher than normal lev-els that are proposed to be used in thediet. Thus. Unilever is going throughthe Novel Foods procedure before itlaunches its margarine containingphytosterols. Because it was alreadyon the market in Finland prior to thelegislation. Raisio's Benecol is notcovered by the Novel Foods proce-dure regulations.

The Dutch Code of Conduct forhealth claims, meanwhile, stipulatesthat there be sound scientific evi-dence, human studies, a focus onproducts rather than ingredients,reproducible data, relevance for targetgroups, and consistency with nutri-tional guidelines.

Functional food research is beingconducted in The Netherlands at fiveuniversities. three institutes, and atleast five major companies, van Pop-pel said.

Describing commercial and regula-tory developments in The Netherlandsand Belgium, Fons Peters of SensusOperations C. V. said four types ofclaims are currently allowed: claimsrelated to dietary guidelines, nutrientcontent claims, comparative claims.and nutrient function claims. ILSIEurope's consensus report would addtwo other types: enhanced functionclaim and reduction of disease riskclaim.

"The second claim is disallowedcurrently in the European Union."Peters said.

United StatesOfficially, functional foods andnutraceuucals do not exist as an indus-try in the United Slates, according toGreg Kitzmiller of Indiana UniversityKelley School of Business.

The U.S. Nutritional Labeling and

(continued on page 22)

INFORM.Vol.10. no. 1 (January 1999)

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FUNCTIONAL FOODS

(continued/rom page 20)

Education Act (NLEA) provides aframework for food claims, while theDietary Supplement Health and Edu-cation Act (OSHEA) specifies howclaims about benefits to body struc-lure and function can be made fordietary supplements. There also is amedicinal foods category for foods forpatients. Products marketed thai couldbe classified as foods providing nutri-tional support include orange juicewith calcium, herbal teams, soy prod-ucts, oat-based cereals, nutrition bars,and medical foods such as Ensure.

Clare Hasler, executive director ofme Functional Foods for Health Pr0-gram at the University of Illinois.meanwhile. cited infonnation showingthai functional foods are the "hottesttopic" in the U.S. food industry.

The U.S. Food and Drug Adminis-tration (FDA) has approved II healthclaims. most of them general in nature.Quaker Oars cereal, which bears ahealth claim on its label noting the solu-ble fiber it provides, is one of the roost-visible functional foods, Hasler said.

FDA has proposed allowing ahealth claim for soy protein based ona petition filed in May by ProteinTechnologies International. This peti-tion. which cites a link between con-suming soy protein and reduced riskof coronary heart disease, asks for aqualifying level of 25 grams of soyprotein and 12.5 milligrams ofisoflavones.

In addition, the American SoybeanAssociation in late October submitteda document to FDA in which it askedfor a permission to make a healthclaim for soy protein products. Thispetition cited the 25-gram level forsoy protein, bUI did not mention anyrequirement for Isoflavones. The FDAproposal follows the suggestions inthe October submission.

"I personally believe theisoflavones are not what produces thebeneficial effect:' Hasler said.

Other research projects withflaxseed, tomato products, garlic.ginkgo, and other food componentsare promising as well, Hasler said.

CanadaSerge Hebert. director of Saini

ewe Hasler, of the Func:tionIII Fooct. fof Health Progr.m .t the Unt¥ersity of nllnols,ouUi,.. ~ efforts In the Untad States, l*1Iculwty wtth aoytNNn •.

Hyacinthe Agri-Food Science Parkand Bioagral Inc., Canada, reportedthai Health Canada has proposedworking definitions for both function-aI foods and nutrnceuticals.

Currently, Canada does nor permithealth claims on food products. Underexisting law, herbal remedies and sup-plements cannot be labeled with ahealth claim. A final "Policy OptionsAnalysis for Functional Foods andNutraceuticals.' slated for releaseearly in 1999, will recommend struc-ture/function/risk reduction claims forfood products, he noted. The newCanadian Functional Foods andNutraceuticals regulations are expect-ed 10 go into effect within two years.An advisory panel has recommendedthat functional foods be regulated asfood, and nutraceuticals as therapeuticproducts, he added.

Products on the market currentlyinclude cereals with psyllium; Quakeroatmeal containing ~-glucan; wholegrains; cranbeny juice; vegetables andfruits; yogurts containing probiorics:milk containing calcium and vitaminD; fish containing n-3 fatty acids; soy-foods with isoflavones; red wine withresveratrol; and black and green teas.

Paul Paquin of the Department ofFood Science and Technology at theUniversite Laval, Quebec, reportedthai research activities in Canada cur-

rently include the federal researchcenter and stations of the NationalResearch Council, the agri-food sectorin the 10 provinces, and universitiesthroughout Canada.

Meanwhile, four nutraceuticalresearch centers are beingformed-Alberta Functional FoodsCenter of Excellence, SaskatchewanNutraceuncal Network, Guelph Func-tional Food Centre, and the Centred' Expertise sur les Produits Nutraceu-riques er les Aliments Fonctionnels.The plan is to coordinate researchbetween the centers.

Under study are (a) bioactive car-bohydrates for baby food formulas,(b) seaweed, (c) genetic engineeringof wheat and barley, (d) fractions fromoat and other grains, (e) lactic acidbacteria and probiotics, (f) optimumn-3 fatty acid balance in infant formu-las, (g) garlic, (h) soymilk. (i) dietaryfat and carbohydrate effect on hor-mone and growth factors, G) flaxseedphytoestrogens and ligands. and (k)pbyroserots and plant sterol effects oncholesterol.

New Zealand and AustraliaIn New Zealand, good nutrition isseen as important by consumers,according to Ray Winger of the Insti-tute of Food, Nutrition and HumanHealth at Massey University, New

INFORM Vol. 10, no. 1 (Jonuay 1999)

Zealand. Eating trends include low-calorie foods, minimal processing,"organic," "natural," food-healthawareness and self-medication. con-sumer demand for information,increased frequency of eating, andcustomized eating habits.

Research objectives include devel-oping and testing products that mayenhance immune performance, deter-mining the bicavailabiliry of a noveliron source, evaluating cheeses as ameans to control high blood pressure,and testing immunoglobulins and car-boxymethyl cellulose for positive rolein gut functions.

Functional foods on the marketinclude prebiotics and probiotics,casein phosphopeptides, modifiedcanola oil, specialized dairy products.high n-3 fauy acid eggs. and phyto-estrogen bread.

In Australia, there is increasedinterest in functional foods, RichardHead, chief of the Human NutritionDivision at CSlRO, said. Foods andfood constituents under scrutinyinclude antioxidants, specific fattyacids. and dietary components thatfavorably affect the gastrointestinalsystem.

"There is an emerging acceptancethat selected foods or food con-stituents can promote health beyondsustenance," Head said, noting thatunder study are resistant starch andfiber for large bowel health; antioxi-dants, flavonoids, and polyphenols forcancer protection; probioncs ; vita-mins, particularly folate; and n-3 fattyacids.

One project, for instance. concernsunderstanding the mechanisms ofaction of n-3 fatty acids found in fishand fish oils to provide cardioprotec-rive properties. Another is to assessthe potential health benefits fromhigher intakes of folic acid and vita-min 812.

JapanCurrently in Japan, offerings includefoods for medical purposes. powderedmilk for pregnant and lactatingwomen, powdered infant formula,foods for the elderly, and foods recog-nized under the Foods for SpecifiedHealth Use (FOSHU) regulation,established in 1991 by the Japanese

Ministry of Health and Welfare. Foodsapproved as FOSHU are defined aseveryday foodstuffs that are expectedto have a specific effect on health dueto relevant constituent(s). This regula-tion allows claims regarding thefood's specific beneficial effect onhealth.

Kazuo Sueki of Roche VitaminsKK in Japan noted that 90% of thehealth claims for products approved asFOSHU have been to "maintain agood gastrointestinal condition."Specifically, lactobacillus represents74% of market share of FOSHU prod-ucts.

In October 1997, revisions weremade to simplify the FOSHU appli-cation process. However, Sueki said,still unresolved are the differentia-tions between functional foods andpharmaceuticals under the pharma-ceutical law, the definition and rangeof functional foods, labeling, andsubstantiation needed for healthclaims

Reporting on research initiativesin Japan, Hiroshi Tsuchita of MeijiMilk Products Co. Ltd. noted that 79out of 108 items approved underFOSHU are related to gastrointesti-nal conditions. These includeoligosaccharides, dietary fibers, andprobiotics.

"Materials related to other func-tions, such as lowering blood choles-terol level, hypotensive effect. andenhancing mineral absorption havebeen studied extensively, and someof these are incorporated inFOSHU," he noted. For instance, 12of the FOSHU approvals were foringredients such as soy protein,dietary fiber, and diacylglycerol, foruse in reducing hyperlipidemia.Also, research and development ofpolyphenols are increasing.

Papers availableA booklet containing preprints ofmany of the presentations from theconference may be ordered fromFiona Angus of Leatherhead FoodR.A., United Kingdom, by calling 44-1372-822217 (fax: 44- 1372-822272;e-mail: fangus@lfra.co.uk). Contacther for information on price and ship-ping costs. •

INFORM. \obi. 10. no. 1 (Jonuory 1999)

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