S224 Asia Pacific J Clin Nutr (2002) 11(S6): S224–S229

Original Article

Implications for food regulations of novel food: Safety and labeling

John R Lupien DSc

Adjunct Professor, Department of Food Science, University of Massachusetts, Amherst, Massachusetts, USA

Novel or functional foods may provide health and nutritional benefits due to non-nutritice components such asfiber, flavonoids, and phenols. National, regional and international regulations are discussed as a means tocontrol label claims, composition and uses.

Key words: functional foods, label claims, novel foods.

Novel foods, what are they?Novel or functional foods have been difficult to define in alegal sense. The European Union (EU) has published reg-ulations for novel foods, but the main thrust of these rules isto control newer foods derived from present biotechnologydevelopments. Despite the difficulty of precise definitions,there appears to be a common public understanding of theconcept that many foods may contain beneficial (or harmful)substances in addition to the common nutrients of digestiblecarbohydrates, proteins, fats, ethanol, and essential vitaminsand minerals. Both from the public point of view, and asa result of science-based experimental test systems, theconcept of novel or functional foods or components is thatsuch foods or components can have a beneficial effect onbodily functions and structures. In some countries well-founded claims for such effects have been allowed, while inother countries no claims have been permitted.

There is no current legal definition for ‘functional food’in most countries and foods of this type are regulated underexisting food or related legislation in countries where func-tional claims are made. In many countries regulations existfor conventional foods, foods for special dietary use, dietarysupplements, and medical foods for use under the super-vision of a physician for management of specific diseases. Inthe EU there are regulations for ‘novel foods’ that in somecases could also be considered as functional foods. Each ofthese categories have regulations that govern which claimscan be made, and either specific rules or guidelines for thetypes of data that are needed to establish the validity of anyclaims on the labels of foods, or in advertising. In mostcountries there are also clear legislative provisions for drugs,and certain claims for disease treatment can make a foodproduct a drug in the legal sense and lead to severe regula-tory consequences, even if that was not intended by thepromoter making the claim for a food.1,2

At the international level there has been discussion aboutfunctional foods, novel foods, and labeling and claims for

these types of foods and foods for special dietary use. TheFood and Agriculture Organization of the United Nations(FAO)/World Health Organization (WHO) Codex Alimen-tarius Commission has adopted a General Standard for theLabeling and Claims for Prepackaged Foods for SpecialDietary Use, and General Guidelines on Claims, NutritionLabeling, and Nutrition Claims, and all of these should betaken into consideration in determining if a claim canbe made, and the nature of the claim.

As discussed here, there are rules in the EU, Australiaand New Zealand that cover novel foods and foods derivedfrom recombinant DNA techniques that are somewhat over-lapping in the EU, while they are separate in Australia andNew Zealand. At the Codex international-level foods derivedfrom biotechnology are being actively discussed, and anumber of FAO/WHO Expert Consultations have been heldto better define basic concepts, examine the quality andsafety aspects of these foods, including possible problemsof allergenicity, and related topics. The FAO/WHO ExpertConsultations have endorsed the approach used in the USAof ‘substantial equivalence’ for foods derived from bio-technology. This has meant up to now that, if the nutritionaland other quality and safety aspects were substantiallyequivalent to similar foods that were not produced usingrecombinant DNA techniques, then specific labeling was notrequired. The Codex Committee on Food Labeling and theCodex Task Force on Foods Derived from Biotechnologyare actively discussing international aspects of labeling anda general standard for foods derived from biotechnology, butno final recommendations have been made for adoption bythe 165 member country members that comprise the CodexAlimentarius Commission.

Correspondence address: Professor John R Lupien, Via d. Fonte d. Fauno 22 00153 Rome, Italy.Tel: 39-06-578-2060Email: lupien@srd.it

Food regulations of novel food S225

Novel or functional food claimsFoods are usually defined as articles for food and drink,while drugs are usually defined as articles intended for usein the diagnosis, cure, treatment, or prevention of disease.In the past there was no middle ground between foodsand drugs, and health-related claims were not permitted onfoods. However, developments in several countries and atthe international level have tended to take into accountnewer features of foods and how they are produced andprocessed, research into the possible beneficial or protectiveeffects of foods and their ingredients. Because of this,regulatory authorities and new legislation in some countrieshave opened up the possibility of properly substantiatedhealth-related claims for foods and their ingredients.

This is an evolving area, in particular with the conceptof ‘novel foods’ and ‘functional foods’, and it has been adifficult task to substantiate claims, and to maintain a goodand constantly stronger scientific database to support claims.In the USA one of the first claims on a food product was onan all-bran cereal product stating that increased intake ofwheat fiber could reduce the risk of colon cancer, and citingthe US National Cancer Institute as the authority for thisclaim. Subsequent nutritional and dietary research has notfully supported this claim. Claims about increased intake ofvitamin A and cancer protection have also been put in doubtdue to a trial of smokers in Finland where results showed thathigher intakes of Vitamin A actually increased the incidenceof lung cancer. Therefore, in making claims about thefunctionality of foods or their ingredients, it is necessary touse caution because a disproved or doubtful claim can leadto regulatory problems or loss of market share for the productin question, and other products of the same company.3–5

Research into phytochemicals, probiotics and prebioticsubstances that do not have traditional nutritive value hasshown a wide range of possible functions for foods. Phyto-chemicals such as indoles, thiocyanates, sulphur-containingcompounds, allium compounds, isoflavones and phenols havebeen shown to have some possible beneficial or protectiveeffects. Probiotics are microorganisms such as lactobacilli andbifidobacteria, which can modify the bacterial flora in theintestine and enhance certain immune functions, possiblypromote absorption of certain essential minerals, and protectagainst some diseases of the intestine and colon. Prebiotics areoligosaccharides, which may be instrumental in modifying therisks on intestinal disorders, osteoporosis, cancer and heartdisease. In each of these areas, considerable additionalresearch is under way, and firmly establishing the beneficialeffects of any of these substances has been shown to bedifficult. In Table 1 a list is given of some examples of foodsor food ingredients that have shown possible benefits.6,7

Other product classifications and their regulationAs mentioned here, in addition to foods sold as such, thereare also foods for special dietary use for the general public,novel foods, dietary supplements, and medical foods, alsocalled neutriceuticals. Each of these product classes has amore specific definition than do ‘functional foods’, and the

regulation of their marketing is more structured in manycountries.

The Codex describes foods for special dietary uses as‘foods which are specially processed or formulated to satisfyparticular dietary requirements which exist because of a par-ticular physical or physiological condition and/or specificdiseases and disorders and which are presented as such. Thecomposition of these foodstuffs must differ significantlyfrom the composition of ordinary foods of comparable nature,if such ordinary foods exist’. Although foods of this natureare obviously intended to be ‘functional’, the specific natureof such products and the restriction on their uses appear toclearly separate them from other types of possible ‘novelfoods’ or ‘functional foods’. The Codex description alsoimplies that newly discovered beneficial effects of tradi-tional foods would not be covered by the Codex descriptionof foods for special dietary uses.

The EU regulation on novel foods and novel foodingredients (regulation EC no. 258/97)8 applies to geneti-cally modified products, foods and food ingredients isolatedfrom microorganisms, fungi, algae, and plants or animals,except for foods and food ingredients obtained from plantsor animals by traditional propagating or breeding practisesand having a history of safe food use. Food additives,flavorings, and extraction solvents are exempted from theEU novel food regulation because they are regulated underother EU rules. The EU novel foods regulations are mainlyconcerned with food safety, are not specific about labelclaims, and have the thrust of having been prepared toregulate foods and food ingredients derived from biotechnol-ogy. Many of the novel foods regulated by EU rules havebeen developed to fit into the concept of functional foods,and are regulated under the EU novel food regulation atpresent. However, a lively level of discussion on theconcept of functional foods is also under way in Europeand elsewhere and could lead to additional regulation,particularly with regard to health claims.

Dietary supplements such as vitamin and mineral cap-sules or tablets, and a wide array of other products such asherbal remedies, and even foods that are labeled as dietarysupplements have become increasingly popular. In the USAthere is specific legislation that exempts these products frommany of the restrictions for foods or drugs contained in theUS Food, Drug and Cosmetics Act.9 Many of these dietarysupplement products, and equivalent products sold over thecounter in pharmacies in Europe, and perhaps elsewhere,have label claims that are considered by many food regula-tors as somewhat exuberant, and possibly false or mislead-ing. In the USA, products of this type must bear a labelstatement that these products have not been approved by theUS Food and Drug Administration (FDA) and that theproduct is not intended for use as a drug.

Medical foods or neutriceuticals are specially formulatedproducts intended for use under the supervision of a physi-cian for the specific dietary management of a disease orcondition. These foods meet distinctive nutritional require-ments that are based on recognized scientific principles and

S226 JR Lupien

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Food regulations of novel food S227

are established by medical evaluation. As with foods forspecial dietary use, medical foods are also intended to befunctional and have a direct and beneficial influence on aspecific medical condition. In the USA, medical foods do notrequire premarket clearance by FDA and there have beensome concerns about the quality and efficacy of some of theproducts that are being marketed as medical foods.

National regulatory systems and requirements and international considerationsBecause ‘novel foods’ and ‘functional foods’ are not definedor set aside as a specific class of product in most countries,they are regulated under existing law as foods, novel foods,special dietary foods, medical foods, or as drugs, dependingon how they are marketed, and the claims that are made forthe products in their labeling, or in advertising.

In the USA many products that are being sold as tradi-tional foods have label claims about their beneficial effectswhen consumed as a part of a varied and balanced diet. The1990 Nutrition Labeling and Education Act (NLEA)10

required additional labeling about the nutritional content offoods beyond that previously required or recommendedunder the Food, Drug and Cosmetic Act. The NLEA alsoallowed for properly substantiated nutrition and healthclaims on the labels of foods. With regard to health claims,FDA tended to require that marketers of foods with healthclaims obtain prior approval of the claim and present evi-dence of ‘significant scientific agreement’ among qualifiedexperts showing that any claims were justified. In practisethis process has not been very effective, but FDA regulationof claims under NLEA was restrictive enough to lead to newlegislation called the Dietary Supplement Health and Educa-tion Act (DSHEA).11,12

The DSHEA further loosened control on products thatare ingested and allowed claims for pills, capsules, tablets, oreven food-like products that were labeled as dietary sub-stances and included a label statement declaring that theproducts and claims were not approved by FDA, and thatthese products were not intended for use as a drug. While nopre-marketing approval is required from FDA, marketers ofsuch products are required to notify FDA of such productsand label claims, and to have evidence that any informationprovided is truthful and not misleading.

The FDA can regulate materials that advertise foods anddietary supplements if the advertising is used in associationwith the sale of a product and is considered ‘labeling’, whileother advertising is regulated by the US Federal TradeCommission. In either case false or misleading claims arenot allowed, but the enforcement of these regulations has notbeen particularly vigorous and products with questionableclaims and possible safety problems continue to be marketedin the USA.13–17

In the EU countries foods are regulated under nationalfood laws, and under EU regulations. In general the controlof claims is more strict that in the USA, but differences existbetween various EU member countries with regard to claims

allowed under national law. These differences can lead toEU-wide marketing of products with hard-to-substantiateclaims, because approval of a product in one or two countriescan lead to EU-wide distribution of these products underexisting EU rules.18

As an example of European control of claims, local levelTrading Standards Officers in the UK have taken Nestle andother food marketers to court over certain label claims.19,20

In June 2000 the Shropshire County Council successfullysued Nestle for marketing a shredded wheat product withlabel claims that eating this cereal would reduce the risk ofcoronary heart disease. Nestle was fined £7500 for makingan illegal medical claim, and also had to pay £13 600 costsinvolved in holding the court proceedings. In the UK thiscourt decision is considered as a test case, and will havesignificance to all food marketers about making futureclaims unless they have adequate scientific data to back upclaims. In many cases it would appear necessary to liaisewith regulatory authorities prior to marketing products, butthis had practical difficulties when central government is notfully involved in regulating products, and at the same timeallows local authorities to take legal action which hasnationwide or EU-wide significance.21

In the EU novel food regulation, companies wishing tomarket a product that is considered a novel food must presentinformation to authorities in a Member State where a productwill first be marketed to demonstrate product safety, and alsopresent information on proposed labeling. Informationprovided should include product specifications, effects ofproduction processes, history of any organism used as asource of the novel food, anticipated intake or extent of use,information of previous human exposure to the product, andnutrition, toxicological and microbiological information. Asnoted here, the main concern is the safety of the novel food,but some consideration of labeling is also possible.22–24

Food and related rules that govern claims for functionalfoods also are in effect in Japan, other European countries,Australia and New Zealand, and there are differencesbetween procedures and products allowed in each of thesecountries. Developing countries also have some legislationin place. Marketers of functional food products in thesemarkets must carefully assess existing rules that applybecause of the differences that exist in each of these markets.

In Japan regulations for Foods for Special Health Uses(FOSHU) have been in force for over 2 years. The Japaneserules require that a manufacturer or marketer of a FOSHUproduct present a dossier to the Japanese government withpertinent information on the ingredients, processing, label-ing, quality, safety, and health effects of each FOSHUproduct. If the government authorities are satisfied that thedossier supports quality and safety requirements, and sub-stantiates the health effects to be put on the label or used inadvertising, approval of the FOSHU product can be given.Over 200 FOSHU-approved products are currently on themarket in Japan, and appear to be freely accepted byJapanese consumers. Similar procedures are also in place inChina.

S228 JR Lupien

In Australia and New Zealand, the Australia NewZealand Food Authority (ANZFA) has published rules underPart 1.5 for Foods Requiring Pre-market Clearance. FoodStandard 1.5.1 covers novel foods, while Food Standard1.5.2 covers foods produced using gene technology.25

Australia New Zealand Food Authority Standard 1.5.1describes non-traditional foods as foods with no history ofsignificant human consumption in Australia or New Zealand,and ‘novel foods’ as non-traditional foods with safety con-cerns. It requires pre-market approval of novel foods on thebasis of a dossier that includes information on the composi-tion of a product, on any undesirable substances that may bepresent, on any known adverse effects from consumptionof the product, on traditional preparation or cooking, and onpatterns and levels of consumption.

Australia New Zealand Food Authority Standard 1.5.2covers food produced using gene technology and limits thetechnology to foods for which recombinant DNA techniqueshave been used. For such foods specific labeling is requiredthat states that the food or certain ingredients have beengenetically modified. It can be seen from the previous para-graphs on current ANZFA rules that the concepts defined inthe EU rules on ‘novel foods’ have been divided into twoseparate ANZFA standards, with somewhat different pro-cedures and results.

At the international level, the Codex Alimentarius Com-mission has not held extensive discussions on functionalfoods. Work has been done on basic labeling rules, onnutrition claims and nutrition labeling, and claims for foodsfor special dietary use. In general these Codex standards andguidelines state that packaged food should not be describedor presented on any label or labeling in a manner that is false,misleading or deceptive or is likely to create an erroneousimpression regarding its character in any respect.26–28

Supporting data for novel food or functional food claims and future perspectivesBased on the discussion here, it is clear that marketers offoods that fit the profile of novel foods or functional foodsmust be prepared to have in their possession adequatescientific data to substantiate any claims that they wish tomake on products. This will involve several steps in buildingan adequate level of data, and must be done with therealization that data to establish the safety and efficacy offoods and food ingredients is considerably more difficultthan is the case with food additives, pesticide residues, orchemical contaminants that are used in or can occur in foodproduction and processing. In previous discussions on func-tional foods three sequential steps have been suggested:(i) basic research and experimentation: identification andunderstanding of the mechanisms of interaction between thefood or ingredient and modification of gene expression orcellular biochemical function in order to demonstrate poten-tial functional effects; (ii) development of models andmethodologies including possible biomarkers to demonstratethrough studies on human nutrition possible functionaleffects and the consequences thereof to justify specific

functional or physiological claims; and (iii) design andcarrying out of appropriate human nutrition studies, whichmay have to be done on a large scale, to demonstratefunctional effects and benefits to health including reductionto disease where pertinent to justify structure/function orhealth claims.

Consumer studies in the USA have shown that 95% ofconsumers believe that certain foods can provide healthpromotion of disease prevention benefits beyond basic nutri-tional benefits. Consumers are willing to accept the conceptof functional foods and want to know more about them. It islikely that consumers in Europe and other parts of the worldhave similar attitudes and desires. Therefore, the future fornovel foods or functional foods appears to be very positive.However, marketers of novel or functional foods or ingredi-ents that can increase the functionality of foods must conductcareful and adequate basic studies and human trials to justifythe claims that may be made for functional food products.

Given the differences in regulation of foods, specialdietary foods, novel foods, foods for special dietary use, andmedical foods in different countries and regions, potentialmarketers of these foods must be prepared to fully under-stand the regulatory requirements that apply in each market-ing area, and be ready to meet these requirements bothbefore marketing a product, and after a product has beenplaced on the market through adequate post-marketingsurveillance. The potential for novel or functional foods isgreat. Those meeting the challenges of successful develop-ment of scientific data so that products can be marketedshould meet with great success.

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