Health claims

A health claim is a message about a positive effect on health of a specific ingredient,dietary supplement or food. At the lowest impact level, a health claim may refer toimprovement of the nutritional status of the consumer and is similar to a nutrientfunction claim. Such health claims are often obvious and do not need specificscientific substantiation. Two other types of health claims can be identified: reducedrisk claims and functional claims (Diplock et al. 1999). Reduced risk claims, alsocalled health claim type A, are used for products that can help to reduce the risk ofchronic nutrition-related diseases. Functional claims (health claim type B) are usedto communicate the positive effect a product may have on a body function. Relevantchronic nutrition-related diseases and body functions are listed in Table 11.1.One problem in Europe with type A claims is that they will be considered bythe authorities as medical claims, which are not allowed for foods. At the moment,type A health claims are formulated in such a way that the name of the diseaseinvolved is not directly communicated. Instead, the reduction of a validate biomarkerfor the disease in question (like serum LDL cholesterol or blood pressure forcardiovascular disease risk) by the consumption of a particular functional food ismentioned.The majority of the scientific community agrees that health claims (types A andB) for functional foods should have a sound scientific basis — for example, asformulated by the Food and Drug Administration in the U.S. (Nutrition Labelingand Education Act 1990):It is also recognized in the Western world that the scientific evidence shouldinclude results of at least two independent studies in human volunteers. (Resultsshould be reproducible.) All relevant information should be compiled in a dossierthat should be submitted by an independent expert panel (preferably before marketingof the functional food) to the institution that organizes the evaluation. Such asystem (code of practice) exists in various European countries, e.g., Sweden (SwedishNutrition Foundation 1997), the United Kingdom (Joint Health Claims Initiative1997), and The Netherlands (Voedingscentrum 1998). These systems have no regulatorystatus, but it is expected that they will be followed in the future by legislationof health claims at a European level.In other major markets, health claims are handled in a variety of ways. Japanprobably has the most well-developed system for recognition of health benefits infunctional foods under the FOSHU (foods of specific health use) scheme. Foods areapproved by the Japanese Minister of Health and Welfare for FOSHU status basedon whether the ingredients used in the foods are proven to have a beneficial effecton health. These foods are identified by the FOSHU logo. As of June 2003, 369FOSHU containing ingredients that have benefits, including digestive health, cardiovascularhealth, mineral balance, blood sugar control and dental health foods,have been approved in Japan.In other countries, schemes similar to FOSHU have not yet been embracedand systems are developing with the common element of handling claims on acase-by-case-basis. In the U.S., three types of health claims are recognized by theFood and Drug Administration (FDA). The first is the NLEA (Nutrition Labelingand Education Act 1990)–authorized health claim, pertaining to substance–diseaserelationships, e.g., “diets high in calcium may reduce the risk of osteoporosis,”which may be made for foods and dietary supplements. These FDA-authorizedclaims are based on significant scientific agreement of the nutrient–disease relationshipestablished though extensive available scientific literature. The secondtype is a health claim based on an authoritative statement, which can be made onfoods only. The authoritative statement must be made by a scientific body belongingto the U.S. government or the National Academy of Sciences. The third typeis a qualified health claim that can be made on dietary supplements only. A qualifiedhealth claim is permitted if more evidence is available for the claim than againstit. However, the claim is not endorsed by the validity of claims made under theNLEA. Details on these claims and further details relating to claims in the U.S.can be found on the FDA website (http://www.fda.gov/).In Canada, Health Canada has drafted proposals for product-specific authorizationof health claims. In permitting companies to apply for the authorization ofclaims specific to their food product, this goes beyond the already published regulationof authorized generic structure/function claims. Further information on theproposals in Canada can be found on the Health Canada website (http://www.hcsc.gc.ca/food-aliment/e_index.html). The Australian and New Zealand Food Authority(ANZFA) has proposed a management framework for health, nutrition and relatedclaims about food. This framework is still under development, but intends to introducea co-regulatory scheme for government and industry to develop a code ofpractice for authorization and control of health claims. Results of the latest developmentscan be found at http://www.anzfa.govt.nz/.Dietary supplements, although falling under the food law in many Europeancountries, should be considered as a separate category of foods, for example, as inthe U.S. Like all foods, dietary supplements should be safe under normal conditionsof use and consumers should not be misled by their nutrition labeling or by nutritionor health claims connected to them. Taking into account the large market for dietarysupplements, the fact that many companies acting in this market are relatively small,and the considerable cost of studies with human volunteers, one may ask whetherit is feasible to perform such studies for all dietary supplements. For this separatecategory of foods, one could consider installing a special code of practice offeringdietary supplement companies the possibility to have the health effects they claimfor their supplements evaluated. A simple scoring system could be worked out toidentify the strength of the scientific evidence for the health effect involved (noevidence < weak evidence < circumstantial evidence < substantial evidence< scientificallyproven). This scoring system could assist the consumer in his decision tobuy or not to buy the product. A dossier should be prepared for evaluation forsubmission under such a code of practice and the applicant could then receive acertificate that could be printed on the supplement label. This system would encourageindustry to protect their product claims from “me-too” companies who copytheir claims.

Дата добавления: 2015-11-16