United States—
A Good System Gone Bad

Japan—The Inventor of Functional Foods
United States—A Good System Gone Bad
        Regulatory Requirements
        Marketplace Implications and Consumer Impact
United Kingdom—Chaos Reigns Supreme

The marketing of functional foods raises fundamental questions concerning the nature of foods and drugs. The central issue for the FDA — and for society at large — to deliberate is whether, and if so where, the line between foods and drugs should be drawn. Traditionally, the FDA has drawn clear distinctions between foods and drugs, but that distinction is becoming fuzzy. For example, psyllium is both an OTC laxative and a food ingredient (with an FDA-approved health claim). Caffeine is sold as an OTC stimulant and is used in soft drinks as a flavor additive. Recently, however, manufacturers have begun adding caffeine to chewing gum and promoting the gum on the basis of its stimulant properties. The development of dozens of other functional foods containing additives with drug-like effects will ultimately force the FDA to determine how such products should be regulated.

Traditionally, the addition of ingredients not normally found in food transforms a food into a drug. In accordance with that view, the FDA has adhered to a policy that food additives must have a "physical, nutritive or other technical effect in food."(117) That is, they must provide nutrients, or act as a preservative, color additive, flavoring agent, etc. In addition, FDA regulations provide that a substance that is the subject of a health claim must "contribute taste, aroma, or nutritive value, or any other technical effect. . . to the food."(118) Similar requirements apply to substances in foods that are the subject of structure/function claims.(119)

Products such as McNeil’s Benecol— a margarine that contains plant stanols designed to reduce cholesterol — arguably do not fall within these definitions since the plant stanols do not contribute to the taste, aroma, or nutritional value of the product and, while they may have an effect on the human body, they do not add nutritional value, or have a technical effect on the food itself. FDA is using the Benecol case to determine whether its requirements should be reconsidered. If FDA abandons its traditional position, companies might be able to add with impunity a variety of drug-like ingredients to food products. The industry, however, argues that the FDA’s current requirements inappropriately prohibit companies from adding beneficial substances to foods and thereby improve the public’s health.

The agency should encourage debate on this issue within the academic, public health, and consumer communities. While the public debate continues, the FDA and the FTC should act to ensure that functional foods are regulated in a manner that maximizes health benefits and minimizes health risks. Those agencies should ensure that only safe and effective products are marketed and that claims on labels and in ads are supported by adequate scientific evidence and are not otherwise misleading. The following steps should be taken to accomplish those objectives:

  • The FDA should prohibit companies from marketing functional foods as dietary supplements.

The DSHEA provides a low level of protection from potentially hazardous ingredients and misleading claims. When companies attempt to label a food as a dietary supplement, the FDA should comprehensively evaluate the product to determine in which regulatory category it should be placed. If, for example, a product replacing another food in the diet, is packaged like a food, is sold in grocery stores next to foods, and/or, is marketed, in part, on the basis of flavor or taste, then the

FDA should determine that the product is a food and not a dietary supplement.(120)

In such cases, the agency should take prompt enforcement action.

  • The FDA should close the loophole that allows unapproved health claims on the labels of medical foods.

The FDA should require that health claims for medical foods be approved prior to marketing, as is required for conventional foods. Presently, companies are taking advantage of the medical foods exemption from the NLEA and are selling functional foods as medical foods simply to escape the FDA’s health claims approval requirements. Furthermore, companies should be prohibited from calling functional foods sold in grocery and health food stores "medical foods" unless they are designed to be used under the supervision of a physician.

The FDA should promptly end those practices by completing its rulemaking proceeding for medical foods. In the interim, the agency should take case-by-case enforcement actions.

  • Functional ingredients in food should be generally recognized as safe or regulated as food additives.

Functional ingredients added to foods to provide a physiological effect should be regulated no less strictly than ingredients added to preserve, flavor, or color a food. Manufacturers should be required to submit a petition to the FDA demonstrating that ingredients pose a reasonable certainty of no harm (the safety standard applicable to food additives) or demonstrate that they are generally recognized as safe (GRAS). The FDA should increase its number of enforcement actions and ensure that all products are in compliance with the agency’s regulations.

In deciding whether to permit in foods a functional ingredient with drug-like properties, the FDA must make safety its top concern. The ingredient would have to present a wide margin of safety so that it could be eaten by virtually all consumers in large amounts without any adverse effects. The substance would have to be safe for all consumers including children, restaurant patrons, or individuals with compromised immune systems, who might unintentionally or unknowingly consume the product. Furthermore, the substance would have to be promoted for health conditions that could be evaluated by the consumer and that do not require the intervention of a health professional.

Furthermore, in certain cases, a post-marketing surveillance system should be established to monitor adverse effects from functional ingredients in foods. For example, manufacturers of products containing olestra, a fat substitute approved by the FDA as a food additive, are required to forward reports of adverse effects to the FDA. Such reporting requirements should also be required for manufacturers of functional foods to track problems if particular ingredients are suspected of causing problems.

  • The FDA should consider requiring that the labels of functional foods indicate recommended dosages and provide related instructions for use.

Functional foods raise other questions often associated with the sale of drugs, such as: who should consume the product, how much should be contained in a serving and how much should be consumed per day, are side effects possible, and can the product be safely consumed in combination with other foods and drugs? Japan’s FOSHU system requires certain products to disclose information of that type. The FDA should consider issuing regulations requiring disclosure of similar information in appropriate situations.

  • Health claims for functional foods should be approved pursuant to the Nutrition Labeling and Education Act.

The FDA should make it clear that the NLEA applies to health claims for functional foods as well as conventional foods and require companies to comply. Companies should be required to demonstrate that claims are supported by significant scientific agreement based on the totality of the publicly available scientific evidence.

  • The FDA should issue regulations controlling structure/function claims for foods.

Some companies are trying to evade FDA’s strict health claim requirements by taking advantage of a legal loophole permitting them to make structure/function claims that do not require the agency’s approval. Many of these claims are unsubstantiated or otherwise misleading. The FDA should end that abusive practice by requiring that structure/function claims be based on universally recognized factual statements concerning known and substantively significant relationships regarding the effect of a substance on the structure or functioning of the body. For example, claims such as "calcium is necessary for bone growth and development" or "vitamin A is necessary for good vision" could be permitted, while claims that "anti-oxidants may play an important role in slowing changes that occur with normal aging" or that "lycopene may help ensure normal functioning of the prostate gland" should be prohibited until those relationships have been established.

Also, the FDA should require that foods making structure/function claims, like those making health claims, meet specified nutrient levels. Functional foods, whether they make health claims, structure/function claims, or simply promote the presence of an ingredient, should not be permitted to have unhealthful levels of fat, saturated fat, cholesterol, or sodium.(121) Furthermore, like conventional foods that make health claims, functional foods should be required to contain, prior to fortification, at least 10% of the Reference Daily Intake of one or more of the following nutrients: vitamin A, vitamin C, iron, calcium, protein or fiber.(122) These requirements would prohibit functional foods like fatty cakes and cookies that contain herbs.

  • The Federal Trade Commission should update its Enforcement Policy Statement on Food Advertising to clarify that health claims for functional foods will be considered non-deceptive only if they meet requirements set forth by the FDA.

Advertisements that hype functional ingredients and make unapproved health claims, or that make misleading or inadequately substantiated structure/function claims, undermine the FDA’s efforts to protect consumers. The FTC’s Enforcement Policy Statement on Food Advertising should be updated to specifically address the marketing of functional foods and be fully harmonized with the regulatory policies of the FDA. Furthermore, the FTC should work with the FDA to develop a consistent policy for the regulation of structure/function claims. Alternatively, the FDA should modify its Memorandum of Understanding with the FTC and resume primary responsibility for regulating claims in food advertising that involve health and nutrition.

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Copyright 1998 by the Center for Science in the Public Interest. References available by request.