United Kingdom—
Chaos Reigns Supreme

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

  • The European Union should issue a directive for health claims for foods.

The inability of the EU to issue a directive on permissible claims has led to regulatory chaos. Although member states, such as the UK, have developed or are developing voluntary codes, the codes suffer from the same fundamental flaw — they are unenforceable.

As an editorial in The Lancet concluded:

A system that relies on medicines, food-safety, and trading regulations with no specific provision for health claims amounts to a free-for-all for producers to mislead, confuse, and even endanger the public. Voluntary codes are too easily abused. So thought should be given to some form of regulation.(168)

The EU directive should establish requirements for pre-market approval of claims. As both the UK and the U.S. have learned, laws that simply prohibit therapeutic claims for foods and the sale of un-licensed medicines are inadequate to deal with the new generation of foods that blur the distinction between food and medicine. Under a pre-market approval approach, no health claim could be made unless the government determined, based on a review of the totality of the available scientific evidence, that there is at least significant scientific agreement by experts in the field that the claim is valid.(169)

  • The Food Standards Agency should be empowered to implement requirements for health claims.

The Food Safety Act should be amended to empower the new Food Standards Agency to implement this new responsibility. Health claims that assist the public in choosing a healthy diet and that reflect scientific agreement — such as claims promoting diets recommended by the Food Standards Agency — should be permitted. Health claims should be prohibited on products that are high in fat, saturated fat, cholesterol, or sodium or otherwise contain ingredients that would prevent them from being considered healthy food. Health claims should also be prohibited on foods with minimal nutritional value such as functional candy and soft drinks.

  • Many elements of the code proposed by the JHCI should be made mandatory.

The JHCI contains a number of important standards for health claims that should be made into binding government rules. For example, directives or regulations should provide that health claims only be permitted for foods that can reasonably be expected to make a significant overall contribution to a healthy diet, and claims should be required to be based on the totality of the scientific evidence.

  • The labels of functional foods should declare the amount of the functional ingredient and other relevant information.

If the term "functional food" is to have any real meaning to consumers, then product labels should fully disclose the amount of the functional ingredient and the extent to which the product supplies the amount of the functional ingredient needed to provide a health benefit. Labels should also clearly describe the population for whom the product is intended (e.g., elderly, diabetics); the length of time for which the product must be used; the minimum and maximum amounts to be consumed in a single day; whether particular cooking methods (e.g. microwave, boiling) enhance or destroy the potency of the product; whether the product should be consumed in conjunction with another product for best results; and whether certain other products should be avoided while the functional food is being consumed. The consumer should also be warned of any side effects and provided with guidance as to warning signs that use of the product should be discontinued and that a physician should be consulted.

  • Mandatory nutrition labeling should be required on all foods.

The debate over health claims for functional foods detracts from other labeling measures that may more effectively help consumers improve their diets. For example, objective, standardized nutrition labeling of all foods may prove more beneficial to consumers who want to improve their diets than health claims used for functional foods for marketing purposes. All food products, whether or not they make health claims, should be required to carry full nutrition labeling.

Nutrition labeling should be: based on standardized serving sizes, as well as 100 gram amounts; list information on nutrients that are the most important to the health of the general population; be displayed in an easy to read format; and disclose the amounts of nutrients that a serving of the food provides towards the maximum or minimum amount of that nutrient that a consumer should eat per day. In addition, nutrient content information should be disclosed in a manner that informs the consumer whether a serving of the food is high or low in particular nutrients. For example, the words "high" or "low" could immediately follow the numerical disclosures of fat, saturated fat, cholesterol, and sodium content on the nutrition label.

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