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

As discussed in section one, Japan was the first country to permit health claims for foods with added functional ingredients. The U.S., however, was the first country to enact a law allowing health claims for nutrients naturally contained in conventional foods. Also, the U.S. is the only country to allow health claims for dietary supplements. U.S. law further permits claims about how foods and dietary supplement ingredients can affect the structure of the body or the functioning of bodily systems (structure/function claims). These statutory provisions are now being relied on by companies wishing to develop and market functional foods in the U.S. even though functional foods are not specifically defined under American law.

Government policies in the U.S. regarding the use of health claims have a rather checkered history. In 1985, the FDA first began experimenting with allowing health claims for conventional foods without requiring pre-market approval by the agency. The result was a few truthful claims followed by a flood of products claiming to cure almost every ailment under the sun. After several years of such experimentation, the cover of Business Week magazine proclaimed "Health Claims for Foods are Becoming Ridiculous."(48)

The U.S. Congress then passed the Nutrition Labeling and Education Act of 1990(49) (NLEA), which permits certain health claims approved by the FDA. The claims can be based on the presence or absence of a nutrient that is linked to a disease or health-related condition. Claims must be supported by "significant scientific agreement." For example, certain foods low in sodium can carry a claim that diets low in sodium can help reduce the risk of high blood pressure. Adding less salt to a processed food can thus, in a sense, turn a conventional product into a functional food.

For a period of four years after the NLEA’s enactment, from 1990-1994, misleading claims practically disappeared, and an orderly system for approving health claims on qualifying food products prevailed. Although the food industry objected to the new system, numerous companies including Kellogg, Quaker Oats, Campbell Soup, and Pillsbury began utilizing approved claims. Beginning in 1994, however, Congress began rolling back the requirements of the law. As a result, misleading claims are again appearing. In brief, the U.S. experience over the last two decades shows that an adequate regulatory framework is necessary to prevent companies from making misleading claims.

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