Abstract

The potential for enhancing foods with ingredients that can prevent disease is enormous. But some functional foods fail to provide genuine health benefits and some may even pose safety problems. New product lines make misleading claims and many of these products contain herbal medicines, which the U. S. Food and Drug Administration (FDA) does not consider to be safe for use in foods. There is no regulatory category for “functional foods” under U. S. law, and the marketing of such products has presented the FDA with a multitude of controversial regulatory issues. The FDA should address these problems by first prohibiting the addition of medicinal herbs to foods. In addition, the FDA should close a variety of loopholes in the law that manufacturers use to justify the marketing of questionable products. The FDA should e. g. issue new regulations requiring that structure/function claims for foods be based on universally recognized factual statements concerning known effects of a substance on the structure or functioning of the body. The FDA must also work more closely with the Federal Trade Commission (FTC) which regulates claims in advertising. It is crucial that functional foods are sold on the basis of regulatory initiatives developed by government health authorities, not marketing strategies generated by companies hoping to capitalize on the latest health fad. Otherwise, functional foods will fail to realize their public health potential and amount to little more than 21st century quackery.

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