The FDA Rules: Food Is Not Medicine

Does the FDA regulate functional foods the same way it does dietary supplements? No, at least not yet.

"Functional foods are different from supplements. Most food products can't make health claims unless they're labeled as dietary supplements," says Mindy Green, director of education for the Herb Research Foundation in Boulder, Colo. "While nutritional labeling for food products is required by the FDA," she explains, "in most instances health claims are not allowed."

Functional foods offer a challenge to FDA rulings since food doesn't neatly fall into existing categories, such as dietary supplements or pharmaceuticals, and yet functional foods contain nutraceuticals for health benefits.

"You face the same issues with functional foods that you do in the dietary supplements world," says Chris Noonan, business development manager for Hero Nutritional Products in San Clemente, Calif. "There are no regulations that mandate manufacturers to guarantee that the level of ingredients put in products provide therapeutic benefits." Noonan suggests shoppers ask questions, such as: Who formulated the product? What's their background? What type of research went into developing the product? "Manufacturers need to be ready to dissect a study and explain why their product works and defend it," he adds. "They need to make this information easily accessible to the consumer."

The FDA recently passed a regulation on dietary supplements and allowable health claims. Now, naturally occurring life conditions, such as PMS, pregnancy and menopause, are no longer considered diseases. Supplements that ease these symptoms or that support nondisease issues such as health maintenance may now say so on their label. Some functional foods manufacturers have petitioned the FDA to categorize their food product as a supplement instead of a food. Those manufacturers who are successful will be allowed to place health claims on their product labels ("FDA Finalizes Rules for Claims on Dietary Supplements," FDA Talk Paper, January 5, 2000).

Functional foods that remain in the conventional foods category may not make any health claims.