FDA finalizes rules for supplement claims

January 6, 2000
Web posted at: 11:36 AM EST (1636 GMT)

WASHINGTON (CNN) -- The U.S. Food and Drug Administration has clarified what manufacturers are allowed to claim on vitamin and supplement labels.

In Wednesday's announcement, the FDA did not make new rules, but clarified regulations put forth in 1994. The regulations are designed to protect consumers from misleading claims.

The government agency said dietary supplements may bear "structure/function" claims -- claims that the products affect the structure or function of the body -- without prior FDA review.

For example, a manufacturer can say a product "helps you relax," but may not, without prior FDA review, say products "prevent, treat, cure, mitigate or diagnose disease." A label claiming the product "prevents osteoporosis" would be such a "disease claim."

For the most part, these rules will not change the claims manufacturers are already making on their products. However, the FDA did expand the number of allowable claims under certain conditions.

Manufacturers will be allowed to say products help treat common problems associated with aging, pregnancy, menopause and adolescence. For example, a product can claim to treat "hot flashes."

The regulations will be published in Thursday's Federal Register and will become effective 30 days after its publication.