FDA Vows Crackdown on Dietary Supplements

November 5, 2004

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The Food and Drug Administration (FDA) says it will crack down on dangerous and mislabeled dietary supplements, in response to criticism that the agency has been too slow to react to the dangers posed by such popular supplements as ephedra and androstenedione.

"We now have a clear roadmap to share with the dietary supplement industry, while at the same time giving consumers a higher level of assurance about the safety of dietary supplement products and the reliability of their labeling," said FDA Acting Commissioner Lester M. Crawford.

Janell Mayo Duncan, legislative counsel for Consumers Union, said the FDA's proposals were inadequate. "What we need now is action, not more discussion of methods and procedures," she said.

Whether consumers are purchasing dietary supplements to improve their appearance, promote general health, or help them maintain a healthier lifestyle, they may fall victim to products that cheat them out of their money or steer them away from products that are proven to achieve the results they are seeking.

On October 22, 2004 FDA sent eight warning letters to dietary supplement distributors making unsubstantiated claims for dietary supplement products promoted for weight loss over the Internet. Since those claims lacked adequate substantiation, they are considered false or misleading; therefore, the products are misbranded.

FDA also sent a letter to major retailers of dietary supplements to inform them that products labeled with unsubstantiated claims are misbranded and that FDA may take enforcement action against misbranded products in their possession.

FDA says it intends to start a program of inspections of retail establishments to identify products bearing unsubstantiated claims in their labeling. "FDA will continue to protect consumers by pursuing products that violate the law," said Crawford.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements do not need approval from FDA before they are marketed; however, in the case of some new dietary ingredients (i.e., dietary ingredients that were not marketed in the United States before October 15, 1994), a pre-market safety notification to FDA is required by law.

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