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Dietary Supplements Must Report Adverse Reactions

December 13, 2006

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A measure enacted by Congress requires dietary supplement manufacturers to begin gathering and reporting information about adverse reactions to their products.

Manufacturers will have to list an address or telephone number on product labels that consumers can use to report serious adverse reactions, and companies will have to promptly turn over such information to the Food and Drug Administration (FDA).

The new requirement will also apply to over-the-counter drugs.

Congress approved the Dietary Supplement and Nonprescription Drug Consumer Protection Act last week, and the bipartisan legislation is expected to be signed by President Bush.

"Making it simple for consumers to report adverse reactions and requiring companies to turn those reports over to the FDA will make it easier for the FDA to protect the public from hazards," stated Bruce Silverglade, director of legal affairs at the Center for Science in the Public Interest (CSPI). "Under the previous voluntary system, the FDA received less than one percent of all reports of adverse reactions to dietary supplements."

"We hope that Congress now provides sufficient funding so that the FDA can quickly respond to reports of adverse reactions and promptly remove hazardous products from the marketplace," Silverglade said.

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