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Congress Requires Dietary Supplement Companies to Report Adverse Reactions to FDA

Labels to provide consumer information by 2008

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WASHINGTON—Within one year, dietary supplement 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.

The Dietary Supplement and Nonprescription Drug Consumer Protection Act was approved by Congress last week, and the bipartisan legislation is expected to be signed by President Bush. The Center for Science in the Public Interest (CSPI) campaigned for the bill, which was also supported by major segments of the dietary supplement industry.

“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, CSPI’s director of legal affairs. “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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Contact Jeff Cronin (jcronin[at]cspinet.org) or Ariana Stone (astone[at]cspinet.org).