CSPI Urges FDA to Facilitate Adverse Reaction Reporting for Dietary Supplements

Industry Opposing Consumer Alert on Labels


WASHINGTON – The Food and Drug Administration (FDA) is under pressure from the dietary supplement industry to weakly implement a law intended to prevent a repeat of the difficulties the agency faced in its nine year effort to ban ephedra, during which time the supplement was linked to 155 deaths and thousands of serious injuries. For much of that time, the, FDA lacked sufficient data to justify a ban in court partly because adverse reactions to ephedra were not reported.

In a letter to the FDA, the Center for Science in the Public Interest (CSPI) said the agency should encourage dietary supplement and over-the-counter drug manufacturers to clearly label packages with information on how to report adverse reactions.

The Dietary Supplement and Nonprescription Drug Consumer Protection Act, passed by Congress last year, requires companies to provide a telephone number or an address that consumers can use to report serious adverse reactions, which then must be turned over to the FDA. The FDA is preparing a guide for industry on how to comply with the new law -- FDA officials have stated that the agency may encourage companies to include a clear statement on labels alerting consumers that adverse reactions can and should be reported by calling the telephone number or writing to the mailing address on the package.

The Council for Responsible Nutrition and the American Herbal Products Association, while previously supporting enactment of the law, are now opposing FDA’s plans to encourage companies to include a consumer alert on labels.

“The FDA is depending on the public to report adverse reactions, but without a clear label statement alerting consumers to call or write, it is possible that many adverse reactions may never be reported and the FDA will not have the data it needs to protect the public from dangerous products,” said Bruce Silverglade, CSPI’s director of legal affairs. “Reporting adverse reactions is especially important for dietary supplements, because unlike over-the-counter drugs, the safety and efficacy of supplements have not been thoroughly reviewed by the FDA.”

Under the law, FDA must make a decision on how to advise companies to label products by September 22, 2007.

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