Resources for Food and Drug Administration (FDA)

CSPI Urges FDA to Facilitate Adverse Reaction Reporting for Dietary Supplements

cspinet.org

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.

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