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Adverse-event reporting closer to reality

US industry associations have applauded the passage of a bill that will force dietary supplement makers to report adverse events to the Food and Drug Administration.

The Senate and the House of Representatives have passed the amendment to the Food, Drug and Cosmetic Act. Industry associations see adverse-event reporting (AER) as a means to draw attention to the generally high standard of its products while simultaneously cleaning up some of the food supplement industry's worst excesses — a reality that exists, critics say, because under the Dietary Supplements Health and Education Act (DSHEA),products do not require pre-market approval as is the case with pharmaceuticals.

Steven Mister, president and chief executive officer of the Washington DC-based Council for Responsible Nutrition (CRN) said: "More than 150 million Americans use dietary supplement products and those consumers deserve to know that if they report a serious adverse event they believe may be associated with a supplement product, that the regulatory body that oversees the supplement industry will be made aware of that report. We believe that ultimately such a system will highlight the strong safety record of dietary supplements."

The bill will require food supplement products to print a phone number where consumers can report AERs, which supplement companies will have 15 days to forward to the FDA.

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