Ensuring Quality for Dietary Supplements - Pharmaceutical Technology

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Ensuring Quality for Dietary Supplements
FDA's long-awaited GMPs for supplements appear as food and drug safety concerns override lingering opposition.


Pharmaceutical Technology


One result of the IOM report of 2004 was to spur Congress to enact the Dietary Supplements and Nonprescription Drug Consumer Protection Act in December 2006. The law replaces voluntary adverse-event reporting for supplements with a required system that goes into effect in December 2007. Manufacturers are working with FDA to clarify reporting policies as the implementation deadline draws near. Key issues include what information should be placed on product labels to advise retailers and consumers how to report adverse events, what qualifies as a "life-threatening" adverse event, and where certain information should be written on FDA's MedWatch form.

When DSHEA was enacted in 1994, it applied to about 4000 products sold in the US. Today, the supplement market includes some 30,000 products. Yet, FDA funds for overseeing supplements have declined. While the new GMP regulations may help improve the quality of these diverse products, FDA will need more resources to establish a level playing field for producing and marketing dietary supplements.

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,
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