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FDA PUBLISHES PROPOSED GMPs for DIETARY SUPPLEMENTS

At 11:30 am EST today the Food and Drug Administration (FDA) announced the publication of the proposed rules for new good manufacturing practices (GMPs) for dietary supplements (DS).

The GMPs were posted on FDA website at 11:30 AM EST today (www.fda.gov) but will not to be published in the Federal Register until Thursday, Mar 13.

There is a 90-day public comment period in which interested parties can review the GMPs and file comments with FDA for its consideration prior the agency’s publication of final rules, presumably later this year.

FDA has scheduled 2 public meetings in which interested parties can attend to voice public comment, ask for clarifications, etc.: the first in College Park, MD on Tuesday Apr 29 and second in Oakland, CA Tuesday, May 6.

In a teleconference this morning with industry trade associations, FDA’s Christine Lewis Taylor expressed FDA’s desire for industry groups to work together and to together teleconferences and/or meetings with industry on a coordinated and consolidated basis, to help optimize the amount of time that FDA staff would have to expend to deal with the industry’s public comment process.

The GMPs include proposed regulations containing requirements for the following areas related to the storage and manufacturing of raw materials and finished dietary supplement products: personnel, facilities, equipment and utensils, production and process controls, testing, packaging and labeling, basic holding for raw materials and finished products, the processing of GMP-related consumer complaints, and manufacture-related record keeping.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) authorized FDA to promulgate GMPs for dietary supplements, which would be more stringent that the GMPs currently in place for conventional foods. Because dietary supplements are classified as foods under federal law, DSHEA stated that the GMPs should be modeled after food GMPs, not GMPs required for drugs.

In 1997 FDA published proposed GMPs for public comment. These GMPs were based on the recommendations of an industry working group, prepared in 1995 by technical experts from companies who are members of the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), the National Nutritional Foods Association (NNFA, and the Utah Natural Products Alliance (UNPA). The effort was chaired by Paul Bolar of Pharmavite Corporation, a member of CRN.  (For more, see articles on this subject on the ABC website at www.herbalgram.org).

Proposed final GMP regulations were rumored to have been ready for publication at the close of the Clinton administration and were later caught up in the administrative freeze that President Bush put on all Clinton-era proposed regulations. Since then industry groups have publicly prompted FDA to publish the GMPs.

After FDA receives the public comments on the new proposal, FDA will publish final GMP rules, which will still not go into effect for about another year. It is worth noting that many responsible manufacturers in the herb and DS industry have not waited for FDA’s publication of GMPs and have voluntarily increased their GMPs to meet or exceed what the FDA is projected to be proposing. Also, some manufacturers, because they produce over-the-counter (OTC) drug products, already operate under high level GMPs.