HHS/FDA on cGMPs: December 2006

(Silver Spring, MD, May 5, 2006) — The Department of Health and Human Services has forecast a date of December 2006 for the publication by the Food and Drug Administration of a final rule for current good manufacturing practice (cGMP) for dietary supplements. This projection was included in that department’s semiannual regulatory agenda of “potential rule-making” published in the Federal Register on April 24.

FDA published proposed cGMP in March 2003 and a final rule has languished at the Office of Management and Budget since October 2005. The normal time for OMB review is 90 days, so the American Herbal Products Association (AHPA) had noted in a press releases dated October 26, 2005, that publication of the final rule might be imminent.

“Industry proposed dietary supplement GMPs to FDA in 1995,” noted Michael McGuffin, AHPA president. “This is not the first time that we have been told that the final rule would be completed by December — but the year keeps changing. If past is prologue, maybe it's time to look for another answer and evaluate a self-regulatory approach in the absence of timely completion of this important rulemaking.”

The same April 24 semiannual regulatory agenda identified four other initiatives related to dietary supplements that FDA intends to address in the coming months. These include:

Reviewing the existing rules for when the terms “high potency” or “antioxidant” may be used on the label or in the labeling of dietary supplements and convention foods;
Finalizing guidance for proposed rules on qualified health claims for conventional human foods and dietary supplements;
Prohibiting specific cattle materials in foods (including dietary supplements) and cosmetics to minimize the risk of exposure of bovine spongiform encephalopathy;
Prohibiting sale of food (including dietary supplements) and cosmetics derived from elk or deer that have been exposed to chronic wasting disease.

The April 24 Federal Register notice is available online at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2006_unified_agenda_&docid=f:ua060408.pdf


The American Herbal Products Association (AHPA) represents the core of the botanical trade -- comprised of the finest growers, processors, manufacturers and marketers of herbal products -- AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbs are manufactured, labeled, and sold. Website: www.ahpa.org.

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