May 2006

Final rule for cGMP in December 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 (OMB) since October 2005.

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; and

• Prohibiting sale of food (including dietary supplements) and cosmetics derived from elk or deer that have been exposed to chronic wasting disease.

Source: American Herbal Products Association, www.ahpa.org

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