May 2007

FDA extends comment period on draft CAM guidance

The Food and Drug Administration (FDA) will extend the comment deadline for its draft guidance document titled “Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration,” as requested by the American Herbal Products Association (AHPA).

The FDA will consider comments submitted through May 29, 2007. The pre-publication version of this announcement reads, “Although the comment period for the draft guidance ended on April 30, 2007, we will consider comments submitted through May 29, 2007, due to confusion as to the closing date for comments on the draft guidance.”

On April 16, AHPA informed the agency that an error was made in the Feb. 27 Federal Register notice announcing the availability of the draft guidance document; the comment deadline was set at April 30. However, the draft guidance stated comments and suggestions should be submitted within 90 days of publication in the Federal Register, which is May 29.  

AHPA submitted comments to FDA on April 27, urging the FDA to withdraw the draft guidance. The full text of AHPA’s comments can be found on its Web site, www.ahpa.org.

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

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