FDA extends comment period on draft CAM products guidance document

(May 23, 2007) -- As requested by AHPA, the Food and Drug Administration (FDA) will extend the comment deadline for its draft guidance document, Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.

Tomorrow’s Federal Register will include a notice from the FDA, announcing that it 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 The pre-publication version of this announcement reads, “Although the comment period for the draft guidance ended on April 30, 2007, we will consider comments submitted through May 29, 2007, due to confusion as to the closing date for comments on the draft guidance.”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the agency that an error had been made in the February 27 Federal Register notice announcing the availability of the draft guidance document; the comment deadline was set at April 30 [online at: http://www.ahpa.org/Default.aspx?tabid=69&aId=382&zId=1]. The draft guidance itself stated, “comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.” The date which is 90 days from February 27, 2007 is May 29, 2007 (next Tuesday).

“Ours was a simple request, to ensure the public has sufficient time to respond to this draft guidance document,” said AHPA President Michael McGuffin. “The comment deadline error and the draft guidance itself have generated significant confusion and concern.”

AHPA submitted comments to FDA on April 27, urging the FDA to withdraw the draft guidance.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 via http://www.ahpa.org/Default.aspx?tabid=69&aId=384&zId=1.

The pre-publication version of this new deadline extension announcement is online at: http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-nec0001.pdf.

The February 27 Federal Register notice is at: http://www.fda..gov/OHRMS/DOCKETS/98fr/E7-3259.pdf.

The 17-page draft guidance document is also online: http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf.

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The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade -- comprised of the finest growers, processors, manufacturers and marketers of herbal products -- our 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 herbal products are manufactured, labeled, and sold. Website: www.ahpa.org.