AHPA to FDA: Error in Date to File Comments to Draft CAM Guidance

(April 16, 2007) -- The American Herbal Products Association (AHPA) today informed the Food and Drug Administration of an error by the agency in identifying the date on which comments are due on an FDA document titled, Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.

AHPA's communication of this matter was in the form of a letter from their General Counsel, Tony Young (Kleinfeld, Kaplan & Becker LLP). Young's letter pointed out that FDA had, in a February 27, 2007, Federal Register notice that announced the availability of this draft guidance, stated that comments are to be submitted by April 30, 2007. Young also noted, however, that the draft guidance itself stated, "comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance."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 (the day after Memorial Day).

Young informed FDA, "It is AHPA's intent to file its comments on the draft guidance on or before May 29, 2007, the date set out in the draft guidance." He concluded by urging FDA "to clarify this date error at the earliest opportunity, so that the general public will be timely informed of the correct date for filing of comments in this matter."

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 The 17-page draft guidance document is also online: http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf.


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.

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