CAM Guidance Deadline in Question

WASHINGTONAn error in a Federal Register notice has resulted in confusion on how long the Food and Drug Administration (FDA) will accept comments on its draft Guidance for Industry on Complementary and Alternative Medicine Products [CAM] and Their Regulation by the Food and Drug Administration. The original FR proposed set of guidelines, published Feb. 27, 2007, allowed for a 90-day window for comments, but stated the deadline would be April 30; a 90-day window would allow comments through May 29.

The American Herbal Products Association (AHPA) originally discovered the error and pushed for the additional time; however, AHPA is also asking in its comments that the agency withdraw the document, as it is creating additional industry and consumer confusion on the regulation of CAM therapies.

In its rationale for issuing the draft, FDA said it was responding to increased confusion about products used by CAM practitioners. But, according to Michael McGuffin, AHPA president: The publication of this draft has had exactly the opposite effect, and both the public and industry are more rather than less confused. This confusion extends to the both the content of the document and to FDAs intentions in developing it.

AHPA is therefore requesting FDA withdraw the draft guidance and make no further effort to develop final guidance on the topic of CAM regulation. At the same time, AHPA filed comments with numerous suggestions for clarification on the topic, including more distinctly defining the industry and noting FDA does not have jurisdiction over medical practice and advice dispensed by practitioners.