(April 27, 2007). The American Herbal Products Association (AHPA) today submitted comments to the Food and Drug Administration (FDA) and called on that agency to withdraw its draft “Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.”
AHPA’s comments state that FDA should “inform the public that the draft guidance has been withdrawn,” and that “no further effort should be made by FDA to develop any final guidance on this subject matter.”
One of the primary reasons that FDA gave for issuing this draft was to respond to what it describes as ‘increased confusion’ about products used by practitioners of complementary and alternative medicine.
“But the publication of this draft has had exactly the opposite effect,” commented AHPA president Michael McGuffin, “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 FDA’s intentions in developing it,” he added.
AHPA’s comments also recognize that FDA may decide to go forward with a final guidance, so provides numerous specific suggestions for clarification. AHPA suggests, for example, that FDA clearly identify which “industry” it is attempting to address, and clearly state its recognition that it “does not have jurisdiction over the practice of medicine or healing arts, including advice given by health care practitioners to patients with respect to products dispensed within such practice.”
AHPA also requests that FDA “refrain from using the term ‘CAM products’ as a convenient way to refer to products that are used by practitioners of complementary and alternative medicine.” AHPA notes that its concern with this term “is that it implies that any product used by a CAM practitioner is a ‘medicine,’ and that FDA’s use of the term “suggests that FDA is attempting to create both a new legal definition and agency mandate, superseding acts of Congress, in contravention of its statutory authority.”
Additional comments will be submitted by May 29
AHPA believes that an error in the Federal Register notice that announced the availability of FDA’s draft guidance should be interpreted to allow additional comments to be filed anytime before May 29, 2007. AHPA intends to submit additional comments near the end of this comment period, and all AHPA members are invited to forward suggestions to Michael McGuffin at [email protected]. Members may also wish to consider submitting their own comments to FDA, both to express support for AHPA’s filing and to expand on any of the specific issues addressed in FDA’s draft.
Posting / distribution of AHPA comments encouraged
“AHPA members are encouraged to distribute our comments broadly and to post them on your websites to try to counter the significant confusion that this draft guidance has raised,” said McGuffin.
The full text of AHPA’s comments can be found at http://www.ahpa.org/Portals/0/pdfs/07_0427_AHPAComments_FDA_CAM_Guidance.pdf.
FDA’s draft guidance is at http://www.ahpa.org/Portals/0/pdfs/06_1200_CAM_Draft_Guidance_FDA.pdf