AHPA opposes FDA's CAM guidance
structure of the dietary industry, the American Herbal Products
Association (AHPA) has issued comments to the US Food & Drug
Administration (FDA) urging the agency to withdraw its draft
guidance pertaining to the CAM industry.
In February, FDA announced the availability of the draft "Guidance for industry on complementary and alternative medicine products and their regulation by the food and drug administration".
Now AHPA says the intended audience of the guidance is unclear and will only lead to further confusion.
"The result is that publication of the draft guidance has had exactly the opposite effect as the agency's expressed intention to address confusion concerning the regulatory status of products used by practitioners of complementary and alternative medicine," wrote AHPA in its comments to FDA.
However, in the document, FDA states the guidance is merely meant to be that: a guidance, and not regulation.
"This draft guidance, when finalized, will represent the FDA's current thinking on this topic," states FDA.
"It does not create or confer any rights for or on any person and does not operate to bind FDA or the public."
But AHPA has accused FDA of not properly identifying what industry this "topic" pertains to.
"AHPA provides the balance of these comments with the assumption that the industry to whom the draft guidance is directed does not consist of the health care practitioner community (whether conventional or CAM)," states AHPA.
"….but is instead meant to be those companies that manufacture or distribute products that FDA has identified as CAM products."
In the draft guidance, FDA uses the NCCAM (National Center for Complementary and Alternative Medicine) definition for CAM: "a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine."
Nevertheless, AHPA reminded FDA in its comments that the agency does not have regulatory authority over health care practitioners.
"…AHPA believes that the publication of the draft guidance has increased rather than decreased the public's confusion about FDA's mandate and jurisdiction over products, including those that may be used by CAM health care practitioners."
The association's has pushed for a complete erasure of FDA's guidance initiative with respect to CAM.
"It is AHPA's view, as expressed below, that the draft guidance should be withdrawn through an announcement in the Federal Register," expressed AHPA in its comments.
"No further effort should be made by FDA to develop any final guidance on this subject matter."
