Many industry members are criticising a US Food and Drug Administration draft document on how best to regulate the complementary and alternative medicines industry for muddying the very waters it seeks to clarify.
According to the FDA, the draft guidance document was issued in response to the increased importation and use of therapeutic CAM in the US and a desire to resolve growing uncertainty about how these products should be classified."CAM encompasses a wide array of health care practices, products and therapies that are distinct from practices, products, and therapies used in 'conventional' or 'allopathic' medicine," the FDA stated.
Many producers of herbal medicines, food supplements and functional foods and beverages, as well as CAM therapists, fear the guidance's suggestion that many CAM products be reclassified as drugs under the Federal Food, Drug and Cosmetic Act or the Public Health Services Act rather than under the auspices of the Dietary Supplements Health and Education Act. They criticise the FDA for not being clear about how these distinctions might be drawn.
For instance, regarding vegetable juice products, the guidance document states, "If juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would also be subject to regulation as a drug under the Federal Food, Drug and Cosmetic Act." Critics wonder how such a directive could be implemented.
"Both the public and industry are more, rather than less, confused," said AHPA president Michael McGuffin. "This confusion extends to the both the content of the document and to FDA's intentions in developing it." According to AHPA, the FDA should abandon the guidance project or identify just which industry it is addressing and reaffirm its recognition that it does not have jurisdiction over the practice of medicine or healing arts.
In addition, AHPA contends, the FDA should also "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" as it implies all products used by CAM practitioners are medicines, which is not the case.
The American Chiropractic Association expressed "grave concerns about the proposed guidance document and its potential impact and would oppose any such regulatory activity the ACA believed to be unwarranted or harmful."
However, Don McLemore, VP of standards at FF&N publisher New Hope Natural Media, said industry's alarmist reaction was unwarranted. "Most responsible industry experts feel that this document is only a clarification of FDA's existing authority to regulate items used for the diagnosis, cure, prevention or treatment of disease, whether in a CAM or conventional practice and does not and would not undermine, amend, or threaten DSHEA," he stated.
Comment on the draft guidance closes on May 29.