According to the notice the FDA released, the guidance is meant to inform practitioners, consumers, and sellers of complementary and alternative medicine (CAM) and its products when a CAM product is subject to regulation under two laws--the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.
The FDA's notice is quick to point out that this guidance doesn't contain any new CAM regulations, meaning it won't affect a person's ability to be treated by a CAM practitioner, to buy or receive any CAM product, or have any effect on state licensing requirements of any CAM practitioners.
However, the folks at Citizens for Health see the FDA's guidance quite differently.
In a commentary, pointedly called "FDA's 'Alternative' Reality," James Gormley, senior policy advisor at Citizens for Health, writes that this document "could open the door to Congressional re-examination of how the agency regulates dietary supplements (including botanicals) and other health products."
For example, Gormley says, that if raw vegetable juice is sold as a treatment rather than just a food, it could be subject to regulation as a drug by the FDA. Gormley is concerned that the new FDA guidelines could lead to more regulation of all dietary supplements, which he fears could decrease the public's access to and ability to receive information about them.
Also, Gormley faults the FDA for soliciting input from consumers and practitioners after issuing these new guidelines, rather than before, and he calls on the FDA to withdraw them until after hearings on all the key issues have been held.
If you've got an opinion on the FDA's CAM guidance, you can submit it by clicking here. The deadline is May 29.