A quick reminder - the FDA is awaiting comments on their proposed guidance document concerning Complementary and Alternative Medicine. It is Docket No. 2006D-0480 and the full-text is here: Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.
I previously urged readers to submit comments here, or send comments via snail mail to:
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Be sure when you do to include Docket Number 2006D-0480 in your submission.
Please carefully read the document and pay attention to the terminology used.
The document, if approved, specifically medicalizes complementary and alternative therapies, along with the products, supplements, devices and even foods often part of those therapies. By using "treatment" rather than "therapy;" - "medical" rather than "modality;" the document terminology sets traditional and alternative approaches to well-being and health inside allopathic or conventional medicine in the United States and will regulate products currently protected by congressional legislation, in DSHEA (Dietary Supplement Health and Education Act of 1994).
The document, if approved, effectively renders the DSHEA null-and-void, not by congressional mandate, but by a cunning use of terminology to eliminate the limitations the law imposes on the FDA in its current oversight of dietary supplements.
Please take a few moments to add your comments that an end-run around congress is unacceptable - DSHEA was enacted into law after extensive public debate and only public debate, in the House and Senate - in our legislature - should preceed any change made to its mandates.
If the FDA wants greater authority to regulate supplements they need to go to congress and make their case to amend DSHEA, not make an end-run around the existing legislation!