The FDA's regulatory plans...

Last December, the FDA issued a comprehensive position paper on "complementary and alternative medicine" (CAM), offering an opinion that deviates pretty radically from current practice. In the United States, there is still a large degree of freedom in choosing herbal medicines, dietary supplements, massage and other somatic therapies, and "functional foods" (like juices) as part of a comprehensive treatment plan. This most recent position paper proposes to bring all of the above under FDA regulation, which (in a worst-case scenario) might even lead to the criminalization of gardeners who grow medicinal herbs. While I can't see how this would be enforced, it does seem to add another voice to the growing governmental chorus that has been pushing against health freedom and the DSHEA (Dietary supplement, health and education act) under which we've been operating for over ten years now.
Here is a link to the FDA recommendations; additionally, please note that the comment period is still open. It is important to offer our opinions on this matter, as there is some historical precedent for the government listening to public comment (as occurred with the organic foods standards in the U.S.). I know, I'm an optimist, but it certainly can't hurt to make our voices heard. Here is the FDA comment page for this paper. Please tell your friends. Someone has to push back.


Rebecca said...

Guido, can you point out to me in the text of the recommendation what points differ from current practice? Maybe I'm missing it in the bureaucrat-ese, but I can't see much that's different from how things are now. (You can't make health claims or whatever you're selling will be regulated like a drug. That's how it is right now, and that's what I see in this recommendation.)

Guido Mase' said...

While the recommendation is not binding (yet), it is part of a disturbing trend. And here's my main problem with the thing: the FDA lays out definitions (e.g., for "biological products") that attempt to bring the products in question under the jurisdiction of Federal Food, Drug, and Cosmetic Act ("the Act") or Public Health Service Act ("PHS Act"). This is new. We've been operating under DSHEA, which allows non-regulation as long as you don't make any claims. But "the Act" and DSHEA have been existing concomitantly for a while now, and apparently provide conflicting guidelines. With this recommendation, the FDA is effectively saying that "the Act" should be considered the law of the land. A clause of concern then becomes:
"Section 201(g)(1) of the Act (21 U.S.C. 321(g)(1)) defines the term "drug," in relevant part, to mean:

(A) articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C)."

Section (C), which says that any product that affects structure or function should be considered a drug, differs substantially from DSHEA and would define most all herbal supplements as "drugs".

Now, DSHEA was written as an amendment to "the Act" in 1994, and places the burden of proof on the FDA for safety of dietary supplements. It also allows structure/function claims. What I feel this recommendation does is set the stage for the repeal, or substantial revision, of DSHEA. If the recommendation is approved, the next step could involve a change is this legislation, which people have been clamoring about in the last few years.
So my bottom line: while no changes are being made, and this is a non-binding document, it calls DSHEA into question and shifts the FDA's position to the much more restrictive, original positions of "the Act". This, I fear, will be used as fodder for an actual law in the near future, if the trends seen in Washington continue. Better to speak up now, while things are still in the embryonic stage.