A few weeks ago, I commented on the increased action by the US FDA against unapproved drugs that have been used for decades but were never subjected to today's formal framework of preclinical and clinical safety and efficacy trials (most recent action here).
Over the last couple of months, FDA has been creating a bit of anxiety amongst herbal medicine stakeholders over their document entitled, "Guidance for Industry: Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration." (PDF here, html here). The term, CAM product, refers to any of the modalities used by complementary and alternative medicine practitioners, not just restricted to herbal and dietary supplements but extending to "energy medicine" products (magnets, lasers, "detectors," etc.) which would qualify as medical devices under the Federal Food, Drug, and Cosmetic Act .
It seems to me that the FDA is putting purveyors of alternative medicine modalities on notice that it may become more stringent in regulating products as unapproved drugs despite the fact that the Dietary Supplement Health and Education Act of 1994 (DSHEA) allows supplements to be sold freely as long as direct, disease-treatment claims are not made on the label. While Congress has not been enthusiastic to give FDA more teeth in regulating 'CAM products,' it seems that FDA is telegraphing that it may be aiming to more aggressively exercise its authority against the marketing of health-promoting supplements and devices. The new draft guidance document is currently in its 'comment period' where stakeholders can comment on actions proposed under the document.
As you might expect, the response has been strong. The American Herbal Products Association has recommended that the FDA withdraw the draft guidance document entirely. John Weeks at The Integrator Blog has compiled other responses, ranging from near-hysterical concerns about health freedom to the well-reasoned statement from Mark Blumenthal (American Botanical Council) that FDA seems to be trying to create a new category of product (without legislation, I infer).
Therein lies my discomfort with the FDA draft guidance document. Now, remember, I am on the record as seeking greater regulation of herbal medicines in some way to prevent the cases of heavy metal contamination and other adulterations that pop up regularly. I also agree that DSHEA grants too much latitude to dietary supplement companies, relieving them of any burdens for proof of safety or efficacy of their products. Most dietary supplements contain molecules that, by scientific definition, are drugs.
But note that FDA is a regulatory body, not a legislative body, and its hands are technically tied by DSHEA from only stepping in when companies make drug claims for their products. In fact, nearly every recent attempt to increase legislative control over dietary supplements has met with consumer outcry, that citizens should have the "right" to use dietary supplements (regardless of whether they are proven safe or effective).
So, while I support greater regulation of dietary supplements and medical devices (like the Healing Broom), especially for those that make drug-like claims, the FDA's proposed action may backfire and create even more hostility toward the good intentions of the agency and tie up its legitimate activities in litigation. The FDA already has the authority to intervene when dietary supplement companies make drug claims for their products and they are already exercising their right to remove unapproved drug products from the market.
But creating a new class of "products" without legislative authority is not the best way to handle the improper promotion of dietary supplements and sale of unapproved medical devices.
There's a better way to protect consumers and their pocketbooks: the FDA should exercise the authority it already has.
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Thanks for this post. I have been scratching my head over the fuss about these guidelines as they do not appear to change anything from earlier regulations. It is just the FDA saying "this is our thinking now". There has been a stink over the FDA banning supplements containing ephedra; even suggestions that the FDA overstepped their role by banning it. Unfortunately, nothing in the guidelines about the safety of dietary supplements.
@ Lab Cat, you are right that manufacturers claimed the FDA overstepped their authority when banning ephedra; but a court recently upheld the ban.
There was a review of the DSHEA law, a couple years ago, that recommended more FDA oversight; but Sen, Orrin Hatch (R, Utah) put a stop to that. It is unfortunate that so much that affects our health is in the hands of people with no training in the field.
Abel, I fear you are right that the FDA may be working contrary to the DSHEA. I think you once mentioned Dan Hurley's book on the industry "Natural Causes." It is scary reading. When the FDA originally tried to block sales of deadly "supplements" (e.g., ephedra), the producers got together and every "health food" store in America became a campaign center. The mail favoring DSHEA swamped Capitol Hill far more than any other issue. Legislators reacted to the mail instead of the science. I am sure the industry can mount another such attack.
The problem with opposing DSHEA is that it could result in the exclusion of older remedies that have at least some anecdotal evidence of efficacy. No one is going to do a sizable, double blind control trial to find out if dandelion root can aid in biliary or hepatic maladies, for example. There's just no money in it.
Some of these same remedies have been evaluated by the German Commission E (albeit with small unblinded studies), and found to be efficacious (and inexpensive). Why deny access to these medications without proving that they don't work in a large, well-designed trial? Some of my patients swear by these meds, though I know the placebo effect is a powerful thing.
I believe the banning of ephedra (which was effective, if not safe) not only had to do with deaths associated with its use, but also with it being a source of raw material for meth labs. That eliminated two headaches with one blow. Right now I think the FDA has its hands pretty full with other regulatory matters like feed imports. I don't think it needs any more on its plate.