New FDA Regulation of Alternative Medicine
I'm not going to single out any one particular online "news" outlet here, but a lot of hyped-up buzz has been going around about a new 17-page document the Food and Drug Administration has posted on its Web site. You may have seen some of this, or been asked via e-mail to write in to the FDA on these rules…
It's called Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.
And it's being positioned by some less-than-reputable "health" Web sites (one of which is actually a front group for the animal rights crowd) as an under-the-radar harbinger of sweeping new rules that would broaden the FDA's power to regulate all vitamins, supplements, fruit juices, and fresh herbs as "drugs" - and things like massage oils, acupuncture needles, and hot rocks as "medical devices."
If you've been a reader of mine for any length of time at all, you'd know that regulating, taxing, or eradicating these kinds of things is the FDA's ultimate goal - and has been since 1992, when Congress authorized the formation of the Office of Unconventional Therapies (later the Office of Alternative Medicine). It's no secret that the powers-that-be in this country are hostile to naturopathic therapies for the treatment of disease…
But in contrast to what the Web wackos are saying to try to get you to subscribe to their anti-meat propaganda, this document isn't about new regulation at all. It's a clarification of the agency's regulatory scope for the entire alternative health industry. I applaud the FDA for releasing this summary - it's the most succinct and easily interpreted overview of EXISTING regulatory scope they've ever published.
That scope, of course, is still offensively invasive. But now it's out on the table for everyone to see. Again, bravo FDA! At last, some honesty from these guys.
Indeed, this "guidance document" reveals that there are laws in place that COULD be used to classify things like fruit juices, herbs, foods, and nutritional supplements as "drugs" - but only if they're specifically marketed as treatments for disease. If they're marketed as overall boons to health and wellness, they're only subject to garden-variety safety laws regarding quality and purity.
This is a distinction that's helpful for people like you and me to know. For those that know which way the regulatory wind blows on The Hill, it becomes much easier to read between the lines when we buy medicinal foods, supplements, vitamins, and herbs…
Because of FDA regulation, the labels on these things may not say "Prevents, treats and cures _______!" But if savvy folks have found out elsewhere (like this column, maybe) that a natural substance really DOES cure or prevent a certain disease, they can now select and buy with more education and confidence.
Yeah, it's a big ridiculous game, but it's one that's worth playing if you want to live as long and healthy as you can.
One thing, though: Don't believe everything you read or are forwarded from so-called "health" Web sites and e-letters. A lot of it is just over-hyped nonsense designed to scare you into clicking on a subscription link. The way this latest FDA document was spun into the naturopathic apocalypse by certain high-profile sites is shameless. One even classified it as an "end game" and "final solution" to eradicating all natural products everywhere…
Don't get me wrong - the FDA loves to neuter the natural health business to funnel more money into Big Pharma's pockets. But they aren't stupid enough to simply legislate it out of existence. This would only create a huge public backlash and land them on the hot seat of every bull-dog journalist and ambitious Congressman under the Stars and Stripes. They need no more bad press than they get already from killer drugs.
If you want to read this "guidance document" for yourself, click here:
http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf
It won't take you long, and it's easy to understand. I strongly suggest you read it.
Because the more you know about the regulatory hoops the natural medicine industry faces, the better you'll be able to make decisions about what natural therapies to take for your own good health - and where to find those cures among a sea of labels that can't call attention to the real power of the products they're pasted on…
Happy to steer you, not "sceer" you,
William Campbell Douglass II, M.D. |
