CAM and the FDA - Part 3
April 26, 2007
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Ok, it’s official. I am now no longer worried or concerned about the FDA proposals regarding Complimentary and Alternative Medicine. An attorney at USANA, a nutritional supplements company (whose products I’ve been using for years) has analyzed the FDA proposals, in detail, and come to these conclusions:
—snip—
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We’ve researched the information from the link you provided below, as well as the Food & Drug Administration’s recently issued Draft Guidance for Industry on “Complementary and Alternative Medicine (’CAM’) Products and their Regulation by the Food and Drug Administration” (the “Draft Guidance”), and we can assure you there is no need for concern in this case.
The information about the Draft Guidance that various activist organizations are circulating on the web is inaccurate and misleading. While it’s true the FDA issued the Draft Guidance almost three (3) months ago (this is NO secret, as it was published in the Federal Register for public comment), it’s completely untrue that the FDA is using the Draft Guidance as a means of “legal trickery” to limit consumers’ access to natural health products (like vitamins, minerals and herbs) or natural health therapies.
The FDA’s intent in issuing the Draft Guidance is only to address industry confusion as to when certain CAM products are subject to regulation under the Food, Drug & Cosmetic Act (the “FD&C Act”) or the Public Health Safety Act (the “PHS Act”).
The Draft Guidance, when finalized, will not have the binding effect of a law or regulation, and it’s very clear it will not directly or indirectly limit consumers’ access to natural health products. In fact, the Draft Guidance merely confirms that foods (including dietary supplements) are already regulated under the FD&C Act (as foods), and unless an individual or company makes medicinal or drug claims about these food products, the FDA will continue to regulate such products as foods under the FD&C Act.
If an individual or entity were to market a food (including a dietary supplement) as a CAM product, the FDA could stop the sale of the product as a food because it is being marketed as an unapproved drug; but the FDA already has the authority to do this, and the Draft Guidance does not affect the Agency’s authority in this regard.
In light of this information, we don’t believe there’s any need for our Associates to be concerned about the Draft Guidance or to take any action regarding it. Rest assured we’ll continue to monitor this situation carefully through our industry trade associations, and if they believe it’s necessary to engage our Associates in any grass-roots efforts relating to this matter, we’ll take necessary action to involve our field in the most effective way possible.
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—snip—
USANA has been around for a few years and is a publicly traded company (USNA, on the Nasdaq.) Their analysis mirrors that of my own (not that I know anything) and that of my own attorney (who I married 10 years ago.)
So let’s all chill, take a deep breath, and relax. This issue isn’t going anywhere.
That said, always do keep on eye on what your government is doing (U.S. or anywhere.) Its workings are always in someone’s interests, but those interests might not be yours.
edit: The quoted material in this post came from a mailing list that I subscribe to. The owner of the list had sent a question to the USANA legal staff, regarding the FDA proposal, and the reply was posted to the list.
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Posted in Complimentary Medicine, Alternative Healing
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April 27th, 2007 at 12:12 pm
I keep my name and email anonymous for spam and other reasons. I have have been a massage therapist and nutritional counselor for 25 years.
While you are correct that the The Draft Guidance for Industry on “Complementary and Alternative Medicine (’CAM’) Products and their Regulation by the Food and Drug Administration” does not contain wording that is an imminent threat to our ability to obtain supplements, herbs, etc., let us not forget the very real threat that the FDA, and our government, is trying to erode our rights, bit by bit, in order to harmonize with CODEX. This Draft by the FDA is simply one of their baby steps in their journey to do so. They must act slowly, so as to no alarm the citizens of America, as we are the last bastion of health rights on our planet. Yet they are inching closer every day, as you can see by the passage of the AER into law. (How did THAT get passed? I thought Senator Hatch was on our side?)
In the Draft, the FDA has labeled herbs, devices, supplements, etc. as “CAM”. This sets a precedent, and if it is not challenged by industry professionals, such as the UNANA, the FDA will likely continue to insinuate that foods of any sorts or supplements, etc. are medicine. We cannot allow them to be called medicine.
Plus, the word “prescribe” used the FDA Draft is vague. What do they mean by “prescribe”? I remember the days when I could be arrested simply by telling someone that Ginko could improve their memory. Seriously! I still couch my nutritional suggestions with “If I had this specific problem, I’d use….”
Even the National Health Federation (the oldest health freedom protectors around) is missing the point a bit. I quote, “On the fear that the FDA will go after MDs practicing CAM - keep in mind, that physician/patient medical records and communications are protected by the federal HIPPA law. If the FDA wanted to go after a CAM practitioner, based on evidence of using a CAM treatment regime, they could not get evidence, without violating this law. The FDA would have to get a patient’s written consent to release records.” http://www.thenhf.com/press_releases/pr_27_apr_2007.html
The most troubling part of the NHF lobbyist, Lee Bechtel’s, letter to the NHF is that he uses the anachronism “CAM” in the context of CAM practitioner and CAM treatment regime, etc. You can see how quickly and insidiously wording can be accepted into the general population’s vocabulary. Then the concept becomes reality. The FDA is not stupid. Thye know how to word things in order to get their needs met.
Secondly, and a bit off topic, I never sign a HIPPA form. Yes, you can refuse to do so… HIPPA does not protect our privacy. It’s a sham law. Any law enforcement agent can demand your records and get them, if they deem a law is being broken. That is stated right on the HIPPA form. So, Lee Bechtel, is wrong there. As much as I appreciate and support the National health Federation, tthey are wrong about this subject, in my opinion.
If you want to help save our rights, please read exactly what is happening with this Draft and also, what to do about it at:
http://www.healthfreedom.net/index.php?option=com_content&task=view&id=214&Itemid=249
I’ve been fighting this battle for 35 years. My mother fought it for 15 years before that. We know how sneaky the FDA can be. With CODEX looming, it seems that we cannot rest for a moment. The thing that helps most is to write your Congressmen and to send MONEY to organizations to help pay their legal and lobbying fees.
Be well and don’t lose hope. Action speaks louder than words.
April 27th, 2007 at 7:18 pm
[…] Connie took the time to make an interesting comment to my last post on this FDA and CAM issue. Go and read it, I’ll wait…. […]