Comments on FDA Guidance for CAM Products and Regulation
There is a crisis in health freedom. On April 30, 2007 the FDA will close the public comment period on a "Guidance" which will classify every alternative practice as medicine so that only licensed physicians can carry out the procedure AND vitamins, minerals, herbs, etc., will suddenly become "untested drugs" which will be forbidden
( Read more... )
The docket seems to be saying alternative herb therapies are no longer exempt from FDA regulation. Personally, I've felt that supplements should be regulated for a long time. (Simply because there is currently no rigorous FDA review of any herb/supplement -- as there is with other medicines and even foods -- and there is no legal recourse if supplements have incorrect labels).
There are some natural herbal therapies out there that can cause considerable damage -- St. John's Wort, for example -- if not properly taken and regulated, so makes sense to me that these herbs be placed under the FDA's jurisdiction. Here's the exact text of the Guidance if you haven't seen it: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.pdf
If I'm wrong about this, maybe you could explain? This is a hot topic for me because my mother has been heavily involved in CAM for 15 or so years.
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Nutrition practitioners are not licensed physicians and the nutrition services we provide are not licensed by the state.
To quote the consent form I have to have clients sign:
My services in nutrition are alternative or complementary to healing arts that are licensed by the State of California. Under sections 2053.5 and 2053.6 of California's Business and Professions Code, I can offer you these services, subject to requirements and restrictions that are described fully on the back of this page(which would be an explanation of my services)
I basically can't diagnose or treat disease, that has to be done with a doctor. But I can work with the doctor and patient/client to come up with advice for a treatment plan.
I agree with you on regulating herbs. Herb supplementation and therapies can be great if the person who is suggesting them knows what they are talking about. However I'm not sure if you have to go through years of med school to know what you are talking about.
Registered dietitian's have to take a "test" every year or every couple years (eh I forget its been a while since I looked into it...) to make sure they are still on top of their game and still understand what they need to to be an RD. I think having some sort of test or screening like this would be a better choice instead of banning everyone but doctor's from using herbs as therapy.
Having it more along the lines of "you need to have this license in order to give herb supplementation suggestions" would be better imo.
I just don't really like the idea of people not having a choice when it comes to how they want to care for themselves. I don't plan on working with sick people, but I know a lot of the people I will be graduating with would like to, and they're all very knowledgeable and very passionate about what they believe in here... I just really don't think our training should be tossed aside because we don't have an MD after our name. I'd rather have to prove myself through tests/required seminars/etc to show I deserve to do what it is that I'm doing thats all
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http://www.healthfreedomusa.org/index.php/?cat=1
After more reading, I guess it isn't just me that doesn't have a problem with regulating herbs and other supplements (honestly it would be nice to not have to deal with supplements that didn't have RDAs o.0) but its more a problem with the wording of the proposed guidance and its inclusion of words like "medicine" and "treatment" which we as alternative medicine practitioners cannot use (according to the Business and Professions code I mentioned above). If it wasn't for this wording I personally wouldn't have a problem with it at all. I think it would be great to have more scientific research done by institutes that can afford to do double-blind placebo studies to get some solid idea of what supplements can do and the pros and cons of using them as therapy or treatment for X and Y
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I totally agree with everything you've said. I didn't notice any specific language about banning nutritionists from recommending nutritional supplements in the Guidance... but I wouldn't be at all surprised if there is something in there that would lead to that outcome but isn't stated explicitly.
It wouldn't be the first time.. hurray for conservative propositions!
I'll have to forward this on to my mom... she works in an acupuncturist's office. I know a large percentage of their income is from supplements, so this would effect their practice quite a lot. :/
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Subject: Fwd: FDA forbids alternative medicine- ACT NOW, URGENT
National Association of Nutrition Professionals News wrote:
From: National Association of Nutrition Professionals News
The US FDA is at it again. They have been notorious for decades for
their biased attacks and uneven handling of natural, non-
drug/surgery/radiation based health options. This time, though, they
are playing for keeps.
The goal is simple: through a "Guidance" about the regulation
of "CAM" (which they conveniently define as "Complementary and
Alternative MEDICINE" the FDA hopes to serve the interests of Big
Pharma by eliminating all CAM practices and products. ALL of them.
Here's how this deadly game is played:
1. By using the term "Medicine" rather than "Modality" for CAM
practices, the FDA sets the stage so that anyone who is not a
licensed physician is breaking the law by using these modalities
since they are therefore 'practicing medicine without a license'.
2. By using the term "treatment" rather than "therapy", the FDA
limits those who can perform these practices to licensed physicians
and, again, anyone who is not a licensed physician is breaking the
law by using these modalities since only licensed practitioners can
treat. So people using these modalities are therefore 'practicing
medicine without a license'.
3. By using the terms "Medicine" and "treatment" instead
of "Modalities" and "therapy", all substances, including vitamins,
minerals, herbs, co-factors, etc., automatically become untested
drugs since they are being used to prevent, treat, mitigate or cure
disease states. Such use can only legally take place with FDA
approved drugs.
Here's How We Protect CAM Practices,
Practitioners and Products
Numbers. Sheer volume of response. Nothing more and nothing less. NOW
is the time to act. Our window of opportunity slams shut on April 30,
2007.
http://tinyurl.com/2u7ghc
That is the link which allows you to send a comment directly to the
FDA about their deadly "Guidance". Will it matter? Yes, if millions
of people respond. So I am asking you to take this "viral".Here is
what you need to do
NOW
if you value your freedom:
1. Click on the link below and add your name to the letter. When you
click "Send" it will be electronically delivered to the FDA docket
site and posted.
2. Write a brief note (or copy the information in this email)
including this link , http://tinyurl.com/2u7ghc , and mail it to
every one you can. In your email please:
a. Include everyone you know and tell them that their freedom to
choose their own health modalities and options is under serious
attack.
b. Send the same email to the the companies which make the vitamins,
minerals and herbs you use and ask them to send it out to their
entire mailing list.
c. Impress upon the people you contact that we are facing a virulent
and highly organized assault on ALL natural products and procedures
because they do not feed the pharmaceutical coffers and that their
help is crucial.
d. Include a link to the Natural Solutions Foundation website
(www.HealthFreedomUSA.org ). Ask them to become familiar with the
site in order to lend their support to the health freedom battle
which threatens their right to make their own health choices.
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