Guiding the Guidance
The Natural Solutions Foundation was so distressed by the abusive and dangerous “FDA Guidance on CAM Regulation ” that we urged people to voice their strong objection to it directly to the FDA. And 185,522 folks did just that! Of course, 445,235 people tried to submit their comments but, because of constant interference with our links and our site, could not get their comments in to the FDA. To help those who had difficulty with the links, I hired 3 fill time people to submit their comments for them since our link continued to work (most of the time) so we were able to submit a huge number of comments that way (which we called “Plan B”).
“Abuse of Power”
You may recall that the Natural Solutions Foundation applied for an extension of the Public Comment period for this skewed and alternative-medicine-hostile FDA “statement of the law” which is, in reality, what Congressman Ron Paul, MD describes as “an abuse of FDA power”.
Well, we got our extension, but very, very grudgingly! Although the Public Comment period was closed on April 30, because of our request for an extension, it was reopened for a meager few days!
We have until May 29, 2007 to get it through to the FDA that their “Guidance on CAM Regulation” is, in fact, a serious misstatement of the law. Our legal analysts believe that it is an apparent preparation for “enforcement” of that misstatement of the law against all natural procedures and products. This is not acceptable to the American public. We need to tell the FDA that in no uncertain terms.
This is the guidance that says …
For example, the guidance says that if the intention in using (or giving to yourself or another person) a food, juice or “CAM Product” [there is no such category but it would seem to refer to supplements, herbs, wheat grass juice, etc., etc.], that item then becomes an untested drug through your intent alone. Untested drugs are illegal in the US and abroad.
The guidance defines “CAM” as “Complementary and Alternative Medicine”, not “Modalities” or “Medicines” so that any CAM modality of any sort (energy, nutrition, massage, acupuncture, homeopathy, etc.) could become a “Physicians only” activity.
Licensed physicians who carried out these treatments instead of following “practice algorithms” (that means drugs) could face disciplinary action including the loss of their licenses and FDA raids by armed marshals and dogs on their offices.
By the way, there has been a lot of internet discussion about whether or not the CAM Guidance is really a threat. Frankly, after reading what has been circulating on this question, those who do not believe that it is a real threat either do not get it or do not want to get it.
The threat could not be more real.
The FDA Office of Policy and Planning has taken the time and effort to mis-state, extend and distort the law setting up the most draconian interpretation of how to restrict CAM — read pharmaceutical free — treatments and therapies.
What do 2/3 of Americans do? They use CAM treatments and therapies. What do the drug companies want to do about that? Smash, totally eliminate, literally kill the most powerful competitor for treatment dollars this side of clean, unadulterated food!
Let’s make our voices count!
The FDA acknowledged that they got a LOT of comments from us (if you remember, comments through our website were the only ones getting to the FDA according to the Office of the Receiver of Dockets). Your voice REALLY COUNTS when you submit your comments through the Natural Solutions Foundation Site, http://www.HealthFreedomUSA.org . The battle is far from over. Submit your comments now if you have not already done so. Even if you have sent in your comments through our site, please send this email with a brief introduction to your friends and colleagues asking them to submit their comments as well.
To submit comments, go to http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=7185
If the link is blocked (or broken), send an email to me at email@example.com with “Submit-CAM” in the subject line and your full name and address in the body of the email. We’ll make sure your comments are submitted to the FDA!
Here is what Ralph Fucetola, the attorney who applied for the extension on behalf of the Natural Solutions Foundation, has to say about the FDA’s hostile and inappropriate response to the Voice of the People:
ANNOUNCEMENT JUST POSTED ON THE VITAMIN LAWYER HEALTH FREEDOM BLOG
05/23/07 2:10 PM – FDA CAM Guidance Period Extended – a bit…
I just received a phone call from Philip J. Chao, FDA author of the CAM
Guidance to let me know that FDA just published an announcement that the
comment period has been extended through May 29, 2007.
The announcement is at:
http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-nec0001.pdf – that statement
indicates, “Public concern based on misinterpretations of the draft guidance
has generated a large volume of comments to the docket.”
I take strong exception to this characterization of public demands to protect
our alternative practices. The FDA still doesn’t get it. Upon whose authority
has the public concern been determined to be based upon “misinterpretations?”
The FDA makes the Guidance and then judges the opponents as “misinterpreters”
– this is the hallmark of bureaucratic hubris. The Agency can’t be wrong, so
the public must be. Even when, as Congressman Ron Paul put it, the Guidance is
“an abuse of FDA power…”?
There is a clear disconnect between the Agency, Congress and the public —
with Congress supporting the public! For example, when the Senate earlier this
month wrote DSHEA protective language into S.1082, the FDA empowerment law now
before the House. It is therefore more important than ever that the House act
to enhance the Senate language by exempting all compounded, nutraceutical,
bioidentical and functional foods.
Ralph Fucetola JD
All rights reserved.
FDA Serves Pharma Masters,
The marketing arm of the pharmaceutical industry, also known as the FDA, wants to take down all competitors to drugs. All of them. If that is not what you want, now is the time to act. Click on this link (http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=7185) (http://tinyurl.com/2u7ghc ) to tell the FDA to correct the abusive power it has laid out for itself in its “Guidance on CAM Regulation” and then click on this link (http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11344) (ttp://tinyurl.com/27oab6 ) to direct the members of the House of Representatives in no uncertain terms to protect your health and your health freedoms from the dangers of Senator Kennedy’s ill advised and devastatingly poorly conceived, but very, very “pharma phriendly” bill, S. 1082.
Thanks for your activism. We have to stay on these issues and that will mean a lot more emails and a lot more activism before this is all over.
I know how hard this is and I thank you from the bottom of my heart for staying the course. This is a long, drawn out battle but we will win in the end if we stay focused and motivated.
Yours in health and freedom,
Rima E. Laibow, MD
Natural Solutions Foundation
PS: You know those three people I hired to submit for you when the links did not work? They get paid. The airline tickets to get to the Codex Meetings and conferences where we spread the message? They cost money. Hotels? Meals? Rental cars? Brochures? Telephones? Ditto. This is your battle. Please make a generous tax deductible donation (recurring donations really help us plan our budgets!) at http://www.healthfreedomusa.org/index.php?page_id=189.
In addition, we have created an all-organic products shop for you. http://www.Organics4U.org allows you to protect your health and your health freedom at the same time! Your purchases are 40% tax deductible, too.