FDA's attempts to slip its CAM Guidelines under the radar fail; deadline for public comment extended to May 29

Wednesday, April 25, 2007 by Mike Adams, the Health Ranger Editor of NaturalNews.com (See all articles...) Tags: CAM Guidelines, the FDA, health news

Following widespread criticism by the public over proposed CAM Guidelines that the agency tried to slip under the radar (see below), the Food and Drug Administration has now extended the deadline for public comment to May 29. (It was previously April 30). The CAM Guidelines (click here to read them yourself) represent a new era of thinking at the FDA and describe the agency's intentions to regulate herbs, functional foods, therapeutic oils, nutritional supplements and even physical devices such as massage rocks as either "drugs" or "medical devices." Click here to read our previous story describing the CAM Guidlines. These guidelines have been widely described as a brazen FDA attempt to destroy naturopathy and alternative medicine.

The FDA was petitioned on April 22 by health freedom attorney Ralph Fucetola, a trustee of the non-profit Natural Solutions Foundation (www.HealthFreedomUSA.com), to extend its deadline for public comment. The petition also specifically requested that the FDA hold public hearings on the issue, but no decision has apparently been made on that issue.

It now seems that the FDA attempted to sneak the new CAM Guidelines under the radar, hoping the public would never notice the guidelines until they had already been adopted and approved. The original CAM Guidelines document was quietly posted by the FDA on the day after Christmas, 2006, yet did not appear in the Federal Register until several months later. By the time the document was able to be found and commented on by the natural health community, only about thirty days remained in the public comment period. Thanks to public pressure and the Natural Solutions Foundation petition, the public comment period has now been extended by an additional thirty days to May 29th.

To date, more than 108,000 comments have been received by the FDA on their CAM Guidelines. The issue has received widespread coverage in the natural health community, including articles on NewsTarget.com. The Natural Solutions Foundation says that an additional 267,000 people attempted to post comments but were unable to do so. NewsTarget previously suggested that comments posted to the FDA might be intentionally ignored or deleted, and according to the NSF, letters that are written to the FDA about this docket are routinely ignored.

Your comments are still needed to protect health freedom

The most effective way to make your voice heard on this topic is to either post your comments electronically, or write your representative in Washington to apply pressure on the FDA from the legislative side.

Click here to post your comments directly to the FDA on the FDA Docket Management Comment Form. Keep in mind that all comments become part of the official FDA record, so write your comments carefully.

The Natural Solutions Foundation also has a web comment form posted here, which uses the "Democracy In Action" engine to send comments to the FDA and adds your name to a petition asserting our collective right to health freedom. This petition needs approximately another 90,000 electronic signatures to be taken seriously by the FDA, so please consider signing this petition as well.

"My middle name is not Darth Vader" claims FDA official

Late last week, John Weeks from The Integrator Blog (click here for the full interview) published an interview with Philip Chao, the only FDA official referenced in the CAM Guidelines document.

That interview asks the important question: Why was the CAM Guidelines document posted in the Federal Register on February 27, with a comment deadline of April 30, when the document itself says there will be a 90 day comment period? The Integrator asks, "Can't you see how, with a suspicious public out there and all this hoopla that just extending to 90 days from February 27 makes some sense."

Later in that interview, Philip Chao is asked if his middle name is Darth Vader. His response? "No it is not." This is the first time, to my knowledge, that an FDA employee has officially denied his name is Darth Vader.

The campaign to keep you uninformed

Interestingly, opinions are split in the health freedom communities over the interpretation of the CAM Guidelines and the involvement of those trying to stop it. NewsTarget has been strongly pressured by certain health freedom individuals to censor its reporting on this topic and remove any mention of the Natural Solutions Foundation or its website.

We have also been told by some health freedom activists that the CAM Guidelines can be safely ignored and pose no threat whatsoever to health freedom. Common sense, however, dictates otherwise. Any document in which the FDA openly states its intention to regulate vegetable juice as a drug is clearly and unquestionably a threat to health freedom, regardless of the noise level in the current health freedom debate.

It is my belief that those individuals and organizations attempting to silence the reporting on these CAM Guidelines are, in fact, working in opposition to health freedom, regardless of their self-proclaimed stance on the issue. Actions speak louder than words. Anyone can claim they're in favor of health freedom, but unless they're actually fighting for it where the rubber meets the road, so to speak, they're only standing in the way of those of us who actually are making a difference. Stopping these CAM Guidelines from becoming official FDA policy is, in my view, one very important action item that deserves our effort right now. There are many more, but this is one that we cannot ignore.

If you believe in your right to purchase herbs, supplements, homeopathic remedies or other naturopathic or "alternative" health items, please consider posting your comments using one (or both) of the links listed above.

The petition to extend the deadline

The April 22nd petition letter to extend the FDA deadline is reprinted, in part, below:

April 22, 2007

Re: FDA Docket No. 2006D-0480
Request to Extend Time Period for Comments

Reference is made to the Federal Register, February 27, 2007 (Volume 72, Number 38, Page 8756-8757), http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-325... entitled: Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.

In the filed comments NSF submitted to the FDA, the organization emphasized what we see as the important distinction between "treatment of disease" and its non-medical alternative, under AMA Ethics Code Opinion 3.04, "therapies that may benefit." The comments raised three demands:

1. That FDA hold public hearings before finalization of the draft guidance.

2. That FDA change the title of the guidance to use the phrase "Complementary and Alternative Modalities" and not the prejudicial "Complementary and Alternative Medicine" as in the draft.

3. That FDA recognize "therapies that may benefit" as not the same as "treatment of disease" and therefore not to be regulated as "medicine."

The organization also alerted its supporters, in keeping with its educational purposes. Many of theses individuals filed their own or supporting comments. As of the date of this request, over 108,822 have done so, by one count. This does not include about 267,063 people who tried to post comments but did not succeed, yet. Many of these remaining people may still want to submit comments, but may not be able to do so by April 30, 2007, a stated deadline for comments. While the Federal Register Notice states such a time limit for the filing of comments, there is other indication of a 90 day comment period, after the date of publication in the Register. This would extend to period until May 28, 2007.

Therefore, we are unsure of the effective end of comment period date, and as many more people want to comment, we must now request a clarification of the final date for the filing of comments and, if that date is April 30, 2007, Natural Solutions Foundation and the undersigned hereby request a 180 day extension of the period to comment, or such other extension as the Agency may consider reasonable. This issue is of such evident concern and importance to so many Americans that a substantial extension is required.

Kindly inform me by return email or facsimile of the Agency’s decision in this regard. The Foundation reserves all rights.

Thank you,
Ralph Fucetola JD, Trustee

Assert your right to health freedom, or you'll lose it

Understand that we, the members of the natural health community, are at war with the FDA. Even though we are peaceful people who would not initiate such a war, that war has been declared upon us. We must fight this effort to regulate our natural medicines out of existence, and we must do so through every peaceful means at our disposal: Signing petitions, writing letters, even perhaps marching in the streets with protest signs if it comes to that.

Do not stand by idly and let the Food and Drug Administration turn America into a medical police state, funded by Big Pharma and enforced by armed FDA agents. (See the true history of armed FDA raids here.) Preserving your access to alternative medicine products is something worth fighting for. We must meet the FDA's attempts at medical tyranny head on, with overwhelming public outrage, and we must keep at it until we restore the freedoms we have been promised by the founding father of our nation.

Today, America is neither a free democracy, nor a totalitarian police state. But it could go either way. And the direction it heads from this day forward is up to people like you. Will you demand your freedom? Or will you let it be slowly, secretly slipped away, one federal document at a time, until you wake up one day and find yourself standing alone in a world or medical tyranny where all the healers have been imprisoned, the herbs have all been banned and the public is chemically controlled under a system of lifetime medical treatment that keeps the drug corporations wealthy?

Think about where this is all headed. The CAM Guidelines spell out the path the FDA wants to take us down. It's up to people like you to stop that effort and help restore genuine health freedom in our world.