Consider this a solid rebuttal from those who claimed we “did not read the PDF” or “could not understand it”. This man’s job is to understand it. Perhaps you should give him an ear.

Commentary by Ralph Fucetola JD

Date: 04/24/07

The US Food and Drug Administration is a confusing and confused agency, charged with administering federal controls over foods, drugs and medical devices under a patchwork of laws and regulations that have drastically increased costs to American consumers and slowed health care progress, without demonstrable safety benefits. It is therefore inevitable that many actions taken by the agency are likely to do more harm than good. Such is the case with the proposed Complementary and Alternative “Medicine” (CAM) guideline that the agency proposed at the end of December, public comment period to extend through April 30th. You can go to HealthFreedomUSA.org to make your comments. Over 128,695 have done this through April 24th.

It is true the FDA anti-CAM guidance merely restates the existing law [as FDA sees it] — that, if you intend to “treat disease” with a CAM product, that product (for example, says FDA, a “juice”) is a “drug.” By codifying this in a guidance document, FDA is setting the stage for another push to control and restrict CAM practices. The FDA uses the term “CAM product” in the guidance, although Congress has never defined such a term. The agency seeks to create a “status” of being a certain type of product when all Congress has authorized is that the FDA can regulate certain products “intended” to “treat disease.” Of course, the responsible FDA Senior Science Advisor did say, in a very recent interview, this is not FDA’s “intent” and using “CAM Products” is just a matter of convenience. Of course, as good Americans, we should all believe exactly what the FDA tells us; trust the agency’s intent; shut up and take all our prescriptions.

In addition to telling us that a juice intended to “treat disease” would be a drug, a careful reading suggests even items used in religious healing ceremonies could now be subject to regulation as drugs or medical devices. Holy water, anointing oils, prayer beads, rosaries, sweat lodges and even religious paintings or icons could be classified as drugs or medical devices and essentially outlawed by the FDA. Does this sound absurd? Well, it is absurd!

Certainly, all this appears a bit less absurd if we are considering using an herb or dietary supplement to stay healthy. Says the FDA, if any supplement is used to treat a symptom, then it is a drug and will be regulated by the FDA, just like any prescription drug. The FDA does give us a little hope — the supplement will be exempted if it is “generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested inthe labeling.” This is essentially the same standard used for substantiating drug claims. In 2004 the FDA gave us the standard for making claims about foods and dietary supplements: “FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission’s (FTC’s) standard for dietary supplements and other health related products of ‘competent and reliable scientific evidence’.” Quite a difference! This is just one difference the anti-CAM guidance will codify. And after codification comes enforcement. All alternative practitioners should take note!

In other words, your freedom to use a dietary ingredient as therapy that may benefit a condition will be at the discretion of FDA “experts” who will determine whether to regulate it as “medicine.” Given the abysmal track record of FDA experts, this could be really bad news. With so much latitude, I cannot predict just how far the FDA might go to restrict access to herbs, minerals and supplements, as well as other CAM the two biggest [problems with the guidance] are broadening the definition of “health claim” and the desire to pre-empt the states in the regulation of some health care issues” The health freedom movement began to take notice of the pending anti-CAM guidance in late March. At the start of April, I assisted one group, Natural Solutions Foundation, to write its commentary to submit to the FDA, with emphasis on 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: products. Many pro-health freedom groups are offering their concerns too. For instance, one commentator, Jenny Thompson of the HSI Newsletter suggested, “…[FDA] could take a widely used supplement off the market if the label states a benefit; such as using lutein to reduce the damage from age-related macular degeneration, or using chondroitin and glucosamine to reduce joint pain, or using probiotics to address digestive problems - the list goes on and on…” The AAHF (American Association for Health Freedom is concerned that…”

1. A public hearing by the FDA before the finalization of the guidance.

2. Changing 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. FDA recognize that “therapies that may benefit” are not the same as “treatment of disease” and do not have to be regulated as “medicine.”

The organization then alerted its elist and asked its supporters to also file comments with the FDA, supporting the group’s requests. We apparently touched a hot button issue; over the following week the buzz spread on the Internet.

Propelled by this strong public support, I believe we now have an opportunity to turn this FDA “end run” around and use it to protect CAM practices. We are now seeking support from members of the US Congress to demand that FDA hold public hearings before making the guidance final. If FDA fails to hold such hearings, it would be time for Congress to step in, hold hearings, and propose legislation to protect CAM practices from FDA action that would deny Americans access to alternatives. With John Galt, we want to say, “Get out of my way!”

It has been settled law in this Country for over a century that medical regulations exist to protect the public, not to entrench licensed allopathic medicine to the detriment of all the evolving healing arts, which would refer to as “CAM practices” - though Traditional and Advanced Health Care might be a more appropriate term.

“The state has not restricted the cure of the body to the practice of medicine and surgery — allopathy, as it is termed, — nor required that, before anyone can be treated for any bodily ill, the physician must have acquired a competent knowledge of allopathy and be licensed by those skilled therein. To do that would be to limit progress by establishing allopathy as the state system of healing, and forbidding all others. This would be as foreign to ours ystem as a state church for the cure of souls. All the state has done has been to enact that, when one wished to practice medicine or surgery, he must, as a protection to the public [not to the doctor], be examined and licensed by those skilled in surgery and medicine. To restrict all healing to that one kind — to allopathy, excluding homeopathy, osteopathy, and all other treatments — might be a protection to doctors in surgery and medicine; but that is not the object of the act, and might make it unconstitutional, because creating a monopoly.”
—North Carolina’s Supreme Court in State v MacKnight, 42 S.E. 580, 1902 at p 582.

As NSF’s medical director, Rima Laibow, MD, has noted:

“Throughout the world today people are looking to traditional methodologies and leading-edge CAM techniques because they offer alternatives to toxic, expensive drugs with their dangerous side effects, other invasive technologies of modern medicine, and un-manageable and unreasonable costs. This search for alternatives is protected by the fundamental right of individuals to communicate and learn; to heal and be healed.”

You can read more about this issue and add your comments to the FDA through the Natural Solutions Foundation, a non profit NGO at http://www.healthfreedomusa.org and submit your comments from the home page. Since the FDA Dockets Supervisor tells us her 9 member staff is overwhelmed — apparently the system crashed and only about 128,695 of the over 315,000 people who have tried to post comments have succeeded so far - we have now made arrangements to email directly to the FDA and expect all future comments to get through, so if you did not succeed last week, please try again.

This Monday morning, April 23rd, the Foundation formally filed a written request with FDA for an extension of time to file comments. Due (1) to the confusion between the April 30th deadline stated in the Federal Register and the 90 day comment period, from the date of publication in the Register, as stated on the FDA CBER web page, http://www.fda.gov/cber/gdlns/altmed.htm (which would put the deadline off until May 28th) and (2) the large number of people who want to comment. On Tuesday afternoon, we received a letter from FDA denying the extension, failing to clarify whether April 30th or May 28th is the deadline, and letting us know, per the statute, the guidance, “does not create or confer rights for or on any persons…” the FDA representative did not say that it would not be used as the basis for actions against persons, or to justify the agency’s expansive view of its authority.

The last time Americans got this mad about health freedom, Congress unanimously passed the Dietary Supplement Health and Education Act of 1994 (DSHEA) protecting our access to supplements. This time, we will protect our complementary and alternative practices; our vitamins, herbs, minerals and healing arts. We are “mad as hell” and “we aren’t going to take it any more!”

Ralph Fucetola JD
Trustee - NSF
www.vitaminlawyer.com

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