Dr. Mercola April 27 2007 32,969 views
I am rather surprised that FDA issued this guidance document because it does not tell us anything that we didn't already know, i.e., FDA has the regulatory authority to regulate products and devices that are used in the practice of complementary and alternative medicine.
The key words are "products" and “devices.” FDA stops short of stating that it has the ability to regulate the practice of medicine. For instance, any topical or ingestible product that is market for the cure, mitigation, treatment, diagnosis, or prevention of a particular disease condition is considered a "drug" by the agency. There are numerous cases on this point going back decades regarding FDA’s regulatory authority over such products so FDA’s position is well-founded on this issue.
However, in recent times, FDA has generally ignored this area of medicine and has left it to individuals to pursue the course of treatment they believe is necessary as long as FDA did not perceive that the product or device did not pose a risk to public safety. Thus, this document does strike me to be a new attempt by FDA to reassert itself in this space.
How serious the agency is about reasserting itself is difficult to gauge because the key to determining whether a product is regulated as a drug, medical device, cosmetic, food, or dietary supplement depends on the products intended use.
Specifically, intended use is generally determined by the product’s label, labeling, and on occasion advertising. Thus, if a company were marketing its dietary supplement product with appropriate structure/function claims, FDA could not seize the product because practitioners are using it to treat their patients.
Moreover, FDA would be hard pressed to take action against a practitioner because how a practitioner uses an otherwise lawful product is within the practice of medicine, which FDA does not have regulatory authority over. With that said, practitioners that have developed their own line of supplements could be challenged by the agency on this issue.
So, I do have some concern that FDA may be indicating that it could regulate transactions between a doctor and their patient. However, this document stops short of stating that FDA would or could.
The few instances that I know of where the agency has arguably attempted to regulate the practice of medicine is with medical devices and controlled substances, in particular hGH. In the 1990's, FDA went after several doctors who were using TENS units in their practices. The units being used, however, had not received clearance from the FDA.
Thus, FDA’s argument is that it was not regulating the practice of medicine, but rather the TENS unit itself. FDA was successful in eliminating those units from the doctors’ offices because the devices lacked the proper regulatory clearances to be marketed in the United States. It is another matter, however, where a product is properly marketed but a practitioner is not using the product consistent with its intended use. In this latter scenario, the agency would likely avoid taking regulatory action because the status of the product is legal.
For instance, there are now several TENS devices that have been cleared by FDA. If a doctor chose to use one of those devices in a manner not consistent with its clearance, this is arguably not an FDA issue unless the manufacturer or distributor of the device is promoting it for an off label use. Indeed, the courts have generally recognized a physician’s right to use or prescribe a lawful drug for a use not indicated on the particular product’s label or labeling.
I have also seen FDA as well as the Drug Enforcement Administration (“DEA”) take issue with the off-label use of controlled substances, in particular anabolic steroids and hGH. However, the Controlled Substance Act does provide a reasonable basis for the agencies to regulate the practice of medicine when it comes to these particular substances. So, I do not consider this situation analogous.
In Summary
While I am surprised that FDA issued this guidance document, it does not contain anything new regarding FDA’s position that the products and devices used by complementary and alternative healthcare practitioners are subject to its regulatory authority. Indeed, FDA has steadfastly taken the position that if these products are marketed to cure, treat, mitigate, diagnose, or cure disease; the products are subject to FDA’s regulatory authority as a drug, biologic, or medical device.
The guidance document stops short of stating that FDA has the authority to prohibit a practitioner from using a lawfully marketed food, dietary supplement, cosmetic, or device to treat or prevent a disease. However, there is some implication that if the product is the practitioner’s own product that FDA could take issue with it even if the product is properly label in the first instance. Whether FDA is willing to actually pursue a practitioner over an otherwise legal product is doubtful because it raises serious issues of whether FDA is attempting to interfere in the practice of medicine.
With that said, if the product is being marketed unlawfully, FDA believes it has the authority to pursue the unlawful use of the product because it is not attempting to regulate the practice of medicine but simply removing an unlawfully marketed product from the marketplace.
You're right. The FDA is much too dangerous to have more power. It's doubly dangerous because the FDA wants to control FOOD as drugs.Example of FDA's danger:Congress told FDA: "Don't 'harmonize' with Codex (World Government Health System, controlled by Pharmaceuticals). But the FDA defied Congress. Hammel was at the Codex meeting to witness the anarchy of the FDA representative who said we will "harmonize" (be controlled).Example of FDA doing the opposite of what the law says:The DSHEA (Nutrition Act, 1994) says people need to know that lack of vitamins-minerals cause diseases. But the FDA and FCC are closing tens of thousands of websites where the vitamin-mineral-disease link is mentioned. Example of FDA's danger: Creating it's own power base with other nations (bypassing Congress).http://www.thepetitionsite.com/takeaction/373269232
CAM Practices, Products and FDA Regulation: A Threat Assessment
DRAFT 1.1d 04/22/07 1443 words - Commentary by Ralph Fucetola JD – www.vitaminlawyer.com
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 http://tinyurl.com/2u7ghc to make your comments.
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 in the 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 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 “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:
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 102,000 of the over 245,000 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. The last time Americans got this mad about health freedom, we got DSHEA. 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 – www.vitaminlawyer.com
http://www.nocodexgenocide.com/page/page/3312735.htm