But first, some quick background.
Dietary Supplements are foods, as are most natural remedies. According to US District Court Campbell, “...the legislative history of the DSHEA indicates that Congress generally intended to harmonize the treatment of dietary supplements with that of foods when it added the dietary supplement subsection to the food adulteration provision…”
While Congress has defined such terms as Dietary Supplement and Drug, it has not created a category as "CAM Product."
Nonetheless, on December 26, 2006, FDA issued its guidance... and then waited two months to tell us... well, the whole story is below, more or less in the order it happened.
In the end, over 197,000 people told the FDA to leave our alternatives alone.
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- that statement indicates, "Public concern based on misinterpretations of the draft guidance has generated a large volume of comments to the docket."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.
05/06/07 - Good News this week! On 05/04 Congressman Ron Paul, physician and presidential candidate, termed the FDA anti-CAM draft guidance "an abuse of FDA power..."
Congressman Ron Paul MD, America's only true Constitutionalist candidate for President (and the Robert Taft or Barry Goldwater of this generation) filed his objections to the antiCAMguidance. He called it "an abuse of FDA power." He concluded his detailed analysis of the failures of the guidance, and its dangers, with these stirring words:"The CAM Guidance is imprudent and will stifle innovation in medicine. The CAM Guidance proceeds from a failure to appreciate the in terrorem effect of government action. . . . There is no reason to believe that the states are ineffective in prosecuting those comparatively few practitioners, CAM or non-CAM, who do cause harm. Thus, without any true need for the guidance, it conveys to CAM practitioners that FDA regards certain therapeutic uses of products to be unlawful. As the agency should know that will, in turn, dissuade those uses, despite the dubious legal basis for FDA's assumption of power. By dissuading those uses, FDA deprives patients of health care options without any proof that its action will improve public health. That is an abuse of FDA power...In sum, I request the FDA to withdraw the CAM Guidance. If the rule is not withdrawn, I urge FDA to amend the rule to state unambiguously in the document that FDA is barred by the FDCA from regulating health care practice and that off-label use of any regulated product by a health carepractitioner is lawful under federal law."
When Natural Solutions Foundation said "We had a great victory!" we are referring to a victory by the broad Freedom Movement in this country, of which health freedom is just one aspect. No one organization has any monopoly over that movement and all deserve due credit for mobilizing the troops. We each have the right to our own opinions as to what correlation of forces led to such quick, and for us happy, congressional action. Our direct contacts on the Hill led us to our appraisal that the storm of protest over the FDA draft guidance last week emboldened our friends in Congress this week, and over-awed their opponents.
Vigilance must continue, but this does show that an aroused public can expect to be noticed by people in power in Washington.
05/01/07 - Comment Period Note: Despite a contrary posting on the FDA web site, the FDA told me in an email today that the Comment Period ended 04/30/07... Details have been reported at NewsTarget, see http://www.newstarget.com/021824.html -and there are those who tell us we should just trust the FDA... and take all our prescriptions...
On the Varying Legal Views of the FDA anti-CAM draft guidance
There are perhaps a dozen lawyers who are well known in the health freedom movement, and dozens others who are involved as well. On an issue as controversial as the meaning and effect of the FDA's pending CAM draft guidance, various lawyers see different issues and ascribe different degrees of threat to the agency action. To say that an agency guideline does not matter at all is to beg the question: why then, did the FDA policy department bother to draft it? My view is that bureaucrats codify rules scattered among regulations (which is what a guidance does) in order to reach as far as they can, and then some.
It is true that a guidance is not "law" but just the agency's official position on what the law is. So, FDA is correct when it says the guidance “does not create or confer rights for or on any persons…” The FDA does not say, however, that the guidance would not be used as the basis for actions against persons, or to justify the agency’s expansive view of its authority. Further, federal courts give a great deal of deference to agency guidelines. If the guidance is adopted as drafted, it will have a growing impact on agency action.
The agency is being disingenuous when it says the guidance merely restates the existing rules. It steps beyond legal limits in a number of places.
First, the very name of the guidance prejudices the issue. The title calls complementary and alternative practices and products “medicine” (we have asked to FDA to change that to the more neutral term, “modality.” As Dr. Laibow put it in the Natural Solutions Foundation comments to the FDA: “CAM is not ‘medicine,’ does not rest in medical models and allopathic methods and does not seek to be considered ‘medicine.’ In fact, CAM seeks to shed the appearance of ‘medicine’ which is not in keeping with CAM traditions and activities.”
Second, several attorneys, including Diane Miller JD and Jim Turner JD, have noted that there is no such legal category as a “CAM Product” – Congress has never, by law, defined such a category. The draft guidance, however, does establish the term, claiming it is just for “convenience.” Congress gave FDA the authority to regulate products labeled with claims intending to “treat disease.” It never gave FDA authority to create a new category of product and then treat that category as “medicine.”
Third, the guidance makes the disturbing suggestion that the product 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!
These are just some of the differences the anti-CAM guidance will codify. And after codification comes enforcement. Therefore I must respectfully disagree with my colleagues who see no threat.
Finally, where there is a threat, there is also an opportunity.
"Treatment of Disease" vs "Therapies that May Benefit"
The powerful groundswell of opposition to the draft guidance can force the FDA to recognize, as the AMA has, that there a range of modalities becoming available to people that do not constitute medicine, but are therapies that may benefit normal structure and function. The AMA has addressed this in its Code of Ethics. While "treatment which has no scientific basis" remains condemned (Opinion 3.01), under Ethics Opinion 3.04, physicians are free to "refer" a patient "for therapeutic or diagnostic services to another physician, limited practitioner or any other provider of health care services permitted by law to furnish suchs ervices, whenever he or she believes that this may benefit the patient." Thus, unscientific "treatment" is distinguished from "health care services permitted by law." "Treatment" -- which means the use of standard medicine and surgery to "cure" disease -- is distinguished from other health care services (therapies) which need only meet the lesser "may benefit" standard.
While physicians "prescribe" treatments for disease, therapies that may benefit may be subject to "referral" thereby further indicating the distinction. And there is a strong distinction between “no scientific basis” and “competent and reliable scientific evidence.” Thus, for example, Dietary Supplements that have been shown to support normal structure and function to support therapeutic outcomes can be seen to complement licensed medicine, but not to be held to its strictures, nor limited in its practice to licensed physicians. Since such therapies are not prescription services, members of the public may choose such services without the permission of their physician.
These concerns are not just bureaucratic niceties. They will ultimately determine how free Americans are to continue to develop complementary and alternative modalities that give people a choice between the dangers of invasive and toxic allopathy and more natural approaches to wellness.
Ralph Fucetola JDhttp://www.vitaminlawyer.com/
A Natural Solutions Foundation Guest Blog http://www.healthfreedomusa.org/index.php/?p=367
Don’t be Duped: Multiple Assaults Need Multiple Responses
Our Health Freedom is threatened again. It’s been going on for centuries, this struggle between healers and bureaucrats. Even back in the age of Henry the 8th the surgeons of London got a law passed effectively outlawing their herbalist competitors by granting themselves a monopoly, and, a couple years later, after many herbalists were brought before the courts, the King had to intervene, obtaining Parliamentary approval for what is now known in the Common Law as The Herbalists Charter, to protect traditional methods of healing and allow their practice “without suit, vexation, trouble, penalty or loss…”1 As recently as the start of the Twentieth Century, one state Supreme Court noted, “"The state has not restricted the cure of the body to the practice of medicine and surgery -- allopathy, as it is termed… 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 system as a state church for the cure of souls… 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." 2
Just such a monopoly was created. For convenience, we can call it the Big Pharma Cartel. It has money and powerful friends in government – who often play bureaucratic “musical chairs” among agencies, big companies and universities. They use that power to harass, jail and even kill their competitors. We honor the memory of doctors Wilhelm Reich and Dinshah Darius, among other victims of this witch hunt (as we honor the memories of those earlier victims of witch hunts who were often Wise Women and Healers.).
In America, after decades of sporadic and arbitrary attacks on health food stores, holistic doctors and alternative practitioners, a powerful groundswell of public opinion surged in the early 1990s. People demonstrated at FDA offices around the country, converged on Washington, flooded Congress with letters and faxes. Those were heady days, when the political establishment first took note of what has come to be called the Health Freedom Movement. The result was congressional passage, without any negative votes, of the Dietary Supplement Health and Education Act of 1994 (DSHEA). That law was supposed to protect the right of nutrient purveyors to make truthful and not misleading claims about the nutritional benefits of their products for the normal structure and function of the body.
This did not, however, stop the attempts of cartel and its friends in power. Numerous times since then efforts have been mounted in the media, through cartel-financed schools and journals, and in the government, to discredit all dietary supplements and all Complementary and Alternative Modalities (CAM). The usual process includes fake science, smear and innuendo. In recent years, add to that, very sophisticated attacks on web sites offering products or information about nutrition and CAM.
The battle is being fought in each state, where now discredited “quackbusters” attacked doctors wanting to practice advanced CAM techniques; in the federal government where important therapies that can benefit many people, such as the responsible use of silver in health 3, are under attack; and on the international level where “harmonization” means reducing our Freedom to some bland bureaucratic “minimum daily requirement.” On the international level Codex Alimentarius, the World Food Code, is the chief bureaucratic mechanism to undermine organic standards, prevent people from knowing what foods are genetically modified – and which are not – and otherwise make the Big Pharma Cartel agenda international policy. Regional bureaucracies, such as the EU, NAFTA and the ominous North American Union play an important role in imposing the harm of harmonization. 4
Recently, even the Journal of the AMA, JAMA, included a highly suspect “meta-analysis” of carefully chosen “studies” to claim that taking vitamins could be bad for your health! This article was strongly criticized by Life Extension Foundation5 and others in the field, but the mass media covered only the fake science, not the response. Literally tens of thousands of good scientific studies prove the value of supplementation. It has been suggested that those who trust the AMA and FDA should certainly not take any vitamins, especially the mega doses many of us have used for decades. Then in a few years, we’ll see who is still around to continue the argument!
Yes, at each turn, the attacks of the cartelists and bureaucrats have been met with stiff public resistance. The attempt to water down organic standards gave rise to a tidal wave of protest. The original FDA “structure and function” regulation in 1999 was successfully opposed and the final rule was rather more friendly to nutritional products. The public outcry in each of these cases was similar to what is happening now with the FDA’s surreptitiously promulgated CAM draft Guidance (“issued” on December 26th; no public notice until February 26th; initially only a short comment period). The grassroots of the Health Freedom Movement caught fire when the people learned that FDA’s bureaucrats, under the guise of “just restating the law” were actually setting the basis for handing over our supplements and alternatives to the Big Pharma Cartel. 6
But the song continues, and big government representative Ted Kennedy, has just introduced S-1082, a bill that may gut our Health Freedom. Curiously, we had heard this bill was dead before submission and would not be submitted. As soon as the current public outcry reached a very high level, along comes the senator, with a bill intended to divert attention from the other anti-supplement bills, Codex, the NAU and the anti-CAM guidance.
It is time to Kill the Kennedy Bill in Committee! While we won’t be diverted from our vigilance of the FDA anti-CAM maneuver, it is important to react to these other assaults on Health Freedom. We would like to see this bill killed in committee. Better to knock it out in congressional committee than allow it to waste our time. While comments directed at the FDA over its anti-CAM draft guidance was the proper response, as required by the Federal Register notice, this back-door effort by the senior senator from Massachusetts should be met with a flood of messages to the chairman and the members of the oversight committee that must approve the bill before it goes before the entire Senate. That will be our strategy in the coming weeks. Of course, if we cannot stop it in committee, it may be necessary to attempt constructive engagement with the committee and senators, to amend the bill to protect supplements. Just this step, according to postings on April 28th on the blog at Mercola.com, has been suggested by leading nutrition attorney Jonathan Emord JD. [NOTE: THE BILL IS OUT OF COMMITTEE AND HEADING TO VOTE; SEE: S.1082 Action.]
All of these multiple assaults are, of course, connected. They are connected in philosophy, proponents and beneficiaries. Their proponents refuse to allow us the freedom to make our own choices, deeming that their political power gives them the authority to decide for us. We have had enough of such deciders. They have given us a medical system that kills hundreds of thousands each year. We reject the philosophy that “the leader is always right;” that we should just shut up and take all the prescriptions Big Pharma sells. We know that the cartel that benefits from all these rules and regulations has plenty of money and jobs to bribe politicians and bureaucrats. None of that matters when the people are alerted and vigilant! We assert our "Right to heal and be healed." 7 We will not be duped by false leaders, naysayers and nitpickers. We are "mad as hell and won't take it anymore!" The time has come to assert that fundamental right. We need, in both law and fact, for this basic human right to be respected. We need an end to the power of the cartel and its bureaucratic allies. And all this will come to pass using the tools of modern communication, which will prove, I believe, in the end, more powerful than cartels and politicians.
It does, however, depend on you. You need to support organizations like the Natural Solutions Foundation, http://www.healthfreedomusa.org/, which shows continuing leadership and, in fact, broke the FDA anti-CAM guidance story. Like everyone else who unmasks the face of the Big Pharma Objective, they are currently being smeared and defamed through disinformation and innuendo. Don't be duped by disinformation any more than you are by bad science. It's up to you to see through to the core of truth and to make your voice heard. It is time to dream of a world where each person has the right to heal and be healed. That is the dream we need to have, for our dream to come true.
Ralph Fucetola JDhttp://www.vitaminlawyer.com/
1. See the Charter at http://home.earthlink.net/~lifespirit23/herbcharter.htm
2. North Carolina's Supreme Court in State v MacKnight, 42 S.E. 580, 1902 at p 582.
3. See: http://www.silverfacts.com/
4. See Dr. Laibow’s Nutricide at http://www.globalhealthfreedom.org/
5. See: http://www.lef.org/featured-articles/consumer_alert_020307.htm
6. See “Take Action” at http://www.healthfreedomusa.org/
7. See: http://www.lifespirit.org/wiltondec.html
CAM Practices, Products and FDA Regulation: Updated Threat Assessment
FDA CAM Draft Guidance Information
Docket No. 2006D-0480 - http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm
Commentary by Ralph Fucetola JD – http://www.vitaminlawyer.com/
© 04/26/07 – 1743 words
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://www.healthfreedomusa.org/ to make your comments. Over 151,000 have done this through April 26th.
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 term1. 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 interview2, 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…”3 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”4The 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 Congress5 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 system 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 only about 145,541 of the several hundred thousand people who have tried to post comments through NSF 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 past 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 29th 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. Today a change has appeared on an FDA web page associated with the guidance, showing May 29, 2007 as the Comment Period End Date, as confirmed by news reports.6
One of the last times 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 - NSFhttp://www.vitaminlawyer.com/
1. Diane Miller JD pointed this out to me - http://www.nationalhealthfreedom.org/
2. See: The Integratorblog.com for the interview, wherein Mr. Chao assures us he is “not Darth Vader.”
3. See: http://www.hsibaltimore.com/index.html
4. See: http://www.healthfreedom.net/
5. Congressman Ron Paul, candidate for president, announced on 04/26/07 that he would also be submitting formal comments to the FDA regarding the CAM draft guidance.
6. See: http://www.newstarget.com/ and http://www.accessdata.fda.gov/scripts/oc/dockets/comments/getDocketInfo.cfm?EC_DOCUMENT_ID=1451&SORT=&MAXROWS=15&START=1&CID=&AGENCY=FDA
From: Natural Solutions Foundation
Re: FDA Docket No. 2006D-0480
These comments are submitted by Major General Albert N. Stubblebine, Rima Laibow, MD and Ralph Fucetola, JD on behalf of Natural Solutions Foundation with regard to the Food and Drug Administration’s draft “Guidance for Industry on Complementary and Alternative Medicine Products and TheirRegulation by the Food and Drug Administration.” They are submitted with reference to the request of FDA for comments on the proposed Guidance stated at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm.
The Natural Solutions Foundation is a tax exempt, recognized nongovernmental organization active in the United States and internationally, communicating Natural Solutions to the many health problems caused by government intervention, with emphasis on FDA and Codex Alimentarius over-regulation of natural foods and supplements.Complementary and Alternative Modalities (CAM), including traditional remedies and nutrition to achieve and maintain a healthy status, are preferred by many Americans to so-called “standard” allopathic medical treatment, primarily due to the well-documented iatrogenic death and disabilities, the dangerous side effects and persistent failures of the so-called “standard” model.
The Dietary Supplement and Natural Remedies market has grown to over $28 billion dollars annually as Americans consistently vote with their dollars choosing CAM products out of un-reimbursed funds.The Foundation urges the FDA to take into account an important legal distinction that FDA appears to ignore totally in the draft Guidance. Thatdistinction is between “treatment of disease” and “therapies that may benefit.”
In keeping with that distinction, explained below, it is suggested that the Guidance be titled, “Guidance for Industry on Complementary and Alternative Modality Products and Their Regulation by the Food and Drug Administration.” CAM is not “medicine”, does not rest in medical models and allopathic methods and does not seek to be considered “medicine.” In fact, CAM seeks to shed the appearance of “medicine” which is not in keeping with CAM traditions and activities.We request the FDA take the following steps: (1) hold public hearings on the proposed Guidance; (2) formally revise the Guidance title to replace the word“Medicine” with “Modality” and (3) use of the terms “therapy” and “therapeutic” with reference to Complementary and Alternative Modality health practices, instead of the words “treat” and “treatment of disease” which are used exclusively in the draft Guidance.
The terms “treat” and “treatment of disease” are, in fact, antithetical to CAM therapies. CAM health practices can be generally defined as traditional or other practices that are used by individuals, often for self-help, to achieve andmaintain a healthy status, either on their own or complementary to standard medical care. These practices do not include the potentially dangerous use ofinvasive techniques and toxic drugs that are the sole province of licensed medicine. They do, however, include developing therapies and nonstandardapproaches that are outside the scope of licensed medicine. Such approaches as Nutrition, Homeopathy, Hands-on-Healing, Magnetics, Sound Health, Energy Therapies, Biofeedback, Meditation, Breath Work, Reiki, Chi Gong, Tai Chi and Herbology are examples of complementary and alternative therapeutic practices. Traditional Chinese, Ayurvedic medicine or folk remedies and "Dr. Mom" home remedies are also examples of CAM practices. These practices aim, in the words of the late Philip J. Hodes, PhD., at "more efficient physiological integration and function of the human organism, leading to optimal wellness." This definition is the polar opposite of non CAM practices which seek to suppress or ameliorate symptoms without an approach to optimal wellness.
The terms “therapy” and “therapeutic” do not occur, for example, in the context of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Rather, that statute, passed by unanimous Congressional Consent, tells us that Dietary Supplements may not “diagnose, treat, cure or prevent” any disease. It does not specifically forbid the use of the word “therapy” (or “therapeutic”). Under the Supreme Court’s rule in the Thompson v Western Medical case, we should expect that these words would not be forbidden by the Courts and should not therefore be overtaken by the regulators.Further, the Code of Medical Ethics of the American Medical Association also acknowledges an independent use of the term “therapy.”
The original Hippocratic Oath, with its injunction to "Do no harm." has been replaced by a complex Code detailing the relationship between physician and patient andalternative practitioner. Changes made during the early 1990's were inspired by anti-trust lawsuits brought (and won) during the 1980's by chiropractorsand other non medical practitioners. These changes are just now becoming recognized by regulators and courts.
While "treatment which has no scientific basis" remains condemned (Opinion 3.01), under Opinion 3.04, physicians are free to "refer" a patient "fortherapeutic or diagnostic services to another physician, limited practitioner or any other provider of health care services permitted by law to furnish suchservices, whenever he or she believes that this may benefit the patient." Thus, unscientific "treatment" is distinguished from "health care servicespermitted by law." "Treatment" -- which means the use of standard medicine and surgery to "cure" disease -- is distinguished from other health care services (therapies) which need only meet the lesser "may benefit" standard. While physicians "prescribe" treatments for disease, therapies that may benefit may be subject to "referral" thereby further indicating the distinction. Thus, for example, Dietary Supplements that support normal structure and function to support therapeutic outcomes can be seen to complement licensed medicine, but not to be held to its strictures, nor limited in its practice to licensed physicians. Since such therapies are not prescription services, members of the public may choose such services without the permission of their physician. Purveyors may restrict sale of therapeutic products to physicians, complementary practitioners, exercise and health care professionals, although they should not be required to do so.
We have analyzed the word “therapy” and the similar word “therapeutic” because these words are not forbidden by DSHEA and are referenced by the AMAEthics Code. We recommend “Therapeutic Nutritionals” for alternative practices centered on Nutrition. We recommend the use of the qualifying word,“Nutritional” in this context to make it completely clear that the practitioner is not offering “treatment of disease.”The claims made for Therapeutic Nutritionals must, of course, be allowed Structure and Function Claims. Thus, for example, under current law asinterpreted by the FDA, one cannot claim that a nutrient lowers cholesterol levels – since there is now a “disease” of hypercholesterolemia – butcan claim that a nutrient maintains normal cholesterol levels for persons with normal cholesterol. A purveyor may say that a certain combination ofmultivitamins was designed to maintain normal structure and function for a person with diabetes, but not that the combination “treats” diabetes oraffects the blood sugar level.
Similarly, any Health Claim made for any alternative practice must meet the FTC standard of "truthful and notmisleading" and must be based on standard commercial substantiation criteria.CAM products are intended to benefit normal structure and function and are not prescribed as treatment for medical or psychological conditions, nor fordiagnosis, care, treatment or rehabilitation of individuals, nor to apply medical, mental health or human development principles.
As the High Court said in Thompson v Western States, "We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information. * * * Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative ofrequiring … a warning..."What is the proper level of substantiation for CAM nutrient or health claims? It is not the "significant scientific agreement" required of drug claims, butrather, the general "competent scientific evidence" standard that applies to all commercial claims. That does not imply that purveyors need to havemultiple double-blind experiments (as may be required for drug approval). Substantiation merely needs to be competent and scientific. We urge this toinclude research studies (which is when scientists review the work of others and apply it to specific questions) and clinical trials (which may be asformal as double-blind, placebo controlled investigations but need not be, since multiple variables, like those involved in CAM practices designed topromote optimal health, are not well studied by double-blind, placebo controlled investigations) as well as traditional knowledge, clinical casestudies, observational reports and clinical experience.
All of these sources of information and experience have a role to play, but ultimately, suchsubstantiation must rest on the informed professional opinion of some credentialed or appropriately experienced person who can (in the case ofDietary Supplements, for example) sign onto the Structure and Function Claims Notice to the FDA, attesting that "the notifying firm has substantiation that the Statement to which this Notice applies is truthful and not misleading." (Regulations under 21 U.S.C. 403(r) (6)). The Natural Solutions Foundation favors a market approach to these issues and urges the FDA to reduce regulation to those minimum levels that will encourage the continued rapid development of CAM approaches. Especially when dealing with Dietary Supplements and Traditional Remedies, we are dealing with foods which, as foods, are presumed to be safe.
There is no need for the high level of regulation that is required for the dangerous and invasive drugs and techniques of so-called “standard” medicine. Even with this stringent level of oversight, drugs are a major cause of death in every developed country while CAM remedies are an insignificant-to-absent cause of death world-wide. Rather, this is a situation where the public is best served by apolicy of Laissez-Faire: allow CAM to develop freely in the public interest.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, un-manageable and unreasonable costs and other invasive technologies of modern medicine.
This search for alternatives is protected by the fundamental right of individuals to communicate and learn; to heal and be healed. This has been settled law forover a hundred years.
"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 anyonecan 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 oursystem 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 onekind -- to allopathy, excluding homeopathy, osteopathy, and all other treatments -- might be a protection to doctors in surgery and medicine; butthat is not the object of the act, and might make it unconstitutional, because creating a monopoly." North Carolina's Supreme Court in State v MacKinght, 42 S.E. 580, 1902 at p 582.
Costs, safety and, most of all, liberty, require that the distinction be made and maintained by the FDA between “treatment” and “therapy” if the USConstitution and public are to be served.
Dated: April 6, 2007
Maj. Gen. Albert N. Stubblebine III, (US Army, Ret.)
Rima Laibow MD
Ralph Fucetola JD
For: Natural Solutions Foundation
Ref: Federal Register: February 27, 2007 (Volume 72, Number 38[Notices - [Page 8756-8757] [wais.access.gpo.gov - DOCID:fr27fe07-95]