Vitamin Lawyer Original
Health Freedom Blog Archive
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19. J. Emord's Proposed House Amendment -
9. BAD NEWS - 05/09/07
3. Guest Blog for NSF - 04/28/07
Rep. Ron Paul on
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06/18/07 - DHEA under attack... again
Although the Vitamin Lawyer handled the cases in 1995 that protected access to DHEA, it appears once again, certain interests are attempting to outlaw this nutrient. For the Back Story, see: How I Kept DHEA Legal, my 2000 report on the cases with link to the Court Order that held DHEA to be a Dietary Ingredient, not a prescription drug or controlled substance.
Now comes a new report from Life Extension Foundation - www.lef.org - that bills have been introduced in Congress (S.762 and HR.1249) to reclassify DHEA as a banned substance. This is, as noted in the article, an attempt to change science by legislative fiat. Sen. Orin Hatch, often a true friend of Dietary Supplements, rightly opposes the bills noting that DSHEA - the Dietary Supplement Health and Education Act of 1994 protected DHEA from being added to the banned steroid category since there is no evidence this natural body substance can possibly cause harm. See: www.lef.org/featured-articles/dheafact - it's time to let your Congressperson know that you want science to protect your foods, not political interference!
06/07/07 - Support for Dr. Paul's Health Freedom Protection Bill Grows
As of 9:15 PM EDT Thursday, June 7th
- total messages sent to the House in support of Dr. Paul's HR.2117 through
Natural Solutions Foundation were 29,351 - the total had been 17,522 Tuesday.
It's been less than a week that this Take Action alert has been active.
06/05/07 - Nutrition Lawyer J. Emord Suggests Amendment to FDA "Revitalization" bill - "Not Unreasonable"
Take Action: Natural Solutions:
Wellness Resources: http://capwiz.com/wellnessresources/issues/alert/?alertid=9773656&PROCESS=Take+Action
From Wellness Resources: "The Senate has
recently passed bill S.1082, commonly known as the FDA Revitalization Act. ...the
legislation, as currently written, opens the door for considerable regulatory
confusion enabling the FDA to use this legislation to undermine my access to
safe and effective dietary supplements. There must be no confusing the safety of
drugs and the safety of food and food ingredients – which are governed by
different laws. ...members of Congress are not intending to
create such concern among the 150 million Americans who rely on dietary
supplements to assist their health, and this matter is easily corrected with the
following amendment, which will not in any way stop the FDA from identifying
truly contaminated food that poses a risk to human health.
"Changes in Existing Law. The following provides a print of the existing statute or part or section thereof to be amended or replaced so as to delete the words “or unreasonable” (existing law proposed to be omitted is enclosed in black brackets, existing law in which no change is proposed is shown in roman):
"CHAPTER IV – FOOD - SEC. 402 (f) – (1) If it is a dietary supplement or contains a dietary ingredient that – (A) presents a significant [or unreasonable] risk of illness or injury under — (i) conditions of use recommended or suggested in labeling, or (ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use:
"Changes in Proposed Bills Proposed amendment to S.1082 and HR.1561:
"The bills are hereby amended to prohibit the Foundation or Institute from evaluating the health benefit or efficacy of foods, dietary ingredients, and dietary supplements and to limit review of foods, dietary ingredients and dietary supplements to a determination of whether they are safe. In assessing whether dietary ingredients and dietary supplements are safe, the Foundation or Institute shall not compare product risks with health benefits or efficacy. Instead, the Foundation or Institute shall determine whether the product presents a significant risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are recommended or suggested in labeling, under ordinary conditions of use..."
My comment: it may seem small, but the words "not unreasonable" do have a big impact... and it is in the small space made by such words (or their deletion) that Health Freedom has room to grow. This amendment, together with the wording of Dr. Paul's HR.2117, would go a long way toward protecting our access to truthful information about the health benefits of foods. Please note that S.1082 does not explicitly mention Dietary Supplements (except for the DSHEA Exemption Amendment adopted 94 to 0) so the suggested Emord Amendment would change existing law to be more protective of Dietary Supplements by attaching the change to the pending bill. One concern I do have with this amendment is that the recent Supreme Court Ephedra decision not to review the appeals court effectively means that nearly any risk of illness may be considered "significant" and therefore, the amendment may not be strong enough. But, one step at a time!
05/31/07 - Head of FDA wants to work more closely with Drug Companies...
Report from Gardner Harris -
"May 30 - When Dr. Andrew C. von Eschenbach took over the Food and Drug
Administration in 2005, the agency had a crisis over drug approvals that had
missed or ignored dangerous side effects in Vioxx, antidepressants and other
Dr. von Eschenbach promised improvements, and agency officials said they would
no longer be caught flatfooted on drug safety.
But this month, The New England Journal of Medicine published a study suggesting
that a major diabetes pill, Avandia, might increase the risk of
Concerns over that drug and others have led Republicans and Democrats in the House and the Senate to call for investigations. A House hearing is planned for June 6. Dr. von Eschenbach said in a briefing on Wednesday that his agency needed to collaborate more closely with drug companies.
"The point is that we need to look at the role of the F.D.A. in being a bridge to the future, not a barrier to the future," he said at his office here."
My question: is working closely with Drug Companies the solution... or the problem?
I suggest that a better solution would be promoting natural remedies without dangerous side effects; not putting up bureaucratic barriers to them. This can best be done by allowing people access to truthful information about traditional, non-drug approaches; by letting natural product purveyors make serious health claims... exactly what Ron Paul's Health Freedom Protection Act would do.
In the twelve hours since www.globalhealthfreedom.org sent an email blast seeking support for the Paul bill over 10,000 people have written their congresspeople supporting the bill! We still need hundreds of thousands to move Congress.
Here's where to do it: http://tinyurl.com/3xwmjm or
05/28/07 - Congressman Paul Reintroduces Health Freedom Protection Act H.R. 2117
Dr. Paul has reintroduced the Health Freedom Protection Act. Essentially this bill shifts the burden of proof onto the FDA whenever the agency wants to deny the public the benefit of health claims information about Dietary Supplements. It provides that reasonable health claims, with proper disclosure language, shall be allowed "unless the Secretary determines that -- `(i) there is no scientific evidence that supports the claim; and `(ii) the claim is inherently misleading and incapable of being rendered nonmisleading through the addition of a disclaimer." Thus, even "a scintilla" of scientific evidence would allow the making of claims that Dietary Supplements may be of benefit to individuals. The requirements of the bill are consistent with the law that already governs the agency's position, announced in 2004, "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'.''
The text of the bill, reintroduced on May 7,
2007, can be found at:
In my opinion, this bill would greatly enhance public access to truthful and not misleading health information, in keeping with the US Supreme Court's dictum in Thompson v. Western States Medical Centers, "If the First Amendment means anything, it means that regulating speech must be a last - not first - resort. *** 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 of requiring ... a warning ..."
This bill, cosponsored by Congressmen Burton of Indiana, Shays, Bartlett of Maryland, and Duncan, presents a clear opportunity to enhance legal protections for Dietary Supplements and natural remedies. Its adoption would shift FDA resources from over-regulation of safe food substances to what could be considered their main task, protecting people from dangerous drugs and medical devices. Currently, we need to encourage other congresspeople to join as cosponsors and get behind the Health Freedom Protection Act.
The FDA "revitalization" bill was recently passed by the Senate; just before it was passed, when Congress noticed hundreds of thousands of people complaining to the FDA to leave our supplements alone, a protective clause was added, exempting Dietary Supplements. The House can now enhance that protection by extending it to all food substances and by adopting the Health Freedom Protection Act. Therefore, we should ask our congresspeople to attach the HFPA to the "revitalization" bill, HR 1561 (House equivalent of S. 1082). While we do not support the bill to increase FDA power, if it is passed, it should include protective language such as the HFPA language.
Support Dr. Paul's bill: http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11754
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.
05/21/07 - Organic Standards being denigrated - little time to complain...
Copy of letter to the Administrator of UDSA's Agriculture Marketing Service:
REQUEST FOR EXTENSION OF
COMMENT PERIOD - Docket ams-tm-07-0062
National Organic Program (NOP) - Proposed Amendments to the National List of Allowed and Prohibited Substances (Processing)
I am writing as a trustee of the Natural Solutions Foundation, a Federally and internationally recognized non-governmental organization (NGO). The Foundation has represented the interests of consumers of natural products and services before various US agencies, including USDA and various international agencies, including Codex.
We and our hundreds of thousands of supporters want a reasonable opportunity to comment on the pending revisions, which appear to substantially dillute the honesty of the organic label, allowing purveyors to provide information which is not "truthful and not misleading" as required by Federal Law and FTC
The 7 day comment period provided in the Federal Registry Notice is not sufficient to allow meaningful public comments.
Natural Solutions Foundation therefore hereby requests a 7 day extension of the comment period, to permit members of the Foundations and other interested members of the public an opportunity to comment.
Ralph Fucetola JD - firstname.lastname@example.org
Trustee, Natural Solutions Foundation
Newton, NJ 07860
Submit comments: http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11431
05/18/07 - New GMP Standards Cleared by OMB – as reported on the Internet
SEN. HATCH: DIETARY SUPPLEMENT GMPS FINALIZED - Completes Effort to Implement Key Aspect of DSHEA
>Washington – Sen. Orrin G. Hatch (R-Utah) today announced the Office of
Management and Budget has given final clearance for good manufacturing practices
(GMP) regulations for dietary supplements.
>“Finally!” Hatch said. “This is very good news. Senator Harkin and I have been pushing the FDA to publish these for more than a decade.”
>Hatch is one of the principal authors of the Dietary Supplement Health and Education Act of 1994, which gave the FDA the authority to write GMP guidelines specific to supplements. GMPs are the standards inspectors will use to assure purity, potency, and all the other requirements of clean, legal manufacturing. The GMPs are expected to be published within the next five weeks.
>“GMPs are crucial because they assure the public that the products they are buying live up to their labels,” Hatch said. “Since it took an unusually long time to issue these final guidelines, I want to review the final version very carefully to make certain they are good regulations. Every indication leads me to believe the Administration was very sensitive to the impact the GMPs might have on the industry, especially on small businesses.”
We are likely to get a look at the GMPs within the next few
weeks. I will keep this Blog informed of these developments, that I have long
predicted. When the GMPs are issued, I will update the standard Vitamin Lawyer
Consultancy SOPs (Standard Operating Procedures) to conform. My current formats
are outlined at:
05/13/07 - EPHEDRA BAN CONTINUED - The United States Supreme Court decided not to hear the ephedra case appeal. This decision leaves standing the appeals court reversal of the Utah district court's voiding of the FDA's ban on the Chinese herb Ephedra. In effect, a drug industry risk/benefit standard has been imposed on the Dietary Supplement industry:
According to NutraIngredientsUSA, "The most recent court ruling on ephedra blurs the distinction between supplements and drugs and could force the industry to conduct clinical tests, says the Natural Products Association..." The "once-popular herbal, was banned by the FDA's final rule in 2004 on the grounds that it does not present a significant health benefit to outweigh the reported increased risk of heart attack, stroke and death. ... A year later the ban was successfully challenged by Nutraceutical in a Utah court since the 1994 Dietary Supplements Health and Education Act (DSHEA) does not make mention of risk-benefit balance in establishing whether a supplement presents an unreasonable risk. Rather, the FDA drew on the medical devices provisions of the Food Drug and Cosmetics Act, which does state that this is a determining factor. ... Since then the pendulum has swung back and forth on appeal..." http://www.nutraingredients-usa.com/news/ng.asp?n=75628-pa-ephedra
Judge Campbell's reasoning, however has not been rejected by the Supreme Court, as it decided in its discretion, not to hear the case. Future cases asserting the same legal claim, that Congress intended Dietary Supplement law to be harmonized with food law, not drug law, could be further strengthened by steps the US Senate took last week to exempt Dietary Supplements when it approved enhanced powers for FDA.
In the 2005 case, Judge Tena Campbell held, “..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…”
therefore incumbent upon Congress to protect this salutary policy and further
enhance it, by writing a much stronger exemption for all foods and natural
products into 1082, the FDA Revitalization Act of
2007 when it comes before the House.
05/12/07 - Take Action: http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11344 Tell your representatives, "S. 1082 fails to protect food and Dietary Supplements, generally regarded as foods, by protecting only DSHEA products, and leaving foods, compounded products, nutraceuticals, compound and bioidentical substances and functional foods without protection."
05/11/07 - Our legal researcher, a graduate attorney, has spoken to Sen. Durbin's office. Here is his report: "S. 1022 is part of the final Senate Bill"
Kndyintern3 (HELP Committee) [mailto:Kndyintern3_Help@help.senate.gov]
Sent: Friday, May 11, 2007 1:40 PM
Subject: Amdt. 1022 status
Dear Mr. G,
The Durbin-Enzi-Kennedy Amendment #1022 you inquired about was agreed upon and is part of the FDARA bill that passed the Senate last Wed. If enacted, it would establish a rule of construction that states that nothing in this title should be construed to effect the regulation of dietary supplements under DSHEA or the reporting system under the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Please let me know if there is anything else I can help you with.
05/10/05 - It still remains unclear whether S Amend 1022 (the DSHEA exclusion provision) was or was not included in S.1082 as it passed the Senate. I expect to have word from aides in the House shortly, when the House members get the bill. This bill will be contested in the House, so stay tuned... we may need you to contact your congressperson, if a member of the Subcommittee on Health.
05/09/07 - BAD NEWS - S.1082 passed the Senate... no mention of Dietary Supplements; no specific exemption (the Durbin Amendment, after being preliminarily approved, was apparently not included in the final bill). While the bill sent to the House does not mention Dietary Supplements anywhere in its language, this bill has so many flaws that IT MUST BE DEFEATED IN THE HOUSE. If not defeated, a strong exemption for foods (including dietary supplements) must be included. People need to contact their Representatives and build pressure on the House to protect our supplements and alternative practices.
Says Mike Adams of www.NewsTarget.com -
by Mike Adams
The U.S. Senate passed the FDA "drug safety" bill today (S.1082) with a 93-1 vote. A key amendment that would have called for genuine drug safety protections for consumers -- the Grassley amendment 1039 -- was defeated by a single vote (47 to 46). The new law deepens financial ties between Big Pharma and the FDA, doubling the amount of money directly paid to the regulator by drug companies, but it fails to explicitly protect foods and nutritional supplements from overreaching FDA regulation efforts. The new law also failed to end Big Pharma's monopoly stranglehold on American consumers, further blocking the ability of citizens, businesses, cities and states to import equivalent medications from countries like Canada (where drugs are far safer than those sold in the United States, by any measure).
Health freedom advocates such as Byron Richards of Wellness Resources (wellnessresources.com), John Hammel of the International Advocates for Health Freedom (iahf.com), and myself (newstarget.com) sought to garner enough grassroots support for achieving the inclusion of key amendments in the bill, such as the Dorgan amendment which, for four days, appeared to end the medical monopoly that currently forces American consumers to pay the highest prices in the world for prescription drugs. Although hundreds of thousands of consumers contacted their lawmakers to demand an end to the monopoly price fixing currently operating in the United States, lawmakers seemed confused and could not bring themselves to support any amendment that would have threatened the profits of Big Pharma. Ultimately, the Dorgan amendment was quickly defeated by the Cochran amendment, trapping Americans in a monopoly medical market that would be considered illegal by nearly everyone if a corporation like Microsoft attempted something similar.
S.1082 ultimately passed with amendments that primarily support the agendas of Big Pharma and the FDA, expanding the powers of both. Very few provisions were accepted that addressed the serious issues of corruption, conflicts of interest, television drug advertising or genuine drug safety.
Health freedom advocates are now characterizing the final bill as the, "Big Pharma Protection Act of 2007" due to its emphasis on protecting the monopoly drug market in the United States while doing very little to accomplish its stated goals of increasing the "safety" of prescription drugs.
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..."
On the same day, S.1082, a bill many viewed as a threat to
health freedom was amended to exclude Dietary Supplements, so they would
continue to be governed by existing law. As to why S.1082 was amended to protect
Dietary Supplement Health and Education Act (DSHEA) products, I have it from
people "on the Hill" that Congress knew a constituent storm was brewing.
I am personally aware that key congresspeople knew about the huge public response to the FDA draft guidance ploys. When people started contacting congresspeople on the S.1082 issue, supporting Counsel J Emord's suggestion that S.1082 be amended, the Senate acted quickly and decisively. They knew what would happen if they did not act, since they had just seen the storm over the FDA guidance, where over 180,000 people told the FDA to leave our alternative health care practices alone. I think it is really naive to assume these events were not connected in Beltway mentality, as some commentators have suggested.
Our view that the antiCAM guidance is dangerous is not some bizarre fringe view. For example, 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 antiCAM
guidance. He called it "an abuse of FDA power." He concluded his detailed analysis of the failures of the guidance, and its dangers, with these
"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 care
practitioner 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.
05/03/07 - Some very good news: Congress has just accepted the following amendment to S.1082 - Enhancing Drug Safety and Innovation Act of 2007 - from Sen. Durbin. It appears that Congress heard our concerns! We understand hundreds of thousands of messages to FDA reverberated through the halls of Congress. The Senate amendment was adopted with 94 out of 100 votes.
Sec. X08. Rule of Construction
Nothing in this title (or an amendment made by this title) shall be construed to affect--
(1) The regulation of dietary supplements under the Dietary Supplement Health and Education Act; or
(2) The adverse event reporting system for dietary supplements created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act.
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...
04/29/07: Enhancing Drug
Safety and Innovation Act of 2007 - see:
http://www.lef.org for more information
Or link to: http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11230 for another petition from NSF.
Late Breaking News: Bill amended on 05/03/07 to exclude Dietary Supplements! S. Amendment 1022
We thought Senator Kennedy's
dangerous S.1082 was going to languish in committee a while, but it's been sent
out of committee without hearings and
may be heading for a Senate vote as early as 04/29 (though, it would still have to pass the House of Representatives, which may be another story...)
See: http://www.lef.org - See: http://www.healthfreedomusa.org/index.php/?p=370
Both LEF and NSF offer ways for you to tell your congresspeople to STOP! So use both! And, if you can, call your Senators to alert them directly.
Says Dr. Laibow:
"Right now the American Public is being whipsawed: first the dangerous FDA CAM Guidance (Complimentary and Alternative Medicine/Modalities) which threatens to turn all health practices into medicine which only physicians could practice and the foods and supplements supporting natural health into
unlicensed drugs – and, yes, there is a real danger to your health freedom despite a good deal of internet chatter to the contrary!) and now the sudden
advancement of Senator Ted Kennedy disastrous bill, S 1082 (“the FDA Revitalization Act of 2007”, plus the identical House bill) from Committee
to the floor of the Senate for a vote in the immediate future without public hearings. It would be easy to succumb to “health freedom vigilance
fatigue”, which is, I believe, exactly what the intended effect is supposed to be. There is even speculation that Senator Kennedy moved this bill forward
so rapidly BECAUSE the American public responded so vigorously to the CAM Guidance and are presumed to be preoccupied with it."
Direct link to action:
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 those rules 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. 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 such
services, 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 JD
A Natural Solutions Foundation Guest Blog Entry
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, 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 JD
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: www.silverfacts.com
4. See Dr. Laibow’s Nutricide at www.globalhealthfreedom.org
5. See: http://www.lef.org/featured-articles/consumer_alert_020307.htm
6. See “Take Action” at 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 – 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 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”4
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 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 - NSF
1. Diane Miller JD pointed this out to me - 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: 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
To: Food and Drug Administration
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 Their
Regulation 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. That
distinction 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 and
maintain a healthy status, either on their own or complementary to standard medical care. These practices do not include the potentially dangerous use of
invasive techniques and toxic drugs that are the sole province of licensed medicine. They do, however, include developing therapies and nonstandard
approaches 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 and
alternative practitioner. Changes made during the early 1990's were inspired by anti-trust lawsuits brought (and won) during the 1980's by chiropractors
and 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 "for
therapeutic or diagnostic services to another physician, limited practitioner or any other provider of health care services permitted by law to furnish such
services, 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. 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 AMA
Ethics 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 as
interpreted by the FDA, one cannot claim that a nutrient lowers cholesterol levels – since there is now a “disease” of hypercholesterolemia – but
can claim that a nutrient maintains normal cholesterol levels for persons with normal cholesterol. A purveyor may say that a certain combination of
multivitamins was designed to maintain normal structure and function for a person with diabetes, but not that the combination “treats” diabetes or
affects the blood sugar level. Similarly, any Health Claim made for any alternative practice must meet the FTC standard of "truthful and not
misleading" 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 for
diagnosis, 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 of
requiring … 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, but
rather, the general "competent scientific evidence" standard that applies to all commercial claims. That does not imply that purveyors need to have
multiple double-blind experiments (as may be required for drug approval). Substantiation merely needs to be competent and scientific. We urge this to
include research studies (which is when scientists review the work of others and apply it to specific questions) and clinical trials (which may be as
formal as double-blind, placebo controlled investigations but need not be, since multiple variables, like those involved in CAM practices designed to
promote optimal health, are not well studied by double-blind, placebo controlled investigations) as well as traditional knowledge, clinical case
studies, observational reports and clinical experience. All of these sources of information and experience have a role to play, but ultimately, such
substantiation must rest on the informed professional opinion of some credentialed or appropriately experienced person who can (in the case of
Dietary 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 a
policy 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 for
over 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 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 our
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 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 US
Constitution 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]
I want to tell you, son,
About some of what we lost
In the headlong rush
Toward that imperial vision
That toppled the Old Republic.
Your family played a role
Living by the world capitol,
Descendants of ancient kings;
Your powerful relation nearly dictator.
How do you protect your own?
And what runes were cast
When he crossed that Rubicon?
Millions in chains… torture
Displayed for all to see.
Grandeur and greatness…
Most powerful army ever.
None can stand before
The might of RomeAmerica.
All the world worships us,
And despairing, must rebel.
The ancient writs no longer apply.
Authority multiples daily.
What’s the market for liberty
When security’s the only coin?
The great believe they have no choice
But to vie for greater power.
The ancient virtues
Of the founding fathers…
The best and noblest lost,
While all the rest prefer not to know.
“We hold these truths self-evident…”
Forgive these mutterings
Of a former Son of Liberty.
The Old Republic never died,
So long as it lives in you.
[The Father in this piece could be imagined to be a somewhat distant relation of the Julii family, in Rome, just about the time cousin Cesare became dictator, late 1st Century BCE. The persona longs for the return of the Old Republic. This story is not about the America of your Greene/Lee/Custis ancestors at the time of the Whisky Tax Rebellion in the late 18th Century... but maybe about an imperial America in the early 21st Century...
© R Fucetola JD
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