John C. Hammell, Founder
International Advocates for Health Freedom
2411 Monroe St.
Hollywood, FL 33020 USA
800-333-2553, fax 954-929-0507
jham@concentric.net, fax on demand 954-927-8795
www.iahf.com
August 2, 1997
Kenneth D. Fisher, Ph.D., Executive Director, Commission on Dietary
Supplement Labels
via email: cdsl@birchdavis.com
via fax: 202-205-0463
The Commission on Dietary Supplement Labels has invited comment upon its draft "Report to the President, the Congress, and the Secretary of Health and Human Services." International Advocates for Health Freedom hereby respond to that invitation by submitting comments for the Commission's consideration.
IAHF feels strongly that the comments period on the Draft Report (which ends August 4, 1997) has not been sufficiently publicized, and is not of sufficient length to properly include input from the millions of Americans who worked hard to pass the Dietary Supplement Health and Education Act of 1994 (DSHEA), and to give them a chance to read the report and respond.
The IAHF emphasizes that the National Nutritional Foods Association, American Herbal Products Assn, and Utah Natural Products Alliance do not speak for consumers. IAHF has evidence that mergers and acquisitions are occurring as the pharmaceutical industry buys their way into the dietary supplement industry, and as consumers we especially distrust the efforts of the aforementioned trade associations to create an OTC drug category for herbs and botanicals. As discussed below, all language in the draft report involving creation of this OTC drug category for herbs and botanicals exceed the statute defined in DSHEA, and by law, must be removed.
IAHF also does not consider the Commission to be in compliance with the Federal Advisory Committee Act, PL 92-463 due to the fact that it did not hold truly open meetings. The bulk of the work was done behind closed doors, in closed sessions and the public was denied access to the committees reports as the process unfolded. IAHF believes that the public meetings that were held were held in order to give the appearance of openness, a sort of "high drama" designed to placate the public. Moreover, the Commission was supposed to be set up as an "independent agency" under the executive branch. So, why was it set up under Health and Human Services, the same cabinet department that houses the FDA??
Although I (John Hammell), as a professional who reads the Federal Register and is immersed in health freedom issues had sufficient awareness of what was going to be able to request your 77 page draft report from the Commission's Response Center at 301-650-0382, how many other consumers are aware of what is going on? Despite requesting your Draft Report the moment it first became available at the end of June, it didn't reach me until 2 weeks ago, I didn't have time to finish reading it until a week ago, and that left almost no time for IAHF to draft comments, much less alert consumers to the issue. I have since learned that your draft report may also be downloaded from www.crnusa.org/draft.htm.
For this reason IAHF created a form letter (attached) calling for an extension on the Comments Period, and within the past week disseminated the form letter via the internet, fax on demand, and discussed its contents in Las Angeles CA on KPFK radio's "Beneath the Surface", encouraging people to request a comments extension. IAHF requests a comments extension until the end of October 1997 in order for the American public to have sufficient time to become aware of these proceedings so as to have sufficient time to submit comments. During the summer, many people are on vacation, and IAHF feels strongly that more time is needed for the public to become aware of this comments period and to respond. IAHF intends to continue appearing on radio shows of this type to continue discussing this draft report especially as more information comes to light regarding the gross injustice of its contents.
IAHF is working closely with Suzanne Harris, JD of the Law Loft in Johnstown Colorado, who will be submitting more extensive comments, paying particular attention to how the draft report threatens consumers as an instrument of Codex harmonization- as a vehicle by which the multinational pharmaceutical industry actively seek to take control of the dietary supplement industry. At the meeting of the Codex Executive Committee in Geneva at the end of June, Harris got into the briefing on the Codex Committee on Sanitary and Phytosanitary Measures, and became aware of the fact that from an emerging international law perspective, it is IMPERATIVE that dietary supplements remain classified as FOODS, otherwise American consumers will lose access to them.
I have been closely following the Codex International Threat to Health Freedom, and so has Harris. (See the IAHF website for details) I was a member of the American Codex delegation to the Codex Committee on Nutrition and Foods for Special Dietary Use meeting in Bonn, Germany, October, 1996, and Harris had a press pass to attend the meeting of the Codex Executive Committee in Geneva, Switzerland in June, 1997. We have both published articles about the Codex International Threat to Health Freedom, and I point you to www.iahf.com for details. When completed, Suzanne's comments will be posted along with these, in the IAHF website in order to educate consumers world wide.
On August 1, 1997, the American Preventive Medical Association (APMA) faxed IAHF a copy of the Joint Comments submitted to you by APMA; the National Health Federation; Trace Minerals Research, L.L.C.; Healthy Directions, Inc; Meditrend Inc., DBA Professional Formulations; Pure Encapsulations, Inc; Julian Whitaker, MD; Charles B. Simone, M.D., M.MS; Harry Preuss, M.D., F.A.C.N; Shari Lieberman, Ph.D., C.N.S.; and Durk Pearson and Sandy Shaw. The comments were prepared by Emord and Associates, P.C. 1050 17th St. N.W. Ste. 600, Washington DC, 20036, (202)466-6937. [These Joint comments will be referred to as the Emord comments, and in time may be available to download from http://www.emord.com] These comments by IAHF will not only be submitted to the Commission before August 4, but in order to educate the public on the topic of Codex harmonization, and to warn them that the Commission has overstepped its congressional mandate by advocating creation of an OTC drug category for herbs which threatens to plunge the supplement industry down a slippery slope towards oblivion, will simultaneously be emailed to a large distribution list, posted in usenet newsgroups, and discussed over talk radio.
Borrowing from Emord's comments, IAHF is alerting Americans that the Commission may only issue recommendations on matters defined by the statute, that the Commission has elected to address issues not defined by the statute, that the Commission has failed to address the central issue defined by statute: "How Best to Provide Truthful, Scientifically Valid, and Not Misleading Information to Consumers So that Such Consumers May Make Informed and Appropriate Health Care Choices For Themselves and Their Families, and that the FDA currently violates the first amendment by engaging in prior restraint on health claims- yet the Commission seems to accept this. Moreover, in its Draft Report the Commission has utterly failed to uphold its mandate by utterly failing to recommend an acceptable calculated approach to best provide truthful, scientifically valid, and not misleading information to consumers so that they may make informed and appropriate health care choices.
IAHF has carefully read and agrees with Emord's detailed comments, and has faxed them to Suzanne Harris to assist her in drafting additional comments which IAHF will also endorse.
In order to generate a deeper awareness of the need for the Commission to make extensive changes in the current Draft Report so as to legally fulfil their mandate, IAHF will hear by summarize some of the main points made in Emord's comments. While these comments will also touch on how the Commission's draft report constitutes Codex harmonization, for details on this subject, we refer you to Harris' comments, which as of this writing, are still in progress.
Emord points out that unlike most presidential commissions, "(which have little import beyond the giving of advice), the President's Commission on Dietary Supplement Labels has substantial importance because each of its recommendations will become proposed rules, published in the Federal Register. (See 21 U.S.C.- 343.) Thus each of its recommendations may become law- placing both a unique burden on the commission while also creating a unique opportunity."
Emord states: "Congress gave the Commission an historic opportunity to improve consumer welfare, recognizing that health benefits attainable from dietary supplements would not be realized if consumers were unaware of those benefits at the point of sale. Congress looked to the Commission for recommendations on how best to reform the FDA's health claims review process "to provide truthful, scientifically valid, and not misleading information to consumers so that such consumers may make informed and appropriate health care choices for themselves and their families. In its draft report, the Commission failed to supply any alternative to the FDA's health claims review process. Unless the Commission's final report repairs that deficiency, the Commission will not only violate its statutory mandate but will also forfeit its historic opportunity to improve consumer welfare."
In the Summary of his comments, Emord goes on to state: "The Draft Report fails to evaluate the extent to which FDA's pre approval requirement for health claims suppresses truthful and non misleading health information on labels and in labeling of dietary supplements. The Draft Report fails to evaluate the impact such suppression has on consumer welfare. The Draft Report fails to present alternatives to existing FDA health claims regulation and fails to evaluate "how best to provide truthful, scientifically valid, and not misleading information to consumers so that such consumers may make informed and appropriate health care choices for themselves and their families in accordance with its statutory mandate. In short the Commission has not performed the essential functions that Congress prescribed for it in the Dietary Supplement Health and Education Act of 1994."
"Moreover, the Draft Report makes several ultra vires recommendations concerning dietary supplement safety, FDA enforcement procedures, notice requirements for statements of nutritional support, substantiation files for statements of nutritional support, over-the-counter regulation for botanical products, consumer research, and public funding of scientific research on dietary supplements. None of those subjects is within the scope of the Commission's delegated authority. If the Commission includes those recommendations in its final report, it will have acted improperly, in breach of its duty to Congress, and unlawfully, beyond the scope of its delegated authority."
"Furthermore, in light of the requirement that FDA promulgate proposed rules based on the committees recommendations, ultra vires recommendations may beget law and beget expenditure of agency time, resources, and public funds in areas not intended by Congress. Ultra vires recommendations will place the FDA in an untenable position: either following the Commission's lead and thereby violate the plain meaning of the statute and the will of Congress by publishing the proposed rules or flouting the Commission's desire and thereby honoring the plain meaning of the statute and the will of Congress."
"The Joint Commenters urge the Commission to repair the report's deficiencies by (1) carefully assessing and analyzing the extent to which the FDA current prior approval requirement for health claims blocks the communication on labels and in labeling of truthful, scientifically valid, and not misleading information; (2) issuing recommendations to change the prior approval process to permit, without prior restraint, the communication on labels and in labeling of truthful, scientifically valid, and not misleading information in accordance with the recommendations made herein; and (3) removing from the report all recommendations that concern any matters other than those pertaining to dietary supplement labels and labeling in accordance with Congress's mandate."
"The Joint Commenters herein supply the Commission with recommendations that can ensure that truthful, scientifically valid, and non misleading information reaches consumers on the labels and labeling of dietary supplements. The Joint Commenters urge the Commission to draw a distinction between the changes that the FDA may make unilaterally and those that would require further congressional action. The Joint Commenters urge the Commission to recognize that Congress's mandate to the commission demands that the Commission articulate how best to provide truthful, scientifically valid, and not misleading information to consumers in labels, and in labeling, whether that methodology is currently codified or not. To fulfill its statutory duty, the Commission must act on the precise demands Congress put to it in the statute."
"Congress expected the Commission to come up with answers to the vexing issue of how best to revise the FDA's health claims prior approval process. Congress acted in light of the profound public objections to the speech suppressive effects of that process and in light of First Amendment limitations on FDA's regulation of speech. It asked the Commission to explain the best way of ensuring that truthful, scientifically valid, and not misleading information reaches consumers so that they may make informed and appropriate health care choices. At best, the draft report only tangentially touches upon that central issue; yet, to fulfill congressional intent, the Commission must make evaluation of the speech suppressive effects of the FDA's prior restraint on health claims the focus of its analysis and the basis for its recommendations to the FDA. It must present a thoroughly reasoned explanation of the best speech protective alternatives to the current prior restraint, not simply place its imprimatur of approval on the existing health claims review process."
"Congressional dissatisfaction with that regime directly led to the creation of the Commission. Congress knew of FDA's prior restraint at the time it passed DSHEA and expected the Commission to identify alternatives for legislative and regulatory reform. Only if the Commission revises its report to do so can it properly discharge its duty to Congress and the American people."
Emord's comments go on to specifically define the Commission's duties under the statute, stating that it has no power or authority other than that defined by statute. IAHF agrees with Emord's assessment that the Commission was created by Congress to address ONLY these functions: (1) to study FDA regulations of dietary supplement label claims; (2) to make recommendations concerning those regulations and the agency's procedure for evaluating label claims; and (3) to evaluate hose best to provide truthful and non misleading information to consumers so that they make informed health care choices in those recommendations.
IAHF shares Emord's concern that the Commission has made no effort to evaluate the speech suppressive effects of the agency's prior restraint on health claims, and why they fail to assess the effect FDA's undefined "significant scientific agreement" standard and general approval process has upon the willingness of companies to pursue health claims.
IAHF shares Emord's view that the Commission utterly fails to provide ANY analysis of the extent to which existing regulations block truthful and misleading health information from reaching consumers on dietary supplement labels. In his serious, critical analysis, Emord presents a strong argument as to the arbitrariness of FDA's non defined "significant scientific agreement" (SSA) standard, corroborating the point by discussing FDA's treatment of the folic acid/neural tube defect claim. (NTD). Emord explains that FDA's "significant scientific agreement standard" is based more on political whim than on science. He states that in 1991, FDA "proposed not to authorize a health claim on folic acid and NTDs on grounds that there wasn't sufficient SSA to support the claim, but two years later, due to political pressure, they reversed this decision- despite the fact that the information they based their reversal on was the same evidence before them at the time they decided to block the claim.
Emord states that from 1992 through 1994, while FDA was deliberating significant scientific agreement, 7,500 babies were born with neural tube defects, of which approximately HALF could have been prevented through consumption of folic acid), a tragedy of horrendous proportions for the infants and their families, involving incalculable pain, suffering, expense, and death.
Emord points to the fact that FDA ignored the US Public Health Services strong recommendation for folic acid supplementation during that same period.
Emord states that in 21 USC- 343(r)(5)(D), Congress did not adopt a standard or procedure for the approval of health claims but expressly ordered the FDA to adopt a standard, while expressly forbidding them from using "significant scientific agreement." So, FDA not only failed to define a standard, but expressly used the very language that Congress forbade them to use (SSA), while refusing to define those terms in any certain or meaningful way- citing no way to subject the standard to judicial review to determine its compliance with the Administrative Procedure's Act.
In fact, says Emord "we are left with a standard less system, one of unbridled agency discretion: precisely that which the First Amendment abhors. (See Graff v. City of Chicago, 986 F. 2nd 1055, 1066 (7th Cir. 1993) "to presume that [the Government] will act in good faith and adhere to the standards absent from the [regulations] face... is the very presumption that the doctrine forbidding unbridled discretion disallows"). Emord declares "this commission should not condone the agency's failure to define any certain, meaningful, and comprehensible standard for review of health claims. By doing so, it supports the agency's suppression of truthful, scientifically valid, and non misleading information and the attendant harms to public health association with this suppression."
Emord goes on to discuss in detail how this suppression of truthful information puts consumers at risk, and states that most consumers simply cannot afford to pay for professional dietary counseling- so it is wholly unjustified to block truthful information from being presented on the label.
Emord states that "FDA's prior restraint of health claims is one of the countries last vestiges of classic censorship. Censorship regimes that rest upon total subjectivity are unconstitutional, whether they regulate forms of speech that are not entitled to constitutional protection (obscenity) or ones that are (health claims on labels and in labeling.) (See Adolph Coor's Company v. Brady, 944 F2nd 1543, 1546 (10th Cir 1991) ("Product labels, which are part of a firm's marketing plan to provide certain information to the consumer,... constitute commercial speech").
Emord goes on to state that "the FDA's prior restraint is constitutionally suspect. The Supreme Court has repeatedly held that "any system of prior restraints of expression bear[s] a heavy presumption against its constitutional validity." (Bantam Books, Inc. v. Sullivan, 372 US 58, 70 (1963); etc.
"The Supreme Court has held that, "only false, deceptive, or misleading commercial speech may be banned" in recognition of the fact that "disclosure of truthful, relevant information is more likely to make a positive contribution to decision making than is concealment of such information." (Ibanez v. Florida Dept. of Business and Professional Regulation 114 S.Ct 2084, 2088 (1994), citing Peel v Attorney Registration and Disciplinary Comm'n of Ill, 496 US 91, 108 (1990)., etc.
After citing many more Supreme Court decisions to bolster this position, Emord recommends the removal of all ultra vires recommendations made in the current report, while presenting a five part analytical construct which would allow for communication "in a manner least likely to mislead the public based on the extent of scientific support for the association." This would include use of appropriate disclaimers "noting the presence or absence of conclusive proof and of agency approval" in order to guard against misleading impressions.
Basically, under Emord's system, a level 1 claim would be one which FDA has not approved, but for which peer reviewed evidence exists to show an association between a nutrient and a disease. The claim could be made, a source cited, and FDA could then state their disapproval. It would be up to the consumer to make their own determination. In level 2 and 3 claims, there is more and more evidence, but FDA still states disapproval. In level 4, evidence is provided to support a claim and FDA also approves. In level 5, Another Federal Health Agency has approved the claim. The existence of a level 4 claim should not preclude use of a Level 1,2,3, or 5 claim on the same label or labeling.
IAHF strongly advocates an extension in the comments period until the end of October, 1997 so that far more consumers can read the Commission's 77 page draft report and have time to submit comments. IAHF reserves the right to submit additional comments after having the chance to review Harris's comments which haven't been finished yet. Harris's comments will detail how the Commission's activities dovetail with the Codex International Threat to Health Freedom. IAHF questions the legality of how the Commission has conducted its activities, and feels that the Commission is deliberately trying to escape public scrutiny as part of Codex harmonization- which is unconstitutional. (Harris will develop this point fully in her comments.)
IAHF shares the conclusions of Emord that the Commission must "repair deficiencies of the draft report by altering it in the following ways: (1) adopt in lieu of its current recommendations on health claims those presented above and (2) eliminate from its report all recommendations that concern any matters other than those directly pertaining to dietary supplement labels and labeling (namely, remove all recommendations concerning the safety of dietary supplements, the format of letters of notification for statements of nutritional support, the maintenance of files substantiating those statements, OTC regulation of botanical products, and public funding and incentives for scientific research on dietary supplements."
To: Kenneth D. Fisher, Ph.D. Executive Director, Commission on
Dietary Supplement Labels
Office of Disease Prevention and Health Promotion
R. 728G Hubert H. Humphrey Building
200 Independence Ave. S.W. Washington, D.C. 20201
Ph. 1-202-401-5811, Fax 1-202-205-0463
Date:
Dear Dr. Fisher:
I understand that the Commission was (supposedly) created "as an independent agency under the executive branch" by the passage of the Dietary Supplement Health and Education Act of 1994 to..."conduct a study on, and provide recommendations for, the regulation of label claims and statements for dietary supplements, including the use of literature in connection with the sale of dietary supplements and procedures for the evaluation of such claims." I understand that in making its recommendations, the Commission is to..."evaluate how best to provide truthful, scientifically valid, and not misleading information to consumers so that such consumers may make informed and appropriate health care choices for themselves and their families." (How can the Commission be said to have been "independent under the executive branch" when it was set up under HHS, the same cabinet dept. which includes FDA??? Was the Commission legally established in accordance with the Federal Advisory Committee Act, PL 92-463? Were all meetings TRULY open? Shouldn't it have been set up as a TRULY "independent agency"???)
I gather that if I call the Commission's Information Response Center at 301-650-0382, they will send me the 77 page draft report of the Commission on Dietary Supplement Labels. Given the time constraints in obtaining this report fast enough to read it in entirety in order to file comments prior to your August 4, 1997 deadline, I am formally requesting an extension on the comments period in order to allow me sufficient time to procure the report, read it as well as to draft more extensive comments. I am appraising my Senators and Congressmen of the following concerns about the draft, which were called to my attention by International Advocates for Health Freedom:
On p.ii, pp.16-17, and p.20 I feel that you should strike all references to ephedra posing a "safety issue" given the fact that a Medline Search indicates that you have no peer reviewed evidence to support your contention that ephedra has caused death, and given the fact that we are currently undergoing a comments period with regards to ephedra regulation. I do not feel that it is appropriate for you to cite ephedra as an example of an "unsafe" product being marketed. A search of Medline turned up zero reports of deaths caused by ephedra, and several reports of death caused by ephedrine, and pseudoephedrine products, including many commonly used OTC drugs such as children's cough syrup. If FDA is concerned with safety, let FDA regulate ephedrine, and pseudoephedrine products which have been documented to cause death. Leave ma huang/ephedra alone. We don't need or want the FDA's double standards incorporated into this report. This information comes from the affidavit of Miloslav Nosal, a biostatistician, who is serving as an expert witness in a lawsuit filed by Freedom of Choice in Health Care against the Canadian HPB.
I feel strongly that the creation of an OTC drug category for herbs and botanicals (as described on p.vii in your report), is not in the long range best interests to consumers. Foods are not drugs. By law, DSHEA established a food definition for dietary supplements. We object strongly to the proposal to create an OTC drug category for herbs and botanicals. Our gains under DSHEA would be put at risk if an OTC drug category were created. We feel that expanded health claims should be allowed under DSHEA based on overwhelming scientific evidence attesting to both the safety and efficacy of dietary supplements for many medical conditions, and we feel that to deny these truthful claims violates our first amendment rights to free speech. We favor a split label in which FDA can say what they want on their half, and the manufacturer can offer validated information on the other half.
We object to a comments period which effectively excludes the views of millions of concerned dietary supplement consumers who have not had sufficient time to procure your draft report, much less to read it and to submit comments. Given the enormous consumer push behind DSHEA, we feel strongly that consumers are being largely disenfranchised, and we would like the comments period to be extended until the end of October, 1997. We are outraged by the ongoing push to regulate foods as "drugs." We would like until the end of October to review your draft report and to file comments. I am appraising my Senators and Congressmen of these concerns.
Signed: ___________________________________
City: ______________________________ State: _______________ Zip: __________
(Info courtesy I.A.H.F. 800-333-2553, www.iahf.com, jham@concentric.net)
International Advocates for Health Freedom is a catalytic entity, a consulting firm which staunchly opposes efforts by an out of control Medical Industrial Complex to control herbs, and other God given healing agents via patent rights and corrupt, coercive political tactics such as the Codex shell game currently being played out at both the international and national levels. Central to our mission is intelligence gathering, education, information dissemination and networking with other TRUE grassroots health freedom organizations world wide.
Our articles have been published world wide, we maintain an internet website and fax on demand server and we promote health freedom via radio, and public speaking. We oppose "astroturf" in its many manifestations. Astroturf= fake grass roots: groups which PURPORT to be on the side of consumers, but which are actually controlled at the top by pharmaceutical companies which have been buying their way into the supplement industry via mergers, acquisitions and strategic alliances with zero concern for the public health.
I.A.H.F. is networking with consumers world wide via the internet. Groups that we network with include the Life Extension Foundation, National Health Federation, the Law Loft, and the American Preventive Medical Assn, International Society of Individual Liberty, the Libertarian Party (US); Freedom of Choice in Health Care, Canadians for Responsible Government, the Abolitionist Party, the Reform Party, the Free World News, (Canada); Consumers for Health Choice, Society for the Promotion of Nutritional Therapy, Maperton Trust (UK); Campaign Against Fraudulent Medical Research, Nexus Magazine, Health and Healing Magazine (Australia), Healthy Options Magazine (New Zealand); PHARMAPACT, (South Africa), Heilsufrelsi (Iceland), ASEED (Netherlands), as well as groups in Jamaica, Spain, and Japan.
John C. Hammell, the founder of IAHF recovered from schizophrenia 18 years ago by taking dietary supplements. He recovered via orthomolecular medicine after mainstream methods almost killed him. The physician who set him on the road to recovery was the late Carl C. Pfeiffer, MD, PhD, founder of the Princeton Bio Center, in Skillman N.J. Pfeiffer was the author of Mental and Elemental Nutrients. Hammell has benefitted tremendously by using dietary supplements and only wants others to have the same chance to heal. He was a member of the ad hoc advisory board that helped establish the Office of Alternative Medicine at the National Institutes of Health. He is of the firm belief that dietary supplements and herbs are gifts to us from our Creator, and for the past 10 years has been working as a professional organizer so that consumers can have unfettered access to these products as well as to truthful health information about their numerous, well documented benefits.
Prior to founding IAHF, Hammell was the Political Coordinator of the Life Extension Foundation of Hollywood, Florida. Hammell totally opposes all governmental efforts to suppress truthful health information about these products, and warns consumers world wide that the Codex International Threat to Health Freedom is an insidious scam being played out through such bodies as the Commission on Dietary Supplement Labels in countries all over the world. The price of freedom is eternal vigilance. Hammell totally distrusts entities such as the Commission on Dietary Supplement Labels, and strongly advocates that consumers place such entities where they belong: under the microscope for intense scrutiny and monitoring. www.iahf.com for more information.
International Advocates for Health Freedom
John C. Hammell, Legislative Advocate
2411 Monroe St.#2 Hollywood, FL 33020 USA
800-333-2553, 954-929-2905, FAX 954-929-0507,
FAX ON DEMAND 954-927-8795,jham@concentric.net
www.iahf.com