To: IAHF LIST
Subject: Report from FDA Meeting on Dietary Supplements: FDA Remains in Contempt of Court Hammell Interrogated by Washington Capital Police Following Inflammatory Oral Comments Hammell's CamCorder Illegally Seized by Guard in Violation of FACA. Hammell's Oral Comments as Presented, Emord's Comments, APMA's Comments
From: John Hammell email@example.com
Date: Sat, 08 Apr 2000 18:09:09 -0400
All Webmasters: Please Post
Everyone: Please forward. I also had meetings with Congressional aides about the need for an oversight hearing on codex, and about the need to cut the 10 Million from the FY 2001 Budget that has been appropriated so that the FDA can attack websites (see lef.org, article by Bill Faloon) Please send donations to cover costs of motel (3 nights) + traveling expenses. Send to IAHF POB 625 Floyd VA 24091 USA.
I left Floyd VA on April 3 at 11pm and drove all night through a driving rainstorm, arriving in DC at 5 am. I got 2 hours of sleep then headed to the hearing in a suitably enraged mood. Prior to leaving I emailed everyone a draft of intended oral comments, however since I had to sit through 6 hours of panel discussions before I had my chance to hammer the FDA with my 5 minute verbal substitute for punching their bloody lights out, I made several changes to my comments while I waited. Based on what I saw at this meeting, it would be justified if an armed band of enraged Americans marched on the FDA's Parklawn Building in Rockville Maryland and made a citizens arrest on Joseph A. Levitt, Director CFSAN, and you should all call your Senators and Congressmen to complain about his criminal actions- demanding that he be fired immediately.
In violation of the Federal Advisory Commissions Act which provides that all government meetings must be open, a guard illegally confiscated by camcorder prior to the meeting, and the Washington Capital Police tried to interrogate me after the meeting because I'm on their Watch List. Nothing has changed inside the District of Criminals. You can see my comments below, along with attorney Jonathan Emord's, and APMA's.
Nothing that occurred at this FDA Public Meeting came as any surprise to me. The FDA is acting in contempt of court by refusing to adhere to the judges decision from Pearson v. Schalala wherein the Judge ruled that under the First Amendment, the FDA could not stop the plaintiffs from making 4 specific health claims*, provided that they were accompanied by disclaimers- which the court even suggested, however 11 months after the court decision, the FDA continues to engage in illegal enforcement against these claims and all of the questions that they asked at their Public meeting placed them squarely in contempt of court, since the Judge had already responded to them all.
* The 4 Claims that the Court Ruled the FDA Must Allow With Disclaimers Are:
(1)"Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers."
(2)"Consumption of fiber may reduce the risk of colorectal cancer."
(3)"Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease."
(4)".8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form."
On Friday in Court (following tuesday's FDA Meeting) oral arguments were heard due to an emergency preliminary injunction filed by Emord to prohibit enforcement of the 4 rules that the Court of Appeals had ruled were unconsitutional. A seperate hearing is scheduled for May regarding the FDA's being in Contempt of Court.
The Public Meeting was chaired by an FDA attorney named Joseph Levitt, Director of Center for Food Safety and Applied Nutrition. Levitt is clearly angling for a high paying job within the pharmaceutical industry after he leaves FDA, hence his zealous efforts to block the making of truthful claims on dietary supplements, even if it results in the FDA being held on contempt of Court. Levitt brought several pro FDA stooges to the meeting including attorney Bruce Silverglade from Center for Science in the Public Interest who actually referred to the now discredited Finnish Beta Carotene study as if were true, (among other highly desperate, ineffective efforts to back FDA's illegal actions).
Perhaps the worst of FDA's adherents at the meeting was H.Logan Holtgrewe, MD from the American Urological Association who seems deathly afraid of health claims being made on saw palmetto extract in the prevention of benign prostate hypertrophy, and who characterized the typical AMA hard line stance against the use of supplements as being "totally unproven."
When the contempt hearing is held in May, if the Judge rules in favor of the FDA, Pearson can immediately appeal the decision to the same Court of Appeals that ruled in their favor in this case already, and there is no reason the Federal judge wouldn't be overruled AGAIN. She's going to have to make a hard decision:If she rules against Pearson as a staunch supporter of the Clinton Administration, and gets overruled on APPEAL a SECOND TIME such a decision would put a HUGE black mark against her career.
I felt a tangible sense of outrage by the fact that my video camcorder was illegally confiscated by a guard at the start of the meeting, which violates the Federal Advisry Commission Act which requires that government meetings be open. Moreover, I suspected an effort would be made to interrogate me by the Washington Capital Police after the meeting since we all had to show identification upon entering, and that proved to be true- so on behalf of all of you guys, I really hit them hard- my comments were by far the most inflammatory and the FDA clearly deserved what I said. I told the Washington Capital Police officer who attempted to interrogate me that he had better start honoring his oath or HE TOO would be added to my list! Compared to me, all the other commenters were only moderates- and I wish they hadn't been so restrained and diplomatic because the FDA deserved to be given some SERIOUS FLACK! Here is what I said, followed by Emord's statement and APMA's:
Comments of International Advocates for Health Freedom: John Hammell:
The FDA has violated the Federal Advisory Commission Act by illegally confiscating my camcorder at the start of this meeting, thus keeping visitors to the IAHF website from being able to view these proceedings. This violates the Federal Open Meeting Rule, and you'd better not doctor the written transcript of this meeting because I intend to post the whole transcript en lieu of a video record.
In light of your security notice,(below my comments) I wish to publicly announce that although I consider the FDA to be in Contempt of Court re not abiding by the Pearson Decision, and that this entire meeting constitutes nothing more than ongoing FDA footdragging for which you are already being sued again by Pearson, I come in peace, for the mere purpose of informing you in person, eyeball to eyeball, that I regard you to be the lowest pack of lawbreakers on the planet, bar none, and your actions repulse not only me, but vitamin consumers all over the world, many of whom already know I'm saying this to you because I emailed it out to them yesterday, in advance of speaking here today. As has already been determined by the Judge in the Pearson decision, Significant Scientific Agreement CAN'T be scientifically defined. It is a TAUTOLOGY. It means whatever you want it to mean, but in the Pearson case the Judge ruled that the law is not in your mouth. We recommend that you OBEY THE LAW and immediately STOP all enforcement actions against the 4 health claims already ruled permissible by the Judge.
In the past, you dragged your feet before finally allowing the healthclaim that folic acid prevents neural tube defects. Through your violation of our first amendment right to free speech you condemned untold numbers of children to lives of ill health and many are currently permanently paralyzed from spina bifida as a result, unable to even walk or talk because you have condemned them to a hellish existence wherein they now require constant 24 hour nursing care due to your genocidal actions.
Today, you want to cause heart attacks, strokes, cancer, and other serious illnesses by dragging your feet on approving health claims on unpatentable nutrients for which there is equally great a body of evidence to support as that for folic acid, but due to the revolving door between you and the pharma cartel, you seek to do THEIR bidding, and NOT the bidding of the people of America, or the US Court of Appeals. So you attempt to drive all the small vitamin companies out of business by creating a regulatory nightmare of red tape, to enable the Drug Cartel to buy them out, and my guess is that your next move will no doubt be to attempt to force the supplement industry to full HACCP GMPs, or as far in that direction as you can, even though such a move would constitute gross regulatory overkill which the American people will not stand for.
Since consumers never trust anything you say and generally ignore it, I urge you to put a skull and crossbones and a statement condemning any dietary supplement that you wish to attempt to condemn, but then give us the other half of the label, let us say anything we can back up in a court of law as Pearson has, and then honor the Judges decision after you lose.
It is my firm opinion that the founders of this nation did not provide us with the second amendment so that we could engage in target practice or or to go squirrel hunting. It is my belief that this right was given to us as a check and balance against corrupt unelected bureaucrats, as well as to balance the power of corrupt members of Congress and a corrupt President.
As a Christian, I pray to God that things never reach the point in this nation where we can't engage in an honest two way dialogue, so I hope you are REALLY listening to me today and not just going through the MOTIONS as you have many times in the past!!!
Before the Revolutionary War against England broke out, many many many PEACEFUL efforts to talk (such as THIS) were made, but the King broke all his promises, to the colonists so they were forced to bear arms.
It saddens me deeply that you are so blatantly ignoring a Judge who ruled against you in the Pearson Decision, and for that reason another lawsuit had to be filed. I will not dignify any of your questions with a reply in my oral testimony as all they represent is more of the same sort of footdragging that you have always engaged in in your zeal to violate our Constitutional Rights as you seek to do the bidding of your Pharmaceutical Masters, of the large companies that manipulate you, but just to humor you, my written comments do address all of your evil questions.
Many of your corporate manipulators are well represented here today, such as Monsanto, Nabisco, Unilever and others that would love to dismantle our dietary supplement laws in order to ban consumer access to these safe, effective healing agents.
As you engage in your corrupt efforts to block the making of truthful health claims on these natural products, and as you seek to violate our civil right to free speech, please just fully know one thing: one day you must answer for these crimes to your Creator who gave us the vitamins for healing purposes. And don't think you can get away with your effort to make an end run around our laws via the UN's Codex Alimentarius Commission, either. Do not think for one minute that Congress will allow this. Do not think for one minute that you are fooling anyone by trying to set us up for Codex harmonization via the NAS so called "Risk Assessment Paper" - A Risk Assessment Model for Establishing Upper Levels for Nutrients which is on the IAHF website at IAHF.COM On my website you will also find gif files with signatures by five Congressmen including Congressman Dan Burton, Chairman of the House Government Reform and Oversight Committee, Ron Paul, DeFazio, Cook, and Stump. They're listed under "Letters from Congress".
On the website of the Life Extension Foundation, which ALSO beat you badly in court much as Durk Pearson has, you will find video footage of Dr.Beth Yetley of the FDA violating current US law. They are at http://www.lef.org/shop/fda2.htm. She illegally put the NAS paper on the table at the Codex meeting in Sept. '98 in Berlin Germany, and I caught her on video as a non voting observer on the American delegation to the CCNFSDU. This unscientific paper was never peer reviewed. It never underwent a public comments period. You'll find it on my website at http://iahf.com under "NAS PAPER" Because it was generated by the National Academy of Science, which is a non profit organization and is not part of the government, they aren't subject to FOIA so we can't get the raw data or the CVs of its authors via FOIA, but we have evidence that many of its authors were indeed very heavily financed via pharmaceutical research grants. The paper was paid for via a combo of pharmaceutical funding and US & Canadian government funding. Clearly, an effort is being made to position the NAS paper as the "Gold Standard" on Vitamin Safety, so that in a trade dispute, the Dispute Settlement Body of the WTO can use it as the basis to force the USA to harmonize to the highly restrictive Codex standard that they hope to shove down our throats via the corrupt UN Codex process which violates every tenet of representative government on which our great nation was founded.
Please, FDA, for the sake of our nation: you MUST obey the law. I pray to the Lord that it will NEVER be necessary for the American people to march on Washington bearing arms. We need Oversight on this Codex Vitamin Issue. I pray to the Lord, for the sake of every American and for the sake of all people world wide, that you hear my humble plea and please, for the sake of the children, for the sake of the old people and for the sake of those who suffer from medical conditions that require we have access to these natural healing substances, I pray that you will please simply obey the law, quit trying to define what is scientficially undefinable (so called "Significant Scientific Agreement") and go on the websites of International Advocates for Health Freedom at http://www.iahf.com and the website of Matthias Rath,MD http://www.rath.nl for more information as well as the website of the Life Extension Foundation http://www.lef.org where I urge you to learn from the exhibits of their FDA Holocaust Museum which documents the numerous ways in which the FDA is killing Americans. Now via the UN"s Codex Alimentarius Commission you seek to extend these killing fields to encompass the entire planet, with a little help from the WTO criminals- especially those on the Dispute Settlement Body, that new International Mickey Mouse Court which seeks to rubber stamp the agenda of the multinationals.
This is our country, please start respecting it and stop trampling our right to free speech. Please listen to the voice of the people, not the voice of the multinational corporations. You are not here to serve them. You are here to serve us. I attach to these oral comments my written comments already submitted, and wish for both to be entered into the official record of this meeting. -
John Christopher Hammell, President
International Advocates for Health Freedom
In the Year of Our Lord April 4, 2000
Emord & Associates, P.C.
Burke Professional Center
5282 Lyngate Court
Burke, Virginia 22015
1050 Seventeenth Street, N.W.
Washington, D.C. 20036
Phone: (202) 466-6937 Fax: (202) 466-6938
Web Site: http://www.emord.com/
FDA PUBLIC MEETING ON IMPLEMENTING THE PEARSON COURT DECISION AND OTHER HEALTH CLAIM ISSUES
"Should health claims be allowed on dietary supplements on a basis other than significant scientific agreement? If so, what should that basis be and what are appropriate criteria for making decisions about such claims?"
PREPARED REMARKS OF
JONATHAN W. EMORD, ESQ.
The questions posed to the panel are in fact legal issues that have already been resolved in a final and binding order of an authority higher than this agency, the United States Court of Appeals for the D.C. Circuit in the case of Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), reh'g denied en banc, 172 F.3d 72 (D.C. Cir. 1999). The questions are thus res judicata: they have been judicially acted upon and decided; they are settled by the judgment of the court. It is thus not the time to ask these questions. It is, rather, long past the time for this agency to comply with the Court's order.
In Pearson v. Shalala, the United States Court of Appeals held unconstitutional under the First Amendment four FDA rules that suppressed four separate health claims my clients wish to make. The Court's decision invalidated the agency's rules. As a matter of law the rules are of no further legal force or effect, yet FDA continues to enforce them.
The Court's mandate to implement its decision issued to this agency on April 20, 1999. Upon receipt of the mandate, FDA's duty was clear. It had to discontinue enforcement of the invalidated rules immediately, and it had to allow my clients' claims to be made with dispatch. In flagrant defiance of the Court's order, this agency, over eleven months later, still enforces all four of the constitutionally invalid rules. Moreover, it has adopted a cumbersome, extensive, and protracted series of regulatory steps that it intends to take before finally addressing the Court's constitutional mandate. Those steps appear calculated to postpone FDA compliance with the Court's order for years. FDA is thus engaged in a pattern of delay and denial of its constitutional duties. This past Friday, my firm filed an application for preliminary injunction with the United States Court of Appeals to stop this agency from continuing to enforce the four invalid rules.
FDA's continued enforcement of those rules is an act of contempt in the face of a final and binding order. It is an act that challenges the Supremacy of the Constitution over contrary agency laws. It is an act taken by officers of this agency who have sworn oaths to support and defend the Constitution. It violates those oaths.
To be sure, FDA is not above the law. It is certainly not above the Constitution. The Constitution is the Supreme law, and FDA must obey it.
FDA should take heed and immediately, this very day, discontinue enforcement of the invalidated rules. It should authorize all four of the Plaintiffs' health claims with the disclaimers specified by the Court. It may thereafter proceed with its rulemaking to determine precisely how, if it all, it should tailor those disclaimers. But it may not, consistent with the First Amendment, continue to suppress my clients' protected speech, their health claims, for a moment longer.
The Supreme Court has held violation of a First Amendment right, even for a very short period of time, an irreparable injury. See Elrod v. Burns, 427 U.S. 347, 373 (1976) (plurality opinion) ("The loss of First Amendment freedoms, for even minimal periods of time, unquestionably constitutes irreparable injury"). When First Amendment rights are violated, the Supreme Court expects Government to eliminate the violation without delay. It considers delay intolerable. See Riley v. National Federation of the Blind, 784 U.S. 781, 793-94 (1988) (internal quotes omitted) ("Speakers . . . cannot be made to wait for years before being able to speak with a measure of security").
So, then, what are the Court of Appeals' legally binding answers to the questions you pose? The Pearson Court held that FDA may not suppress health claims on the basis that they do not satisfy its "significant scientific agreement" standard regardless of how FDA defines that standard. 164 F.3d at 654. In letters to me of October 5, 1999, and February 17, 2000, Director Levitt accepts this legal requirement. Thus, separate from FDA's health claims review standard, by which FDA officially authorizes and approves claims under 21 U.S.C. § 343(r), is the First Amendment, by which it must allow even claims it does not authorize and approve if those claims can be rendered non-misleading through the addition of a disclaimer. FDA may not substitute a new scientific validity test for the First Amendment standard articulated in the Court's decision. The Constitution is Supreme law, and the agency must ensure protection for all lawful commercial speech, not just a subset of that universe. The FDA must do so in strict accordance with the standards articulated in the Pearson decision itself.
Consistent with rules of statutory construction, FDA may not construe its statutory obligation under 21 U.S.C. § 343(r) (to establish a procedure and standard for the authorization of dietary supplement health claims) as in conflict with the First Amendment. See generally DeBartolo Corp. v. Florida Guild Coast Building & Construction Trades Council, 485 U.S. 568, 573 (1988). Rather, as the Pearson Court explained, 164 F.3d at 652; 659, under the statute FDA must define a procedure and standard for authorization and approval of health claims but under the First Amendment, even if a claim is not authorized and approved by the agency, it must nevertheless be allowed to be made so long as the addition of a disclaimer can render the claim non-misleading. The purpose of the disclaimer is to inform consumers of the lack of conclusive evidence for a claim and of such other information as is necessary, on a case by case basis, to avoid consumer misperception. In light of the infinite variety of potential nutrient-disease claims, case by case evaluation is unavoidable.
The Pearson Court held that inconclusive health claims may not be suppressed by FDA unless they convey no scientific information or unless they otherwise cannot be rendered nonmisleading through the addition of a disclaimer. 164 F.3d at 659. Rather, FDA's remedy for inconclusive claims is the addition of a disclaimer, making the inconclusiveness clear to consumers.
The Pearson Court squarely placed the burden upon FDA to favor disclosure over suppression in every instance where a disclaimer can eliminate a misleading connotation. Thus, for example, if a claim accurately conveys a nutrient-disease association, FDA must allow it even if the agency believes the evidence preliminary unless FDA also reasonably finds no disclaimer capable of eliminating a misleading connotation. The First Amendment makes FDA, like every other government agency that censors speech, meet a high threshold burden of proof to justify claim suppression: proof that a claim cannot be rendered nonmisleading through use of a disclaimer. The general rule is disclosure of information. That is the constitutionally preferred means for overcoming misperceptions in the market.
Turning to the four claims at issue in Pearson, this agency should note well that the Court found all of the claims, at worst, only potentially misleading. The Court wrote specific disclaimers for each of the claims to cure that potential. The Court explained that FDA could avoid the erroneous public view that the agency had authorized the claims by including an additional disclaimer, to wit: "The FDA does not approve this claim." 164 F.3d at 659.
Given the Pearson Court's constitutional order to this agency, FDA must immediately discontinue enforcement of the four invalidated rules and must, until it ultimately decides the precise language it prefers for the disclaimers, authorize on an interim basis all four Pearson claims with the disclaimers the Court has recommended.
Pearson tells this agency that its legacy of suppression must come to an end; that it must henceforth favor disclosure over suppression as the rule, not the exception; that it may not use its health claims review standard as a barrier to the communication of any claim that can be rendered non-misleading through the addition of a disclaimer; and that the Court will view as dubious any agency justification for suppression that is based on alleged "benefits" of public ignorance.
Consumers can make choices they perceive in their own best interests if well enough informed. It is the constitutional duty of this agency to ensure that they are so informed and to favor disclosure over suppression as its standard practice. Thank you.
ADDRESS TO THE FDA
April 4, 2000
My name is Candace Campbell. I am the Executive Director of the American Preventive Medical Association, one of the plaintiffs in the Pearson case. I think you probably know what I'm going to say. For the past nine years APMA has asked FDA to approve four dietary supplement health claims. FDA denied the claims and refused to permit them even with disclaimers, despite our successful arguments that the First Amendment prohibited outright suppression of the claims and required their authorization with disclaimers.
On January 15, 1999, the United States Court of Appeals for the D.C. Circuit agreed with us and held FDA's four rules suppressing the claims invalid under the First Amendment. The Court ruled that FDA may not suppress health claims if it can render them nonmisleading through the addition of disclaimers. The Court ordered FDA to favor disclosure over suppression and found "almost frivolous" FDA's arguments to the contrary. The Court gave the agency precise disclaimer language that the Court found acceptable for use with each of the four claims FDA suppressed. In other words, the Court gave FDA a precise road map to follow to assure full compliance with the First Amendment. Despite the Court's orders and over one year after the Court's decision, FDA continues to enforce the four rules the Court held invalid. My attorney has been told by CSFAN Director Levitt that FDA will prosecute anyone who uses the claims the Court found wrongfully suppressed even if those claims are used with the Court's preferred disclaimers. In short, FDA is continuing to violate the First Amendment and it is resisting compliance with the Pearson Court's constitutional order. Where I come from that is called contempt of court.
The Pearson Court's decision is extraordinary in many respects. First, the Court not only ruled that FDA violated the First Amendment by suppressing the four health claims rather than disclosing them with disclaimers, it also spelled out in detail the kinds of disclaimers it found sufficient to eliminate the potentially misleading connotations FDA identified. In other words, the Court not only told FDA why its actions were unconstitutional, it also told FDA precisely how to comply with the Constitution-by authorizing the claims in a nonmisleading way. After the Court's clear explanation to this agency, one would have thought FDA would act immediately to authorize the claims with those disclaimers. But FDA did not. Instead, FDA has spent over fourteen months enforcing the very rules the Court invalidated and struggling to find some legal argument for not complying with the Court's order. FDA has refused to set a date certain by which it will authorize the claims with disclaimers despite five letters from our attorney requesting a date. FDA has refused to allow APMA's members to use the claims with disclaimers, threatening enforcement action against them if they do. In today's meeting, FDA does not identify a date by which it will authorize the claims, rather FDA asks questions which reveal that it seeks yet another scientific validity test to prevent authorization of the claims. Moreover, FDA is now trying to redefine the term health claim to exclude treatment claims from those permitted without drug pre-approval.
To be blunt, this nonsense has got to come to an end. Rather than follow the law faithfully, FDA is doing everything it can to evade, circumvent, and disobey the law. Those actions are reprehensible. I realize from recent communications with the FDA, that you believe that you are responding with all due haste. Let me assure you, you are alone in this perception. FDA's duty to comply with Pearson is clear and immediate. We have suffered nine years of speech suppression and should not be made to suffer an additional moment. The Court ordered this agency to authorize the claims with disclaimers. The Court told this agency what disclaimers it found acceptable. Do what is required of you and stop these obvious evasive tactics. Authorize all four of the health claims with the disclaimers the Court has given you and do so immediately.
It is mind boggling to me that we spent six years and hundreds of thousands of dollars - not tax dollars - and won a landmark law suit, yet the agency has yet to comply. If an individual acted with such impunity, he would be in jail by now. I came here today to urge you to stop playing games with our Constitution and to stop running roughshod over our free speech rights. FDA is not above the law.