To: Michael.Wehr@cfsan.fda.gov, email@example.com, Ellen.Anderson@cfsan.fda.gov
Subject: OPEN LETTER TO MICHAEL WEHR, CFSAN, FDA Re NEED FOR MEETING PRIOR TO CODEX, Milton Bass's Legal Interpretation of Codex Vitamin Threat - Polarly Opposes FDA's: Open Letter to Michael Wehr of CFSAN, FDA; Beth Yetley, and Ellen Anderson FDA and to Congressmen Burton, Paul, De Fazio, Cook, Stump as well as Senator Hatch - and to Vitamin Consumers World Wide as well as Matthias Rath, MD on the eve of his demonstration against CCNFSDU in Berlin
From: John Hammell firstname.lastname@example.org
Date: Sun, 21 May 2000 12:58:56 -0400
All Webmasters: Please Post
Everyone: Please forward to your lists & read thoroughly. We must have a dialogue with FDA regarding Milton Bass's interpretation of the Federal Statute that implements GATT as his interpretation is polarly opposed to FDA Attorney Melinda K. Plaiser's (she has left FDA).Comment deadline with FDA on Codex is monday (tomorrow). Use the form letter at very end of this letter and send it in. KEEP sending it even after the comments period ends. Send it til the end of the Codex meeting on June 23rd and send it to your members of Congress.
I need to do as many radio shows about this as possible. Gary Null, Lou
Epton, Others- Please read this information very carefully. Thanks.
To: The United States Food and Drug Administration:
Michael Wehr,CFSAN ,Ellen Anderson,CFSAN, Beth Yetley,CFSAN
Members of Congress Concerned With Health Freedom and Vitamin Consumers World Wide on the IAHF List and From Allied Groups
Dear Drs. Wehr,Anderson and Yetley:
Please take a very close look at the legal interpretation below (BIG BOLD LETTERS) of Milton Bass, JD who has carefully examined the Federal Statute which implements the Uruguay Round of GATT (which created the WTO and its outrageously unfair so called "Dispute Settlement Body"- the very same body which has ruled against the environment and against the public health in 10 out of 10 decisions it has made, spawning massive angry demonstrations in Seattle, DC, and cities around the world (including Berlin in '98 in front of the CCNFSDU meeting where Dr.Rath is planning to demonstrate again this year. (See his website: http://www.rath.nl/new_default/new_main_us/def_usa.htm
Bass's interpretation of this Federal Statute differs POLARLY from former FDA attorney Melinda K. Plaisier's, which Dr.Yetley is basing her comments on wherein she attempts to assure us that "nothing in the Codex Vitamin Guidelines could ever, in any way impact the American vitamin consumer's access to dietary supplements."
I need to meet with you, Dr.Wehr, possibly also with Dr.Lake and with whoever Plaisier's successor is, prior to the Berlin CCNFSDU meeting and I'd like for Beth Clay from Congressman Burton's office to accompany me, along with Norman Singleton from Congressman Paul's,along with Senator Hatch's aide, - because this is a matter which could impinge directly on the lives and health of millions of vitamin consuming Americans, and we can't afford to err.
As things stand, I contend that FDA is in direct violation of US law with your Draft Comments to the CCNFSDU, and that you're trying to SET US UP for a trade dispute in which the WTO's DSB could easily rule against us and threaten to impose trade sanctions if we don't harmonize our dietary supplement laws to a very restrictive emerging Codex standard, a standard which you are ILLEGALLY helping to develop!!
You must realize that Milton Bass,JD, recently retired from the famous New York lawfirm of Bass and Ullman, (with which I'm quite certain you are PAINFULLY FAMILIAR) has over 40 years of experience in Food and Drug Law and he is not prone to making mistakes in his interpretations. He has a track record as a staunch defender of consumers right to access the dietary supplements of their choice, and has earned our trust as a man of impeccable integrity- something that can't be said for some other lawyers in today's dietary supplement industry who are entirely too cozy with multinational pharmaceutical firms for our taste and who would pimp their own SISTERS if they thought they could make a buck doing so.
I contend that it is ILLEGAL for FDA to attempt to advance the Codex vitamin guidelines, or to even take ANY ACTION intended to help build CONSENSUS on the issue via participation in Discussion Papers such as in Agenda Item #10 where you're attempting to spread internationally your "Guidance Document to Industry on Significant Scientific Agreement" even as you're being charged with contempt over this issue in the Pearson case and even as the GMA have filed a Petition demanding complete withdrawal of that document.
I need to know who Melinda Plaisier's successor is at ORA, because I did a search via http://directory.psc.gov/employee.htm and Melinda Plaisier appears to no longer be employed at FDA.
I first became aware of Plaisier back in '96 when she formulated FDA's official legal position relative to concerns that Codex vitamin deliberations could impact us domestically via a trade dispute. She formulated her response as a result of a form letter of mine that was published in Life Extension Magazine along with an article that I wrote about Codex after returning from the Bonn meeting where I observed Dr.Yetley violate US law when she seconded the motion of Margaret Cheney of Canada that the negative list for herbs issue be farmed out to a "special panel of experts" at WHO rather than be addressed at CODEX.
This action of Yetley's was illegal because under CODEX, herbs are regulated as FOODS, which is consistent with how they're regulated in the USA under DSHEA. At WHO, herbs are viewed as DRUGS, and it is thus INCONSISTENT with US law for Dr.Yetley to have seconded the Canadian motion, which was done in a direct effort to dodge the wishes of the Canadian people who flooded Ottawa with angry demands that the negative list issue for herbs be KILLED ENTIRELY, as well as with American consumers who called Washington for the same purpose and with consumers world wide who caused the draft proposal for vitamins and minerals to be rolled back to step 3 at the Geneva meeting when they SHOULD HAVE BEEN WITHDRAWN ENTIRELY.
This illegal action of Dr.Yetleys, combined with her currently being charged with being in Contempt of Court over Pearson causes vitamin and herb consumers all over the world to totally distrust her actions as well as the motives of the FDA at Codex, as well as Melinda K. Plaisier's legal interpretation of the Federal Statute which implements the Uruguay Round of GATT (which created the WTO and with it the very unfair international Court known as the Dispute Settlement Body, which refuses to hear ANY TESTIMONY from individuals or NGOs, no matter how well qualified they may be.
Given that 10 out of 10 DSB decisions have gone AGAINST the environment and the public health, and that this information is very publicly available at http://www.tradewatch.org in the Harmonization Alerts section, and given that I led the charge which resulted in the FDA Modernization Act of 1997 being amended to specifically EXEMPT dietary supplements from the harmonization language, I distrust your actions because it is painfully apparent to me that you are attempting to set us up to be threatened with trade sanctions in a trade dispute unless we harmonize to a restrictive Codex standard, which you'd obviously love to see happen... and I'm not going to sit idly by and not challenge your legal interpretation as a result of the genetic need I have for the supplements I take.
There is just going to have to be a very up front and open dialogue on this in advance of the Berlin meeting, and as I have a press pass from the American Media Assn, and would like to write a story about this for Life Extension Magazine, the Spotlight, and other publications as well as websites, you will have to allow me to videotape the meeting. Please tell me when I can come to your office for this meeting. Feel free to have as many cops as you want in attendance.
Contrary to your paranoid view, I am not a violent person unless physically provoked. For the sake of your awareness, the only way I would ever BECOME violent would be if you in fact ever DID succeed in blocking my access to the supplements for which I have a genetic need, and I'm bending over backwards to assure that this life threatening situation WILL NEVER OCCUR. Thus, I am bending over backwards to be as DIPLOMATIC as possible under the circumstances in an effort to try to PEACEFULLY resolve this matter, and it is important to me that you understand FULLY my intentions and FULLY realize that I am a non violent person unless my life is DIRECTLY threatened, which I define to be a state of affairs that would exist if I were suddenly ACTUALLY deprived of my access to nutrients.
As I've said before, I do not HATE the FDA, hell, my cousin works there doing work that even I have to admit is necessary. I just want you guys to do stuff that you SHOULD be doing, not stuff that you SHOULDN'T.
I'm a journalist, but you can think of me as a very fair COP, because I think like a cop thinks and I don't like being messed with by anyone. All I want is for you to OBEY THE LAW, something which you have a very poor track record as an Agency of doing. In fact, I intend to give copies of this letter to the FBI, Washington Capital Police, and your own security people just so we're all on the same page. As a martial artist I don't want to EVER have to do more than talk, because I do not LIKE hurting people, nor do I want to EVER have to become militant and bring a gun to DC, something I've never done, and would ONLY do as a matter of last resort. What I am saying here is also not a "threat"- it is an explanation intended to fully clarify how I think so that there are no misunderstandings between us.
Several years ago I had a current "FDA Locator" phone directory, but I don't have the current one. Aside from the url above, do you have a phone directory someplace on the FDA website? I couldn't find one when I looked, but perhaps you can help me with this as there is a clear need for dialogue relative to Plaisier's statements, which Dr.Yetley is currently reiterating as there is good reason to distrust them.
I realize that you know that CRN and NNFA have no problem with what Plaisier is saying, but neither trade association speaks for the American consumer, and I do- I speak for consumers all over the WORLD, while CRN and NNFA speak for multinational corporations. Moreover, there is growing distrust of these trade associations amongst consumers due to the huge number of pharmaceutical members they have and especially due to the fact that some of their members were busted by the USDOJ last year for engaging in illegal price fixing in the sale of vitamin raw materials which ripped off consumers as well as manufacturers for 10 years. As I'm sure you must realize, Hoffman La Roche was fined $500,000,000. for this, and BASF was fined $250,000,000. Both are members of CRN. Rhone Poulenc would have been charged if not for their assisting DOJ in their investigation. They're listed as a member of NNFA in their 1998 Membership Directory, (the only one they've ever published.) Daiichi Fine Chemicals and Takeda were also fined, as were Merck, Degussa, and a few other companies.
We consumers aren't stupid Dr.Wehr, and it has crossed our minds that that the multinational corporations that DOJ caught in that price fixing scam value money above all else, and we'd put nothing past them.
It is our belief, due to the legal interpretation below of Milton Bass, JD, (see below) that these companies may be attempting to get via CODEX what they've been blocked from doing by the DOJ and our courts- via such things as the Pearson decision, and we think FDA is trying to help them.
Given your unwillingness to obey the law vis a vis the Pearson decision, (http://www.emord.com) and given the fact that there is a revolving door between FDA and the pharmaceutical industry, given that John Hathcock of CRN used to work directly with you and we distrust his scientific views on risk assessment due to the criticisms of many able scientists such as Dr.Brian Leibovitz and Dr.Rick Malter who've reviewed his work and totally distrust it, (see http://www.iahf.com) I need to meet with you and whoever Plaisier's successor is in advance of the meeting in Berlin in order to thoroughly discuss my misgivings with Yetley's vehement assertion that "Codex will only effect American manufacturers offshore and will have no domestic impact." (The impression we have is that Yetley is well versed in Adolph Hitlers "BIG LIE" technique: if you want people to believe you, tell a BIG lie and tell it REPEATEDLY.)
Milton Bass,JD retired a year ago after 40 years of experience as a food and drug attorney with the firm of Bass and Ullman in NYC. He was involved in dietary supplement legislation going back to the 1950's through the present. I'd like to put him in touch with whoever Plaiser's successor is because his concern about the vagueness of the statute that implements the Uruguay Round of GATT is quite valid, especially given that it would be interpreted by the Dispute Body of the WTO, (a new international court) that refuses to hear individual testimony, or testimony from NGOs.
This situation casts considerable doubt on Dr.Yetley's emphatic assertion that nothing happening at Codex could in any way effect consumer access to supplements in the USA. By assisting other countries to build consensus on the codex vitamin issue, FDA is setting us up for an adverse ruling by the Dispute Settlement Body of the WTO which refuses to hear any testimony from indivduals (no matter how well qualified) (such as Milton Bass, Matthias Rath, MD, and others).
This assertion is not mere opinion- it has been carefully analyzed and proven conclusively by the Global Trade Watch Division of Public Citizen which has analyzed the outcomes of all DSB rulings. 10 out of 10 so far pertaining to the environment and the public health have gone against both.
The multinationals have clearly devised a very slick means of making an end run around the sovereign laws of nations, and around our courts. The FDA is bound by law to uphold current US law at Codex, and there needs to be an ongoing dialogue to insure that you stay within the law.
See specific concern in form letter that I generated below and add this to my previous comments:
IAHF LIST: I got the Codex comments period extended til Monday May 22. You must email/fax the enclosed form letter to FDA by the end of business on monday, but can get it to Congress after that date. Due to my not having FDA's draft Codex Comments til Wednesday when they passed them out at the meeting, this form letter has material in it that none others have had, so even if you've emailed them before, you must add these comments to your previous ones. I had a press pass so they couldn't stop me from videotaping the whole meeting. See my seperate report on what happened. The legal interpretation below is from Milt Bass who has been on our side against the FDA for decades. He is a very experienced attorney. It is IMPERATIVE that you forward this to more people!
URGENT! YOU MUST EMAIL THIS FORM LETTER TO FDA NO LATER THAN MONDAY May 22!
COMMENTS TO FDA ON CODEX VITAMIN ISSUE: CCNFSDU
To: Ellen Anderson,FDA, fax (202) 205-5532, Ellen.Anderson@cfsan.fda.gov
Senator Hatch,attn Chris Roche fax 202-224-6331, fax 202-224-6333;
Congressman Burton,fax 202-225-3974 attn Beth Clay email@example.com;
Congressman Paul c/o Norm Singleton fax 202-226-4871, firstname.lastname@example.org;
Congressman De Fazio c/o Lisa Bart fax 202-226-3502 email@example.com,
In your draft comments for the Codex CCNFSDU meeting coming up in Berlin (June 19-23), you state:"The proposed Codex Guidelines for Vitamin and Minerals Supplements will not, in any way, adversely effect the availability of these products to US consumers. The absence of science based Codex Guidelines however, could adversely affect the ability of US manufacturers to compete in the international marketplace."
We disagree with FDA's Melinda Plaiser's legal interpretation of the Federal Statute by which the US ratified the WTO agreement in the Uruguay Round: It says "No provision of any of the Uruguay Round Agreements, nor the application of any such provision to any person or circumstance, that is INCONSISTENT (emphasis added) with any law of the United States shall have any effect." [19 USC section 3512(a)(1)]
The problem is how will this be argued in EACH CASE? On the surface it APPEARS that we're protected by US dietary supplement laws (Proxmire and DSHEA), but what if we don't HAVE something in our law that could be called for by a finalized Codex vitamin standard (eg restrictions on availability of high potency vitamins except by prescription)? Could such a restriction be said to be "inconsistent" with our law? (It would all depend on who is doing the interpretation.) The problem is that there is nothing comparable to a restrictive Codex vitamin standard currently IN our law, so if its not IN our law, it can't be SAID to be INCONSISTENT!
This opens a PANDORAS BOX as to how it will be interpreted, and given that it could be interpreted by the WTO's Dispute Settlement Body, which disallows testimony from individuals, no matter how well qualifted, as well as from NGO organizations, given that it ONLY hears testimony from government Codex reps such as Dr.Yetley of FDA, who we do not trust given that she is currently being sued for contempt of court due to refusing to implement the Pearson decision wherein a Judge ruled that the FDA had to allow 4 specific health claims for nutrients, I hearby make the following demand:
I demand that FDA call for a dicontinuance of all deliberations at Codex pertaining to the Codex vitamin issue. I demand that FDA remove the NAS paper "A Risk Assessment Model for Establishing Upper Levels for Vitamins" from the table as it never underwent a public review, it was funded by pharmaceutical interests, its conclusions aren't scientific and it goes diametrically against the will of the people as expressed via the Proxmire Act and DSHEA.It is not legal for FDA to attempt to help Germany build consensus on the Codex vitamin issue. The NAS paper and rebuttal can be viewed at http://www.iahf.com Malter's rebuttal has been submitted in comments by IAHF and has been accepted for publication by the Journal of Orthomolecular Medicine. Additional comments discrediting NAS's attack on vitamins have been submitted by the Life Extension Foundation in the form of an article by Bill Faloon, available at http://www.lef.org Additionally I demand that FDA remove the guidance doc on significant scientific agreement from Agenda Item #10 as FDA is being charged with contempt of court over this issue. I am apprising Senator Hatch, Congressman Burton, and my own members of Congress of these facts.
With Real Concern,