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To: edward.scarbrough@usda.gov, eyetley@cfsan.fda.gov, robert.lake@cfsan.fda.gov, michael.wehr@cfsan.fda.gov, jgrimmett@crs.loc.gov, mplaisie@oc.fda.gov, execsec1@oc.fda.gov, norman.singleton@mail.house.gov, kim.newin@mail.house.gov, yonce.shelton@mail.house.gov, christopher_rosche@hatch.senate.gov, lisa.bart@mail.house.gov, amy.sander@mail.senate.gov, Jeff.Starling@mail.senate.gov
Subject: To: Ed Scarbrough:Indisputable Evidence from CRS at LOC that WTO DSB Rulings Have Gone Against USA - Response to Yetley's Fax to Me of 6/8/2000: Demand that Yetley/Plaisier Respond IMMEDIATELY. Demand that FDA Change Codex Comments to CCNFSDU Meeting 6/19 IMMEDIATELY. Request that Congress HELP! (Codex meeting starts in Germany 6/19- FDA is Breaking Law)
From: John Hammell jham@iahf.com
Date: Fri, 09 Jun 2000 16:59:11 -0400

All Webmasters: Please post.

Everyone: Please forward widely. Copy this to Scarbrough and the others in the to line yourselves, cc it to your Senators/Congressmen. If outside USA, forward to friends inside USA- this effects us all!

Members of Congress: Immediate Action Necessary to stop violation of US dietary supplement laws by FDA at Codex. FDA Actions at Codex threaten consumers world wide and diametrically oppose US Dietary Supplement Laws- Set us up for harmonization.Detailed proof of FDA wrongdoing cited herein.

Evidence from Congressional Research Service, Global Trade Watch, and other sources.

From: John C. Hammell, President June 9, 2000
International Advocates for Health Freedom
POB 625 Floyd, VA 24091
http://www.iahf.com
800-333-2553, 540-745-6534, fax 540-745-6535
jham@iahf.com

To: F. Edward Scarbrough,Ph.D., US Manager for Codex Alimentarius
United States Department of Agriculture
Office of the Undersecretary for Food Safety
USDA Rm 4861 S, Washington, D.C. 20250-3700
202-205-7760
fax 202-720-3157
edward.scarbrough@usda.gov
also to FDA Commissioner Jane Henney,MD
also to Beth Yetley,Ph.D., Senior Scientist, FDA CFSAN, US Delegate to CCNFSDU
also to Melinda Plaisier, FDA Associate Commissioner
also to numerous members of congress, (inc Hatch, Burton,Paul)
and to Gary Null,PhD, The Life Extension Foundation, The Spotlight Newspaper, Matthias Rath,MD
and to vitamin consumers world wide.

Dear Dr.Scarbrough:

In a letter faxed to me on June 8, 2000, Dr.Beth Yetley, US Codex delegate to the CCNFSDU has made numerous false allegations, some that have already been made along with some new ones in an obvious attempt to thwart my efforts to force the FDA to obey US law at the rapidly upcoming meeting in Berlin Germany of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). In the face of the facts presented below, Yetley's juvenile attempt to throw me off the US Codex delegation must be viewed in the proper context. In light of this information, I hereby reiterate my demand that you do your job and remove Yetley from the US delegation, replace her with someone who WILL obey US law, and that you reinstate me to it.

Yetley stated that my request for a written statement relating to exemptions from harmonization specified in the U.S. legislation implementing the GATT would be "issued seperately."

I demand that this request be answered IMMEDIATELY by Melinda Plaisier, as the CCNFSDU meeting starts in just 10 days, and the following information from attorney Jeanne J. Grimmett at the Congressional Research Service proves that the Federal Statute* which implements the Uruguay Round of GATT does not in fact protect the USA from harmonization to international standards as Melinda Plaisier, FDA Associate Commissioner of Legislation,Dr.Yetley, CRN, NNFA, and others falsely claim. *[19 USC section 3512(a)(1)] (see letter to Plaisier, below)

This also clearly indicates that the FDA is in violation of current US law (amendment to FDA Modernization Act of 1997 which exempts dietary supplements from the harmonization language of that act which effects the whole REST of the FD&C Act.)

This amendment forbids that FDA take ANY ACTION which could set us up for harmonization to a more restrictive international standard which could unequivocally impact our dietary supplement laws, as indicated in Grimmett's citing of the facts pertinent to WTO DSB decisions that have already adversely impacted current US law forcing numerous "harmonizing" changes under threat of trade sanctions.

Due to it, and the facts cited below which unequivocally PROOVE that the Federal Statute does not protect US law from forced harmonization to international standards- I demand that immediate changes be made to the draft US Comments, deleting anything within them that fosters consensus building towards completion of of a Codex vitamin standard. Moreover, I demand that FDA immediately copy me on a letter which they MUST SEND to the Chair of the CCNFSDU calling for a complete END to all deliberations regarding Codex vitamin standards, as the matter is truly best left to national authorities to decide. In the letter which FDA must send to CCNFSDU prior to the meeting on June 19, I demand that FDA withdraw the NAS paper "A Risk Assessment Model for Establishing Upper Levels for Nutrients" from the table, as it was illegal under US law for it to ever be put on the table in the first place, and I make the same demand regarding the Discussion paper in Agenda Item #10 from this years meeting "Discussion Paper on Review of Provisions for Vitamin and Minerals in Codex Standards: Vitamins and Minerals in Foods for Special Medicinal Purposes".

Congressman Paul's aide, Norman Singleton ran the concerns of Milton Bass and I past attorneys at the Congressional Research Service at the Library of Congress who confirmed our concerns as valid. Our concerns re the Federal Statute which allegedly protects us from harmonization, and which is discussed in detail (below) in my letter to Plaisier, are indeed, and most emphatically true. The statute is very loosely worded, and it opens a Pandora's Box in terms of interpretation in each case. Don't take my word for it, check for yourself, and I demand an immediate response from Plaisier to my specific questions as to the reach and scope of the statute where I want her to show me specific examples of where she thinks it would or would not apply, citing her reasons. I also want Plaisier to respond to the information provided in Grimmett's article, given that it directly contradicts her empty assertion that [19 USC section 3512(a)(1)] "protects US law from harmonization"

My contention that the Federal Statute which FDA, CRN, NNFA, Citizens for Health, and others claim protects our dietary supplement laws from forced harmonization to a restrictive international standard in fact, does NOT protect us from harmonization! This is really not open to any dispute, as the proof that it does NOT protect us from harmonization is right there in black and white, in print: factual, INDISPUTABLE information provided by attorney Grimmett of the CRS at Library of Congress: HERE IT IS and this is not "opionion" (which might be disputable) these are FACTS coming from a well known, well respected government legal authority:

If you go on the website of the Congressional Research Service at http://www.congress.gov/brbk/html/ebtra56.html (Norm Singleton faxed this to me, the public does not have access to this congressional website) You will find an article titled "WTO Dispute Settlement" by Jeanne J. Grimmett, (jgrimmett@crs.loc.gov) who is an attorney in the Congressional Research Service at the Library of Congress.

Grimmett cites PROOF that DSB rulings have indeed been made against the United States, not only against Federal laws, but even against State laws! This prooves conclusively that the WTO has already begun a process of dismantling our sovereign laws, and that what they have done to our Clean Air Act, and to our Endangered Species Act, they could also do to our Proxmire Act, and to DSHEA! It is for this reason that Congressman Ron Paul has introduced House Joint Resolution 90 which would get us OUT of the WTO!

I quote from pages 1 and 2 of Grimmett's report starting with the last paragraph on the first page, and continuing over to the second page:

"The WTO Secretariat lists 188 complaints (involving 147 distinct matters) as having been filed from January 1, 1995 through February 1, 2000. Of these, some 92 have involved the United States: 54 as a complaining party, and 38 as a defendant.

The United States has generally been successful in cases that it has brought, prevailing in 12 of 14 cases in which panel and Appellate Body reports were issued; where it was a defendant, the United States received adverse panel reports in 7 of 8 cases where panel or appellate reports were issued, with aspects of some reports modified on appeal. These covered Clean Air Act regulations on conventional and reformulated gasoline; import restrictions on imports of underwear; transitional safeguards on imported wool products; import prohibition on shrimp and shrimp products; antidumping duties on DRAM semiconductors; tax treatment for foreign sales corporations (FSC's); countervailing duties on steel from the United Kingdom (in which US methodology for finding subsidies involving privatized companies was challenged); and Section 301 of the Trade Act of 1974. The panel report on Section 30, which was favorable to the United States, was adopted by the Dispute Settlement Body January 27, 2000.

As of February 1, 2000, there were 5 active panels involving cases brought before the United States and 8 involving the United States as a defendant. Cases in the latter category involve challenges to the Massachusetts law restricting state procurement from firms doing business in Burma (panel suspended in February 1999); the Antidumping Act of 1916 (seperate panels for complaints by the European Communities (EC) and Japan); section 110(5) of the Copyright Act, regarding non payment of royalty fees (complaint by the EC); withholding from customs liquidation on EC imports prior to authorization to retaliate by the DSB; section 201 safeguards on EC wheat gluten; Section 201 safeguards on lamb from Australia and New Zealand; and antidumping orders covering stainless steel imports from Korea. As of February 1, 2000, the WTO Secretariat listed 39 cases involving the United States that are in the consultations: 25 in which the United States is the plaintiff, and 14 in which it is the defendant."

While it is true that I was asked by the Committee Chair to stop videotaping, and while it is true that he polled the delegations, and a handful requested that they didn't want videotaping, at no time was anything ever said to me prior to the meeting, at the start of the meeting, or by Dr.Yetley during the half hour that I was taping to indicate that I could not do so. Apparently it is expected that I be clairvoyant.

I can't help but recall that the first to speak out against videotaping when Grossklauss (the Committee Chair) polled the delegates was none other than Dr.Margaret Cheney, the Canadian delegate, who will always be angry that I alerted Canadian consumers to the fact that a Canadian motion to create a "negative" or "no trade" list of herbs was on the table prior to the CCNFSDU meeting in Bonn in '96. Canadian consumers deluged Ottawa with complaints about this motion, demanding that Cheney back off from it since it threatened to ban consumer access to many safe and effective herbs which "interfere" with pharmaceutical profits.

This situation forced an obvious conference behind closed doors between Yetley, Cheney, and several other delegates so as to craft an "artful dodge" around my whistleblowing. The result was that Cheney first announced at the '96 meeting that Canada was "backing off" from the negative list proposal, and then she made the motion a second time at the end of the meeting, which Dr.Yetley illegally seconded, in complete disregard for the fact that herbs are regulated as foods under US law. (Yetley seconded a motion to shift herbs out of Codex (where they would at least have been regulated as foods, as is consistent with US law) over to a "special panel of experts" at the World Health Organization (which regards all dietary supplements to be "drugs", a stance that runs diametrically OPPOSITE US law, making Yetley's action to second the Canadian motion purely illegal.

As to Yetley's allegation that I "inappropriately" sent "rude and hostile" emails to the Committee Chair of the CCNFSDU and to delegates from other countries, I'd just like to refer you to the full page ad in USA Today, 6/9/2000 of Matthias Rath, MD who has called for a reopening of the Nuremburg War Trials in light of the ongoing crimes against humanity being committed by Hoechst, Bayer, BASF (former IG Farben) which he documents are heavily involved in the German effort to ban consumer access to high potency vitamins and herbs. See Rath's sites http://www.rath.nl and http://www.justiceandawareness.org

What I in fact sent to the Committee Chair and to delegates from other countries was the form letter that Dr.Rath has on his website for that purpose which can be seen at http://www.rath.nl. The purpose of the letter was to serve notice to all Codex delegates that if they take any action to advance the Codex vitamin standard towards completion, they are engaging in crimes against humanity. That is not an empty assertion. Dr.Yetley may regard this statement to be "rude and hostile" but I regard it to be factual. I demand that Dr.Yetley, and everyone at FDA obey US law. I demand that the US Codex Comments to the CCNFSDU changed in light of these concerns. I demand that Yetley immediately email the CCNFSDU to announce that the USA is calling for a complete stoppage to all deliberations on Agenda Item #5: Vitamins and Minerals, because the matter truly is best left to national authorities to decide, and FDA is obviously attempting to make an illegal end run around current US law.

The as yet unanswered letter to attorney Plaisier at FDA is found below. I demand an immediate response to it, with the addition of all the information presented above also requiring her immediate response. I demand that Dr.Beth Yetley be REMOVED from the US delegation to the CCNFSDU for violating US law, and that I be reinstated to the delegation as I have done nothing wrong, all I've done is fulfull my constitutional obligation as an American to do my best to uphold the law- something which, you, Dr.Scarbrough, aren't doing if you should fail to act properly in light of these facts. If you don't act properly in light of these facts, I feel strongly that you should be fired from your job, along with Dr.Yetley.

For the Public Health,
John C. Hammell, President
International Advocates for Health Freedom

attached: Letter to Plaisier sent previously:

To: Melinda K. Plaisier, Associate Commissioner of Legislation,FDA
mplaisie@oc.fda.gov, Commissioner Henney

Dear Melinda Plaisier, and Commissioner Henney:

I require a detailed written statement from the two of you pertaining to the extent and reach of the exemption clause contained within the Federal Statute which implements the GATT trade agreement, especially given that there are numerous undeniable examples in which the Dispute Settlement Body of the WTO has forced us, under threat of trade sanctions, to harmonize our laws in ways that have been deletrius to the public health and to the environment. In fact, in 10 out of 10 decisions rendered by the DSB of the WTO, the decisions have gone AGAINST the environment and the public health as the DSB was clearly designed to rubber stamp the greed driven agenda of the multinational corporations (See http://www.tradewatch.org Harmonization Alerts section)

It is due to this very problem that over 70,000 angry demonstrators shut down the WTO meeting in Seattle as you can see at http://www.indymedia.org and as was widely reported on network TV.

It is due to this very problem that Matthias Rath, MD demonstrated against the Codex Committee on Nutrition and Foods for Special Dietary Use Meeting in Berlin in '98, and he is planning another demonstration as you can see from http://www.rath.nl

The Federal Statute which I require your detailed legal interpretation of in writing reads as follows:

"No provision of any of the Uruguay Round Agreements, nor the application of any such provision to any person or circumstance, that is INCONSISTENT (my emphasis added) with any law of the United States shall have any effect." [19 USC section 3512(a)(1)]

I require, in writing, to know in detail, what the reach and extent of this exemption is. In other words, where would it NOT come into play? What kinds of provisions would NOT be inconsistent with US law, given that there are numerous examples where the DSB of the WTO has ruled against us and forced changes to our laws under threat of imposing trade sanctions?

In light of my concerns, please read and comment on this paper:
International "Harmonization" of Social,Economic and Environmental Standards
http://www.harmonizationalert.org/harmbk.htm

In light of the following examples of where the US has been forced to harmonize its laws, convince me that the Federal Statute above protects my access to dietary supplements:

See http://www.harmonizationalert.org/Nov98/wtoshrmp.htm
Challenge of U.S. Endangered Species Act (Shrimp/Turtle Case) forced changes to our endangered species act.

See for example http://www.harmonizationalert.org/October99/Mondev.htm
to learn how a Canadian Corporation used NAFTA to attack the US judicial system.

See http://www.harmonizationalert.org/Nov98/beetles.htm
Challenge of U.S. Forest Protection Rule (Asian Longhorned Beetles)

The problem with the Federal statute cited above which allegedly exempts us from harmonization 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!)

Do you dispute the contention that this opens a PANDORAS BOX as to how it will be interpreted?

Do you dispute my contention that it could be interpreted by the WTO's Dispute Settlement Body?

Do you dispute my contention that the DSB disallows testimony from individuals, no matter how well qualifted, as well as from NGO organizations?

Do you dispute the contention that the DSB of the WTO ONLY hears testimony from government Codex reps such as Dr.Yetley of FDA?

Do you dispute the contention that Dr.Yetley is currently being sued for Contempt of Court for refusing to implement the Pearson court decision? (see http://www.emord.com)

Do you dispute the contention that the Grocery Manufacturers of America have petitioned the FDA demanding that FDA immediately implement the Pearson court decision and also WITHDRAW the "Guidance Document to Industry on Significant Scientific Agreement" which FDA has included in Agenda Item #10 at CCNFSDU? (Is it APPROPRIATE for FDA to attempt to go around our courts, the USDOJ, and Congress this way?)

In light of Dr.Rick Malter's rebuttal to the NAS paper "A Risk Assessment Model for Establishing Upper Levels for Nutrients" please explain to me how the NAS paper is consistent with the will of the American people and the will of Congress as clearly expressed via Proxmire and DSHEA, and please explain to me why the FDA has ignored a Congressional request that it be removed from the table at Codex. (See http://www.iahf.com for NAS paper and Malter's rebuttal, and letters from congress.)

As you can see from the website of Matthias Rath, MD at http://www.rath.nl/new_default/new_main_us/def_usa.htm
vitamin consumers world wide are emailing all of the CCNFSDU delegates demanding that all deliberations on the Codex vitamin issue immediately CEASE!

Given that at Codex, its one country, one vote, and the vote of any tiny little country counts just as much as the US vote, regardless of population size, don't you think it should follow that when the USA develops its Codex Comments that my written comments, and those of each person on my email distribution list should logically count just as much as the written comments of CRN, NNFA, or other trade associations which don't speak for the people of America but who represent the will of multinational pharmaceutical companies, including those who got nailed by the USDOJ for engaging in illegal price fixing in the sale of vitamin raw materials? Please explain your answer in detail because I am going to tabulate all of the written comments as "votes" and I am certain we have CRN outvoted.

Under these circumstances, wouldn't it be appropriate for Dr.Yetley to take the following steps vis a vis the US position on the vitamin issue at CCNFSDU? (If not, state your reasons in writing):

1) Immediately email the German hosts of the meeting to remove the NAS paper "A Risk Assesssment Model for Establishing Upper Levels for Nutrients" from the table at Codex as it was generated via pharmaceutical funding, it never underwent a public comments period, it was never peer reviewed, and it is inconsistent with the will of the American people as clearly expressed under Proxmire and DSHEA.

2) Forcefully call for an immediate CESSATION on all Codex deliberations regarding the vitamin guidelines.

Commissioner Henney, and Melinda Plaisier: after you provide me with detailed written comments addressing all questions asked herein, will you please agree to be interviewed by me, on video, for the sake of total transparency prior to the CCNFSDU meeting on June 19th? I will be flying to Germany for the meeting on June 17th, my birthday, and prefer to meet with you regarding this prior to that date. Please let me know, in writing, if this would pose any problem.

For the Public Health of Vitamin Consumer World Wide,
John C. Hammell, President
International Advocates for Health Freedom
Member: The American Media Association