Introduction: A One Page Overview of the Problem
Congressional oversight is urgently needed as the FDA has violated current US law via an illegal submission to the Codex Commission which was made in September, 1998 at the meeting of the Codex Committee on Nutrition and Foods for Special Dietary Use (CCNFSDU) in Berlin Germany. Dr. Beth Yetley (an unelected bureaucrat from the FDA) who was the offical U.S. delegate, and the only member of the US delegation with voting power, made he illegal submission which requires immediate scrutiny and congressional action to correct, as it directly contradicts our system of representational government, and totally undermines our constitutional rights and protection under due process of law.
Prior to the meeting in Berlin, Dr.Yetley was asked in writing Exhibit (A) by Congressman Dan Burton, Chair of the House Government Reform Committee, along with Congressmen Paul, Stump, Cook, and De Fazio, to remove the second paragraph from the current US Comments on agenda item #5, Vitamins and Minerals, because they lent credence to the unscientific concept of developing recommended safe upper limits on vitamins or minerals in supplements- a fraudulent concept, and arbitrary control mechanism obviously intended to limit consumer access to high potency vitamins, except by prescription. Anything is toxic at some level, even water, and it is most hypocritical to create a "UL" reference value for ANY substance, especially for safe dietary supplements when FDA approved drugs kill over 100,000 people per year and you sure won't find a "UL" on any of those drugs. I videotaped Dr.Yetley in Germany admitting that she'd seen the congressional letters, which she clearly indicated she would ignore, (and which she did in fact ignore.)This videofootage was uploaded to the Life Extension Foundation website at http://www.lef.org where it has been viewed by consumers world wide who will question the resolve of the US Congress to enforce its own laws if nothing is done about this.
What has transpired represents a gross breach of our constitutional rights, and goes directly against the tenets of representational government on which this country was founded. It provides a perfect example of why Congress should support Congressman Ron Paul's HR 1146, The American Sovereignty Restoration Act, which would get us completely out of the UN.
These actions at CODEX are clearly not consistent with current US law regarding dietary supplements as expressed under the Proxmire Act, the Dietary Supplement Health and Education Act, or under the amendment to the FDA Modernization Act which exempts dietary supplements from the harmonization language. They constitute an effort to make an end run around current US law, and pose a threat to harmonize American dietary supplement laws to emerging Codex standards. There is an immediate need for Congressional Oversight to force the FDA to officially withdraw the illegal comments via official notice to the Codex Commission, and via a Federal Register notice, prior to the upcoming Codex meeting on June 28 in Rome Italy. Additionally, there is a need for judicial review through the appropriate Federal District Court as discussed in detail below.
Corroborating Evidence
Yetley admitted on videotape to having seen the letters from Congressman Burton, Paul, Stump, Cook and De Fazio at a pre-meeting of the US delegation which was held in Berlin the day before the Codex meeting began, and then proceeded to ignore them despite my efforts to apprise her of the fact that what she was doing directly violated US law which expressly forbids doing anything to harmonize our dietary supplement laws to Codex standards or to any more restrictive standards anywhere.
Exhibit (B) see excerpts from digitized video footage of Yetley admitting having read the letters, while showing no intention to change the US comments in accordance with them at http://www.lef.org/shop/fda2.htm Click on the second film segment listed.
The German Chair of the meeting STOPPED the meeting 1/2 hr into it to FORCE me to stop videotaping, illustrating how non transparent the Codex process is. Exhibit (C) Click on the first film segment listed to see that. http://www.lef.org/shop/fda2.htm The Codex Commission clearly does not want people to scrutinize these proceedings, because then everyone could see the lack of scientific honesty, lack of objectivity, and lack of fairness inherent in the Codex process itself. This illustrates that they are trying to operate under cover of darkness.
(The FDA Modernization Act of 1997, Public Law 105-115 was signed into law on November 21, 1997 and specifically exempts dietary supplements from the harmonization provisions found in the section on "Mutual Recognition Agreements and Global Harmonization" but the FDA's subsequent actions do not show any sign of recognizing this exemption, except as part of Melinda Plaiser's effort from FDA to deceive members of Congress who inquired about this. ) (Exhibit D) (Analysis of Plaiser's statement follows.)
The FDA's comments submitted to the CCNFSDU on agenda item #5, (vitamins and minerals) state as follows:
"The United States remains opposed to the continued consideration of the Proposed Draft Guidelines for Vitamin and Mineral Supplements. Public health needs and safety concerns as the related to the use of vitamin and mineral supplements vary from country to country, depending on each country's legal and regulatory framework, dietary patterns, the nature of their public health concerns, and national cultural beliefs as to the role of supplements in diet and health. We believe that guidelines for vitamin and mineral dietary supplements are best addressed by national laws and regulations."
This part of the US comments is acceptable. It does nothing to threaten harmonization to Codex standards, or to any more restrictive regulations anywhere in the world. It is consistent with the will of Congress and with the will of the American people as expressed via the Dietary Supplement Health and Education Act of 1994, and through P.L. 105-115, which specifically exempts dietary supplements from the harmonization language in the FDA Modernization Act of 1997.
The problem with the US comments on agenda item #5 lies with the second paragraph, which reads as follows:
"The United States does, however, support consideration of one element of the proposed guidelines, namely, the consideration of developing recommended upper safe limits of vitamins or minerals in supplements, provided that the recommendations are based on scientifically sound risk assessment criteria. To this end, the United States has submitted to the committee for consideration and discussion, the document "A Risk Assessment Model for Establishing Upper Intake Levels for Nutrients."
Note:
This document did not undergo any public comments period, and as a member of the US delegation, I wouldn't have been sent a copy of it at all if I hadn't specifically asked for one. I didn't receive it until shortly before the meeting in Berlin, or I would have had even MORE members of Congress sent letters to the FDA opposing it. It is outrageous that members of the US delegation are kept in the dark this way. I should have been sent a copy of this paper at least a month in advance of the meeting so as to have sufficient time to review it and to send it out to more people in order to encourage a dialogue regarding it with Dr.Yetley. It is painfully obvious that the FDA has an agenda here, and seeks to avoid scrutiny.
Melinda K. Plaiser, Deputy Associate Commissioner for Legislative Affairs sent a letter (Exhibit E)to the aforementioned Congressmen and to others members of Congress who inquired about this following receipt of my form letter. Plaiser attempts unsuccessfully to use sleight of hand (omission of numerous pertinent facts) to refute the assertion that US comments on agenda item number 5 (vitamins and minerals) were in fact illegal.
Plaisier asserted that although the United States reiterated the past objection to continuing work in this area, she stated that "The draft comments also recognized the fact that, if the Committee, despite the objections of the United States, elected to continue its consideration of the guidelines, the United States would request that consideration of establishing upper safe limits of vitamins and minerals in dietary supplements be limited to an approach based on sound scientific risk assessment criteria rather than on arbitrary limits of the Recommended Daily Allowances (RDAs) or similar nutrient intake reference values." Plaiser then mentioned that to support this position, the United States submitted an abridged version of the National Academy of Sciences document entitled "A Risk Assessment Model for Establishing Upper Intake Levels for Nutrients," citing that the full version of the document was being used in its ongoing assessment of the RDAs."
Plaiser, the FDA, the NAS, and their pharmaceutical masters are, of course, making the assumption that all of this will sound like a perfectly fine explanation to an overworked Congress and their spread thin staffs who don't have time to go and READ the NAS document, much less consider if the concepts expressed within it are in FACT scientifically sound, AND consistent with the will of Congress and the will of the people as expressed under DSHEA, and under PL 105-115 which forbids doing anything which threatens to harmonize our laws to Codex standards, or to any other more restrictive standards.
Plaisier's asserts that "Concerns that Codex guidelines may restrict the availability of dietary supplements in the United States or limit the amount and type of information that may legally be disseminated by manufacturers are unfounded. These concerns arise from, in part, a misunderstanding of the requirements that the United States is obligated to abide by under the Final Act of the Uruguay Round of the General Agreement on Tariffs and Trade, which created the World Trade Organization and was signed in 1995. Nothing in this trade agreement or the Codex process, will restrict either the sale of dietary supplements in the United States or the type of information that manufacturers may provide to consumers about their products. The submission of draft comments by the United States to the Committee's Meeting in no way establishes a guideline to which dietary supplements in the United States must adhere, nor does it obligate the United States to conform to a guideline, should one be adopted by Codex. "
Should We Take Plaisier's Word for It That Gatt/Codex Pose No Threat?
Why should we take Plaiser's word for it that nothing in the Uruguay Round of GATT which resulted in the creation of the WTO poses a threat to restrict the sale of dietary supplements in the United States? Plaiser's statements, are very misleading, and warrant very close scrutiny.
Given the fact that the FDA has a long standing bias against the use of dietary supplements as evidenced by the the statement by David Adams, FDA Deputy Commissioner for Policy before the Drug Information Association Annual Meeting, July 12, 1993 (Exhibit F) and via the Dykstra Report (the ANPR following passage of the Nutrition Labeling and Education Act) (Exhibit G) and given the fact that there is a revolving door between the agency and the pharmaceutical industry to which former FDA employees often go after leaving the FDA in search of better paying jobs in the private sector, should we uncritically just accept an FDA attorneys analysis of this situation?
Suzanne Harris, JD, interprets the situation differently in an article titled "S.830, The Federal Food, Drug, and Cosmetic Act-Asking the Right Questions, Finding the Right Answers" (Exhibit H)(http://iahf.com/s830expl.html)
Excerpting from Harris' article we get a markedly different perspective on the threat to harmonize our laws to more restrictive standards:
"Harmonization is a term that comes to us from trade law. It does not mean make harmonious or compatible. It does mean make alike. Thus harmonizing American Law to International Standards means making American law the same as internationally drafted laws or to internationally drafted regulations.
Although the term harmonization has been around in the trade law area for at least thirty years, it has taken on a new and ominous meaning in the recent past. When the United States ratified both the results of the Uruguay Round of the General Agreement on Tariffs and Trade and the North American Free Trade Agreement, the US signed on to several international agreements WITHIN these agreements that pledged the United States to enter into a continuing process designed to harmonize American Food and Drug law to internationally achieved standards. For example, there is a language in the Sanitary Phytosanitary Agreement within the new GATT agreement that pledges each member country to harmonize its food safety laws to internationally achieved standards. In addition, these agreements created new international bureaucracies that are designed to monitor the process of international harmonization. The GATT agreement also created a new international court with jurisdiction to assure that member nations were complying with the obligations contained in these agreements.
Whenever a major shift in the location of the law and regulation making processes takes place, every American who cares about the preservation of his or her rights, has to be concerned about these changes and to ask if the new process will: adequately protect his or her rights, is based on principles of representative government,contains protections against industrial interests overcoming consumer interests, provides for accountability of the new decision makers to the American public."
(The article goes on to provide a lot more detail, and bears close scrutiny because she effectively refutes what Plaiser is saying.)
It must be realized that Harris wrote the article to offset propaganda being sent to Capital Hill in opposition to my efforts to amend the harmonization language of S.830 (the FDA Moderniza
tion Act of 1997). Nature's Way, a powerful American vitamin company with two German phytopharmaceutical partners (Madaus and Schwabe) had been making a very active effort to attack and discredit me, and to block my efforts on Capital Hill because it wasn't in their best interests, or that of their German partners, that I succeed in getting dietary supplements exempted from the harmonization language.
(These companies are members of a trade association called the European-American Phytomedicines Coalition, which has lobbied the FDA as a group and also via both the German and French embassies in an effort to try to persuade the FDA to create an OTC drug category for herbs. These comments from the German and French embassies, along with the EAPCs comments to the FDA are on public file at the FDA, but most members of Congress will never realize this or even think to investigate this sort of thing. I saved the text of the German embassy's letter to the FDA on behalf of the EAPC on the iahf website at http://www.iahf.com/world/980830.html (Exhibit I) :
LETTER FROM GERMAN EMBASSY TO FDA IN EFFORT TO TURN HERBS INTO "DRUGS"
Botschaft der Bundesrepublik Deutschland Washington October 4, 1994
Embassy of the Federal Republic of Germany
Volkwer Schlegel (Minister of Economics)
Dr.David Kessler
Commissioner
Food and Drug Administration
Room 14-71
5600 Fishers Lane
Rockville, MD 20857
Re: July 24, 1992 EAPC Citizen Petition
Dear Dr.Kessler:
I am writing to inquire into the status of the FDA's deliberations on its policy regarding the use of scientific data in evaluating products, especially phytomedicines and sunscreen milk. Previous letters of inquiry were written to Michael Taylor on November 3, 1992 and in January 1994. However the FDA has not yet provided a formal response despite assurances that the policy would be reviewed.
A petition filed by the European-American Phytomedicines Coalition (EAPC) on July 24, 1992, asks the FDA to change its policy that exludes from the OTC Drug Review ingredients that have no United States marketing history. The petition asks the FDA to accept marketing histories on phytomedicines from my country and several other European countries, as well as scientific data and information supporting the safe and effective use of these phytomedicines as non prescription drugs. As the representative of a country that has a long standing tradtion on the use and marketing of phytomedicines, I fully support the EAPC's request.
This embassy has also made several attempts to receive a definitive answer with regard to the data on sunscreen milk. Again, no response has been received.
I understand that an important meeting is coming up on October 13, 1994. I would very much appreciate your taking the time to look into the matter before that date.
Sincerely,
Volker Schlegel
More fully illustrating a pattern of "roll up" as pharmaceutical interests buy their way in to the dietary supplement industry is an article by Jorg Grunwald titled "The European Phytomedicines Market Figures, Trends, Analyses" (Exhibit J) by Jörg Grünwald, Ph.D.Director, Medical-Scientific Department, Lichtwer Pharma GmbH Berlin, Germany The article can be viewed at http://www.healthy.net/hwlibraryjournals/herbalgram/1995/summer/features/phytomed.htm
The article shows numerous tables of data and clearly indicates that Germany leads the world and Europe in the sales of phytopharmaceuticals, with retail sales of $3,000,000,000. in 1993 (1/2 of the total European Market.) The article discusses how forced harmonization to EEC 65/65 throughout Europe would help Germany to increase this market. (Under EEC 65/65 any substance having any therapeutic effect is regulated as a "drug." Additionally, the article includes "Table 6" which shows the acquisition of several phytopharmaceutical companies (mostly German companies), by a number of multinational pharmaceutical giants who clearly stand to benefit from harmonization, and who are actively trying to dominate the industry. The following mergers/acquisitions are discussed in "Table 6". (The first company listed is the multinational giant, with the company or companies next to it being the phytopharmaceutical companies acquired by each.)
American Home Products/ Dr. Much (Germany)
Boehringer Ingelheim/ Pharmaton (Switzerland)/Quest (Canada)
Boots/Kanold (Germany)
Bausch and Lomb/Dr. Mann (Germany)
Degussa/Asta Medica (Germany)
Fujisawa/Klinge (Germany)
Johnson & Johnson/MerckWoelm Pharma (Germany)
Pfizer/Mack (Germany)
Rhone Poulenc Rohrer/Natterman (Germany)
Sanofi/Plantorgan (Germany)
Searle/Heumann (Germany)
SmithKline Beecham/Fink (Germany)
Solvay/Kali Chemie (C)
Discussed/Rejected:]
Sandoz/Madaus (Germany)
If I had failed in my efforts to get the harmnonization language removed from the FDA Modernization Act of 1997, Natures Way and their German partners, would have profited from the unlevel playing field that would have been created if the harmonization language had been left IN the bill, because it would have forced harmonization to such restrictive European laws as EEC 65/65, under which any substance having any therapeutic effect is regulated as a "drug" (just as it is now in Germany.) (Exhibit K) See http://www.iahf.com/world/9806221.html re EEC/65/65
As stated in their website, Nature's Way is certified by the FDA as an OTC drug manufacturing facility. (Exhibit L) (see http://www.naturesway.com/naturesway/company/index.html)
They and their German partners are already geared up to manufacture to full pharmaceutical GMP standards. Many of their N.American competitors are not. If harmonization had occurred, many of their smaller competitors would have been driven out of business. Although Madaus rejected an offer from Sandoz to buy them out, the fact that they even had negotiations is a clear indication of the direction which pharmaceutical interests are trying to push things in.
If I had failed in my efforts to remove the harmonization language from S.830, (The FDA Modernization Act of 1997) the FDA would have proceeded to harmonize our laws, as they openly announce their intention to do on their website via Dr. Friedman's speech, and through an Advance Notice of Proposed Rulemaking in the Federal Register. (Exhibit M)(July 7, 1997 Federal Register notice IAHF website at http://www.iahf.com/codx-fda.txt.
Most members of Congress and their staffs don't have time to analyse any of this, and would probably be prone to just accepting Plaiser's biased "analysis" uncritically, without doing any investigation to see if it is in fact true. I then received calls from people who's congressmen had sent Plaisier's letter, and they were very confused. I had to spend a lot of time educating them as to what was really going on outside their field of view.
On March 19, 1997, (prior to passage of PL 105-115 which specifically exempts dietary supplements from the harmonization language), Acting FDA Commissioner Friedman stated the following before the Senate Labor Committee: "FDA plans to amend its regulations and procedures for consideration of standards adopted by CODEX. This action is being taken to provide for the systematic review of CODEX STANDARDS in order to enhance consumer protection, promote international harmonization and fulfill the obligations of the United States under international agreements." (Exhibit N):
(The full text of this speech can be found by going to http://www.fda.gov/search.html and entering the search terms "Codex Standards,International Harmonization"
Then read the first two items listed: 0.69 FDA/CFSAN Federal Register 62 FR 36243 July 7, 1997 , and 0.63 TESTIMONY MICHAEL A. FRIEDMAN, M.D. (MARCH 19, 1997) The urls of both of these are too long to even print out, which is why you can only locate them this way.
UNDERSTANDING CODEX DECISIONS REQUIRES UNDERSTANDING
INTERRELATIONSHIPS BETWEEN WHO/ THE AGREEMENT ON TECHNICAL BARRIERS TO TRADE (GATT)/ AND THE RELATIONSHIPS BETWEEN CODEX AND SANITARY PHYTOSANITARY MEASURES OF BOTH NAFTA AND GATT
In order to understand the full effect of decisions taken at Codex Alimentarius or at WHO, it is absolutely necessary to understand the new interrelationships between WHO and The Agreement on Technical Barriers to Trade [GATT] and the relationships between Codex Alimentarius and the Agreement on the Application of Sanitary and Phytosanitary Measures [GATT] and the [Agreement on] Agriculture and Sanitary and Phytosanitary Measures [NAFTA]. Suzanne Harris discusses these issues in depth in Codex comments that she wrote for the Life Extension Foundation which were submitted to the Codex Commission in advance of the meeting in Bonn, Germany in October of 1996. These comments were included in an article titled "How the German Proposal at Codex Would Limit Global Access to Herbs and Botanicals" (Exhibit O) can be viewed at
http://www.lef.org/shop/codex-comments.htm
Exerpts from the digitized footage of my encounter with Dr. Yetley can be found in the Life Extension Foundation's website at http://www.lef.org/video/codex-vid3.ram Exerpts from the footage showing the German Chairman of the meeting stop the meeting in order to force me to stop videotaping can be found at http://www.lef.org/video/codex-vid4.ram (This illustrates the gross lack of transparency in the Codex process, which is nothing more than a thinly disguised shell-game with a predetermined outcome that is put on for public consumption to lend the appearance of fairness and objectivity.)
Footage of me discussing the meeting while standing in front of a huge protest banner draped off the side of a building on a busy Berlin traffic circle can be viewed at http://www.lef.org/video/codex-vid2.ram Footage of GS Odin of Nutrient Carriers, Inc. discussing the Codex meeting and the demonstration organized by Matthias Rath, MD held in front of the gates of the compound where the meeting was held can be viewed at http://www.lef.org/video/codex-vid1.ram Dr. Rath's views on the pharmaceutical suppression of the use of dietary supplements and on the criminality of the Codex process can be viewed at http://www.rath.nl
MY ANALYSIS OF THE CODEX THREAT TO HEALTH FREEDOM
Unfortunately today, there is a revolving door between the FDA and the pharmaceutical industry, and I'm concerned that this has often biased the FDA against the use of dietary supplements, interfering with the development of regulations that lead to sound public health policy. With the advent of NAFTA and GATT, decisions made regarding access to vitamins and minerals by the FDA through such international bodies as the UN's Codex Alimentarius Commission effect not only Americans, but also people all over the world, many of whom I have met in the course of my battle to defend health freedom and I care a great deal about these people, whether or not they live in America, Canada, the UK, South Africa, Chile, Jamaica, Germany, Australia, New Zealand, France, Iceland, or anywhere else in the world. Information about consumer efforts to maintain access to dietary supplements both within the USA and in other countries can be found at
Twenty years ago I recovered from a life threatening illness (schizophrenia) via a suppressed alternative treatment mode (orthomolecular medicine), and have a genetic need for the high potency vitamins and other supplements that I take. All I want is for others to have the same chance I've had in which to heal, and to not be forced to have to constantly fight to preserve consumer access to these healing substances. The right to choose ones own form of health care is a God given unenumerated 9th amendment right guaranteed to each of us by the United States Constitution, and I am offended that I have had to fight so hard to defend a right, which is supposedly so thoroughly protected.
I am one of the people who helped establish what is now the Center for Alternative Medicine at NIH, and in 1992 I helped write "Alternative Medicine- Expanding Medical Horizons" a 372 page report for NIH, which is still for sale through the US Government Printing Office (NIH Publication No.94-066) As a member of the American Codex delegation, I have identified a pattern of FDA abuse, corruption and manipulation which runs contrary to the public health, and to current US law as pertains to the sale and consumption of dietary supplements.
A global pharmaceutically driven campaign seeks to severely limit consumer access to dietary supplements except by prescription, all over the world. The FDA, and its international counterparts are currently engaging in a very deceptive, highly illegal campaign with regards to dietary supplements at Codex, and I need your assistance in order to immediately bring a stop to the FDA's illegal actions.
The Food and Drug Administration Modernization Act of 1997 was specifically amended to exempt dietary supplements from the harmonization language in the bill which applies to all other products regulated by the FDA, and specifically forbids the FDA from doing anything which threatens to harmonize our dietary supplement laws to Codex standards, or to more restrictive standards being developed abroad such as EEC 65/65 in the European Commission, or to countries such as South Africa or Norway where any substance with a therapeutic effect of any kind is being heavily restricted as a (so called) "drug". (See http://www.iahf.com/S830vict.html re our amendment,
See http://www.iahf.com/world/9806221.html re EEC/65/65 To learn about the situation in South Africa, visit the PHARMAPACT website at http://www.angelfire.com/biz/pharmapact/MAIN.html To learn about the situation in Norway (and also in depth analysis of the Codex threat), see letter from Ron Birchead at http://www.lef.org/shop/codex-mail.htm)
I am painfully aware of all of this as the person who spearheaded the cliffhanging grassroots campaign to get the aforementioned amendment, which we got at the last possible minute, on November 9, 1997 when the Food and Drug Administration Modernization Act (S.830) was in the Conference Committee, just prior to going onto the President's desk for his signature. Senator Jeffords was the author of the harmonization language which we amended, and I worked extensively with his staff. (see http://www.iahf.com/s830vict.html
CONSUMER GROUPS WORLD WIDE CAN VERIFY PHARMACEUTICAL TAKEOVER PATTERN
I am also painfully aware of the current situation from attending two Codex meetings in Germany, the first in 1996, and the most recent being last September, where I witnessed the shell game first hand and could see how it is being played, from doing a lot of public speaking, writing and grass roots organizing in Canada, the USA, and South Africa, as well as through efforts to organize health freedom campaigns in numerous other countries through International Advocates for Health Freedom. A global pharmaceutical campaign to suppress the use of dietary supplements and to buy up dietary supplement companies is glaringly apparent to us, with the same takeover patterns being used in cookie cutter fashion world wide. I can put you in touch with consumer groups in several countries who can verify this, and some such as Citizens Voice for Health Rights in Canada have websites and are linked from the IAHF website at http://www.iahf.com
Pharmaceutical tentacles have even found their way inside dietary supplement trade associations to the point where they no longer represent the will of the people on these issues as many companies have either sold out or are positioning themselves to.
It is painfully obvious to me that the FDA is currently engaged in an illegal campaign to make an end run around my amendment, as they seek to assist pharmaceutical interests in breaking past the consumer generated impasse at the Codex Committee on Nutrition and Foods for Special Dietary Use which has been blocking movement on agenda item #5: vitamins and minerals. We knocked the draft proposal for vitamins and minerals backwards from step 5 to step 3 in Geneva via an overwhelming international consumer backlash which has been demanding complete cessation of all work on agenda item #5.
ANALYSIS OF THE SO CALLED "SAFE UPPER LEVEL" STANDARD
The FDA's current ploy to ignore the will of the people and the will of Congress stems from their effort to develop a scientifically fraudulent standard at Codex for vitamins and minerals called a "Safe Upper Limit" (U.L.) FDA's effort to do this is not consistent with current US law, and represents an illegal effort on the part of the agency to harmonize our laws. It also does not represent
sound public health policy, and threatens the lives of consumers all over the world, many of whom need vitamins and minerals and who's access would be needlessly restricted by this unecessary and scientifically fraudulent standard. (Anything, even WATER is toxic at some level- but you don't see a move to create a "U.L." for water, because it would be impossible to enforce such a restriction, and because the use of water doesn't compete with the sale of any FDA approved drugs.)
The FDA (and the pharmaceutical interests who have a vested interest in taking over the dietary supplement industry by raising the regulatory hurdles in order to create an unlevel playing field) realize that IAHF has mounted an international campaign to block their forward movement and kill agenda item #5 (vitamins and minerals), and they needed a foolproof means of breaking past the will of the people, and the will of Congress, (as clearly expressed via DSHEA and via the aforementioned amendment). The FDA knew that they had to devise a method that would NOT be subject to public scrutiny: that is, it couldn't be subject to the Freedom of Information Act. They needed to put a paper on the table at Codex that would advance their agenda of restricting high potency vitamins and minerals, it had to come from the United States (as the worlds largest manufacturer of dietary supplements), but it couldn't be written directly by the FDA because they are subject to investigation under the Freedom of Information Act.
So, the way around the "problem" posed by the consumer generated impasse has been to have the Food and Nutrition Board, at the Institute of Medicine, at the National Academy of Sciences generate this all "important paper", which is titled "A Risk Assessment Model for Establishing Upper Intake Levels for Nutrients".http://vm.cfsan.fda.gov/~download/nutrisk.exe)
The rationale was simple. The NAS is regarded by the multinational pharmaceutical industry to be "in line" with their thinking on public health policy in matters such as this. NAS created the fraudulent concept known as the "RDAs" and continues to generate similar non peer reviewed fraudulent acronyms for the purpose of restricting use of dietary supplements, the so called "DRI", "NOAEL", "LOAEL", "EAR", and "UL" being among them. These acronyms are created out of thin air, and are not grounded in sound science. They serve pharmaceutical interests by needlesslly confusing people, especially politicians and members of the public, and provide the smokescreen necessary for the multinational pharmaceutical industry to attempt to regain the control which was legislatively stripped from them via DSHEA, and via the aforementioned amendment. (Exhibits from Brian Leibovitz, PhD and Bonnie Camo, MD)
The beauty of providing government grant money to NAS in order to generate this all important paper is that NAS is not part of the Federal Government, and as such, they're not subject to scrutiny under the Freedom of Information Act. Moreover, as demonstrated from the enclosed information from the International Society of Fluoride Research titled "Two Unanswered Letters" I am demonstrating to you that the National Academy of Science engages in pseudoscience by selectively reviewing the data in order to support various corporate agendas that are not at all consistent with developing sound public health policy. This is amply illustrated through the example of fluoride, an experimental, unapproved drug which has NEVER been approved on a basis of safety by the FDA because toxicity data would make approval IMPOSSIBLE. Despite this, the FDA does nothing to restrict fluoride, and the NAS Food and Nutrition Board has adopted an unsound and dangerous policy relative to fluoride which clearly ignores conflicting evidence as cited by the imminent scientists who authored the two letters which NAS has refused to respond to (enclosed).
Indeed, when I queried NAS with my own questions, when they finally did reply, it was with a form letter (enclosed), which answered none of my questions, and which attempted to pass the buck by referring me to the USDA, claiming that NAS "lacks the resources" to respond to individual questions.
Therefor, there is no way for people such as my physician and I, who distrust NAS's motives, to get answers to ANY questions, much less to procure their raw data in order to run it past the people who we happen to trust: orthomolecular MDs, and the more honest, openminded scientists and alternative medical practitioners who don't have vested economic interests in suppressing the use of vitamins and minerals. The people who I trust aren't attempting to dominate the sale of dietary supplements as some pharmaceutical interests currently are. Many pharmaceutical companies are making their moves on the dietary supplement industry and on its trade associations, the politics of which are increasingly being dominated by vitamin companies that wish to position themselves in such a way as to sell out to pharmaceutical companies such as Solgar just did when they were bought by American Home Products. Bayer is now referring to herbs as "green pharmaceuticals."
As NAS is not subject to FOIA, there is no way to find out how much money was spent, and by whom to generate the paper, and there is no easy way to probe its authors for conflict of interest. (It is well known that mainstream nutritionists have a vested interest in making money by creating patentable analogs of natural products and that they receive research grants through pharmaceutical companies so would be prone to making decisions that would favor the interests of those companies.)
"Carnitour", a patented analog of the amino acid l-carnitine, is an example of this. It is manufactured by Sigma Tau pharmaceutical company. I have the transcript of an FDA Vitamin hearing held on August 29th, 1990 at the Masur Auditorium of the National Institutes of Health at which Kenneth Mehrling of Sigma Tau urged the FDA to ban all l-carnitine products except "Carnitour". Stephen De Felice, MD, who holds the patent on Carnitour, has been lobbying for exclusivity rights for years, and is the author of "Nutraceuticals- Developing, Claiming, and Marketing Medical Foods" http://www.fimdefelice.org/books.nutra.html
It is not in consumers best interest if Dr.De Felice, or anyone else get a monopoly on the sale of any single nutrient or that nutrients be restricted as "drugs"- which they are not. "Carnitour" sells (by prescription) for $75. for 90 333 mg capsules, while I priced the same quantity of l-carnitine sold as a 600 mg dietary supplement at $16.88 for 30 capsules. (Life Extension Foundation) Thus the patented "drug" version of the amino acid l-carnitine costs .0025/mg, while the amino acid itself sells for .00093/mg Thus, as a prescription "drug" the analog of l-carnitine sells for $2.50 for 1000 mg, while as a natural, untampered with amino acid, 1000 mg of l-carnitine sells for just .93 cents, or $1.57 less (more than 3x less, not counting the cost of the Dr.s prescription.) If Dr.De Felice or Kenneth Mehrling of Sigma Tau could succeed in getting the FDA to ban l-carnitine, except by prescription, they'd dominate the market, and could then charge whatever the market would bear, certainly much more than $2.50/ gram.
Based partly on De Felice's recommendation, Gary Dykstra of the FDA issued his (now infamous) "Dykstra Report" in the form of an advanced notice of proposed rulemaking (following the passage of the Nutrition Labeling and Education Act) which was every bit as restrictive as today's draft proposal for vitamins and minerals at Codex. Dykstra's heavy handed action triggered the grass roots rebellion which led to the passage of the Dietary Supplement Health and Education Act of 1994, my amendment to the Food and Drug Administration Modernization Act of 1997, the first amendment court victory of Pearson v. Schalala, the introduction of the Access to Medical Treatment Act, the introduction of the Consumer Health Free Speech Act, and the consumer revolt which has generated the current impasse on agenda item #5 (vitamins and minerals) at Codex.
Clearly the people and Congress have spoken, and it is wrong for the FDA to not consistently adhere to their will by staunchly opposing any and ALL efforts at Codex to harmonize our laws to more restrictive standards, such as to the absurdly restrictive 35 mg UL for niacin which NAS proposes in "A Risk Assessment Model for Establishing Upper Intake Levels for Nutrients."
Additional proof that the FDA is ignoring current US law which expressly forbids the harmonization of our dietary supplement laws to any more restrictive standards, including Codex standards, can be found on the FDA's website in the text of a speech given by former Acting Commissioner Friedman before the Senate Labor Committee
The Food Advisory Board of Health Canada participated in the funding of "A Risk Assessment Model for Establishing Upper Intake Levels for Nutrients", and they are well known by Canadian consumers as being very heavily biased against the use of all dietary supplements.
Their Chief, Dr.Margaret Cheney of Canada's so called "Health Protection Branch", has been Canada's delegate to all meetings of the Codex Committee on Nutrition and Foods for Special Dietary Use, and as a member of the United States delegation, I have interacted with her and seen her biases very prominently displayed in the context of Canadian positions on Codex issues, as well as through the actions of the Canadian HPB to heavily suppress consumer access to dietary supplements. Cheney was the creator of a Canadian Codex proposal to create a "negative", or "no trade list" of herbs for the purpose of banning the international sale of many safe and effective herbs.
Although her proposal was heavily opposed by Canadian consumers, and was killed at Codex, at the meeting in Bonn in '96, I witnessed Dr.Cheney make a motion to simply shift this matter from the Codex Commission to the World Health Organization. Her motion was heavily seconded by several delegates, including Dr.Yetley who seconded it without asking any of us on the American delegation if we thought she should or not, and when Yetley did this, the eyes of the German, French, Swiss, and Italian delegates were riveted expectantly on her, and the moment she raised her hand, they did too. The whole thing had been orchestrated and scripted as a direct effort to circumvent the will of consumers world wide who had protested creation of the negative list for herbs.
At Codex, herbs would have been regulated as foods, but at WHO, they are viewed as "drugs"-- so they did a great job of shifting the "pea" under a different "shell"--- one which consumers have no access to as WHO holds meetings that are off limits to the consuming public, especially such meetings as the International Council on Drug Regulating Authorities, and the Council on Harmonization where regulators from all over the world convene in closed door sessions.
It is no accident that Canada helped fund the writing of "A Risk Assessment Model for Establishing Upper Intake Levels for Nutrients.". Under the sanitary and phytosanitary measures and under the TBT sections of NAFTA and GATT, an obvious effort is being made to force so called "harmonization" upon us, and "A Risk Assessment Model for Establishing Upper Intake Levels for Nutrients" was obviously generated as part of that effort.
Clearly there is an urgent need for Congressional oversight on this matter. Clearly the FDA has violated the will of Congress and must be forced to withdraw their current Codex comments on agenda item #5. Clearly the FDA must petition the appropriate Federal District Court to request judicial review to determine what their obligations are, if any, under international law with regards to Codex, given the constitutional constraints upon them. Clearly there is a need for Congress and the court to carefully review this matter in light of comments submitted by the Law Loft to the FDA ANPR of July 7, 1997: "ANPR on Consideration of Proposed Rulemaking Proposed Rules on Consideration of Codex Alimentarius Standards"
(http://www.iahf.com under "Codex Oversight")
Clearly oversight must occur prior to the next Codex meeting which is June 24, 1999 in Rome, Italy or FDA will only continue on with their illegal agenda, and will have no respect for the resolve of Congress to stop them through oversight.