This article was written upon request from a member of Senator Hatch's staff who is trying to understand our concerns about the harmonization language in S.830 (see http://www.iahf.com/s830-sen.txt)(explains how S.830 is dangerous)
It is imperative that we get the harmonization language removed from S.830, or our food and drug laws will be made the same as the European Union's. (We must be equally vigilant regarding a house companion bill, although none has been introduced yet.) As this article discusses, the EU is on the verge of severely restricting access to dietary supplements (unless consumers there rally to fight back hard.) Please email and fax this before Friday, 9/19 to every member of the Senate along with the notice posted on my website at http://www.iahf.com/s830-sen.txt (The Senate will invoke cloture tomorrow 9/16, and will probably vote on S.830 on Friday.
By John C. Hammell, legislative advocate
International Advocates for Health Freedom
2411 Monroe St. Hollywood, FL 33020 USA
fax 954-929-0507, fax on demand 954-927-8795
On January 30, 1996 the FDA sent a memo of rebuttal to people who had expressed concern regarding the proposed draft guidelines for dietary supplements pending before the Codex Alimentarius Commission Committee on Nutrition and Foods for Special Dietary Uses, which was held in Bonn, Germany in October of 1996. (The complete text of FDA's form letter can be found at http://www.healthy.net/public/legal-lg/fedregs/fdacodex.htm)
People had expressed concern that the proposed guidelines would "nearly end my access to dietary supplements in the United States" and would create circumstances where "manufacturers will not be able to advertise the numerous health benefits of taking dietary supplements." Furthermore, people stated that they were "angry that the U.S. gave away so much of our sovereignty by signing the GATT."
FDA asserted that these contentions are unfounded, and alleged that they stem from a misunderstanding of the requirements by which the US is obligated to abide by as a signatory to GATT.
FDA went on to assert that there was nothing in the trade agreements or coming out of the process that will either restrict the sale of dietary supplements in the US or the type of information that manufacturers could put out to consumers about their products.
FDA went on to assert that the response they were formulating for the meeting in Bonn would be developed in accordance with applicable US law, and that it would consider all comments received before developing the US position.
FDA went on to question the assertion that by participating in the Codex process, we are surrendering to an international organization our sovereign authority to protect the health and safety of Americans. They went on to state that under the SPS Agreement, the US does not relinquish its rights to enact and enforce laws to ensure the health and safety of its citizens. They state that "while the SPS Agreement contains a general obligation to use international standards, it protects the ability of governments to use different standards if they determine that the relevant international standard does not adequately meet their nation's food safety needs."
FDA ends their spin controlled rebuttal by trying to put people to sleep, asserting that "the proposed guidelines for dietary supplements are at a very early stage in their development" and they discussed the fact that the process can take several years. They discussed the fact that there will be opportunity at each step for comments and revision to be made on the proposal, and they stated that they could not predict if the Committee would eventually adopt final guidelines, and if so, what recommendations the guidelines would contain. In order to assist people in fighting back world wide (resulting in the German proposal being knocked back to step 3 from step 5), I have been too busy writing articles, organizing and doing public speaking about the Codex International threat to health freedom to bother rebutting FDA's spin controlled memo of January 30, 1996, but am doing so now due to a request made in September 1997 from an aide on the Senate Judiciary Committee.
Although many of the FDA's statements are technically true, they are also quite misleading. This can readily be seen from the comments submitted by Suzanne Harris, JD of the Law Loft on behalf of the Life Extension Foundation to the Codex Commission at about the same time the FDA issued their rebuttal. (See Life Extension Foundation's Codex comments as submitted to the FDA and to the Codex Commission prior to the Bonn meeting at http://www.lef.org/cgi-local/shop.pl/page=codex-comments.htm/SID=1550224382)
Consumers were (and still are) quite correct in expressing concern about the Codex process, because they were correctly perceiving a process which did (and still does) threaten their access to dietary supplements. This is even more obvious now, on September 15, 1997 than it was when FDA issued their memo 18 months ago. If consumers, and vitamin companies don't exercise vigilance, and don't continue monitoring these proceedings, it is obvious that we will lose our access to dietary supplements.
Although it is true that the FDA did uphold US law by voting against the German Codex proposal in Bonn, despite the strong objections of the US, UK, Canada, Netherlands, Japan, Australia, and New Zealand, the draconian German proposal advanced over our objection from step 3 to step 5 in the 8 step process, indicating that consumers concerns were (and are) quite justified. I was in Bonn as a member of the American Codex delegation, where I saw what happened. One thing that happened was that Dr. Cheney of the FDA supported a motion by the Canadian delegate to create a Special Panel to examine the issue of whether or not to create a negative, or "no trade" list of herbs.
Cheney never conferred with the rest of the delegation to see whether or not we supported the Canadian motion, which I opposed. (Allegedly, Cheney cared about our views.) I discuss what happened in Bonn in my "Report from Bonn" which is available at http://www.lef.org/cgi-local/shop.pl/page=codex-bonn-report.htm/SID=1550224382
Although the German Codex proposal was later set back to step 3 at the meeting this past June in Geneva, that was only due to my efforts to sound an international alarm, especially in Canada where I did a lot of public speaking and galvanized the public on the issue. My articles were also published in Australia and New Zealand and influenced a public outcry there. I am working with people in Australia, Canada, and South Africa who have filed lawsuits against their governments for overly restricting access to dietary supplements. Consumers were, and still are quite justified in expressing great concern about this process. Although the German proposal was knocked back to step 3, harmonization efforts around the world currently threaten to enable it to move forward once again. See the Canadian section of the IAHF website at http://www.iahf.com/index.html#canada
At issue is not just the German codex proposal, but Codex harmonization efforts which are ongoing, world wide, in an effort to restrict natural products. In Canada, by working with Freedom of Choice in Health Care out of Toronto, we filed a lawsuit against the HPB which stopped the third phase of cost recovery, which would have driven a lot of small to mid sized manufacturers out of business. Cost recovery is an illegal tax that was never debated by parliament, which was scheduled to be levied against dietary supplement companies. Cost recovery was scheduled to go into effect in July, but the lawsuit was filed just in time to stop it.
The European Commission has circulated a start-up position paper titled "Addition of Vitamins and Minerals to Foods and Food Supplements" to which comments are due before September 30, 1997. Since the EC is the primary entity which generates proposals for new legislation for the EU (the Council of Ministers being the body that actually formally creates new legislation in the form of European Union directives), having read the text, I view the circulation of this document as a first step toward tightening EU regulations against dietary supplements and fortified foods even more than it has in the past. A copy of the EC discussion paper can be procured from Consumers for Health Choice, Abbey House, 4 Abbey Orchard Street, London, UK SW1P2JJ Tel.44-171-222-4182, Fax 44-171-222-4192, email firstname.lastname@example.org
Moreover, EU law supersedes the laws of the individual countries that are members of the EU. In other words, the nations that are members of the EU are free to promulgate their own laws on particular subjects unless and until the EU issues a "directive" on the topic and removes the right of the individual countries to legislate for themselves in that particular area.
So far, since the promulgation of EEC 65/65, dietary supplements have technically fallen within the classification of drugs since they have preventive and therapeutic effects. However, individual nations have been left relatively free to regulate them on their own. The Nordic Council, as a regional trading bloc, has already heavily restricted dietary supplements by harmonizing their laws with WHO guidelines for dietary supplements, but that decision did not extend beyond the Nordic countries to the rest of Europe. An upcoming EU decision would heavily restrict the rest of Europe, much as the Nordic countries have already been.
In an increasingly global marketplace, what happens in any large market like the EU is of interest because it has commercial implications for our own companies and indirectly for our own ability to access dietary supplements. If European products can monopolize the European marketplace because dietary supplements are classified as drugs, obviously our companies lose market access.
Conversely, as the EU products enter the US market as drugs, the EU products will be better able to compete here than domestic products because as drugs, they will be labeled with preventive and therapeutic indications. (While this process is not complete, it is definitely happening. The European-American Phytomedicines Coalition has already petitioned the FDA for O-T-C drug status for European products, and the Commission on Dietary Supplement Labels will be recommending the expansion of the OTC drug category as a result.)
(See comments submitted on August 4, 1997 by the European-American Phytomedicines Coalition to the Commission on Dietary Supplements. Comments were filed by their multinational law firm, Akin, Gump, Strauss, Hauer, & Feld, L.L.P. 133 New Hampshire Ave. N.W., Ste. 400, Washington, DC 20036, 202-887-4000)
From a standpoint of defending American exports of dietary supplements abroad, it is imperative that we NOT blur the lines between foods and drugs, but keep our dietary supplements classed as FOODS. If we ever have to go before the dispute settlement body of WTO to contest an effort to blockade our vitamins, we'd stand on far more solid grounds if the products were regulated as foods (under the Sanitary Phytosanitary Measures Agreement), than if our products are regulated as drugs (which fall under the Technical Barrier on Trades Agreement.) This is due to how risk/benefit is measured under these respective agreements. (It is much easier for another country to justify blocking the import of dietary supplements on scientific grounds if we class them as drugs, because the risk benefit analysis under TBT is far more stringent. If we classify them as foods, and a country tries to arbitrarily block them due to safety concerns, they wouldn't have a leg to stand on before the Dispute Settlement Body. (See the NHF-LEF Comments to the President's Commission on Dietary Supplement Labels, by Suzanne Harris at http://www.iahf.com/cdsl-su2.html)
Moreover, President Clinton has announced the conclusion of an MRA, multi recognition agreement between the US and EU with sectoral annexes covering GMPs for drugs and for food products contained from animals (i.e. meats, eggs, cheeses, etc.) These MRA annexes empower European inspectors to act on behalf of the FDA and vice versa. It is clearly the intent to harmonize, that is, to make the US and EU food and drug laws the same across the board. (See the Agreement on Mutual Recognition Between the United States and the European Community at http://www.ustr.gov/index.html)
What we are seeing here are the opening salvos in that USA/EU harmonization process, (although the intent to proceed in this manner goes all the way back to 1980 in closed door meetings at ICDRA (The UN's International Council of Drug Regulating Authorities, the umbrella group which coordinates the activities of FDA, HPB, MCC, TGA, etc, world wide.)
It is also the intent to harmonize EU and US laws that deal specifically with dietary supplements as well as other foods and drugs. S.830, the currently pending FDA Modernization and Accountability Act of 1997 (on which a cloture vote will be held tomorrow in the Senate) says point blank that the FDA's new mission is to work towards harmonizing US laws that it administers with EU laws. Harmonization language is specifically put forth in sections 101, 202, and 807. (See S.830 http://thomas.loc.gov/cgi-bin/query/D?c105:2:./temp/~c105gUg4::
Given the fact that the only two countries in the EU holding out against severe restrictions on dietary supplements to only slight multiples above RDA are the UK and Holland, and given the fact that the UK Ministry of Agriculture, Fisheries, and Foods (MAFF) has announced on their website that they intend to restrict vitamin B-6 to just 10 mg without a prescription, there is no reason for Americans to feel complacent about the harmonization language in S.830. (If MAFF is able to impose their arbitrary ban on B-6 above 10 mg, there would be nothing to stop them from harmonizing the UK's food and drug laws with the EC's, and we would lose them as allies against the German Codex proposal. See MAFF's July press release on vitamin B-6 at http://www.maff.gov.uk/inf/newsrel/1997/jul/970704A.HTM
Consumers are quite correct to be concerned when legislation such as S.830 empowers the FDA to harmonize its regulations to match the EU's. Consumers are quite correct to monitor all activities of the FDA's Office of International Relations, and to be distrustful of international bodies such as the Codex Alimentarius Commission which are very heavily influenced by delegates representing pharmaceutical interests. (See FDA's Office of International Relations at http://www.fda.gov/oia/fdaintl.htm, See Codex Alimentarius Commission at http://www.fao.org/waicent/faoinfo/economic/esn/codex/codex.htm)
Additional information about the Codex International Threat to Health Freedom is available on the IAHF website at www.iahf.com