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LE Magazine October 1997

Despite Victory Over One Codex Proposal
The Need Remains for Further Activism

By John C. Hammell

image While an international effort to regulate and restrict vitamins worldwide was beaten back setback this summer, public and private moves on a number of fronts in several countries still pose a threat to health care freedom.

A victory has been achieved in Geneva, Switzerland, at the executive committee meeting of the United Nation's Codex Alimentarius Commission. When the German representatives tried to advance their Codex proposal which threatens worldwide access to high-potency vitamins, the concern of other countries helped push back those efforts to an earlier phase in the testimonial process.

The German proposal still threatens to reduce consumer access to dietary supplements to no higher than recommended daily allowances. If successful, the proposal would become the international reference standard under the NAFTA and GATT international trade treaties. Numerous supplements would become unavailable.

And there are other concerns. Codex functions like a board of directors meeting in that the only official things that occur are what are noted in the minutes of the final report. Thus, the Canadian proposal to create a negative, or "no trade," list of herbs appeared to have been defeated during the meeting, but because no express statement was made in the final report to kill this proposal, an independent "expert" panel could be convened on this topic at any time without a vote of the Codex Commission.

International Advocates for Health Freedom contributed to the victory by sounding the alarm to allied groups around the world who rallied their citizens in opposition to the German Codex proposal. The war is just heating up, however, as Codex harmonization efforts continue at high speed in countries around the world.

Citizens worldwide need to continue to oppose Codex. Canadians need to help sustain the two lawsuits filed against the Canadian Health Protection Branch, and fight for the "foods are not drugs" amendment. The British need to oppose an effort to limit consumer access to vitamin B6 to just 10 mg. And Americans need to resist the effort to give new enforcement powers to the Food And Drug Administration, and resist as well over-the-counter drug status to herbs and botanicals. Form letters on the International Advocates for Health Freedom website and via fax on demand make it easy to keep fighting the forces threatening free access to dietary supplements.

A Proposal Knocked Back

Suzanne Harris of the Law Loft in Colorado attended the Codex executive committee meeting in Geneva at the end of June. Harris also was able to procure information vital to the struggle by gaining access to the World Trade Organization briefing on the Committee on Sanitary and Phytosanitary Measures.

The German proposal could have been accepted by the Codex Commission at step 5, bypassing the remaining three steps in the process, if no nation had objected to its acceptance. It could have progressed to step 6 if a "consensus" of the Commission had agreed. Under the Codex procedure, this is the point where nations can draw attention to economic problems for domestic industries that any proposed guidelines would cause. This also is the stage at which work proposals can be dropped altogether or pushed back to an earlier stage in the process.

Opposition to the German Codex proposal began with the Netherlands, which has special status as the head of the European Union. According to notes taken by Harris at the meeting, Dutch representatives stated, "We have some difficulty here. The area is a minefield. There was fierce opposition in the committee. Also, essential parts in square brackets remain unresolved. How can we advance this proposal to step 6 when there is so much uncertainty? We have reservations. We do not agree to advance this proposal to step 6."

Canada agreed with the Netherlands, requesting that, "Development of the proposal should cease altogether. In our view, consideration of this proposal could interfere with the development of international practices. A significant number of consumers believe that they have a right to consume these vitamins and minerals. Worldwide guidelines are not required. Canada strongly opposes adoption at step 5. We recommend that 1) we cease development of these guidelines altogether, or 2) at least return the proposal to step 4."

German representatives then admitted there had been controversy, but argued forcefully that only seven out of 39 countries had argued against adoption of their proposal at step 5, and stated that the Commission had to decide if the proposal should advance to step 6, or return to step 3.

United States representatives then declared, "This is not an appropriate topic for international standardization at this time. . . ."

Australia, New Zealand and Japan then strongly endorsed the position of the U.S., Canada and the Netherlands. South Africa agreed with the Netherlands not to advance to step 6, but argued that work shouldn't be discontinued, while Norway, Austria and Hungary supported Germany, calling for a continuation of the work.

The chairman of the committee then stated, "I see a consensus to return the proposal to step 3. We need a fundamental re-thinking on the developing discord on this issue." Thus, while the long-range German Codex proposal suffered a major setback, ongoing harmonization efforts continue full throttle in individual countries. There will be further reports on both the long-range and ongoing harmonization threats via an E-mail distribution list. Send E-mail to International Advocates for Health Freedom at jham@concentric.net to be added to the list. Donations to Suzanne Harris to continue her work can be sent to The Law Loft, P.O. Box 709, Johnstown, Colo. 80534, USA.

Canadian Update

In Canada, International Advocates for Health Freedom has been able to catalyze widespread awareness of the Codex threat, and has assisted Freedom of Choice in Health Care in filing two lawsuits against the Health Protection Branch in order to stop the third phase of "cost recovery," which threatens to drive small Canadian supplement manufacturers out of business. If successful, these lawsuits will stop the Health Protection Branch from violating people's rights under the Canadian Charter of Rights and Freedoms, will challenge an overly broad definition of what constitutes a "drug," and will block imposition of an illegal tax that was never debated by Parliament.

Donations and assistance are badly needed to keep monitoring the HPB and to sustain the legal effort. Send donations to Freedom of Choice in Health Care, 5863 Willow St., Suite 711, Willowdale, Ontario M2-1J8, Canada. For more information call 416-690-5558. To assist the British Columbia chapter call 604-793-9087.

United Kingdom Update

New legislation has been introduced in the United Kingdom to limit free access to vitamin B6 supplements above 10 mg in strength. Under this proposed law, supplements of vitamin B6 of greater than 10 mg would become licensable medicines. Products containing up to 200 mg of vitamin B6 have been on the market in the U.K. and U.S. for decades without adverse reactions reported at that dosage level (there have been reports of neurologic symptoms in some people consuming 500 mg a day or more of vitamin B6 without the other B complex vitamins).

The toxic dose of vitamin B6 in dogs is 3,000 mg per day. The British government's advisors, known as the Committee on Toxicity, say this should be divided by a factor of 300 to arrive at the safe dosage level for humans of 10 mg, but leading science policy experts consider the factor of 300 to be arbitrary, not based on scientific evidence.

This is a good example of the threat of Codex harmonization. Consumers should be alarmed at this threat because the United Kingdom is the world's second largest manufacturer of dietary supplements. If the U.K. arbitrarily regulates vitamin B6 at 10 mg, ignoring volumes of safety data presented by the Council for Responsible Nutrition and other organizations, what would stop them from limiting consumer access to other nutrients to RDA levels? If the U.K. harmonizes with the German Codex proposal in this way, we could lose them as an ally and the Germans could still push their proposal through.

Consumers worldwide must come to the aid of people in the U.K. Letters protesting this restriction on vitamin B6 should be faxed or mailed to two key members of Parliament: Jeff Rooker, M.P., House of Commons, London SW1A 0AA, U.K., fax +44 171 219 5823; and Paul Boateng, M.P., House of Commons, London SW1 0AA, U.K., fax +44 171 219 4970.

United States Update

Over-the-counter drug categorization for herbs and botanicals in the United States is being pushed by the National Nutritional Foods Association, the Utah Natural Products Alliance and the American Herbal Products Association, apparently under the influence of German phytopharmaceutical companies with designs on the North American market.

It appears that the National Nutritional Foods Association and Citizens for Health (which also supports this move) don't even want their own members to know that they are pushing for herbs and botanicals to be regulated as OTC drugs. At a discussion on Codex they sponsored at the recent National Nutritional Foods Association convention in Las Vegas, there was no mention of their advocacy for herbs and botanicals being regulated as OTC drugs.

The recent report by the Dietary Supplements Label Commission recommends that herbs and botanicals be treated as OTC drugs, and has other provisions to restrict freedom in healthcare. Although the Commission Report doesn't carry the force of law, Congress is strongly influenced by reports of this kind, and could try to repeal the gains made by consumers under the Dietary Supplement Health and Education Act of 1994.

It is important to understand that some of the larger dietary supplement companies may not mind this because they can afford the added bureaucracy, but it could drive smaller competitors out of business. Competition helps keep prices down; it doesn't help consumers when smaller companies are squeezed out of the market, especially when those on top are the major pharmaceutical companies.

The Dietary Supplements Label Commission's report was released very quietly, and the vast majority of dietary supplement consumers in the U.S. are unaware of it. It also provided a much-too-short period of time for public comments. The 77-page draft report can be obtained by calling 301-650-0382.

By press time, the comments period will be over. However, since FDA may still use the report to attack the supplements industry through rule-making, it is important that Americans fax or mail letters protesting the report's recommendation to make herbs and botanicals OTC drugs. They should protest the fact that adequate time has not been given for commentary on the report.

Fax or send your letters to Kenneth D. Fisher, Ph.D., Executive Director, Commission on Dietary Supplement Labels, Office of Disease Prevention and Health Promotion, R.728G Hubert H. Humphrey Building, 200 Independence Ave., S.W., Washington, D.C. 20201, phone 202-401-6245, fax 202-205-0463. Your senators and Congressional representatives can be called through the U.S. Capitol Switchboard at 202-225-3121 for the House, and for the Senate 202-224-3121. If you don't know theirnames, just state your state and zip code and they will connect you.

Further information about these issues and form letters to help you register your protests are available by telephone at 1-800-333-2553.