Regulating supplements

Townsend Letter for Doctors and Patients,  May, 2005  by Jule Klotter

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After 13 years of development, the Codex Committee on Nutrition and Foods for Special Dietary Uses finalized its international guidelines for vitamins and minerals in November 2004. Robert Verkerk, PhD, executive director of Alliance for Natural Health (www.alliance-natural-health.org), says that the core of these guidelines resides in the "nutrient-appropriate' risk assessment system which is presently open to consultation ... it is of key importance that such a risk assessment does not deem dosages and forms of nutrients that give rise to health benefits as excessive and 'unsafe.'" In the hope of influencing the risk assessment system, the Alliance for Natural Health submitted its own proposal for risk assessment to the International Programme on Chemical Safety of the World Health Organization in December 2004.

The European Union Food Supplements Directive, which harmonizes member states' supplement regulation in anticipation of Codex, goes into effect on 1 August 2005. The Directive rigidly defines acceptable forms and maximum dosage of vitamin and mineral supplements. It will prohibit the sale of 75% of the vitamin and mineral supplements currently on the UK and Netherlands market, according to Alliance for Natural Health (ANH). ANH has challenged the Directive in the European Court of Justice, which is expected to render its judgment in June 2005.

According to Suzan Walter, president of American Holistic Health Association, the official position, presented at November's Codex meeting, is that member countries can decide how and if they want to use the Codex documents; they are not mandatory. However, Codex has signed agreements with the World Trade Organization (WTO). These agreements give the WTO the right to use any Codex document as a mandatory international trade standard. In addition to mandating doses and forms (synthetic or food based) of vitamins and minerals that can be marketed, Codex is also defining "what nutrient claims can be made about a product, what educational information can be provided to consumers, what nutrient information can be placed on a supplement product label." Codex is scheduled to be adopted in the US by 2007, according to John Wilson, Jr., MD (American Association for Health Freedom newsletter).

The US is seeing increased pressure to revise the Dietary Supplement Health & Education Act of 1994 (DSHEA), the act that protects consumer access to nutritional supplements. In January 2005, the Institute of Medicine released a report, commissioned by the National Center for Complementary and Alternative Medicine and sponsored by the Agency for Health Care Research and Quality. Natural Products Insider summarized the report's six recommendations: "new measures for seed-to-shelf quality control; accuracy and comprehensiveness of labeling; enforcement against inaccurate and misleading claims; research into consumers' supplement use; incentives for privately funded research of supplements; and consumer protection against all potential hazards of supplement use" (emphasis added). This report provides fuel for those who seek to limit supplement access.

American Association for Health Freedom, a 501c4 nonprofit advocacy group for alternative medicine, reports that federal legislation that aims to weaken or repeal DSHEA is again being proposed by Senator Richard J. Durbin (IL-D). Senator Durbin and Representatives Henry Waxman and Susan Davis, both of California, have sponsored 'staff only' briefings focusing on botanicals. Because of its nonprofit status, American Association for Health Freedom can "freely lobby." It is working with ACAM, ICIM, AAEM, CA Citizens for Health Freedom, and other organizations to promote choice and access to alternative treatments.

American Association for Health Freedom. Eye on Health Freedom. Vol. 05 Issue I

Associated Press. Panel wants rules for diet supplements. 14 January 2005 www.cnn.com/2005/HEALTH/01/14/alternative.medicine.ap/index.html

Hasslberger, Josef. Supplements: Eu Court Hears Case as UK Commons Debate Directive. 26 January 2005 www.newmediaexplorer.org

IOM's CAM Report Calls for Changes to DSHEA. 12 January 2005 www.naturalproductsinsider.com

Understanding and Stopping the Codex Conspiracy. Total Health 1 October 2004 www.lef.org/lefcms/aspx

Verkerk, Robert, PhD. How proposals for EU, US and Codex regulation could destroy natural healthcare: the critical need for a new regulatory paradigm. Presented at American College for Advancement in Medicine Conference (San Diego, CA) 18 November 2004. www.alliance-natural-health.org

Walter, Suzan. Guidelines Completed. Now What? http://ahha.org/codexwalter2004.htm

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