Frequently Asked Quesions about Codex Alimentarius
1.Will my rights to sell or buy supplements end if the Codex guideline is approved this summer?
No. But two important events this summer will undermine access to dietary supplements. 1) The Codex Commission meets to establish international agreement on vitamin and mineral regulations as a first step toward regulating all supplements, and 2) if, as is likely, the new European Food Supplement Directive (EFSD) is upheld in court, beginning August 1, 2005 many Europeans will lose access to thousands of dietary supplements. (For more on the EFSD, please visit http://www.citizens.org/hill/eufsd.cfm )
2.What are the major concerns with Codex’s vitamin and mineral guidelines?
If the Commission approves the proposed guidelines, it will establish a restrictive international framework for dietary supplements. Here is where Codex is, and where it is headed, and why we need to be concerned:
A. Codex is developing "upper limits" (maximum potencies) for each vitamin and mineral formulation based on a risk assessment model used to assess the health risks for toxic chemicals and environmental hazards rather than a nutrition science model. The upper safe limits model, based on norms and population groups instead of biochemical individuality, attempts to set one safe and useful value for all individuals rather than promote an optimum nutrient intake level for each person.
B. Codex is establishing international guidelines intended to apply to the entire world population from standards drawn from the nutrition profile of the "developed" world. Such Codex standards would marginalize the nutrient supplement possibilities of the nearly one billion people worldwide, who, by international standards, go hungry. These guidelines also under-appreciate the diminished nutritional status of the remaining 5.6 billion people, a majority of whom do not consume health-enhancing (optimal) amounts of one or more essential nutrients.
C. Codex, through setting maximum vitamin and mineral consumption limits, is laying the cornerstone of prerequisites for a “prior restraint” approach to regulating dietary supplements that might require that dietary supplements receive regulatory approval before being marketed. This approach is contrary to the principles of U.S. law established in DSHEA (the Dietary Supplement Health Education Act of 1994), which acknowledges that nutrients are food and presumed safe in the absence of contrary evidence.
D. Codex is reinforcing its existing prohibition on the dissemination of truthful information about the ability of foods and nutrients to prevent, alleviate, treat or cure disease. World hunger experts recognize that nutrient supplementation can be extraordinarily useful in improving world health and eliminating disease (one dollars’ worth of vitamin A supplementation in developing countries can offer 30 times as much social improvement as one dollar of development aid), a fact ignored by the Codex vitamin and mineral guidelines.
E. Codex undermines its supplement guidelines by saysing "Most people who have access to a balanced diet can usually obtain all the nutrients they require from their normal diet." The assumption that everyone has access to sufficient levels of nutrients is flawed. The 1992 UN Earth Summit documented 50 years of massive mineral depletion in our soils. Other research shows the reduced nutritional profile of an industrial food system diet. Billions of people, rich and poor, lack optimally nutritious food. The Codex guidelines make this problem worse.
The restrictive precautionary principles underlying the Codex proposed guidelines for vitamins and minerals, rightly express concern over the use of dangerous chemicals built into modern food law. Adding dangerous industrial chemicals to food could harm a lot of people; care and precaution are advised. However, nutrients are not industrial chemicals. The Codex nutrition committee's recommended vitamin and mineral guidelines, based on the recommendations of the FAO/WHO Nutrient Risk Assessment project, intends to protect consumers from "the dangers of nutrients" by effectively, if not intentionally, restricting access to dietary supplement products. The unintended consequences of this approach (limiting the amount of available nutrients) undermine individual and social health, increase economic and political costs and unnecessarily limit world trade and product innovation.
3. Do Codex guidelines automatically replace U.S. DSHEA (The Dietary Supplement Health Education Act) and immediately restrict U.S. access to dietary supplements?
No. Codex guidelines do not automatically replace DSHEA. Changing DSHEA requires Congress to change U.S.law. Codex does create binding international trade standards like the WTO Sanitary & Phytosanitary Standards Agreement (“SPSA”) rules. SPSA governs international food hygiene limiting filth or pathogens that endanger health. However, Codex guidelines are subject to the WTO trade dispute process which recognizes national rules less restrictive than Codex standards (i.e. US’s DSHEA). Codex will prohibit U.S.companies from exporting high potency supplements to countries utilizing Codex standards. It will also open markets in countries that currently have strict supplement regulations.
But, Codex effectively, even if not intentionally, establishes an international norm that treats dietary supplements as unnecessary, and nutrients as dangerous substances warranting extreme caution and restraint by regulators. Codex agreement will bolster the arguments of dietary supplement Capitol Hill and regulatory agency detractors. The Codex recommended vitamin and mineral guidelines could begin the process of undermining American law unless consumers get organized now to support DSHEA for adoption as the international vitamin and mineral trade standard.
4. Can FDA bypass Congress and use a regulatory process to harmonize U.S. law with Codex guidelines?
No. If FDA determines that it would like to modify U.S. law to conform to Codex vitamin and mineral standards, it must, to pass muster with US courts, go through the regulatory process and any new dietary supplement regulations will have to be within the law established by DSHEA. The Codex approach to establishing upper limits on vitamins and minerals is contrary to DSHEA.
5. Can congress Change DSHEA?
Yes. All dietary supplement consumers must inform their members of Congress that DSHEA must remain in force in the U.S. and that it is the proper standard for international trade in dietary supplements. Take Action!
