A great deal of misinformation alleges that the manufacture and sales of U.S. supplements will be controlled by the World Trade Organization (WTO) due to the adoption of the Codex Guidelines on Vitamin and Mineral Food Supplements. Contrary to what some consumers have read or been told, these guidelines will not affect the sales and access of supplements in the United States. There will be no direct impact on the U.S. market. Following are some frequently asked questions—and answers—that will help to set the record straight about Codex.

• Click here to download "Codex Alimentarius—Frequently Asked Questions " shown below (PDF) 10.25.05

What is Codex?

•  The Codex Alimentarius Commission was founded in 1963 by the Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO). It is responsible for implementation of the FAO/WHO Joint Food Standards Program.

•  The FAO/WHO Joint Food Standards Program was established to protect consumer health, ensure fair trade practices in the food trade, and promote coordination of all food standards work undertaken by international governmental and non-governmental organizations.

•  The Codex Commission has more than 25 active committees dealing with a variety of food-related issues. Development of science-based guidelines on the composition and labeling of vitamin and mineral supplements has been completed by the Codex Committee on Nutrition and Foods for Special Dietary Use (CCNFSDU) and discussion is beginning on standards for implementation.

•  The United States is one of the 172 member countries that participate in Codex. Standards adopted by the Codex Alimentarius Commission are relevant to the agreements made through the World Trade Organization (WTO), of which the United States is also a member.

•  The American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN) and the National Nutritional Foods Association (NNFA) have become involved with Codex to assure that the freedoms of the Dietary Supplement Health and Education Act (DSHEA) were extended to other countries.   CRN is recognized by Codex as a Non-Governmental Organization (NGO) and is able to participate directly in Codex meetings.

What initiatives is the Codex Commission currently undertaking?

•  At a July 2005 meeting, Codex Alimentarius Commission adopted Guidelines on Vitamin and Mineral Food Supplements, which, among other things, recognized that maximum levels should be set only on the basis of risk assessment and not on the basis of RDAs.   In addition, other manufacturing items such as packaging, labeling and good manufacturing processes were addressed.

Are U.S. Products Affected by Codex Guidelines?

•  Freedom of access to dietary supplements and information about supplements are guaranteed in the United States by the Dietary Supplement Health and Education Act of 1994 (DSHEA).

•  The adoption this past July of the Codex Guidelines on Vitamin and Mineral Food Supplements will have no direct effect on DSHEA or the dietary supplement choices of consumers in the United States. In spite of many Internet-based communications to the contrary, the U.S. is under absolutely no obligation to change its existing laws and replace them with Codex guidelines, but is required to accept for import any products that conform to such guidelines.  

•  When entering into international trade agreements, Congress took care to add provisions that protect U.S. law, including public health statutes like DSHEA.

•  Fears that other countries will use international standards to force the United States to conform to Codex guidelines are unfounded. Such guidelines can be used by countries to challenge restrictive barriers to trade.   If U.S. law is more liberal than Codex, there is no basis for a WTO case. The supplement trade associations will continue to be actively engaged to ensure that business interests and consumers' rights are protected.

•  Additionally, the Food and Drug Administration Modernization Act specifically exempted dietary supplements from harmonization with international standards.

•  It's important to keep in mind that Codex are guidelines are voluntary. The United States has never adopted Codex guidelines for any products.

What is the position of the leading trade associations - AHPA, CRN, NNFA?

•  When threats to DSHEA, either domestic or international, materialize, the top priority of the U.S. supplement industry is to protect this important law. CODEX is not a threat to DSHEA.

•  The principles embodied in DSHEA if applied internationally will allow consumers everywhere to enjoy the benefits of a wide array of dietary supplements manufactured by a world-wide industry that takes very seriously its commitment to the health of its consumers.

•  Development of appropriate Codex guidelines will facilitate the export of U.S. made products.

10/25/05