In the past few months, numerous articles have been published on the Internet and elsewhere concerning a series of guidelines, the Codex Guidelines on Vitamin and Mineral Food Supplements, promulgated by the Codex Alimentarius Commission.In the eyes of some, the guidelines could severely limit access to dietary supplements in the United States. In response, two of the nation's leading supplement industry associations have released statements addressing the proposed Codex guidelines.
The Codex Alimentarius was formed in 1963 as a joint project of the World Health Organization and the Food and Agriculture Organization. More than 170 nations belong to the Codex, including the United States. Its mission is to "develop food standards, guidelines and related texts such as codes of practice," with the intention of "protecting the health of consumers and ensuring fair practices in the food trade." The Codex Alimentarius Commission (CAC) is the top-level body that oversees all Codex activities. Delegations from the member countries meet annually in alternating locations - at the FAO's headquarters in Rome and the WHO's headquarters in Geneva.
In 1991, the CAC charged the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), based in Germany, with the task of drafting guidelines on vitamins and mineral supplements. The result of the committee's work is the Codex Guidelines on Vitamin and Mineral Food Supplements. As of this writing, the guidelines have progressed through seven of eight regulatory steps required for adoption, and will be voted on when the Commission meets in Rome this July.
The most controversial aspect of the guidelines pertains to what constitutes "safe levels" for vitamins and minerals. Section 3.2.2 of the Codex Guidelines states:
"Maximum amounts of vitamins and minerals in vitamin and mineral food supplements per daily portion of consumption of recommended by the manufacturer shall be set, taking the following criteria into account:(a) upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into consideration, as appropriate, the varying degrees of sensitivity of different consumer groups;
(b) the daily intake of vitamins and minerals from other dietary sources.
When the maximum levels are set, due account may be taken of the reference intake values of vitamins and minerals for the population. This provision should not lead to setting of maximum levels that are solely based on recommended nutrient intakes (e.g., population reference intake or recommended daily allowance values)."
In response to the Codex Committee's work, the American Herbal Products Association (AHPA) and the National Nutritional Foods Association (NNFA) have issued statements clarifying what effect, if any, the Codex Guidelines will have on the sale and distribution of dietary supplements in the United States. In April, the AHPA published a document that addresses many of the concerns posed by herbal suppliers and consumers. The document, which is available online at www.ahpa.org/05_0413_CodexAndDS.pdf, states, in part:
"The presumed final adoption this summer of the Codex Guidelines on Vitamin and Mineral Food Supplements will have no direct or immediate effect on 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.
"... In summary, there will be no immediate effect on U.S. consumers of the final approval of the Codex Guidelines on Vitamin and Mineral Food Supplements. That fact should not, however, lull consumers or marketers of dietary supplements away from the inevitability that any restrictive elements from these guidelines will be used by critics of this industry to try to change our domestic laws."
In a similar document, titled "Codex: Just the Facts" (available at www.nnfa.org/codex/pdf/CodexFactSheet.pdf), the NNFA delivered its position on both the Codex Guidelines and the European Food Supplements Directive, another proposal that could affect the sales of more than 5,000 supplements in Europe. According to the NNFA: "If the Codex Guidelines and the European Directive regulation on food supplements are passed, they will not affect sales of supplements in the United States.
"The United States has never adopted Codex guidelines for dietary supplements or any other products. It is also important to be clear that the European Directive applies only to products sold in the European Union. It does not apply to retailers in the United States. There is no direct impact on the U.S. dietary supplement market."
