Aside from some superficial changes and last-minute consumer group campaigns to stall the ratification, global standards for vitamin and mineral supplements were adopted by Codex Alimentarius (established by the United Nations in 1961.)

The guidelines--which were debated by Codex committee members for more than a decade--recognize vitamin and mineral supplements as a food category and are expected to expand markets for supplement makers. Worse:

• The guidelines will now serve as a model for countries that do not currently have supplement regulations in place.

• They may also be used under World Trade Organization agreements to force countries to allow the importation and sale of products that conform to those guidelines.

Setting Permitted Levels of Vitamins and Minerals

One element of the new guidelines that is projected to be particularly influential for the supplement industry: Setting new limits on the maximum level of vitamins or minerals based on a scientific risk assessment, rather than recommended dietary intake (RDA) that result in significantly lower amounts than those based on risk assessment.

Adversaries of these measures strongly believe the new guidelines will force vitamins and minerals offered in higher dosages to be classified and regulated as drugs. Moreover, the executive director of the Alliance for Natural Health, stated:

It appears that the Codex guidelines for food supplements include faulty procedures that contradict Codex's own rules, as pointed out by the U.S.-based National Health Federation, itself a Codex participant. We have also demonstrated that the risk assessment system being considered by Codex is scientifically flawed.

Conversely, the vice president of scientific and international affairs at the U.S. trade association the Council for Responsible Nutrition (CRN) claims the risk assessment project attempts to harmonize risk assessment methodology across nations and that consumer groups claiming that the Codex guidelines would lead to restrictions on supplements were misinformed.

The Food and Agriculture Organization of the United Nations (FAO) is expected to produce a report in a few months on its risk assessment methodology; it will be several years, however, before this is adopted.

(The draft version of the Codex Guidelines is on the AHPA Web site; the final version is identical, with the exception of the addition of the word "only" to section 1.3, which now reads: These guidelines apply only in those jurisdictions where products defined in 2.1 are regulated as foods.)

Food Navigator.com July 5, 2005

NPI Center July 5, 2005