The future of dietary supplements may be determined by what happens this summer. Not just one, but many different yet related matters are all coming to a head during the spring and summer months of 2005. Since everything is interrelated, you will want to track national, regional, and international events.
When you review articles and e-mails dealing with supplements (and there are a number making the rounds), it is important that you understand the impact of each of these events individually, as well as collectively. The following review is presented to assist you in understanding the nuances of each issue and in recognizing when some sources blur and confuse the distinctions.
Codex Guidelines for Vitamin and Mineral Food Supplements
The Codex Guidelines for Vitamin and Mineral Food Supplements is an international document drafted to be guidelines for vitamin and mineral supplement products. It states that it is only for countries that designate these supplements as food, exempting countries that designate supplements as drugs. Last November, after over a decade of wrangling over numerous supplement regulation issues, a Codex committee completed an eight-step process that created the official Guidelines document. Finalization of the Guidelines document is on the agenda for the Rome July 4-9, 2005 session of the top Codex body, the Codex Alimentarius Commission. At this time, there does not appear to be anything that can be done to stop this final action. Under Codex authority, these Guidelines are optional suggestions, not a mandatory trade standard that must be followed in trade between countries.
However, there are agreements between Codex Alimentarius and the World Trade Organization that allow the WTO to use Codex documents (such as the Guidelines) as mandatory international trade standards to settle trade disputes. The WTO can enforce dispute decisions by pressuring the losing country through trade sanctions if they do not change their national laws or other regulations to conform to international trade standards. Therefore, the regulations in the Guidelines must be taken seriously.
The section of the Guidelines expected to have the most significant impact is the criteria by which the maximum amounts of vitamins and minerals that will be allowed in a supplement product are determined. The Guidelines state that "... upper safe levels of vitamins and mineral established by scientific risk assessment based on generally accepted scientific data...." As there is currently no generally accepted scientific risk assessment protocol available, what these limits will be is unknown. Some individuals are very concerned that the upper limits will be set too low. This could mean that instead of one convenient high-dosage capsule, the consumer might need to take a handful of low-dosage capsules.
FAO Risk Assessment Protocol
The Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO) announced in December, 2004, that they were accepting applications from individuals who wish to serve as the experts on a joint nutrient risk assessment project to define a scientifically-based nutrient risk assessment. Work is scheduled to begin in May, 2005. The balance of perspectives of the experts selected will be the first sign of how this project will progress. It is anticipated, but not guaranteed, that this nutrient risk assessment protocol will be used to define the upper safe limits of the Codex Guidelines.