The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 8 No.
4 • October 2005
Codex Alimentarius Commission: Latest U.S. Draft Position on the Scientific Basis of Health Claims
The United Nations Codex Alimentarius Commission is working steadily to develop an international regulatory regime for dietary supplements, including health claims. While theoretically the rules developed by the Codex would apply only to international trade and could not be required of purely domestic trade within the United States (except via new legislation passed by Congress), the workings of the World Trade Organization, which would administer the Codex rules to international trade, are complex, and one can never be sure that there isn’t a gotcha (now or later) that could be used to force these standards upon the U.S. Hence, vigilance is important to keep track of what Codex is doing and especially to learn of any attempts to impose this on the domestic U.S. market. (Just what we need: another layer of top-down, unaccountable, meddling bureaucracy between us and the ability to purchase what we want and to get the information we desire.)
We report here a few of the U.S.’s official statements in the U.S. Draft Position as of October 14, 2005, on the “Codex Committee on Nutrition and Foods for Special Dietary Uses, 27th Session.” The U.S. agrees that:
- Claims should be prohibited if they cannot be substantiated. (p. 68)
Comment: The U.S. already has clear laws and court rulings specifying that health claims can be prohibited only if they are inherently misleading (that is, no disclaimer can correct for potential misleadingness in the claim). Moreover, “substantiation” for health claims is defined under U.S. law and may have little to do with “substantiation” as understood by the Codex Commission, which is, after all, an international body made up of a large number of countries. The commission, in fact, is dominated by Europe and its anti-health claim philosophy.
- Health claims should be consistent with national health policy, including nutrition policy, and support such policies where applicable. (p. 68)
Comment: This is a purely political policy, having nothing to do with the scientific basis of a health claim. In the consideration of acceptance (or not) of health claims, the truth of the health claim should be all that matters. In the United States, denial of a health claim that is scientifically accurate is a violation of the First Amendment.
- This preliminary assessment [of a proposed health claim] may serve as a basis for identifying prohibited health claims (e.g., if the claim is about treatment of a disease), and for selecting studies to evaluate a health claim. [Emphasis added] (p. 73)
Comment: As we have noted before, there is no constitutional or statutory authority for the FDA to prohibit health claims about the treatment of disease, provided the claim is truthful and not misleading. There is ongoing legal action by us and others on this point, as the legal monopoly of pharmaceutical drugs on “treatment” claims is at stake and worth billions. Also, the fact that treatment claims are given as an example of prohibited claims implies that there are others.
- The expected beneficial effects and, if appropriate, its adverse effects, which may appear after long-term consumption of the [food(s) bearing a health claim] should be considered. (p. 76)
Comment: Here, the FDA proposes to grant itself the authority to do risk/benefit analyses on dietary supplements, as is done on drugs, which has not been authorized under Congressional statute. Dietary supplements are, according to U.S. statute, to be treated as foods, which are not required to provide evidence of benefits before sale and are not subject to FDA risk/benefit analysis.
The July 2005 official version of the “Proposed Draft Recommendations on the Scientific Basis of Health Claims at Step 3” of the “Codex Committee on Nutrition and Foods for Special Dietary Uses, 27th Session” includes additional threats to freedom of informed choice. The Codex Committee proposes that safety requirements include:
- The expected level of consumption shall not exceed any relevant internationally recognized level of safe intake (e.g., ADI, if an ADI has been set), for any constituent present in the food. (p. 4)
Comment: This is outrageous! The U.S. would be expected to comply (at least in international trade) with a standard set internationally (that is, largely by other countries). All such issues are covered under United States law.
- The risk from a change in the dietary pattern of the consumer, triggered by the emphasis on the product, resulting in its excessive consumption, leading to nutritional imbalance. (p. 4)
Comment: There is a great deal of interpretation and judgment to be made here, with an inherent risk of excessive and unreasonable regulation, especially when “proper” nutritional intake is based upon political policies. (An example of a political food policy: the USDA beef-grading system assigns the highest ranking to “prime,” which is the meat highest in fat content. Thanks a lot, federales.)