Time to Regulate Dietary Supplements?
The Center for Science in the Public Interest (CSPI) has formally requested that the FDA take enforcement actions against manufacturers of dietary supplements containing more than 3 mg of synthetic beta-carotene unless the products include a label warning consumers that the supplement may cause lung cancer in smokers.
CSPI based their request on a review of the literature conducted by the World Cancer Research Foundation and the American Institute for Cancer Research which found that the “evidence that beta-carotene supplements cause lung cancer in current smokers is convincing.”
CSPI’s warning label request raises the broader issue of how, if at all, dietary supplement labels should be regulated. FDA cannot simply make labeling decisions on an ad hoc basis each time a new study is published. Fortunately, the agency already has the legal framework in place for making such labeling decisions, it is the same legal mechanism and standards that should be applied to the labels of all FDA-regulated products including over-the-counter and prescription drugs; the Paperwork Reduction Act and the Data Quality Act including the Peer Review Bulletin and Principles for Risk Assessment.
In short, warning labeling decisions for all products, not just dietary supplements, should be based on the PRA and the Data Quality guidelines. CSPI’s request was deficient since it failed to explain how it complied with the PRA and DQA controlling legal authorities.
See CSPI Press Release
See CSPI letter to FDA
