Presidential Supplement Commission Issues Final Report

WASHINGTON—The seven-member presidential Commission on Dietary Supplement Labels issued its final report in which it urged companies to support health claims with publicly available scientific data but not requiring review of that data by the government. It also urged consumers to do their homework when purchasing supplements to make sure they are not wasting money.

The commission recommended that dietary health claims should be based on the same “significant scientific agreement” required for foods and called for greater use of outside experts by FDA in reviewing petitions for health claims.

The commission also: provided guidance on statements of nutritional support; emphasized industry responsibility for safety and called for improvements in post-marketing surveillance and adverse-reaction reporting systems; urged FDA to establish an OTC review committee for botanical drugs when evidence supports a therapeutic claim that goes beyond statements allowed by DSHEA.

The Commission also recommended the establishment of an expert advisory committee to advise on supplement safety and benefits and recommended that the NIH Office of Dietary Supplements be funded and become a focal point for research.

The Secretary of HHS, Donna Shalala, now has 90 days to decide whether to propose the recommendations as formal rules.