Food Labeling; Dietary Supplement Health Claims; Public Meeting Concerning Implementation of Pearson Court Decision and Whether Claims of Effects on Existing Diseases May Be Made as Health Claims

Resumo

The Food and Drug Administration (FDA) is announcing a public meeting to solicit comments on two topics pertaining to health claims in dietary supplement labeling. The first topic concerns implementation of the recent court of appeals decision in Pearson v. Shalala (Pearson). InPearson, the U.S. Court of Appeals for the D.C. Circuit held that FDA's decision not to authorize four health claims for dietary supplements violated the First Amendment because the agency did not consider whether the claims, which failed to meet the "significant scientific agreement" standard of evidence by which the health claims regulations require FDA to evaluate the scientific validity of claims, could be rendered nonmisleading by adding qualifying language. The second topic on which we are requesting comments is whether claims about an effect on an existing disease may be made as health claims, or whether such claims should subject the product to regulation as a drug. We are holding this meeting to give the public an opportunity to provide information and views on these topics.