Food Labeling; Health Claims and Label Statements for Dietary Supplements; Update to Strategy for Implementation of Pearson Court Decision

Samenvatting

The Food and Drug Administration (FDA) is updating its strategy for implementation of the court of appeals decision in Pearson v. Shalala (Pearson). The updated implementation strategy includes an interim enforcement strategy for dietary supplement health claims that do not meet the "significant scientific agreement" standard of evidence by which the health claims regulations require FDA to evaluate the scientific validity of claims. It also includes changes in the process that will be used for reconsidering the four Pearson health claims and for responding to future petitions for dietary supplement health claims. The agency is taking this action to inform interested persons of the latest developments in FDA's plans for implementation of Pearson.