A federal judge rejects a class action plaintiff’s parsing of a US Food and Drug Administration OTC monograph to exclude the gelcap format and a rapid release indication and to negate federal preemption of challenging a claim for a Tylenol internal analgesic formulation.
US OTC Internal Analgesic Monograph Includes Gelcap Format, Rapid Release Indication – Court
Putative class-action complaint alleging false advertising for Tylenol Rapid Release gelcaps recently dismissed on J&J Consumer’s motion arguing that federal preemption prohibits requiring different or additional labeling for drugs available under FDA OTC monograph.