FDA Issues 4 Warnings for Unfounded Infection Prevention Labeling Claims
The Food and Drug Administration issued four warning letters to companies that manufacture and market over-the-counter (OTC) drug products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylococcus aureus bacteria (MRSA). Labeling and marketing materials for the affected…
Sign up for a free preview to unlock the rest of this article
Export Compliance Daily combines U.S. export control news, foreign border import regulation and policy developments into a single daily information service that reliably informs its trade professional readers about important current issues affecting their operations.
products also claim that they can prevent infection from other disease-causing agents and some hand sanitizing drug products make claims related to preventing infection from E.coli and/or H1N1 flu virus. FDA does not have sufficient evidence demonstrating that these products are safe and effective for these purposes.