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
Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.
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.