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…
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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.