FDA warns of false claims of MRSA prevention for OTC products

The FDA issued four warning letters to companies that manufacture and market over-the-counter drug products, such as hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylococcus aureus bacteria, according to an FDA press release.

Labeling and marketing materials for these products also claim that they can prevent infection from other disease-causing agents, including Escherichia coli and/or H1N1 influenza virus.

The FDA does not have sufficient data to indicate that these products are safe and effective for these purposes. Therefore, companies making false claims were given 15 days to correct the violations and failure to do so may result in legal action, including seizure and injunction, according to the release.

Warning letters were sent to the following companies:

Tec Laboratories for Staphaseptic First Aid Antiseptic/Pain Relieving Gel;
JD Nelson and Associates for Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant;
Dr. G.H. Tichenor Antiseptic Co., for Dr. Tichenor’s Antiseptic Gel;
Oh So Clean Inc., (d/b/a CleanWell Company) for CleanWell All-Natural Foaming Hand Sanitizer, CleanWell All-Natural Hand Sanitizer, CleanWell All-Natural Hand Sanitizing Wipes, and CleanWell All-Natural Antibacterial Foaming Handsoap.

Consumers who have purchased these products and suspect their skin infection is worsening or not improving should contact their physicians. Health care professionals and patients should report adverse events associated with the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

“MRSA is a serious public health threat,” Deborah M. Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the press release. “The FDA cannot allow companies to mislead consumers by making unproven prevention claims.”

Follow InfectiousDiseaseNews.com on Twitter.