FDA cracks down on MRSA product claims

January 12th, 2015

I am not aware of any study that shows that Methicillin-resistant Staphylococcus aureus (MRSA) is more difficult than susceptible staph strains to deactivate and remove by hand washing. The Centers for Disease Control and Prevention recommendation that health care workers “clean their hands with soap and water or an alcohol-based hand rub” before and after caring for a patient is the same for drug susceptible staph infections and MRSA.

So in other words, MRSA is resistant to antibiotics, not hand hygiene. That said, companies that make prevention claims against MRSA are running afoul with the Food and Drug Administration, which doesn’t care if I am aware of any studies on the matter or not. (Of course, any product claim that implies treatment – as opposed to prevention -- of MRSA infection would certainly be expected to raise a red flag in the FDA’s eyes.)

The FDA has issued four warning letters to companies that manufacture and market over-the-counter drug products, including hand sanitizers, that claim to prevent infection from MRSA.

“Labeling and marketing materials for the affected products also claim that they can prevent infection from other disease-causing agents,” the FDA stated. “In addition, the labeling of some of the firms’ hand sanitizing drug products makes claims related to preventing infection from E. coli and/or H1N1 flu virus. The FDA does not have sufficient evidence demonstrating that these products are safe and effective for these purposes.”

The FDA warning letters were sent to the following firms:

• Tec Laboratories for Staph aseptic First Aid Antiseptic/Pain Relieving Gel;
• JD Nelson and Associates for Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protestant;
• Dr. G.H. Michener Antiseptic Co. for Dr. Michener’s Antiseptic Gel;
• Oh So Clean, Inc dab Clean Well Company for Clean Well All-Natural Foaming Hand Sanitizer, Clean Well All-Natural Hand Sanitizer, Clean Well All-Natural Hand Sanitizing Wipes, and Clean Well All-Natural Antibacterial Foaming Hand soap

The warning letters explain that the companies are marketing these products in violation of federal law.

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

The companies were given 15 days in the April 20 notice to correct the violations cited in the warning letters. Failure to do so may result in legal action including seizure and injunction. Health care professionals and patients are encouraged to report adverse events or side-effects related to the use of these products to the FDA's Med Watch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report.htm¹

Consumers that have purchased these products should contact their physicians if they suspect a skin infection is either worsening or not improving, the FDA advised.