MRSA prevention claims not supported by FDA

April 26, 2011

FDA recently issued warning letters to companies that manufacture and market over-the-counter products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylocococcus aureus.

FDA recently issued warning letters to companies that manufacture and market over-the-counter products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylocococcus aureus (MRSA).

“MRSA is a serious public health threat,” said Deborah Autor, 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.”

Labels for some of the firms’ hand-sanitizing drug products also claim that they help prevent infection from Escherichia coli, H1N1 influenza virus, or both. FDA noted that it does not have sufficient evidence to demonstrate that these products are safe and effective for these purposes.

The FDA warning letters, which inform companies they are violating federal law, were sent to the following:

  • 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., dba 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

These companies have 15 days to correct the violations cited in the letters. Failure to do so may result in legal action, including seizure and injunction.