The U.S. Food and Drug Administration (FDA) has issued warning letters to four manufacturers of over-the-counter hand sanitizers that claim to prevent infection from methicillin-resistant Staphylococcus aureus (MRSA) bacteria.
Labeling and marketing materials for the products also claim that they can prevent infection from other disease-causing agents. In addition, the labels of some of the firms' hand sanitizers claim they prevent infection from E. coli and/or the H1N1 flu virus.
"The FDA does not have sufficient evidence demonstrating that these products are safe and effective for these purposes," the agency said in a news release.
The warning letters were sent to the following firms:
- 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 for Dr. Tichenor's Antiseptic Gel
- Oh So Clean (doing business as 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
The warning letters say the companies' marketing violates federal law.
The companies have 15 days to correct the violations cited in the warning letters. Failure to do so may result in legal action including seizure and injunction.
