The FDA has issued warning letters to four hand sanitizer manufacturers to cease making claims that its’ products prevent methicillin-resistant Staphylococcus aureus infections.
“MRSA is a serious public health threat,” Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in a press release. The FDA cannot allow companies to mislead consumers by making unproven prevention claims.”
The following companies and products are in question:
- 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. for CleanWell Hand Sanitizing Wipes and CleanWell All-Natural Antibacterial Foaming Hand Soap.
The FDA said that there is not sufficient evidence to demonstrate that these products effectively prevent MRSA infections, or infections from other bacteria listed on the packaging of some products, including Escherichia coli and influenza A H1N1.
The companies will have 15 days to correct the violations cited in the letters, or face legal action including seizure and injunction.
Consumers should contact their health care provider if a skin infection treated with these products worsens or does not improve. The FDA encourages health care professionals and patients to report adverse events to MedWatch.