FDA Cracks Down on False Claims by Hand Sanitizer Manufacturers
Anti-MRSA Infection Claims Misleading, FDA Says
The U.S. Food and Drug Administration recently sent warnings to four manufacturers of over-the-counter (OTC) hand sanitizer products who made marketing claims that the products prevent methicillin-resistant Staphylococcus aureus bacteria (MRSA) infections.
The labels and marketing materials related to the products also made claims that the products can prevent other types of infections and some also suggested they could protect against E. coli infection and the H1N1 flu virus. According to the press release, “the FDA does not have sufficient evidence demonstrating that these products are safe and effective for these purposes.”
The following firms received letters from the FDA stating that they were marketing their products in violation of federal law. They have been given 15 days to address the violations cited in the letters, and have been warned that failure to do so could result in legal action.
- 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
“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.”
