FDA Says 4 Hand Sanitizer Companies Making False Claims

April 22, 2011 Updated: April 3, 2020

The U.S. Food and Drug Administration this week said four hand sanitizers have falsely claimed they can kill off potentially deadly methicillin-resistant Staphylococcus aureus bacteria (MRSA) infections.

On the labels of the hand sanitizers wered claims that the products could kill off E.coli and/or H1N1 flu virus, the FDA said. “The FDA does not have sufficient evidence demonstrating that these products are safe and effective for these purposes,” the agency noted.

The agency sent letters to 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, and Dr. G.H. Tichenor Antiseptic Co. for Dr. Tichenor’s Antiseptic Gel.

A letter was also sent to 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.

The FDA said that if companies make false or unfounded claims, it violates federal law. The companies that received the letters have 15 days to make necessary changes or they may face legal action. The products could be seized if the companies do not correct their inaccurate claims.

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