FDA cracks down on hand sanitizers claiming to prevent MRSA infections
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by Aimee Keenan-Greene
The U.S. Food and Drug Administration today issued warning letters to four companies who make over-the-counter (OTC) hand sanitizers claiming to prevent infection from methicillin-resistant Staphylococcus aureus bacteria, known as MRSA.
The warning letters explain that the companies are marketing these products in violation of federal law.
The companies contacted were 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.”
The Centers for Disease Control and Prevention say methicillin-resistant Staphylococcus Aureus (MRSA) is a type of staph bacteria resistant to antibiotics called beta-lactams. These antibiotics include methicillin, oxacillin, penicillin, and amoxicillin. Most MRSA infections are skin infections. More severe life-threatening MRSA infections occur among patients in healthcare settings. While 25 to 30 percent of people are colonized in the nose with staph, less than 2 percent are colonized with MRSA.
Labeling and marketing materials for the affected products also claim that they can prevent infection from other disease-causing agents.
The labeling of some of the firms’ hand sanitizing drug products make claims related to preventing infection from E.coli and/or H1N1 flu virus.
The FDA does not have sufficient evidence demonstrating that these products are safe and effective for these purposes.
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.
Last year a study published in the Journal of the American Medical Association showed lMRSA infections in healthcare settings are declining. Down 28 percent from 2005 through 2008. Decreases in infection rates were even bigger for patients with bloodstream infections.
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