(Updated) On Wednesday, the Food and Drug Administration (FDA) said it had sent warning letters to four makers of hand sanitizing products that claim to prevent infection from methicillin-resistant Staphylococcus aureus, or MRSA.
The products in question also promise to prevent infection from a host of other disease-causing pathogens, including Salmonella, E. coli and the H1N1 flu virus. In the letters, the FDA warns the companies that their products’ marketing is in breach of federal law, and gives the manufacturers 15 days to correct the violations cited.
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“FDA has not approved any products claiming to prevent infection from MRSA, E. coli, Salmonella or H1N1 flu, which a consumer can just walk into a store and buy,” said Deborah Autor, compliance director of the FDA’s Center for Drug Evaluation and Research, in a statement. “These products give consumers a false sense of protection.”
MRSA is a strain of staph bacteria that is resistant to most commonly used antibiotics and can cause severe illness. Infections may start on the skin, then develop into deep, painful abscesses; the bacteria may also move into the bloodstream, causing potentially life-threatening infections. MRSA often circulates in hospitals, nursing homes and other health-care settings, but has been found to spread in the community, particularly in school locker rooms and child-care facilities. A 2007 study even found the bug on airplane tray tables.
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The offending products, according to the FDA, are:
- Staphaseptic First Aid Antiseptic/Pain Relieving Gel (Tec Laboratories)
- Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant (JD Nelson and Associates)
- Dr. Tichenor’s Antiseptic Gel (Dr. G.H. Tichenor Antiseptic Co.)
- CleanWell All-Natural Foaming Hand Sanitizer, CleanWell All-Natural Hand Sanitizer, CleanWell All-Natural Hand Sanitizing Wipes, and CleanWell All-Natural Antibacterial Foaming Handsoap (Oh So Clean, Inc, doing business as CleanWell Company)
The FDA advises consumers not to buy these products or any others that make similar claims. Further, if you find products on the Internet that you think make false or unproven claims, the FDA asks you to report them; you can do so by following the instructions here.
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To protect yourself from infection with disease-causing germs, the standard recommendation still holds: wash your hands with soap and water thoroughly and frequently, especially before handling food or touching your eyes or mouth. And feel free to continue using alcohol-based (at least 60% alcohol concentration) hand sanitizers like Purell, which effectively kill most harmful bacteria and viruses, and do not contribute to antibiotic resistance.
Update [8:10 p.m.]: The maker of Staphaseptic First Aid Antiseptic/Pain Relieving Gel spoke to the Oregonian in response to the FDA letter:
Wendy Langly, who’s in charge of regulatory affairs for Tec Laboratories, said the company “will work with the FDA in getting this straightened out. We want to be complaint [sic] with the FDA.” She said the company may change the label but does not expect to have to take its product off the market.
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