Drugstore Hand Sanitizers Don’t Kill MRSA, Warns FDA

Drugstore Hand Sanitizers Don’t Kill MRSA, Warns FDA

April 21st, 2011 // 12:50 pm @

Makers of some hand sanitizers and antiseptic products are making false claims they prevent MRSA infection, says a warning issued Wednesday by the U.S. Food and Drug Administration.

“Don’t believe them. These statements are unproven,” the agency said.



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Edward Cox, MD, director of the FDA Office of Antimicrobial Products, said that the problem is being recognized with some products that are purchased in a drugstore. These products that haven’t undergone specific FDA antimicrobial testing for their ability to combat strains of Staphylococcus aureus, which are resistant to the antibiotic, methicillin, the agency said.

“Consumers are being misled if they think these products you can buy in a drugstore or from other places (such as through the Internet) will protect them from a potentially deadly infection,” says Deborah Autor, compliance director at the FDA’s Center for Drug Evaluation and Research.

“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,” says Autor. “These products give consumers a false sense of protection.”

Unproven claims found on labels that should prompt concern include these: “kills over 99.9% of MRSA,” “helps prevent skin infections caused by MRSA and other germs,” and “is effective against a broad spectrum of pathogens, including MRSA.”

On Wednesday the FDA issued warning letters to four companies that make or distribute the following over-the-counter products, saying that if they don’t correct the violations, the products may be seized:

• Staphaseptic First Aid Antiseptic/Pain Relieving Gel by Tec Laboratories

• Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant, by JD Nelson and Associates

• Dr. Tichenor’s Antiseptic Gel, by Dr. G.H. Tichenor Antiseptic Co.

Clean Well All-Natural Hand Sanitizer, Clean Well All-Natural Hand Sanitizing Wipes, and Clean Well All-Natural Antibacterial Foaming Hand Soap, by Oh So Clean Inc., also known as CleanWell Company.

The agency said that one company claims its lotion prevents infection from E. coli and the H1N1 flu virus and another says its “patented formulation of essential plant oils” kills Salmonella. “These claims are also unproven, and therefore illegal,” the FDA said.


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