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Don't Believe Hand Sanitizer MRSA Claims, FDA Says

Apr 27, 2011 | Parker Waichman LLP

Consumers who purchase over-the-counter hand sanitizers because of claims they can kill or prevent infections like methicillin-resistant Staphylocococcus aureus (MRSA) could well be wasting their money.  According to the U.S. Food & Drug Administration (FDA), claims that over-the-counter hand sanitizers are effective against MRSA, E. coli, Salmonella and even the H1N1 flu are unproven.

To that end, the FDA is cracking down on unproven hand sanitizer claims.   Last week, it sent warning letters to four manufacturers of over-the-counter hand sanitizers, telling the companies to stop making those kinds of claims.  The companies receiving those letters included:

  • 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


These companies have 15 days to correct the violations cited in the letters. Failure to do so may result in legal action, including seizure and injunction, the FDA said.

In a posting on its website, the FDA advised consumers not to believe claims that over-the-counter hand sanitizers will work against pathogens like MRSA, E. coli, Salmonella or H1N1. 

“Consumers are being misled if they think these products you can buy in a drug store or from other places will protect them from a potentially deadly infection,” said Deborah Autor, compliance director at FDA’s Center for Drug Evaluation and Research.

Rather than spending money on such products, the FDA advised consumers to practice good hand-washing techniques, especially after handling food.  "Wash hands with warm water and soap for 20 seconds. For children, this means the time it takes to sing the “Happy Birthday” song twice," the agency's posting says.


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