FDA Warns Companies Against Claiming Hand Sanitizers Fight MRSA

Federal regulators are warning companies that make over-the-counter hand sanitizers to stop exaggerating the bacteria-killing benefits of their products.

FDA warning letters were sent on April 20 to four companies, accusing them of making unsupported claims that their hand santizers can prevent infections from methicillin-resistant Staphylococcus aureus bacteria (MRSA).

FDA officials told the manufacturers to stop making such statements, as there is no evidence to back up the claims.

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The warning letters were sent to:

  • Tec Laboratories — Staphaseptic First Aid Antiseptic/Pain Relieving Gel
  • JD Nelson and Associates — Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant
  • Dr G.H. Tichenor Antiseptic Company — Dr. Tichenor’s Antiseptic Gel
  • Oh So Clean, Inc. – CleanWell hand sanitizer and antibacterial soap products

The companies have 15 days to address what the FDA considers to be violations of federal law. Some of the labels claimed to kill 99.9% of MRSA bacteria, prevent infections from MRSA, E. Coli and the N1N1 flu virus and make other claims the FDA says are unsupported and most likely not true.

“MRSA is a serious public health threat,” said FDA Office of Compliance Director Deborah Autor. “The FDA cannot allow companies to mislead consumers by making unproven prevention claims.”

MRSA infections, have accounted for more than 60 percent of hospital staph infections in recent years. The CDC reports that about 126,000 hospital MRSA infections occur each year, resulting in about 5,000 deaths. But some researchers suggest that the number of deaths from MRSA in the U.S. is closer to 20,000 annually.

The FDA recommends that consumers not buy hand sanitizers and other products that claim to prevent MRSA, E. Coli and Salmonella infections, ask a pharmacist or health care professional’s advice on which product labels are reliable, and wash hands often with warm water and soap for at least 20 seconds. The agency also asked consumers to report any product making false or unproven claims on the internet to the agency’s site for reporting unlawful internet sales.


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