Feds Warn Companies That Claim Their Products Fight MRSA

a petri dish with methicillin-resistant Staphylococcus aureus (MSRA) The U.S. Food and Drug Administration sent warning letters to four companies that make over-the-counter products, including hand sanitizers and antiseptic gels, alleging the businesses make claims that their products prevent infection from methicillin-resistant Staphylococcus aureus bacteria (MRSA) and other bacteria including e.coli.

The FDA said it doesn't have enough evidence to show the products are effective for these purposes.

MRSA is a staph bacteria that's resistant to certain antibiotice including oxacillin and penicillin, said the U.S.Centers for Disease Control. While most of the severe MRSA infections occur most frequently in hospitals and other health-care settings, infections can be spread elsewhere through close contact including places like gyms, day cares and prisons.The FDA sent warning letters to:
  • Tec Laboratories for its Staphaseptic First Aid Antiseptic/Pain Relieving Gel.
  • JD Nelson and Associates for its Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant.
  • Dr. G.H. Tichenor Antiseptic Co. for its Dr. Tichenor's Antiseptic Gel.
  • CleanWell Co. for its CleanWell All-Natural Foaming Hand Sanitizer, CleanWell All-Natural Hand Sanitizer, CleanWell All-Natural Hand Sanitizing Wipes and CleanWell All-Natural Antibacterial Foaming Handsoap.
In a statement sent to Consumer Ally, CleanWell said it was "working on our response to the FDA and look forward to reviewing our data with them within the deadlines they have set. We're happy to provide you with an update once the issue is resolved."

Tec Laboratories said in a statement that it would work with the FDA to address the issues raised in the warning letter. Neither JD Nelson nor Dr. G.H. Tichenor Antiseptic Co. could be reached for comment.

The FDA said the warning letters allege the companies are breaking federal law because the products could be considered unapproved new drugs by making claims that the products kill staph and other bacteria.

"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 in a statement. "The FDA cannot allow companies to mislead consumers by making unproven prevention claims."
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