Hand Sanitizer Companies Received Warning Letters From FDA For Making Unproven Prevention Claims

By on Apr 22, 2011 in Health, Science, United States, World Comments
Hand Sanitizer
Hand Sanitizer
Image Credit: Rewaj.com

The U.S. Food and Drug Administration (FDA) announced on their website on a news release dated April 20, 2011, that warning letters were issued to four companies that manufacture and market over-the-counter (OTC) drug products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylococcus aureus bacteria (MRSA).

It was reported that these products also claim to prevent infection from E.coli and H1N1 flu virus.

According to the news release, the FDA does not have sufficient evidence that these products are safe and effective for these purposes.

The warning letters were reportedly sent to the following companies:

  • 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

According to the report, the warning letters explain that these companies are marketing these products in violation of federal law.

“MRSA is a serious public health threat. The FDA cannot allow companies to mislead consumers by making unproven prevention claims,” Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research was quoted saying.

The companies were reportedly given 15 days to correct the violations mentioned in the warning letters. Failure to do so may result in legal action.



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