FDA warns firms of MRSA prevention claims

WASHINGTON, April 28 (UPI) -- The U.S. Food and Drug Administration issued four warning letters to companies that claim to prevent methicillin-resistant Staphylococcus aureus infection.

FDA officials said labeling and marketing materials for the products in question also claim they can prevent infection from other disease-causing agents. In addition, some of the firms' hand sanitizing products make labeling claims that their product prevents infection from E.coli and/or H1N1 flu virus, but the FDA does not have sufficient evidence demonstrating that these products are effective for these purposes, FDA officials said.

The warning letters, which explain the companies are marketing these products in violation of federal law, were sent to:

-- 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., doing business as CleanWell Co., 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.

"MRSA is a serious public health threat," Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in a statement. "The FDA cannot allow companies to mislead consumers by making unproven prevention claims."