FDA ACCUSES FIRMS OF MAIKNG UNPROVED CLAIMS REGARDING HAND SANITIZERS

The following is an excerpt from the FDA web site.  According to the FDA various manufacturers were making claims that their product prevented infections from certain bacteria when the FDA did not have the evidence to back up the claims :


" The U.S. Food and Drug Administration issued four warning letters to 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).

Labeling and marketing materials for the affected products also claim that they can prevent infection from other disease-causing agents. In addition, the labeling of some of the firms’ hand sanitizing drug products make claims related to preventing infection from E.coli and/or H1N1 flu virus. The FDA does not have sufficient evidence demonstrating that these products are safe and effective for these purposes.
The FDA warning letters were sent to the following firms:

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


The warning letters explain that the companies are marketing these products in violation of federal law.
The companies have 15 days to correct the violations cited in the warning letters. Failure to do so may result in legal action including seizure and injunction. "