FDA Warns Companies About Hand Cleaner Health Claims

Four companies have been sent warning letters from the FDA telling them to stop making claims that their over-the-counter (OTC) hand sanitizers and other products prevent infection from methicillin-resistant Staphylococcus (MRSA) bacteria.

Labeling and marketing materials for the products also claim that they can prevent infection from other disease-causing germs and viruses, and some claim to protect against E. coli and the H1N1 swine flu virus. There is no proof to support these claims and the companies are marketing them in violation of federal law, the FDA said.

The warning letters 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. Tichenors 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 companies were given 15 days to correct the violations. Failure to do so may result in legal action, including seizure and injunction, the FDA said