Hand sanitizer MRSA-prevention claims unproven

Share this article:

The FDA has issued warning letters to four hand sanitizer manufacturers to cease making claims that its' products prevent methicillin-resistant Staphylococcus aureus infections.

“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 press release. The FDA cannot allow companies to mislead consumers by making unproven prevention claims.”

The following companies and products are in question:

  • 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. for CleanWell Hand Sanitizing Wipes and CleanWell All-Natural Antibacterial Foaming Hand Soap.

The FDA said that there is not sufficient evidence to demonstrate that these products effectively prevent MRSA infections, or infections from other bacteria listed on the packaging of some products, including Escherichia coli and influenza A H1N1.

The companies will have 15 days to correct the violations cited in the letters, or face legal action including seizure and injunction.

Consumers should contact their health care provider if a skin infection treated with these products worsens or does not improve. The FDA encourages health care professionals and patients to report adverse events to MedWatch.

Share this article:
You must be a registered member of Clinical Advisor to post a comment.
close

Next Article in Web Exclusives

More in Web Exclusives

Post-concussion, look for physical regression in high-school athletes

Post-concussion, look for physical regression in high-school athletes

Teen athletes who have re-entered athletics following a concussion are reported regressing abilities in their physical abilities.

Birth control pill as effective as antibiotics for acne management

Birth control pill as effective as antibiotics for ...

Although antibiotics may be superior at three months, oral contraceptive pills s are equivalent to antibiotics at six months in reducing acne.

Aspirin after anticoagulation lowers recurrent venous thromboembolism risk

Aspirin after anticoagulation lowers recurrent venous thromboembolism risk

After a first unprovoked venous thromboembolism, aspirin following anticoagulation treatment reduced VTE occurrence.