The U.S. Food and Drug Administration issued four warning letters to companies that manufacture and market over-the-counter drug products, including hand sanitizers, that claim to prevent infection from MRSA.
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/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
Labeling and marketing materials for these 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 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.
Read the FDA news release about its warning letters for OTC products claiming protection against MRSA.
Read other coverage about MRSA:
- Study: No Advantage in Only Screening and Identifying MRSA in Hospital ICUs
- Wound Dressing With Silver Kills MRSA, Other Antibiotic-Resistance 'Superbugs'
- New Website Ranks Maine Healthcare Providers Based on Quality of Care
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/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
Labeling and marketing materials for these 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 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.
Read the FDA news release about its warning letters for OTC products claiming protection against MRSA.
Read other coverage about MRSA:
- Study: No Advantage in Only Screening and Identifying MRSA in Hospital ICUs
- Wound Dressing With Silver Kills MRSA, Other Antibiotic-Resistance 'Superbugs'
- New Website Ranks Maine Healthcare Providers Based on Quality of Care
