The U.S. Food and Drug Administration (FDA) just issued four warning letters to firms that manufacture and market over-the-counter (OTC) drug products, including hand sanitizers that make MRSA claims that they prevent infection from methicillin-resistant Staphylococcus aureus bacteria.
Labeling and marketing materials for these products also claim the products prevent infection from other disease-causing agents. The labeling of some of the firms’ hand sanitizing drug products also make claims concerning the prevention of infection from E. coli and/or the H1N1 flu virus. The FDA states that it does not have sufficient evidence to demonstrate that these products are safe and effective for these purposes.
The FDA warning letters were sent to the following firms and concerning the products named. Consumers who have purchased these products should contact their physicians if they suspect a skin infection is either worsening or not improving:
• Tec Laboratories: Staphaseptic First Aid Antiseptic/Pain Relieving Gel. The warning letter can be accessed at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm251975.htm.
• JD Nelson and Associates: Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant. The warning letter can be accessed at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm252038.htm.
• Dr. G.H. Tichenor Antiseptic Co.: Dr. Tichenor’s Antiseptic Gel. The warning letter can be accessed at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm251938.htm.
• Oh So Clean, Inc doing business as (dba) CleanWell Company: 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 letter can be accessed at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm251979.htm.
The letters explain that the companies are marketing these products in violation of federal law. “MRSA is a serious public health threat,†said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA cannot allow companies to mislead consumers by making unproven prevention claims.†The companies have 15 days to correct the violations. Failure to do so may result in legal action including seizure and injunction.
We’ve long reported on the escalating issues with MRSA, a type of staph that causes infections resistant to most antibiotics and has sickened tens of thousands of Americans annually in recent years. Fully preventable, MRSA is very treatable in early stages with early and proper diagnosis and general-purpose antibiotics, a bandage, and a clean environment. MRSA is resistant to all but the one antibiotic of last resort, which is being used more and more, and with decreasing success. Without treatment or with incorrect diagnosis and treatment, MRSA spreads rapidly, leading to respiratory failure and surgeries, attacking vital organs like the lungs and heart. Survivors are not always returned to their pre-MRSA condition, losing limbs, hearing, and full use of damaged organs.
Health care professionals and patients are encouraged to report adverse events or side-effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report.htm or download the form at: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
