RODALE NEWS, EMMAUS, PA—The Food and Drug Administration (FDA) is cracking down on a handful of hand sanitizer companies, saying the germ-fighting claims stamped on their packaging have not been approved by the federal agency. "FDA has not approved any products claiming to prevent infection from MRSA, E. coli, salmonella, or H1N1 flu, which a consumer can just walk into a store and buy,” says Deborah Autor, compliance director at FDA’s Center for Drug Evaluation and Research. "These products give consumers a false sense of protection."
To be clear, the FDA is not saying that the claims on the targeted hand sanitizers are false; the issue is they haven't gone through the necessary process to be regulated as a drug, which is what is required when specific over-the-counter products make drug- and disease-prevention claims.
THE DETAILS: The FDA says the following over-the-counter products violate the law because they have not been cleared to make some of the germ-killing claims on their packaging. To be able to do that, the products need to be assessed for effectiveness and cleared by the FDA, an agency spokeswoman said:
• Staphaseptic First Aid Antiseptic/Pain Relieving Gel, by Tec Laboratories
• Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant, by JD Nelson and Associates
• Dr. Tichenor’s Antiseptic Gel, by Dr. G.H. Tichenor Antiseptic Co.
• Clean Well All-Natural Hand Sanitizer, Clean Well All-Natural Hand Sanitizing Wipes, and Clean Well All-Natural Antibacterial Foaming Hand Soap, by Oh So Clean Inc., also known as CleanWell Company
Some of the labeling faux pas pointed out by the FDA include unproven claims like "kills over 99.9% of MRSA," "helps prevent skin infections caused by MRSA and other germs," and "is effective against a broad spectrum of pathogens, including MRSA." The agency also took aim at CleanWell's patented essential oil formulation said to knock out salmonella. (Cleanwell says it uses essential oils instead of alcohol and harsh chemicals to sanitize.)
The company released the following statement:
"CleanWell shares FDA’s concern that the public not be misled regarding self treatment for serious infections. CleanWell is confident that its extensive scientific research, information, data, and other evidence supporting CleanWell products provide ample justification for the claims made in connection with its products, and welcomes the opportunity to share this information with FDA and to address FDA’s questions, some of which appear to be based on a fundamental misunderstanding of CleanWell’s products."