FDA Warns About Hand Sanitizer Anti-MRSA Claims

Emma Hitt, PhD

Disclosures

April 27, 2011

April 27, 2011 — The US Food and Drug Administration (FDA) has issued warning letters to 4 companies about over-the-counter drug products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylococcus aureus bacteria (MRSA) and other organisms.

The FDA described their actions in an April 20, 2011, Consumer Update report. The 4 companies that received warning letters are Tec Laboratories, JD Nelson and Associates, Dr. G.H. Tichenor Antiseptic Co, and Oh So Clean Inc (also known as Clean-Well Company).

According to the FDA, the companies have made unproven claims about efficacy against S aureus (including MRSA), H1N1 influenza virus, Salmonella, Streptococcus, and Escherichia coli. The warning letters indicate that marketing of these products is in violation of federal law.

Products reported to carry these unproven claims include Staphaseptic First Aid Antiseptic/Pain Relieving Gel, Safe4Hours Hand Sanitizing Lotion, Safe4Hours First Aid Antiseptic Skin Protectant, Dr. Tichenor's Antiseptic Gel, Clean Well All-Natural Hand Sanitizer, Clean Well All-Natural Hand Sanitizing Wipes, and Clean Well All-Natural Antibacterial Foaming Hand Soap.

The companies have 15 days to correct the violations stated in the letter; failure to do so may result in the FDA seizing their products or other legal actions.

When asked by Medscape Medical News whether the warning letters pertain to products used in hospitals also, or just those sold in stores for consumer use, the FDA press office indicated that the warning extends to all products marketed by any of the 4 firms.

"The FDA cannot allow companies to mislead consumers by making unproven prevention claims," noted Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, in a written release.

Consumers are being misled if they think these products you can buy in a drug store or other places will protect them from a potentially deadly infection.

"Consumers are being misled if they think these products you can buy in a drug store or other places will protect them from a potentially deadly infection," Autor added. The FDA advises against buying over-the-counter products that claim to be effective against specific infectious agents.

The FDA also advises that consumers be active in reporting false product claims and adverse effects caused by products.

If consumers believe that a company is making false claims about their products, it should be reported to the FDA through their Web site.

Adverse events or quality concerns related to the affected products should be reported to MedWatch by telephone at 1-800-332-1088, by fax at 1-800-332-1078, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20857.

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