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The Food and Drug Administration has sent warning letters to four companies that manufacture or distribute hand sanitizers carrying an unproven message that they can prevent MRSA.
The four companies are: Tec Laboratories (Staphaseptic First Aid Antiseptic/Pain Relieving Gel); JD Nelson and Associates (Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant); Dr. G.H. Tichenor Antiseptic Co. (Dr. Tichenor’s Antiseptic Gel); and Oh So Clean Inc., also known as CleanWell Company (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 from the date of the FDA's Warning Letter (April 20) to correct product labeling, or they risk other legal action and/or product seizure.
The FDA also issued advice to consumers that they should not buy over-the-counter products that claim to prevent infection. "Consumers are being misled if they think these products you can buy in a drugstore or from other places will protect them from a potentially deadly infection," Deborah Autor, compliance director at the FDA’s Center for Drug Evaluation and Research, said in a press release.
Examples of claims found on the labels include: "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."
Any side effects believed to be caused by the use of these hand sanitizing products should be reported to MedWatch.
The Food and Drug Administration has sent warning letters to four companies that manufacture or distribute hand sanitizers carrying an unproven message that they can prevent MRSA.
The four companies are: Tec Laboratories (Staphaseptic First Aid Antiseptic/Pain Relieving Gel); JD Nelson and Associates (Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant); Dr. G.H. Tichenor Antiseptic Co. (Dr. Tichenor’s Antiseptic Gel); and Oh So Clean Inc., also known as CleanWell Company (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 from the date of the FDA's Warning Letter (April 20) to correct product labeling, or they risk other legal action and/or product seizure.
The FDA also issued advice to consumers that they should not buy over-the-counter products that claim to prevent infection. "Consumers are being misled if they think these products you can buy in a drugstore or from other places will protect them from a potentially deadly infection," Deborah Autor, compliance director at the FDA’s Center for Drug Evaluation and Research, said in a press release.
Examples of claims found on the labels include: "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."
Any side effects believed to be caused by the use of these hand sanitizing products should be reported to MedWatch.
The Food and Drug Administration has sent warning letters to four companies that manufacture or distribute hand sanitizers carrying an unproven message that they can prevent MRSA.
The four companies are: Tec Laboratories (Staphaseptic First Aid Antiseptic/Pain Relieving Gel); JD Nelson and Associates (Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant); Dr. G.H. Tichenor Antiseptic Co. (Dr. Tichenor’s Antiseptic Gel); and Oh So Clean Inc., also known as CleanWell Company (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 from the date of the FDA's Warning Letter (April 20) to correct product labeling, or they risk other legal action and/or product seizure.
The FDA also issued advice to consumers that they should not buy over-the-counter products that claim to prevent infection. "Consumers are being misled if they think these products you can buy in a drugstore or from other places will protect them from a potentially deadly infection," Deborah Autor, compliance director at the FDA’s Center for Drug Evaluation and Research, said in a press release.
Examples of claims found on the labels include: "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."
Any side effects believed to be caused by the use of these hand sanitizing products should be reported to MedWatch.