The U.S. Food and Drug Administration (FDA) posted a Consumer Update today, warning consumers not to rely upon any over-the-counter hand sanitizers or similar over-the-counter products making claims that they kill bacteria such as MRSA, E. coli, Salmonella, or H1N1 flu or prevent infections caused by these serious bacteria. These claims are false and illegal, warns the FDA.
At the same time, the FDA issued Warning Letters today to four companies that make or distribute products making such claims, directing them to cease the cited legal violations within 15 days or face seizure of their products or other legal action.
“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, the compliance director at FDA’s Center for Drug Evaluation and Research. “These products give consumers a false sense of protection.”
Warning to Consumers
The FDA alerted consumers that some hand sanitizers and antiseptic products are being falsely labeled with claims that they can prevent MRSA infections or other serious infections.
“Don’t believe them. These statements are unproven,” wrote the FDA.
MRSA (methicillin-resistant Staphylococcus aureus) is a bacterium that can cause severe and life-threatening infections which do not respond to standard treatment with the antibiotic methicillin, according to the FDA.
“Staphylococcus aureus itself is a very aggressive organism,” says Edward Cox, M.D., M.P.H., director of FDA’s Office of Antimicrobial Products. “It’s often associated with patients in hospitals who have weakened immune systems, but the bacterium can also cause significant skin infections and abscesses in a normal, healthy person. And it can get into the bloodstream and, less frequently, may involve the heart valve, which is very difficult to treat.”
MRSA, the antibiotic-resistant strain of Staphyolococcus aureus, is even more difficult to treat. “With MRSA, a number of the antibiotic drugs we typically used often don’t work, so we lose treatment options we used to rely upon,” says Cox.
“Consumers are being misled if they think these products you can buy in a drug store or from other places will protect them from a potentially deadly infection,” says Deborah Autor, compliance director at FDA’s Center for Drug Evaluation and Research.
In its Consumer Update posted today, the FDA warns consumers to beware of unproven product claims, whether the product is sold in a retail store or over the Internet.
Examples of unproven product claims cited by the FDA, and which it found on product labels, include:
- “kills over 99.9% of MRSA”
- “helps prevent skin infections caused by MRSA and other germs”
- “is effective against a broad spectrum of pathogens, including MRSA”
- “prevents infection from the bacterium E. coli and the H1N1 flu virus” (found on a hand sanitizing lotion)
- “kills the bacterium Salmonella” (found on one company’s “patented formulation of essential plant oils”)
“These claims are unproven and, therefore, illegal,” warns the FDA.
FDA Advice for Consumers
The FDA posted the following advice to consumers:
- “Don’t buy over-the-counter hand sanitizers or other products that claim to prevent infection from MRSA, E. coli, Salmonella, flu, or other bacteria or viruses.
- Ask your pharmacist or other health care professional for help in distinguishing between reliable and questionable information on product labels and company websites.
- In general, wash hands often, especially before handling food, to help avoid getting sick. Wash hands with warm water and soap for 20 seconds. For children, this means the time it takes to sing the “Happy Birthday” song twice.
- If you find products on the Internet that you believe make false or unproven claims, tell FDA by following the instructions on Reporting Unlawful Sales of Medical Products on the Internet.
- Report side effects that you think may be related to using hand sanitizers or other medical products to FDA’s MedWatch Adverse Event Reporting Program either online, by fax, or by phone:
- Online, using MedWatch Online Voluntary Reporting Form 35000
- Fax: 800-FDA-0178
- Phone: 800-332-1088″
FDA Warning Letters Issued to Companies
The companies to whom the FDA Warning Letters were issued today include four companies that make or distribute the following products:
- 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
These companies are directed to correct the violations explained in the Warning Letters within 15 days, or the FDA may seize the products or take other legal action.
The FDA’s Consumer Warnings that Hand Sanitizers Carry Unproven Claims to Prevent MRSA Infections were posted on April 20, 2011 on the FDA’s Consumer Updates page.
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