FDA Warns Companies about Unproven MRSA Prevention Claims
Some antiseptic products and hand sanitizers claim they prevent MRSA infections, but the U.S. Food and Drug Administration (FDA) wants consumers to know the claims are unproven.
MRSA can cause severe infections that do not respond to standard treatment, and in some cases, can lead to death.
The FDA is taking a hard line with companies who say — without agency approval — that their products prevent MRSA infections and other diseases.
Examples of some of these claims 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”
Despite the claims, the FDA advises consumers that it has not approved ANY products that claim to prevent MRSA, E. coli, Salmonella or H1N1 flu.
The FDA issued warning letters to four companies that make or distribute products that can be bought over-the-counter, giving the companies 15 days to correct violations or face legal action. The companies are:
- 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
Methicillin-resistant Staphylococcus aureus bacteria (MRSA) is type of staph bacteria that is resistant to treatment with certain antibiotics. In healthcare settings, MRSA occurs mostly among patients who have invasive medical procedures, invasive devices or who have weakened immune systems.
According to the Centers for Disease Control and Prevention (CDC), you can lessen your chances of contracting MRSA if you:
- Keep your hands clean by washing thoroughly with soap and water or using an alcohol-based hand rub.
- Keep cuts and scrapes clean and covered with a bandage until healed.
- Avoid contact with other people’s wounds or bandages.
- Avoid sharing personal items such as towels or razors.
Edward Cox, M.D., M.P.H., director of FDA’s Office of Antimicrobial Products, said in a press release:
“Staphylococcus aureus itself is a very aggressive organism. 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.
“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.”