Hey, hand sanitizers. You can only do so much – and preventing MRSA infection isn’t one of those things -- so stop over-promising! That was the gist of warning letters from the Food and Drug Administration to four makers of the popular products.
Apparently, the manufacturers of Staphaseptic, Safe4Hours, Dr. Tichenor’s and CleanWell products had suggested that various gels, protectants and what-not could protect against infection with methicillin-resistant Staphylococcus aureus bacteria. The FDA takes issue with that.
It wasn’t too enamored with claims about preventing infection from E. coli or the flu either.
The letter to one of the companies, which claimed their product kills 99.9% of MRSA, gives the general tone: “Below is an analysis of the regulatory status of Staphaseptic First Aid Antiseptic/Pain Relieving Gel which includes excerpts of the violative labeling and the specific new drug and misbranding charges. Note that this is not an all inclusive description of all violative labeling for your OTC drug product.”
The description may not have been all-inclusive, but it seems fairly thorough. And at that point, the agency was just getting started.
They took serious issue with CleanWell Hand Sanitizer, which provides "laboratory data" on their website that 99.99% of MRSA, E. coli and other bacterial nasties would be gone in 15 seconds. Sorry, those data don't count, says the FDA:
"However, we are not aware of sufficient evidence that shows CleanWell All-Natural Hand Sanitizer is generally recognized as safe and effective for the uses noted above. In particular, we are not aware of evidence that this product is safe and effective in preventing individuals from becoming infected by E. coli, Klebsiella pneumoniae, MRSA, Pseudomonas aeruginosa, Salmonella, and Staphylococcus aureus."
And if you’re wondering why the big deal about MRSA, let’s just say it’s best not to treat it lightly. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0004520/
It can cause common infections and uncommon ones and, sometimes, can even lead to death.
So if you’re counting on a hand sanitizer to protect you, don’t.