FDA: Hand Sanitizers Make False Claims

April 21, 2011 – Hand sanitizers protect us from germs, don't they? A new FDA initiative has consumers confused.

The FDA yesterday warned consumers not to buy hand sanitizers "that claim to prevent infection from MRSA, E. coli, salmonella, flu, or other bacteria or viruses." But isn't that why we use them?

An FDA spokesperson tells WebMD that consumers should continue to follow CDC advice to use hand sanitizers when water is not available.

The CDC advice specifically says alcohol-based hand sanitizers help protect against MRSA and other germs. During flu season, the CDC continually warns Americans to prevent flu by using hand sanitizers when soap and water aren't around.

So what's the FDA's problem with hand sanitizers?

The FDA points to four companies whose products, it says, are in violation of FDA regulations. Each of these products specifically claims to kill MRSA, staph, or other bacteria or viruses:

• Staphaseptic First Aid Antiseptic/Pain Relieving Gel from Tec Laboratories
• Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant from JD Nelson and Associates
• Dr. Tichenor’s Antiseptic Gel from Dr. G.H. Tichenor Antiseptic Co.
• CleanWell All-Natural Foaming Hand Sanitizer, CleanWell All-Natural Hand Sanitizer, CleanWell All-Natural Hand Sanitizing Wipes, and CleanWell All-Natural Antibacterial Foaming Handsoap from Oh So Clean Inc. (doing business as CleanWell Company).

But what about other products? The label of a very popular 62% ethyl alcohol hand sanitizer says "Kills 99.99% of Germs." The product web site stresses that it "kills" the bad germs on your hands.

The FDA's rule on the question is a "tentative final monograph" (a confusing term itself) published in June 1994. It says that makers of over-the-counter antiseptic products may claim only that they "help reduce bacteria that potentially can cause disease." They may not claim a product "kills micro-organisms."

FDA spokesperson Shelly Burgess tells WebMD that the FDA is sending warning letters only to the four firms listed above.

"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," Deborah Autor, FDA compliance director, says in a news release. "These products give consumers a false sense of protection."

Here's the bottom line: Don't count on hand sanitizers for 100% protection from anything. Do wash your hands often. And when you can't wash your hands, do use hand sanitizers. Even the FDA agrees they get rid of a lot of the germs that are on your hands.