FDA: Hand Sanitizers Do Not Prevent MRSA Infection

April 21, 2011 — -- You can't always believe what you see on a label. The FDA accused four hand sanitizer and antiseptic companies Wednesday with making false claims that their products prevent the potentially-lethal MRSA infection.

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.'s Dr. Tichenor's Antiseptic Gel and Oh So Clean, Inc. CleanWell Company's CleanWell All-Natural Hand Sanitizers all are under the FDA's microscope for the alleged false claims.

Statements such as "Kills Staph and MRSA," "KILLS OVER 99.9% OF MRSA, STAPH AND STREP," and, "essential plant oils proven to kill 99.99% of germs including MRSA, Salmonella, Staph, and E.coli." are not approved by the FDA and must be removed from labels, websites and promotional materials, according the FDA's warning letters.

"It's really the claims, the labeling and how they're marketing," said FDA spokeswoman Shelly Burgess. "We sent these warning letters because they claim to prevent against a MRSA infection, and that's in violation of federal law because there is not sufficient evidence to back up that claim. They're making a false claim and you can't do that."

MRSA is an antibiotic-resistant strain of staph infection that killed more than 18,000 people in the U.S. in 2005, according to the Center for Disease Control. The majority of these infections occurred in hospitals among patients with weakened immune systems. While infection rates declined 28 percent from 2005 to 2008, MRSA is still a high priority for the CDC.

Burgess said the FDA's scrutiny is confined only to the four companies cited and that consumers should not be concerned about other types of hand sanitizers.

The companies have 15 days to submit a remedy plan or the FDA could file suit against them, seize their products and file an injunction preventing them from selling any of the items in question.

"We are starting immediately. We are going to remedy this," said Wendy Langley, the regulatory affairs director at Tec Laboratories.

Companies Argue Their Claims Are Truthful

Tec already has made changes to its website and is considering re-designing its labels. Langley said the company tested Staphaseptic before putting it on the market and found that it did, in fact, kill MRSA bacteria.

"We truly believe the claim is truthful and not misleading," Langley said. "We have done lab tests, yes. We are going to submit all that information to the FDA."

Because Staphaseptic is an over-the-counter drug, it has not been through the rigorous FDA testing and approval process necessary in order to say that it in any way prevents, stops or cures a disease.

"They are concerned with MRSA and people using products that are for MRSA. They don't want people to have a false sense of security, I guess," Langley said.

CleanWell said in a statement that there is "ample justification for the claims" and that some of the FDA's concerns "appear to be based on a fundamental misunderstanding of CleanWell's products."

Dr. G.H. Tichenor Antiseptic Co. declined to comment.

JD Nelson and Associates could not be reached for comment.