FDA questions effectiveness of antimicrobial soaps

The marketplace is flooded with antibacterial hand soaps and body washes that supposedly prevent the spread of bacteria. Problem is, according to the FDA, there’s no evidence that they work.

Prove the claims

FDA recently proposed a rule that would require the makers of these products to prove their effectiveness. If they cannot, manufacturers would either have to change the labeling on the products or remove them from shelves. Such items include Softsoap products from Colgate Palmolive, Cetaphil from Galderma Laboratories, and Dial products from Henkel AG.

"Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water," according to FDA.

In-depth data

Two industry groups, the Personal Care Products Council and the American Cleaning Institute, issued a joint statement saying they were perplexed by FDA assertions that there’s no evidence antibacterial soaps work.

"Our industry’s Topical Antimicrobial Coalition has submitted to the FDA in-depth data showing that antibacterial soaps are more effective in killing germs when compared with non-antibacterial soap,” the statement read. “Additionally, a review of two dozen relevant published studies analyzing the effectiveness of antibacterial soaps showed that hand washing with these products produces statistically greater reductions in bacteria on the skin than when using non-antibacterial soap."  

The groups said they look forward to providing FDA information backing the effectiveness of antimicrobial agents.

Bacterial mutation

FDA asserts that long-term exposure to antimicrobial agents such as triclosan and triclocarban could have hormonal effects and allow bacteria to mutate into harder-to-control strains. The proposed rule would not affect hand sanitizers, wipes, or antimicrobial products used in healthcare settings. FDA estimates that about 2,000 soap products in the United States contain antimicrobial chemicals.

"Due to consumers' extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit ... to balance any potential risk," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

The proposed rule will be available for public comment for 180 days. Manufacturers will have one year to submit data and information.