FDA Wants More Efficacy Studies For Antibacterial Soaps to Stay on Shelves



The Food and Drug Administration announced this morning that it wants stricter rules on antibacterial soaps.

In particular, the FDA is concerned about two chemicals in the soap—triclosan and tricolcarbon—that may be linked to hormone imbalance. This morning's announcement targeted hand- and body-wash products but not mouthwashes, cosmetics or cleaners in which the antiseptic chemicals are also used.

FDA regulators say they want manufacturers of antibacterial soaps to take one year to prove the safety and effectiveness of their products in order to remain on U.S. store shelves.

“Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school and public settings, where the risk of infection is relatively low.”

The FDA said this morning that even though millions of Americans use antibacterial hand-soap and body-wash products, "there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water. Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan and triclocarbon—could pose health risks, such as bacterial resistance or hormonal effects."

The proposed rule does not require the antibacterial soap products be removed from the market at this time. When the proposed rule is finalized, as previously stated, either companies will have provided data to support an antibacterial claim, or if not, they will have to reformulate (remove antibacterial active ingredients) or relabel (remove the antibacterial claim from the product's labeling) these products in order to continue marketing.