Proposed rule requires manufacturers to submit trial data showing benefit versus regular soap
TUESDAY, Dec. 17, 2013 (HealthDay News) -- The U.S. Food and Drug Administration has issued a proposed rule requiring antibacterial soap manufacturers to demonstrate that their products are both effective at preventing illness and safe for long-term daily use.
The proposed rule is part of a broader FDA review of antibacterial active ingredients. The reevaluation is due to the widespread use of these products, combined with growing scientific concern that active ingredients in these products (triclosan in liquid soaps and triclocarban in bar soaps) can contribute to bacterial resistance or have hormonal effects.
The FDA says that manufacturers who want to continue marketing antibacterial soap products must, within one year, provide the agency with data from clinical studies demonstrating that these products are superior to regular soap in preventing human illness or reducing infection. Companies not providing data supporting the antibacterial claim will be required to reformulate (remove antibacterial active ingredients) or re-label (remove the antibacterial claim from the product's labeling) if they want to continue marketing the soap. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.
"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," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement.
More Information (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm378542.htm )