Over-the-counter antibacterial soaps containing any of 19 specific active ingredients can no longer be marketed, the FDA announced Friday, including those with triclosan and triclocarban.
The rule does not affect antibacterial products used in healthcare settings, FDA said in a release, nor does it apply to OTC alcohol handrubs or wipes.
An FDA review of chemicals in OTC consumer antiseptic wash products did not find concrete evidence that the 19 banned chemicals prevent illness and infection better than plain soap and water, or are safe for long-term daily use.
"Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water," said Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research, in the release. "In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term."
Friday's announcement follows a 2013 preliminary ruling by the agency, which asked companies to provide additional data supporting the use of these ingredients to better protect consumers without inducing long-term harm, if they wanted to continue marketing the products. Some data has suggested instead that long-term exposure to active ingredients found in antibacterial products could lead to bacterial resistance or hormonal problems.
"Either no additional data were submitted," the FDA said Friday, "or the data and information that were submitted were not sufficient for the agency to find that these ingredients are Generally Recognized as Safe and Effective."
Manufacturers have one year to comply with the ruling and some manufacturers have already begun removing these ingredients from their products, the agency said.
Companies manufacturing consumer wash products with three other ingredients -- benzalkonium chloride, benzethonium chloride, and chloroxylenol -- were given 1 year to develop and submit new safety and effectiveness data; they can continue marketing products with these ingredients in the meantime.
Primary Source
United States Department of Health and Human Services
Source Reference: FDA "Safety and effectiveness of consumer sntiseptics; topical sntimicrobial drug products for over-the-counter human use" HHS 2016.