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WASHINGTON — Over-the-counter consumer antiseptic soaps with certain active ingredients can no longer be marketed, according to a final rule issued by the Food and Drug Administration.
The FDA said the final rule, published Tuesday, applies to consumer antibacterial hand and body wash products containing one or more of 19 active ingredients, including triclosan and triclocarban, the most commonly used ingredients. Manufacturers of these products haven’t shown that the ingredients are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections, according to the agency.
“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,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a statement. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”
Some manufacturers have already started phasing out these ingredients — including triclosan and triclocarban — from their products in the wake of a rule proposed by the FDA in 2013, the agency reported.
But in a media briefing on Friday, Theresa Michele, director of the FDA’s division of nonprescription drug products, told reporters that most of the more than 2,000 consumer wash products labeled “antibacterial” or “antimicrobial” now on the market contain at least one of those ingredients.
The FDA noted that the rule doesn’t apply to consumer hand sanitizers and wipes or antibacterial products used in health care settings.
Manufacturers have one year to comply with the final rule by pulling products from the market or reformulating the affected products by removing the antibacterial active ingredients listed in the rule.
The FDA issued the proposed rule in 2013 after some data indicated that long-term exposure to certain active ingredients used in antibacterial wash products — such as triclosan (liquid soaps) and triclocarban (bar soaps) — could pose health risks like bacterial resistance or hormonal effects. Manufacturers were required to provide the agency with additional data on the safety and effectiveness of the ingredients in question if they wanted to continue marketing antibacterial products containing those ingredients. However, the FDA said, makers of antibacterial hand and body wash product didn’t provide the necessary data to establish safety and effectiveness for the 19 active ingredients cited in the final rulemaking.
In response to industry feedback, the FDA said it has deferred rulemaking for a year on three other ingredients used in consumer wash products — benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX) — to allow for the development and submission of new safety and effectiveness data. In the meantime, consumer antibacterial washes with these ingredients can be marketed, the agency said.
