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FDA bans antibacterials in consumer soaps

Agency says manufacturers have not demonstrated safety or effectiveness of 19 chemicals, including triclosan and triclocarban

by Britt E. Erickson
September 8, 2016 | A version of this story appeared in Volume 94, Issue 36

Photo of a hand dispensing soap into the other hand over a sink of running water.
Credit: Shutterstock
FDA prohibits more than a dozen antibacterial chemicals in hand and body soaps sold in the U.S.

As of next year, companies will no longer be allowed to sell hand and body soaps in the U.S. that contain certain antibacterial ingredients, including triclosan and triclocarban.

In a final rule issued on Sept. 2, the Food & Drug Administration says that manufacturers have not shown that the chemicals are safe for long-term daily use. Companies also haven’t shown that the chemicals are more effective than washing with regular soap and water to prevent the spread of germs, FDA says.

“Some data suggest that antibacterial ingredients may do more harm than good over the long term,” says Janet Woodcock, director of FDA’s Center for Drug Evaluation & Research. FDA proposed the rule in late 2013, citing concerns about potential hormonal effects and antibiotic resistance associated with the chemicals.

The rule goes into effect on Sept. 6, 2017, but many manufacturers have already stopped using the ingredients. As alternatives, most have switched to one of three other antibacterial chemicals: benzalkonium chloride, benzethonium chloride, and chloroxylenol. At the request of manufacturers, FDA deferred from including these three compounds in the new rule.

The American Cleaning Institute and its member companies plan to submit to FDA safety and effectiveness data for these three ingredients in the coming year, says Brian Sansoni, a vice president of the trade group. In the meantime, manufacturers can continue to market products that contain the three substances.

FDA’s action is part of a settlement made with the environmental group Natural Resources Defense Council. The group sued FDA in 2010 for not finalizing a 1978 rule that would have banned triclosan in consumer soaps.

NRDC is now raising concerns about benzalkonium chloride and benzethonium chloride, which belong to a group of chemicals called quaternary ammoniums. “There is some burgeoning science showing there might be health concerns associated with these chemicals,” says Mae Wu, a senior attorney at NRDC.



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