US FDA to take final action on triclosan

The US Food and Drug Administration (FDA) has committed itself to publishing a final monograph on triclosan used in consumer hand soaps by 2016, under a consent decree entered in a US district court.

The move was in response to a 2010 suit filed by the Natural Resources Defense Council (NRDC). This alleged that the FDA had violated the Administrative Procedure Act and the Federal Food, Drug and Cosmetics Act by “unreasonably delaying the issue of monographs establishing conditions for the use of certain products containing triclosan as the active ingredient.”

Following a court order issued in July 2013, the FDA provided an estimated timeline for completing the monographs for three products containing triclosan, including consumer antiseptic hand wash products.

For consumer hand soaps, the FDA has committed itself to publishing a tentative final monograph by 16 December 2013 and, after taking comments and reviewing data, to issuing a final monograph by 15 September 2016.

The NRDC, which called triclosan “a suspected endocrine disruptor linked to reproductive and developmental harm in laboratory studies,” said it is “outrageous” that the FDA has waited 35 years to protect the public from this harmful chemical. "This final rule should prohibit triclosan from use in soaps,” says the NRDC.

“Washing your hands with soap containing triclosan doesn’t make them cleaner than using regular soap and water. In fact, not only do soaps containing triclosan fail to provide benefits consumers might expect, they carry potential health risks,” said Mae Wu, an attorney in NRDC’s health program.

The FDA did not comment beyond confirming the consent decree.

Further Information

NRDC release
Consent decree