A federal court in New York has approved the consent decree entered by the Natural Resources Defense Council (NRDC) and the U.S. Food and Drug Administration (FDA) obligating the agency to complete by certain dates monographs “establishing conditions for use of certain products containing triclosan as the active ingredient.” NRDC v. FDA, No. 10-5690 (U.S. Dist. Ct., S.D.N.Y., order entered November 21, 2013).
Without admitting any of NRDC’s claims that FDA violated the Administra- tive Procedure Act, the agency agreed to finalize the “Consumer Antiseptic Hand Wash Products Monograph” by September 15, 2016; the “Healthcare Antiseptic Products Monograph” by January 15, 2018; and the “Consumer Antiseptic Hand Rub Products Monograph” by April 15, 2019. The agreement binds successors to Health and Human Services Secretary Kathleen Sebelius and FDA Commissioner Margaret Hamburg and accounts for the possibility of delay due to government shutdowns.
According to an NRDC press release, “FDA first proposed in 1978 to remove triclosan from certain consumer products. Because it took no further action, the chemical has been widely used in antimicrobial soaps sold in the United States.” NRDC attorney Mae Wu stated, “It’s outrageous that FDA has waited 35 years to protect the public from this harmful chemical. This final rule should prohibit triclosan from use in soaps. 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.” See NRDC Press Release, November 22, 2013.