On March 28, 2012, Rep. Ed Markey, D-Mass., sent a letter to the US Food and Drug Administration (FDA) requesting that the Agency issue a draft regulation limiting the use of the antimicrobial agent triclosan in consumer products. Markey’s request comes two days after Environment Canada/Health Canada issued a preliminary report noting that triclosan was toxic to the environment (but safe for use in consumer products). Triclosan is currently used to formulate a large percentage of liquid hand soaps available to American consumers. Rep. Markey had previously asked FDA to ban the use of triclosan in April 2010, but was told by FDA at the time that it did not have enough safety evidence to recommend changing consumer use of triclosan products. Rep. Markley has asked FDA to respond to his March 28 letter by April 17, 2012.

This matter arises at a time when FDA is trying to complete work on the consumer product section of the Monograph for Over-the-Counter Healthcare Antiseptic Drug Products. In the most recently released federal regulatory agenda published in the Federal Register in early February 2012, FDA stated that it hoped to publish a Proposed Rule covering consumer healthcare antiseptics on or about April 2012. However, the timing of such a proposed rule may be in jeopardy, as FDA has been taking an unusually long time to complete its work on the OTC Healthcare Antiseptic Monograph (FDA last published a proposed rule to the Healthcare Antiseptic Monograph in June 1994).

In any event, the Markey letter, coupled with the Health Canada announcement on triclosan, is not good news for members of industry who support the use triclosan in their product formulations. For additional information, please contact Georgia C. Ravitz, James R. Ravitz, or Jim Hartten at Arent Fox LLP.