Rep. Slaughter Tells FDA That Triclosan Should Be Banned From Consumer Products

November 25, 2010

By Susan J. Matthees

Congresswoman Louise Slaughter (D-NY) recently sent a letter to FDA Commissioner Margaret Hamburg requesting that FDA ban the use of triclosan in consumer products.  Triclosan is commonly used as an antibacterial agent in topical antiseptic products, such as soaps and hand sanitizers, and is also found in some toothpastes, mouthwashes, and similar consumer health products.  The ingredient is included in FDA’s ongoing review of over-the-counter (OTC) healthcare antiseptic and first aid antiseptic drug products, but the use of triclosan in toothpaste was approved via an NDA.  Although FDA states that “[t]riclosan is not currently known to be hazardous,” some recent studies have suggested that triclosan may be an endocrine disrupter and may contribute to antibiotic resistance.  Congresswoman Slaughter’s letter points to those recent studies as a cause for concern and justification for a ban on the use of triclosan in consumer products.  In particular, the letter states that that antibiotic resistance and contaminated water, due in part to the use of triclosan, “have created a public health crisis in the United States.”  The letter also points to studies that suggest that triclosan may harm the environment and human health as reason for the ban. 

Slaughter’s letter comes just months after the Natural Resources Defense Council (“NRDC”) filed a Complaint in the U.S. District Court for the Southern District of New York against FDA to try to force the Agency to finalize its topical antimicrobial drug products monograph.  We posted on the suit in August.  The NRDC subsequently filed a Motion for Summary Judgment asking the court to declare unreasonable FDA’s delay in finalizing the Agency's topical antimicrobial drug products monograph and to order FDA to finalize the monograph within ninety days.  FDA is in the process of reviewing the safety of triclosan and intends to make those findings public in spring 2011.

Categories: Drug Development