NRDC Sues FDA for Failing to Take Action on Triclosan and Triclocarban

August 3, 2010

By Kurt R. Karst –   

Last week, the Natural Resources Defense Council (“NRDC”) filed a Complaint in the U.S. District Court for the Southern District of New York against FDA in an effort to force the Agency to finalize its topical antimicrobial drug products Over-the-Counter (“OTC”) drug monograph with respect to triclosan and triclocarban.  Both ingredients are found in myriad OTC drug products, including antibacterial soaps.  According to the NRDC, “[t]hese chemicals are suspected endocrine disruptors linked to reproductive and developmental harm in laboratory studies. . . .  FDA needs to issue a final rule on triclosan and triclocarban now, and that rule should ban both chemicals in hand soaps.”

The NRDC alleges in its Complaint that FDA has unreasonably delayed the publication of a final OTC drug monograph with respect to triclosan and triclocarban.  According to the NRDC, “both recent and older studies associat[e] triclosan and triclocarban with significant health risks,” and as such, immediate action by FDA is needed. 

FDA first proposed to regulate topical antimicrobial drug products for OTC use (including those products containing triclosan and triclocarban) in September 1974 in an Advance Notice of Proposed Rulemaking (39 Fed.Reg. 33,103) – one of the earliest actions in FDA”s OTC Drug Review.  Both ingredients (i.e., “conditions”) were designated as “Category II” (i.e., conditions excluded from a monograph on the basis that they are not generally recognized as safe and effective) for certain uses, and triclosan was designated as “Category III” (i.e., conditions excluded from a monograph on the basis that there are insufficient data for FDA to determine their status as generally recognized as safe and effective) for other uses.  Neither ingredient was designated as a “Category I” ingredient (i.e., conditions generally recognized as safe and effective and not misbranded). 

FDA took additional actions in subsequent years, including issuing a Tentative Final Monograph (“TFM”) in 1978 (43 Fed. Reg. 1210), which was later stayed, and a second TFM in 1994 establishing OTC healthcare products as separate from first aid antiseptics (59 Fed. Reg. 31,402).  In the 1994 rule, FDA designated both triclosan and triclocarban as Category III ingredients for most uses, but singled out triclosan as a Category I ingredient for short-term use in patient pre-operative skin preparation, according to the NRDC.  Finally, in May 2003, FDA reopened the administrative record (68 Fed. Reg. 32,003) to accept comments and data on OTC healthcare antiseptic drug products.  FDA has taken no further action under the OTC Drug Review on the ingredients to date.

After meeting with FDA to ascertain a timeline for the Agency’s finalization of the OTC drug monograph for triclosan and triclocarban – and getting nowhere – the NRDC decided to take out its frustration with FDA in court, and highlighted the glacial pace at which FDA has moved to finalize the monograph:

Sixteen years after publication of the amended tentative final order, thirty-two years after publication of the original tentative final order, and thirty-six years after the initial proposed order, the FDA has yet to finalize the Monograph.  In the meantime, [OTC] antimicrobial drug products containing triclosan and triclocarban have proliferated on the market.

Although the NRDC’s Complaint is a bit sketchy on the legal details of its case, the organization broadly argues that FDA has violated the FDC Act and the Agency’s implementing regulations by failing “either to (1) establish the safety, effectiveness, and branding accuracy of products containing triclosan or triclocarban, or (2) prohibit such products from entering interstate commerce.”  In addition, the NRDC asserts that FDA has violated the Administrative Procedure Act (“APA”) by “unreasonably” delaying finalization of the monograph with respect to triclosan and triclocarban, and requests that the court declare such delay violates the APA and the FDC Act and order FDA to finalize the monograph within 90 days of granting the requested relief.

There has also been Congressional interest in the issue, notably a January 5, 2010 letter from Rep. Edward Markey (D-MA) requesting a timeline for FDA’s final action on OTC topical antimicrobial drugs.  FDA declined to provide one, but the Agency did vow to publish a proposed rule and “finalize the rule as quickly as possible thereafter.”  FDA indicated that the Agency would disclose the results of its review of the ingredients in Spring 2011.

Categories: Drug Development