Consent Decree Orders FDA Action On Triclosan OTC Monographs

A Nov. 21 consent decree sets multiple deadlines over a five-year period to make FDA finalize its OTC topical antimicrobial drug products monograph with respect to triclosan. Under one deadline of note to triclosan product makers, the agency must publish a tentative final monograph for consumer antiseptic hand wash products by Dec. 16, with a final monograph due by Sept. 15, 2016.

Under a consent decree signed Nov. 21, FDA is required to finalize its OTC topical antimicrobial drug products monograph as it applies to triclosan and conform to multiple deadlines over a five-year period in the process to completion.

The decree comes under a settlement of a 2010 lawsuit filed by the National Resources Defense Council against the agency seeking an order that FDA issue its final regulatory position on antimicrobial triclosan use in OTC drugs.

In March, the U.S. Court of Appeals for the Second Circuit allowed NRDC to proceed with the lawsuit, vacating a previous summary judgment ruling in New York federal district court that NRDC’s argument lacked standing under the Administrative Procedure Act (Also see "Cold Indication For Antihistamines Targeted In Regulatory Agenda" - Pink Sheet, 7 Jan, 2013.).

The tentative final monograph for consumer antiseptic hand wash products – a subcategory of the OTC topical antimicrobial drug products monograph – is slated to be published Dec. 16 and will mark the first step of what will be a more than five-year process to complete the oft-delayed overall monograph. The monograph, which currently is under review at the Office of Management and Budget, was targeted for release in September 2013 in FDA’s most recent semi-annual regulatory agenda (Also see "In Brief" - Pink Sheet, 22 Jul, 2013.).

Non-governmental organizations and Congress have pressured the agency for years to finalize the OTC Topical Antimicrobial Drug monograph, with then-Rep. Ed Markey, D-Mass., leading the charge with a January 2010 letter (Also see "Triclosan Concern In Congress Spurs Call For Final Antimicrobial Monograph" - Pink Sheet, 11 Jan, 2010.).

Efficacy, Safety Will Be Center Stage

Triclosan has been under fire from NGOs concerned about its suspected endocrine disruption properties and the ingredient’s impact on the environment.

In the personal care space, companies including Procter & Gamble Co. and Johnson & Johnson have affirmed the safety of triclosan but have removed or announced their intent to remove the ingredient from their products in response to increased consumer concerns (Also see "In Brief: Clearblue estimates weeks, Barry Meltzer dies, P&G eliminating phthalates and triclosan, NPLEx adds Delaware" - Pink Sheet, 2 Sep, 2013.).

On its website, FDA asserts triclosan’s safety, stating that it is not hazardous to humans and that the agency “does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.”

However, FDA states that evidence does not show that triclosan’s use in antibacterial soaps offers additional health benefits versus use of soap and water alone and advises consumers worried about the effects of the ingredient to wash with soap and water instead.

Brian Sansoni, American Cleaning Institute’s VP of sustainability initiatives, communication and membership at, said the trade association was puzzled by FDA’s assertions regarding triclosan and the category’s efficacy, arguing that ACI and the Personal Care Products Council previously “submitted very solid information to the agency that definitely showed germ killing benefits of antibacterial soap,” and will do so again during the comment period (Also see "Triclosan Does Not Contribute To Antibacterial Resistance – Study" - Pink Sheet, 17 Oct, 2011.).

In an interview, Sansoni said the key takeaway from the consent decree was the establishment of deadlines for the monograph.

“It gives ACI [and its members] the ability to provide updated, scientific data to FDA that show the benefits and the safety of antibacterial products and antibacterial products with triclosan,” he said.

While ACI does not know what the monograph will entail, the trade association anticipates FDA will not solely address triclosan but focus on the entire category.

“We certainly want to make sure that manufacturers have a full palate of ingredients to choose from when they formulate the antibacterial hand wash products,” Sansoni said. “Consumers should continue to have access to these safe, effective and beneficial products.”

NRDC hopes FDA will ban triclosan from soap products as part of the final monograph.

“It’s outrageous that FDA has waited 35 years to protect the public from this harmful chemical,” says Mae Wu, an attorney in NRDC’s health program, in a Nov. 22 release. “This final rule should prohibit triclosan from use in soaps.”

Decree Deadline Mandates

According to the consent decree, the court ordered FDA to establish an estimated timeline for the three monograph subcategories with respect to triclosan, which was submitted to the court on Sept. 11 and agreed upon by NRDC.

For consumer antiseptic hand wash products, FDA is tasked with publishing a tentative final monograph by Dec. 16, and accepting comments through June 16, 2014. Following new data submissions, a “rebuttal” comment period and review by the Department of Health and Human Services and the Office of Management and Budget, the agency will publish the final monograph by Sept. 15, 2016.

Final monographs for healthcare antiseptic products and consumer antiseptic hand rub products will be published by Jan. 15, 2018 and April 15, 2019, respectively.

FDA and NRDC can agree to extend the deadlines set out in the consent decree. In addition, FDA is required to issue status reports every six months to NRDC and the court until each monograph is finalized.

OTC topical antimicrobial drug products monograph subcategory deadlines

Consumer Antiseptic Hand Wash Products Monograph
Publication of tentative final monograph	Dec. 16, 2013
Comment period for tentative final monograph	June 16, 2014
End of period to submit new data and information for tentative final monograph	Dec.16, 2014
Rebuttal comment period for tentative final monograph	Feb. 17, 2015
FDA review of comments, data, and information; drafting of the final monograph; and final review and approval by FDA, Department of Health and Human Services, and Office of Management and Budget	Aug. 31, 2016
Publication of Final Monograph	Sept. 15, 2016
Healthcare Antiseptic Products Monograph
Publication of tentative final monograph	April 30, 2015
Comment period for tentative final monograph	Oct. 31, 2015
End of period to submit new data and information for tentative final monograph	April 30, 2016
Rebuttal comment period for tentative final monograph	June 30, 2016
FDA review of comments, data, and information; drafting of the final monograph; and final review and approval by FDA, Department of Health and Human Services, and Office of Management and Budget	Dec. 31, 2017
Publication of Final Monograph	Jan. 15, 2018
Consumer Antiseptic Hand Rub Products Monograph
Publication of tentative final monograph	June 30, 2016
Comment period for tentative final monograph	Dec. 31, 2016
End of period to submit new data and information for tentative final monograph	June 30, 2017
Rebuttal comment period for tentative final monograph	Aug. 31, 2017
FDA review of comments, data, and information; drafting of the final monograph; and final review and approval by FDA, Department of Health and Human Services, and Office of Management and Budget	March 31, 2019
Publication of Final Monograph	April 15, 2019