Lawsuit Seeking FDA Triclosan Action Stays Alive On Appeal

A court ruling allowing an advocacy group to move forward in its suit against FDA could pave the way for future litigation intended to force the agency to complete delayed regulations.

A federal appeals court ruled the National Resources Defense Council can pursue litigation seeking an order that FDA finalize its regulatory position on antimicrobial triclosan use in OTC drugs.

The decision handed down March 15 by a three-judge panel in the U.S. Court of Appeals for the Second Circuit vacates a summary judgment previously issued by a New York federal district court, which ruled that NRDC’s argument lacked standing under the Administrative Procedure Act.

The APA authorizes parties to sue a federal agency if they are “adversely affected or aggrieved” by its failure to act, potentially compelling the agency to take action that has been “unreasonably delayed.”

The appeals court ruling could pave the way in some instances for similar complaints from other activist groups or stakeholders in other business sectors. The case also potentially has implications for other OTC drug segments where perceived delays in FDA rulemaking have drawn complaints from industry and raised public health concerns.

A final monograph for sunscreen products has been long in coming, for example, with stakeholders teaming in the past to petition FDA in the interest of making the latest sunscreen ingredients – many of which are approved for use overseas – available to U.S. consumers (Also see "Industry, Docs And Congress Combine Voices In Call For Final Sunscreen Regs" - HBW Insight, 8 Dec, 2008.).

In a March 14 press briefing, the Public Access to SunScreens Coalition said it would recommend a user-fee program to help fund FDA’s work on Time and Extent Applications for OTC sunscreen ingredients, which have been in the agency’s queue “for several years” with little evidence of progress (Also see "U.S. Sunscreen Group Suggests User Fees To Expedite Ingredient Reviews" - HBW Insight, 18 Mar, 2013.).

Potential For Injury Is Sufficient Grounds

In its consideration of the NRDC case, the appeals court concluded that the environmental group’s evidence sufficiently demonstrates that its argument has standing, based on two components of the law.

First, at least one of the organization’s members has suffered an “injury in fact,” and second, that injury is “fairly traceable” to FDA’s alleged delay in finalizing its monograph for topical antimicrobial OTC drugs, the court asserts.

FDA has released two tentative final monographs for such active ingredients, in 1978 and 1994, and excluded triclosan from both due to a lack of compelling safety data at the time.

To establish injury-in-fact, NRDC submitted testimony from Diana Owens, a member and veterinary technician who said that in the course of her work, she washes her hands more than 50 times a day using antibacterial soap that contains triclosan.

“Owens avers that she has a slightly increased risk of ovarian cancer and is concerned about the hormone-disrupting effects of triclosan,” the decision explains.

NRDC provided the court with a statement from a doctor with expertise on endocrine-disrupting chemicals to underscore the link between triclosan and documented adverse effects on the reproductive system, among other potential hazards.

Furthermore, the group referred the court to communications from FDA, including a 2010 letter to Rep. Edward Markey, D-Mass., in which the agency acknowledges the emergence of data that raise concerns about triclosan safety and questions about the ingredient’s benefits versus plain soap and water (Also see "Rep. Markey Calls For Triclosan Ban, Galvanized By Sympathetic FDA Letter" - HBW Insight, 12 Apr, 2010.).

As the bulk of data suggesting triclosan risks has come from animal studies, however, triclosan’s safety relative to human exposure remains an issue of debate.

The court was tasked with determining “whether exposure to triclosan constitutes an injury ... notwithstanding the scientific uncertainty as to whether triclosan is harmful to human health,” according to the decision.

Citing various precedents, the court decided that exposure to potentially harmful products, or products that represent a “credible threat,” qualifies as an injury in itself, noting that “the relevant ‘injury’ for standing purposes may be exposure to a sufficiently serious risk of medical harm – not the anticipated medical harm itself.”

Under federal food and drug law, the court adds, the public has a legal interest to be protected from products not proven to be safe and effective for their indicated uses.

It states: “There is no genuine dispute that triclosan is potentially harmful and that NRDC member Owens is exposed to triclosan at her workplace,” representing an injury in fact.

Court Upholds “Causal Chain”

With regard to traceability, FDA has held that NRDC lacks standing because Owens’ alleged injury is “self-inflicted,” insofar as the NRDC member could avoid triclosan exposure by bringing soap to work that does not contain the ingredient or by encouraging her employer to provide triclosan-free soap.

The appeals court disagrees, noting that “incurring the expense of buying such soap would itself constitute an injury in fact,” and Owens’ “failure to advocate more forcefully with her employer” is not sufficient to “break the causal chain.”

It maintains that “FDA’s allegedly unreasonable delay in regulating triclosan remains a contributing factor to Owens’s exposure.” Based on NRDC’s evidence, “but for FDA’s challenged inaction, triclosan-containing soaps would not be available on the market,” the court says.

Therefore, the traceability element is present in the context of the injury-in-fact, and NRDC has ample standing for its case concerning triclosan.

NRDC had lumped in related substance triclocarbon in its charges against FDA, but the court determined that the group’s evidence – primarily related to the ingredient’s potential for contributing to antibiotic resistance – did not meet criteria for standing under the law.