By Njideka Chukwu*
Antimicrobial, sometimes referred to as antibacterial, hand soaps contain certain chemicals not found in plain soaps.1 The purpose of these added chemicals is for the reduction or prevention of bacterial contamination.2 Many antimicrobial hand soaps contain a chemical called triclosan.3 Triclosan is a chemical that concerns many environmental and industry groups because studies show that in testing done on animals, triclosan is a hormone disrupter, meaning that it has been classified as a chemical that prevents the natural flow of hormones to specific parts of the human body.4 In addition, some studies indicate that triclosan exposure actually makes bacteria resistant to antibiotics; thus, such research leaves open the possibility that triclosan exposure may lower the effectiveness of medical treatments.5 Triclosan has chemical properties that allow it to accumulate in fatty tissues and has been found in animal and human samples.6 There have also been toxicity studies in humans that assessed the effect of chronic exposure to triclosan.7 Alarmingly, triclosan has a similar chemical structure to nonsteroidal estrogens found in humans.8 There have also been in-vitro studies done with triclosan.9 For example, studies done in 2007 and 2008 have shown triclosan to affect anti-androgenic and anti-estrogenic levels in human breast and testosterone cells.10 Specific endocrine-disruptor compounds have been shown to increase the development of prostate cancer.11 Although there has been a link to prostate cancer, not enough is known to prove the link some researchers have found.12
This article highlights the most recent legal challenges brought against the Food and Drug Administration and hand soap companies. I will examine how plaintiffs have successfully brought suit against parties who play a role in either regulating or promulgating the presence of triclosan in U.S. markets. I argue that there should be an increase in the regulation of triclosan in antimicrobial hand soaps.
II. Litigation Against The Food and Drug Administration
According to § 201(g) of the Federal Food, Drug & Cosmetic Act (FFDCA), antibacterial hand soaps are classified as “drugs.”13 The Food & Drug Administration (FDA) regulates antibacterial hand soaps as over-the-counter drugs.14 Plaintiffs wishing to sue the FDA must have standing to sue the regulatory body.15 To prove standing to sue the FDA, a plaintiff must show: 1) injury in fact; 2) causal connection between injury and the conduct; and 3) that the conduct was likely and not merely speculative.16
Natural Resources Defense Council (“NRDC”), a nonprofit environmental advocacy organization, filed a lawsuit against the FDA for violating the Administrative Procedure Act (APA) by failing to regulate triclosan and another potentially dangerous substance, triclocarban, that are both used in over-the-counter antimicrobial soap.17 NRDC’s lawsuit under the APA, 5 U.S.C. § 500 et seq., alleged that the FDA failed to regulate triclosan and triclocarban and that the FDA should issue final guidelines on the use of these chemicals in topical antimicrobial drug products.18 Plaintiffs filing an APA claim have to prove that an agency failed to regulate conduct that they were mandated to regulate.19 In NRDC, the organization had to prove that the FDA was mandated under the FFDCA to regulate triclosan and triclocarban and that the FDA failed in their duty to regulate these two chemicals. The United States District Court for the Southern District of New York granted summary judgment to the FDA on the question of whether the NRDC had standing to sue the FDA.20 The NRDC appealed and the Second Circuit held that the organization had standing to enforce the regulation of triclosan but not triclocarban; the district court’s judgment was vacated and the case was remanded for further proceedings.21
The Second Circuit concluded that a NRDC member’s workplace exposure to triclosan satisfied the injury-in-fact standing requirement.22 Echoing its holding in Bauer v. Veneman,23 the Second Circuit stated that the injury-in-fact requirement could be satisfied by “exposure to potentially harmful products.”24 Triclosan posed a credible threat of harm based on studies that showed the chemical “has endocrine-disrupting properties, easily absorbs into the human bloodstream, and may contribute to the growth of cancer…There is also evidence that triclosan can disrupt thyroid regulation, and earlier FDA studies cited concerns about liver damage.”25 The Second Circuit also noted that NRDC provided enough evidence to meet the causation standing requirement.26
The Second Circuit’s ruling that NRDC had standing to compel triclosan regulation is important because this is one the few lawsuits that has allowed people trying to force the FDA to finish its final assessment on the health and safety of triclosan in U.S. markets to gain headway in the courts. The Second Circuit validated many of the arguments presented by NRDC on the issue of triclosan. The Second Circuit’s holding in NRDC could mean that the Southern District of New York will take those arguments about standing more seriously when the case is heard on remand.
III. Litigation Against Hand Soap Companies
Another litigation strategy showing promise is suing hand soap companies directly. There are currently two consolidated class action lawsuits: one is against Colgate-Palmolive Company, and the other is against Dial Corporation. Both lawsuits were filed in the District Court of New Hampshire.
A class action lawsuit was brought against Colgate-Palmolive Company (“Colgate”) for “false and misleading marketing claims” that induced class members to purchase Softsoap Antibacterial.27 Triclosan is the active ingredient in Softsoap Antibacterial, and Colgate had been marketing the effectiveness of that chemical in its hand soaps.28 The plaintiffs claimed that scientific studies have raised doubts about the safety and effectiveness of triclosan and that consumers were mislead by Colgate’s marketing strategy.29 Colgate argued that the case should be dismissed or stayed under the primary jurisdiction doctrine.30
This doctrine is applied when a claim is first addressed in an administrative agency before being addressed by a court.31 When a factual issue can be determined by a competent administrative agency, a court may choose to suspend the judicial process until the administrative agency offers guidance on how to resolve that factual issue.32 The three factors courts assess when deciding whether to apply the primary jurisdiction doctrine are “1) whether an important issue in the case lies at the heart of an administrative agency’s task…; 2) whether the issue requires the agency’s technical expertise…; and 3) whether, though perhaps not determinative, the agency determination would materially aid the court.”33
The District Court of New Hampshire rejected both the application of primary jurisdiction and Colgate’s motion to dismiss or stay the case.34 The first factor weighed against the application of the doctrine because the FDA’s findings regarding triclosan’s safety in consumer products is based on current scientific knowledge, not knowledge that was known in the past.35 The second factor weighed against the application of primary jurisdiction because 1) courts are competent enough to do the historical fact finding of scientific evidence available to Colgate at the time Softsoap Antibacterial was marketed; 2) Courts, not the FDA, have the technical expertise to determine fraud or misleading statements or conduct; and 3) the Federal Trade Commission, and not the FDA, has enforcement authority on marketing claims related to questions of comparative safety and efficacy of an over-the-counter drug.36 Finally, the third factor also weighed against the application of primary jurisdiction because the FDA’s final assessment of triclosan’s safety in hand soaps would not materially help the court in resolving the case at hand.37
Dial Corporation (“Dial”) is being sued on similar claims to those brought against Colgate.38 The District Court of New Hampshire denied Dial’s motion to dismiss for the same reasons given in Colgate.39 It is encouraging that the District Court of New Hampshire is allowing plaintiffs’ lawsuits against Colgate and Dial to proceed. Consumers are demonstrating that when the FDA is responding slowly to the need to regulate triclosan in hand soaps, they (the consumers) will take matters into their own hands.
Concerned members of the public are using different litigation tactics to eliminate the use of triclosan in hand soaps. The NRDC has proven that it has standing to compel the FDA to regulate triclosan, and it will be interesting to see how far the organization goes with its lawsuit. Unfortunately, it is very difficult to prevail in lawsuits compelling agency action because of the doctrine of sovereign immunity. There would have to be a specific law saying a federal agency was not immune to a lawsuit. There are few laws under which one can sue the FDA. Even if NRDC is ultimately unsuccessful, hopefully their lawsuit will expose the FDA’s sluggishness encouraging others to seek legal remedies against the FDA, and perhaps substantial litigation might persuade the agency to finish their assessments on the suitability of triclosan in hand soaps.
Consumers have so far been successful surviving motions to dismiss their claims against hand soap companies. With enough class action litigation, Colgate, Dial, and other hand soap companies may realize that even without the FDA’s help, consumers will force these companies to refrain from using triclosan in their products. Since it is easier to sue companies directly rather than force action upon federal agencies, consumers stand a chance in ultimately prevailing against hand soap companies and their use of triclosan through this new litigation strategy.
* Candidate for Juris Doctor, May 2015, Northeastern University School of Law.
1 FDA, Taking a Closer Look at ‘Antibacterial’ Soap, http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM378615.pdf (2013).
4 Id. at 2.
6 Gilles Bedoux, et al., Occurrence and Toxicity of Antimicrobial Triclosan and By-Products in the Environment, 19 Envtl. Sci. & Pollution Res. 1044, 1065 (2012), available at http://link.springer.com/article/10.1007%2Fs11356-011-0632-z.
7 Id. at 1058.
8 Id. at 1059.
13 Int’l Sanitary Supply Ass’n, ISSA'S Guide to the Regulation of Antibacterial Hand Soaps (2003), available at http://www.issa.com/data/files/articles/88/soap.pdf.
14 Id. at 1 (“Antibacterial products that fall under the jurisdiction of FDA include all hand soaps, dips, and alcohol based washes for use when water is not available, also known as instant hand sanitizers.”).
15 James T. O’Reilly, Food and Drug Administration § 4:17 (3d ed. 2014) (“Regulations of the FDA can be challenged by those with standing to sue.”).
17 NRDC v. FDA, 710 F.3d 71 (2d Cir. 2013).
18 Id. at 76.
20 Id. at 74. (“At issue is whether NRDC has standing under Article III of the U.S. Constitution to bring this action to compel FDA to finalize its regulation of triclosan and triclocarban, two chemicals used in over-the-counter antiseptic antimicrobial soap.”).
21 Id. at 86.
22 Id. at 80.
23 352 F.3d 625 (2d Cir. 2003).
24 NRDC, 710 F.3d at 80-81.
25 Id. at 81; see also id. at 82 (“Considering the potential harms caused by triclosan-containing soap together with FDA’s inability to confirm that the soap will not cause these harms, and keeping in mind that the FFDCA establishes an interest in being protected from products of unproven safety, we conclude that NRDC has presented evidence sufficient to withstand summary judgment that member Owens’s frequent exposure to triclosan is an injury in fact under Article III.”).
26 Id. at 84-85 (“NRDC’s evidence shows that FDA’s conduct contributes to Owens’s triclosan exposure because triclosan would not be available on the market but for FDA’s failure to finalize its regulation.”).
27 In re Colgate-Palmolive Softsoap Antibacterial Hand Soap Marketing and Sales Practices Litigation, No. 12-md-2320-PB, 2013 WL 1124081, at *1 (D.N.H. March 18, 2013).
30 Id. (“Colgate has responded by arguing, among other things, that the action should be dismissed or stayed because the Food and Drug Administration (‘FDA’) has primary jurisdiction over certain factual questions that must be answered to resolve plaintiffs’ claims”).
31 Id. at * 2. (“The primary jurisdiction doctrine applies when a claim that is originally cognizable in either the courts or an administrative agency ‘requires the resolution of issues which, under a regulatory scheme, have been placed within the special competence of an administrative body.’”).
32 Id. at * 3.
33 Id. (citing Ricci v. Chi. Mercantile Exch., 409 U.S. 289, 305 (1973); Mashpee Tribe v. New Seabury Corp., 592 F.2d 575, 580-81 (1st Cir. 1979)).
34 In re Colgate–Palmolive, 2013 WL 1124081, at * 9.
35 Id. at * 6.
36 Id. at * 6-7.
37 Id. at * 8. The District of New Hampshire also implied that any benefits from the FDA’s final ruling on trislcosan’s safety and use in the market will not help resolve the case at hand in a timely manner. Id. at * 5 (“Moreover, the final monograph is not the end of the road: It may be appealed to the federal courts, and the Commissioner has discretion to stay the effective date for all or part of the monograph pending final court adjudication.”).
38 In re Dial Complete Marketing and Sales Practices Litigation, No. 11-md-2263-SM, 2013 WL 1222310, at * 1-2 (D.N.H. March 26, 2013).
39 Id. at * 5-7.