Envtl. Working Grp. v. U.S. Food & Drug Admin.

301 F.Supp.3d 165

ENVIRONMENTAL WORKING GROUP, et al., Plaintiffs,

v.UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants.

Case No. 1:16–cv–2435–TNM

United States District Court, District of Columbia.

Signed March 19, 2018

Kathryn L. Barcroft, Stephen M. Sinaiko, Pro Hac Vice, Ronald F. Wick, Cohen & Gresser, LLP, Washington, DC, for Plaintiffs.

Jocelyn Cooper Hines, U.S. Department of Justice, Washington, DC, for Defendants.

MEMORANDUM OPINION

TREVOR N. MCFADDEN, United States district Judge

The Plaintiffs, Environmental Working Group (EWG) and Women's Voices for the Earth (WVE), oppose the use of formaldehyde and formaldehyde-producing chemicals in hair-straightening products, contending that they constitute a serious health risk. In 2011, EWG filed a Citizen Petition with the U.S. Food and Drug Administration, asking the FDA to investigate deceptive labelling of such products, require appropriate labelling, and consider implementing a complete ban on formaldehyde-releasing chemicals in hair-straightening products. Frustrated by the FDA's failure to provide a substantive response, EWG filed suit in 2016 along with WVE, contending that action on the Petition was legally required. Although the FDA issued a formal response to the petition in 2017, the Plaintiffs amended their complaint, and now seek an order requiring the FDA to grant the petition and initiate rule-making processes.

Before a federal court can rule on such an issue, the constitutional requirement of injury-in-fact must be satisfied, and I conclude that the Plaintiffs here have not satisfied the requirements for either organizational or associational standing. With no alleged injury to the Plaintiffs' ability to conduct their standard programs, they cannot manufacture standing by explaining how they have spent additional resources to combat the FDA's alleged illegal inaction. And with only allegations of past injury, rather than a "real and immediate threat" facing association members in the future, Coal. for Mercury–Free Drugs v. Sebelius , 671 F.3d 1275, 1280 (D.C. Cir. 2012) (citation omitted), the Plaintiffs cannot establish associational standing for the purpose of gaining a prospective injunction. Lacking a justiciable case or controversy, "[t]he Constitution therefore requires that [the Plaintiffs] direct their objections to the Executive and Legislative Branches, not to the Judiciary." Id. at 1283.

I. Background

EWG filed a Citizen Petition with the FDA on April 12, 2011, "requesting that the FDA take immediate action to protect the public from formaldehyde-containing keratin hair straighteners." Am. Compl. ¶ 41. The Petition asked the FDA to take three specific actions: (1) "[i]nvestigate and respond appropriately to the deceptive practices of companies that conceal the fact that their hair-straighteners release formaldehyde," (2) "[r]equire labels for hair-straighteners that contain ... formaldehyde in solution, and formaldehyde-releasing chemicals that warn users about the risk of exposure during the treatment process, and (3) "[r]eview whether to ban the use of ... formaldehyde in solution, and formaldehyde-releasing chemicals as ingredients in hair straighteners." Am. Compl. Ex. A at 3, ECF No. 19. About five months later, the "FDA sent EWG a tentative response ... on or about September 6, 2011," explaining that "due to ‘competing priorities’ the agency was unable to reach a decision on the petition." Am. Compl. ¶ 63. On December 13, 2016, EWG filed this suit along with WVE, alleging that the FDA's failure to act on the petition violated the Administrative Procedure Act, the Food, Drug and Cosmetic Act, and the FDA's own regulations, and that the FDA and its Commissioner were required to act. Original Compl. ¶ 80 (Compl.).

The FDA requested additional time to respond to the complaint, and subsequently issued a formal response to the Petition on March 29, 2018. Am. Compl. ¶ 70–71. The response granted the Petition in part and denied it in part. Mot. Dismiss Ex. B at 1. The FDA "grant[ed]" EWG's request that the agency review the appropriateness of a ban, and discussed "next steps" in that process, including a pending "scientific evaluation" of the issue. Id. at 5. The FDA also explained that the agency "ha[d] in fact already" investigated certain manufacturers for deceptive advertising in the hair straightening¹ industry (even issuing public warning letters to two such manufacturers) and would "continue to take actions regarding specific products and/or manufacturers on a case-by-case basis as appropriate."Id. at 5–6. However, the FDA denied EWG's request to initiate rulemaking for a formaldehyde warning label, explaining that doing so "before [the] FDA has completed its analysis and has the opportunity to determine whether to propose a rule to ban the use of [formaldehyde] in hair smoothers [ ] is not the best use of [the] FDA's limited resources," and noting that "a rule requiring warning labels for hair smoothers is not necessary for FDA enforcement action." Id. at 6–7.

The Plaintiffs then amended their complaint, naming the FDA and its Acting Commissioner as defendants.² Instead of asking the Court to order the Defendants to merely "act on the Petition by a date certain," Compl. ¶ 80, the amended complaint seeks an order "[d]irecting Defendants to grant the Petition by a date certain." Am. Compl. ¶ 96 (emphasis added). The Defendants moved to dismiss the amended complaint for lack of jurisdiction under Fed. R. Civ. P 12(b)(1), and for failure to state a claim under Fed. R. Civ. P 12(b)(6). Mot. Dismiss, ECF No. 20.

The Plaintiffs attached two affidavits to the record via their opposition, with factual allegations that now form the heart of their standing claims. Melanie Benesh, an attorney employed by EWG, declares that "EWG has dedicated substantial time and economic resources ... to focus [the] FDA's attention on regulating these harmful products, even to the detriment of ... other important advocacy activities." Opp. Att. 1, Benesh Decl. ¶ 4, 6 (Benesh Decl). EWG has also undertaken education efforts, such as "investigative research and publish[ed] articles," "reports on these products," and the creation of a seal "to help consumers quickly identify personal care products meeting EWG's high safety standards," complete with a "specific part of the [safety seal] program specifically for formaldehyde related to hair keratin straighteners as a result of the FDA's delay in acting on the Petition." Id. at ¶ 4–7. "Over the past six years," Ms. Benesh claims that "EWG has incurred approximately $1,365,000 in total expenses to combat hazardous cosmetic ingredients ... [a] substantial portion of [which] are attributable to EWG's efforts to address ... formaldehyde in keratin hair straighteners, and were necessitated by the FDA's inaction on the Petition." Id. at ¶ 8.

Jamie McConnell, the Director of Programs and Policy at WVE, states that the organization has spent "approximately $371,000 [ ] over the past six years on the hair keratin straightener issue," despite WVE's annual budget of only "$500,000 per year," diverting "resources away from other issues" on which WVE engages in advocacy. Opp. Att. 2, McConnell Decl. ¶ 13 (McConnell Decl). Ms. McConnell says that "WVE currently has approximately twenty persons identified as salon workers in its membership database, but there are likely many more," and "many of these salon workers have been directly impacted by the use/exposure to formaldehyde." Id. at ¶ 5. These members include "[s]alon worker Jennifer Arce" whose "symptoms from exposure to formaldehyde ... escalated into bloody noses, blistery rashes, and choking on phlegm in her sleep," as well as "[b]ronchitis" and coughing up "chunks of blood." Id. at ¶ 6. The affidavit explains that "[t]he WVE website also tells the stories of other salon worker members, identified by first name only, who experienced similar symptoms to Arce," including "Dawn" and "Natalija." Id. at ¶ 7. These facts, the Plaintiffs contend, are sufficient to confer standing.

II. Legal Standards

"Article III of the Constitution limits federal courts' jurisdiction to certain ‘Cases’ and ‘Controversies.’ " Clapper v. Amnesty Int'l USA , 568 U.S. 398, 408, 133 S.Ct. 1138, 185 L.Ed.2d 264 (2013) (quoting U.S. Const. art. III, § 2). "No principle is more fundamental to the judiciary's proper role in our system of government than the constitutional limitation of federal-court jurisdiction to actual cases or controversies," and "[t]he concept of standing is part of this limitation." Simon v. E. Kentucky Welfare Rights Org. , 426 U.S. 26, 37, 96 S.Ct. 1917, 48 L.Ed.2d 450 (1976) (citation omitted). "Relaxation of standing requirements is directly related to the expansion of judicial power," Clapper , 568 U.S. at 408–9, 133 S.Ct. 1138 (quoting United States v. Richardson , 418 U.S. 166, 188, 94 S.Ct. 2940, 41 L.Ed.2d 678 (1974)(Powell, J., concurring) ), and the usurpation of "the powers of the political branches." Id. at 408, 133 S.Ct. 1138. "To establish Article III standing, an injury must be "concrete, particularized, and actual or imminent; fairly traceable to the challenged action; and redressable by a favorable ruling." Id. at 409, 133 S.Ct. 1138 (quoting Monsanto Co. v. Geertson Seed Farms , 561 U.S. 139, 149, 130 S.Ct. 2743, 177 L.Ed.2d 461 (2010) ) (other citations omitted).

"The party invoking federal jurisdiction bears the burden of establishing [it]," Susan B. Anthony List v. Driehaus , ––– U.S. ––––, 134 S.Ct. 2334, 2342, 189 L.Ed.2d 246 (2014) (citation omitted), and when facing a motion to dismiss under Fed. R. Civ. P. 12(b)(1), must state a "plausible" claim to such an injury. Food & Water Watch, Inc. v. Vilsack , 808 F.3d 905, 913 (D.C. Cir. 2015) (citation omitted).³ "While the district court may consider materials outside the pleadings in deciding whether to grant a motion to dismiss for lack of jurisdiction ... the court must still accept all of the...