Envtl. Working Grp. v. U.S. Food & Drug Admin.
Envtl. Working Grp. v. U.S. Food & Drug Admin.
Opinion of the Court
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 *168immediate threat" facing association members in the future, Coal. for Mercury-Free Drugs v. Sebelius ,
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 straightening
The Plaintiffs then amended their complaint, naming the FDA and its Acting Commissioner as defendants.
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 ,
*170(Powell, J., concurring) ), and the usurpation of "the powers of the political branches." Id. at 408,
"The party invoking federal jurisdiction bears the burden of establishing [it]," Susan B. Anthony List v. Driehaus , --- U.S. ----,
"An organization ... can assert standing on its own behalf, on behalf of its members or both." Equal Rights Ctr. v. Post Properties, Inc. ,
III. Analysis
Both of the Plaintiffs assert organizational standing, while WVE also asserts associational standing. Opp. 13-16. For the reasons that follow, I conclude that both claims fail.
A. Organizational Standing
The central question I must consider in an organization standing case is *171whether the plaintiff "has suffered a 'concrete and demonstrable injury to [its] activities,' mindful that, under our precedent, 'a mere setback to its abstract social interests is not sufficient.' " PETA ,
To satisfy the first prong-"an injury to its interest"-"an organization must allege that the defendant's conduct perceptibly impaired the organization's ability to provide services."
To be sure, the Plaintiffs allege significant expenses. EWG has spent "approximately $1,365,000 in total expenses to combat hazardous cosmetic ingredients," a "substantial portion" of which is "attributable to EWG's efforts to address ... formaldehyde in keratin hair straighteners, and were necessitated by the FDA's inaction on the Petition." Benesh Decl. at ¶ 8. WVE's tally is more concrete, reaching "approximately $371,000 [ ] over the past six years on the hair keratin straightener issue," despite WVE's annual budget of *172only "$500,000 per year." McConnell Decl. ¶ 13. But much of this money appears to have been spent on lobbying. And to the extent that the money was spent on educating the public, the Plaintiffs do not allege that these expenditures have imposed "operational costs beyond those normally expended ." Food & Water Watch ,
First, let us consider the Plaintiffs' advocacy expenses. "EWG has dedicated substantial time and economic resources ... to focus [the] FDA's attention on regulating these harmful products," Benesh Decl. at ¶ 4, and "WVE has expended substantial effort to focus [the] FDA's attention on this issue," McConnell Decl. ¶ 9-13. But injuries to an organization's government lobbying and issue advocacy programs cannot be used to manufacture standing, because that would allow lobbyists on either side of virtually any issue to take the Government to court. Ctr. for Law & Educ. ,
Neither do the Plaintiffs' educational efforts suffice, because this type of work is exactly what these organizations always do. "EWG ... is a research and advocacy organization dedicated to empowering people to live healthier through its educational reports, online guides, mobile apps, and related campaigns." Benesh Decl. ¶ 3. EWG has published numerous "consumer guides" on topics that include water filters and tap water, genetically modified food, pesticides in produce, seafood, cleaning products, sunscreens, cosmetics, "Safer Cell Phone Use," and bug repellants. Reply. Ex. A. Similarly, "WVE ... is a woman led environmental organization with the mission of amplifying women's voices to eliminate toxic chemicals that harm health and communities." McConnell Decl. ¶ 3. WVE has also actively published educational reports on various topics, including "Toxic Chemicals in Feminine Care Products," Reply Ex. C, "What's Hiding in Your Cleaning Products," Reply Ex. D, "Health Hazards Associated with Toxic Exposure to Nail Salons," and the "Impacts of Toxic Chemicals on Salon Workers," which addressed formaldehyde in hair-straightening products, among other issues. Reply Ex. F. In sum, both organizations are squarely focused on warning the public about health hazards in consumer products. To the extent that the Plaintiffs rely on their anti-formaldehyde educational efforts, they offer no evidence that the FDA's alleged inaction required them to spend anything beyond their typical annual expenditures. Cf. Nat'l Taxpayers Union, Inc. ,
The Plaintiffs attempt to rely on PETA ,
In sum, lobbying expenditures will not suffice, and neither EWG nor WVE plausibly allege that their educational programs have been perceptibly impaired. I therefore conclude that the Plaintiffs have failed to carry their burden to establish organizational standing. See Susan B. Anthony List ,
B. Associational Standing
Neither can WVE establish standing to sue on behalf of its members.
As an initial matter, the relief that Plaintiffs seek is purely prospective and injunctive in nature. They ask that "the Court enter judgment ... [d]eclaring that Defendants have unreasonably delayed and unlawfully withheld action on the Petition ... [d]eclaring that Defendants' actions ... are arbitrary and capricious ... and [d]irecting Defendants to grant the Petition by a date certain." Am. Comp. 31. The Plaintiffs also ask that the Court retain jurisdiction "to ensure that Defendants comply," for an award of "costs and disbursements incurred in connection with this action," and for "such other and further relief as the Court deems just and proper."Id. In sum, the Plaintiffs want this Court to declare that the Defendants are legally obligated to grant the Petition's requests, order compliance, and then supervise the Government's performance. Such an order would force the FDA to investigate deceptive labeling in the manner that the Petition requests, and kick-start the regulatory process for instituting a ban on formaldehyde-producing chemicals in hair-straightening products. Compare Am. Compl. Ex. A at 3 (the Petition's "Actions Requested") with Mot. Dismiss Ex. B at 5-7 (explaining the "FDA's Responses to [the Petition's] Requested Actions"). That is the essence of prospective injunctive relief.
In contrast, the injuries that WVE alleges occurred in the past. McConnell Decl. ¶¶ 6-7 (Jennifer Arce "described symptoms that escalated," "had" bronchitis, and "cough [ed] up chunks of blood," while Dawn and Natalija "experienced similar symptoms") (alteration original). Ms. McConnell does not allege that the injured individuals will likely use or be exposed to formaldehyde-releasing hair straightening products in the future. Id. at ¶¶ 5-7. The declaration does not even speculate about possible future injuries, although such conjecture would also be insufficient. Pub. Citizen, Inc. v. Nat'l Highway Traffic Safety Admin. ,
The available record makes this case similar to Coalition for Mercury-Free Drugs v. Sebelius , in which the D.C. Circuit held that an association and several of its members who had been injured by thimerosal-preserved vaccines lacked "standing to challenge [the] FDA's decision to allow other people to receive thimerosal-preserved vaccines."
The same logic applies here. Confronted with only past injuries to WVE's members, no allegations that these members or others are likely to use or be exposed to formaldehyde-releasing hair straighteners in the future, and evidence from WVE itself indicating that alternative products are available on the market, I cannot conclude that future injuries constitute a "real and immediate threat" to WVE's members.
All of the cases upon which Plaintiffs rely, Opp. 16, involved allegations of impending future injuries. Ctr. for Biological Diversity v. EPA,
IV. Conclusion
Accepting all of the Plaintiffs' allegations as true, they have ultimately "alleged nothing more than an abstract injury to [their] interests that is insufficient to support standing." Food & Water Watch, Inc. ,
The Plaintiffs refer to hair straightening products, while the Defendants prefer the term hair smoothing products. At the motion to dismiss stage, this opinion will use the Plaintiffs' phraseology except when quoting the FDA's filings.
Pursuant to Fed. R. Civ. P. 25(d), the current Commissioner, Scott Gottlieb, M.D., will be substituted for the former Acting Commissioner, Stephen M. Ostroff, M.D.
Because I conclude that jurisdiction is lacking, I will not recite the Rule 12(b)(6) standards.
Similarly, a challenged action that deprives the plaintiff of information may constitute a concrete injury, but only if the loss actually inhibits the organization's ongoing work in a "concrete and specific" manner. Action Alliance of Senior Citizens of Greater Philadelphia v. Heckler ,
The Plaintiffs purport to rely on Scenic America, Inc. v. U.S. Dep't of Transportation , Opp. 15, which held that an organization's efforts to combat digital billboards conferred standing to challenge agency guidance which made such billboards easier to legalize at the state level.
See id. at 1099 (Millett, J., dubitante) ("The majority opinion holds that standing exists because the government's inaction injured PETA's 'interest ' in having the Animal Welfare Act enforced against certain third parties, and because PETA chose to devote its own resources to make up for the government's enforcement 'omission .' ... If circuit precedent has brought us to the point where organizations get standing on terms that the Supreme Court has said individuals cannot, then it may be time, in an appropriate case, to revisit the proper metes and bounds of 'organizational standing.' ") (emphasis in original).
Because I conclude that jurisdiction is lacking on other grounds, I need not decide today whether "WVE fails to establish associational standing because it has not shown that it is a traditional membership organization or 'the functional equivalent' thereof." Reply 8 (citations omitted).
The same declaration alludes to "approximately twenty persons identified as salon workers in [WVE's] membership database," asserting that "many of these salon workers have been directly impacted by the use/exposure to formaldehyde." Id. at ¶ 5. However, a plaintiff asserting standing bears the burden of offering "specific allegations establishing that at least one identified member had suffered or would suffer harm." Summers v. Earth Island Inst. ,
To the extent that the Plaintiffs seek a declaration that the Defendants have unlawfully failed to act on the Petition, rather than an order requiring the Defendants to grant the Petition, that claim has been mooted by the FDA response.
Reference
- Full Case Name
- ENVIRONMENTAL WORKING GROUP v. UNITED STATES FOOD AND DRUG ADMINISTRATION
- Cited By
- 9 cases
- Status
- Published