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American Academy of Pediatrics v. Food and Drug Administration

United States District Court, D. Maryland, Southern Division

May 15, 2019



          Paul W. Grimm United States District Judge

         It was bound to happen. Just as email and text messages replaced “snail mail, ” social media made face-to-face communications passé, and the internet rendered libraries all but obsolete, it was only a matter of time before “electronic cigarettes”[1] replaced combustible tobacco products as a desirable means of nicotine delivery. As it turns out, even addiction has become electronic. And not only among adults, but particularly for teenagers (and younger kids). Especially, as manufactures of e-cigarette products have learned, if they are fruit or dessert flavored, and marketed as cool and alluring. Stmt. of FBA Commissioner, ECF No. 43-2.

Since 2014, [e-cigarettes] have been the most popular nicotine product among American teenagers.
And e-cigarettes' popularity is accelerating: From 2017 to 2018, … the number of high-school-age children reporting use of e-cigarettes rose by more than 75 percent. Use among middle-schoolers also increased nearly 50 percent. That is an epidemic.
The surge in e-cigarette use by teenagers is alarming because nicotine is highly addictive and can harm brain development, which continues into young adulthood. Worse, kids who start on e-cigarettes are actually more likely than non-user peers to migrate to smoking tobacco ….
It is crucial that e-cigarettes do not become an on-ramp for children to become addicted to nicotine.
… [N]early 90 percent of adult smokers started when they were teens.

Alex M. Azar & Scott Gottlieb, We cannot let e-cigarettes become an on-ramp for teenage addiction, Wash. Post (Oct. 11, 2018) (“Azar & Gottlieb Op. Ed.”).[2]

         To address public health concerns associated with tobacco use, and use by minors in particular, Congress enacted the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”), Pub. L. No. 111-31, 123 Stat. 1776 (2009) (enacting 21 U.S.C. §§ 387 - 387u and amending and redesignating other statutes), which requires manufacturers of various nicotine products, now including e-cigarettes, [3] to apply for and obtain premarket authorization before introducing new products into interstate commerce for commercial distribution. 21 U.S.C. § 387j(a)(1)-(2), (b)(1); see also Defs.' Mem. 1, ECF No. 36-1; Pls.' Mem. 3; Guidance 2, ECF No. 48-1, at 715, GAR 423.[4] Yet, although it might come as a surprise to a reader of the Tobacco Control Act, currently, "certain e-cigarettes-particularly the products with flavors that might appeal to children[5]-can remain on the market without submitting a premarket application to the FDA until 2022," id., and some can remain on the market while their application is pending, Aug. 2017 Guidance 3, ECF No. 48-1, at 716, GAR 424 (emphasis added). This is because the Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule: Guidance for Industry (Revised) ("August 2017 Guidance"), which the FDA issued in August 2017 regarding the statutory requirements for "newly deemed tobacco products" like e-cigarettes, provides that manufacturers of those products can continue to market and distribute these products while they seek FDA approval; they do not have to seek FDA approval until 2021 or 2022; and for some of the products, once the manufacturers have submitted their applications, they can continue to market and distribute the products until the FDA "renders a decision." Aug. 2017 Guidance 3, 8, ECF No. 48-1, at 716, 721, GAR 424, 429; see Compl. ¶¶ 1-3, ECF No. 1.

         Alarmed by this exemption, the American Academy of Pediatrics; the Maryland Chapter - American Academy of Pediatrics; the American Cancer Society Cancer Action Network; the American Heart Association; the American Lung Association; the Campaign for Tobacco-Free Kids; the Truth Initiative; Dr. Leah Brash, MD; Dr. Cynthia Fishman, MD; Dr. Linda Goldstein, MD; Dr. Steven Hirsch, MD; and Dr. David Myles, MD filed a Complaint for Declaratory and Injunctive Relief against the FDA, then-Commissioner of Food and Drugs Scott Gottlieb, the U.S. Department of Health and Human Services, and Secretary of Health and Human Services Alex M. Azar II. Compl. 1. In Plaintiffs' view, the exemption violates the Tobacco Control Act's requirement of premarket review of newly deemed products before they are marketed or distributed to consumers. Id. They brought three claims for the same relief pursuant to the Administrative Procedure Act (“APA”), 5 U.S.C. § 701 et seq. Specifically, Plaintiffs ask the Court to vacate the August 2017 Guidance, claiming that it is unlawful in that it “exceeds the agency's statutory authority” and “is an express and deliberate abdication of FDA's responsibilities under the Tobacco Control Act” (Count I); “was not promulgated in accordance with the APA's notice and comment requirements, ” despite being a substantive rule (Count II); and “is arbitrary and capricious and not the product of reasoned decisionmaking” (Count III). Compl. ¶¶ 4-7, 92-118.

         Plaintiffs filed a Motion for Summary Judgment, ECF No. 31, and Defendants filed a Motion to Dismiss or, in the Alternative, for Summary Judgment, ECF No. 36.[6] Defendants argue that the Court lacks subject matter jurisdiction because (1) the August 2017 Guidance does not cause any cognizable harm to Plaintiffs and therefore they do not have standing to bring this lawsuit; (2) the FDA has unreviewable discretion in deciding how to enforce the Tobacco Control Act and its rules; and (3) the August 2017 Guidance is not final agency action, rendering it beyond the reach of judicial review. Defs.' Mem. 3-4. Alternatively, they contend that Plaintiffs' claims fail on the merits because the August 2017 Guidance does not conflict with the Tobacco Control Act; it is a policy statement, not a rule, and therefore is exempt from the notice and comment requirements; and the FDA provided a rational explanation for the policy. Id. at 4-5.

         On March 13, 2019, while the motion remained pending, the FDA published draft guidance that, “if finalized, would modify the August 2017 Guidance challenged in this case.” Mar. 26, 2019 Ltr. Order, ECF No. 62; see Defs.' Second Notice, ECF No. 59. Noting that the agency was “accepting public comments on the draft guidance for a 30-day period that closes on April 15, 2019, ” with the revisions intended to “take effect 30 days after the publication of a final guidance document, ” I denied the parties' motions without prejudice to renewal following the FDA's finalization or rejection of the draft guidance. Mar. 26, 2019 Ltr. Order; Defs.' Second Notice; see also FDA, Modifications to Compliance Policy for Certain Deemed Tobacco Products: Guidance for Industry: Draft (March 2019), ECF No. 59-1; Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars 2 (Mar. 13, 2019), ECF No. 59-2.

         Plaintiffs promptly moved for reconsideration, arguing that “[t]here is . . . no reason to expect that a final Guidance is imminent, and substantial reason to doubt that it will issue this year, ” and that having “the benefit of a ruling on [the August 2017] Guidance” would increase the FDA's “ability to issue a legally sustainable replacement” and “thus obviat[e] or at least simplify[] challenges to that replacement.” Pls.' Ltr. Mot. 1, ECF No. 63. Defendants responded in favor of “postpon[ing] resolution of this case while the draft guidance is finalized, lest the Court unnecessarily expend resources-and potentially issues what could, in practical terms, largely amount to an advisory opinion-on a policy that is under revision and soon stands to change in material ways.” Defs.' Ltr. Opp'n 1, ECF No. 71. They contend that, “[i]f finalized, the draft guidance would modify the deferred-enforcement policy set forth in the August 2017 Guidance challenged in this case with respect to . . . the[] same products [that] are the apparent focus of Plaintiffs' public-health concerns, ” that is, “e-cigarettes targeted to youth and flavored cigars.” Id. at 1, 2. But, as Plaintiffs note in their reply, ECF No. 72, Defendants do not state, even generally, when the draft guidance will be finalized; they simply state that “the FDA has given every indication that it plans to finalize the draft guidance as quickly as possible, ” after it finishes reviewing the approximately 15, 467 comments it received electronically and the additional comments it received via U.S. mail. Defs.' Ltr. Opp'n 5. Given the pace at which the FDA has implemented the premarket review provisions of the Tobacco Control Act, its notion of “as quickly as possible” must be taken with a grain of salt.

         Upon further review of their briefing of Plaintiffs' letter motion for reconsideration, as well as their briefing of their cross-motions for summary judgment, I am persuaded that Plaintiffs have standing and that this Court has jurisdiction to review the August 2017 Guidance, which was not a nonreviewable discretionary decision and which qualifies as final agency action for purposes of the APA. Moreover, the undisputed evidence establishes that Defendants were required to, but did not, follow the APA's notice and comment requirements issuing the August 2017 Guidance, and therefore Defendants violated the APA by issuing it. Accordingly, I will grant Plaintiffs' motion for reconsideration and reopen the parties' cross-motions. Having done so, I deny Defendants' motion, which I treat as a motion for summary judgment; grant Plaintiffs' motion for summary judgment; and order supplemental briefing on an appropriate remedy.


         Congress enacted the Tobacco Control Act in 2009 to “protect the public health and to reduce tobacco use by minors.” Guidance 2, ECF No. 48-1, at 715, GAR 423. The Act “granted FDA the authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco (RYO), and smokeless tobacco products . . . .” Id. Additionally, pursuant to the Act the FDA can “deem[] other products that meet the statutory definition of a tobacco product” to be subject to the Act. Id. These products are referred to as “new tobacco products.” 21 U.S.C. § 387j(a)(1). On May 10, 2016, the FDA issued the “Deeming Rule, ” bringing approximately 25, 000 new tobacco products, including various cigars, e-cigarettes, pipe tobacco products, and hookah within the purview of the Act. Defs.' Mem. 1; Pls.' Mem. 6; Guidance 2, ECF No. 48-1, at 715, GAR 423. The Deeming Rule went into effect 90 days after its publication. Deeming Rule, 81 Fed. Reg. 28, 974-01, 28, 976 (May 10, 2016).

         The Act requires “[m]anufacturers of products subject to the Act [to] generally register with the FDA, submit lists of their products and ingredients, obtain premarket authorization before marketing new products, and include health warnings on packaging and advertisements.” Defs.' Mem. 1. To obtain premarket authorization, a manufacturer must submit to the FDA either

(1) a “premarket tobacco application” demonstrating that the product would be appropriate for the protection of the public health, [21 U.S.C.] § 387j(b)-(c); (2) a “report” establishing that the product is “substantially equivalent” to a predicate product, id. §§ 387j(a)(2)(A)(i), 387e(j)(1); or (3) a request for an “exemption” from the substantial equivalence requirement, id §§ 387j(a)(2)(A)(ii), 387e(j)(3).

Id. at 5.

         If products are marketed without adhering to these requirements, they may be considered “adulterated” and seized, and the manufacturers, distributors and retailers may be subject to civil injunctions and/or criminal prosecutions. 21 U.S.C. §§ 331(a)-(c) (prohibited acts), 332 (court jurisdiction to issue injunction), 333(a) (criminal penalties), 334 (seizure), 387b(6) (“A tobacco product shall be deemed to be adulterated if . . . it is required by section 387j(a) . . . to have premarket review and does not have an order in effect under section 387j(c)(1)(A)(i); or . . . it is in violation of an order under section 387j(c)(1)(A).”).

Initially, the Act required the FDA to permit the four products then subject to the Act to remain on the market during premarket review so long as their manufacturers submitted premarket applications by March 2011. But there is no statutory grace period for products later deemed subject to the Act. Thus, when the deeming rule took effect in August 2016, all newly deemed products then on the market were suddenly noncompliant with the statute.

Defs.' Mem. 1.

         It is undisputed that the FDA has some “discretion to adapt those provisions to the special circumstances of products that become subject to the TCA [Tobacco Control Act] by virtue of deeming” and, to that end, to “[p]ermit[] a compliance period for newly deemed products.” Id. at 2 (quoting Organizational Plaintiffs' comments on the proposed deeming rule, AR 145, 551, 145, 607, ECF No. 48-1, at 566, 622). And, when it published the Deeming Rule, the FDA, in what it called an “exercise of enforcement discretion, ” stated that “newly deemed, new tobacco products” would not “be subject to enforcement” during “compliance period[s]” that the Deeming Rule established. Deeming Rule, 81 Fed. Reg. at 28, 978. Specifically, the Deeming Rule “establish[ed] staggered initial compliance periods based on the expected complexity of the applications to be submitted, followed by continued compliance periods for FDA review, ” with the FDA's “exercise of enforcement discretion [set to] end twelve months after each initial compliance period.” Id. Thus, the Deeming Rule provided that

manufacturers of all newly deemed, new tobacco products [would] have a 12-, 18-or 24-month initial compliance period in which to prepare applications for marketing authorization, as well as a 12-month continued compliance period after those dates in which to obtain authorization from FDA (resulting in total compliance periods of 24, 30, or 36 months).


         The FDA established these specific compliance periods because it “determined that exercising enforcement discretion indefinitely could put youth and young adults at risk for tobacco-related death and disease.” Id. at 28, 977; see also Aug. 2017 Guidance 3, ECF No. 48-1, at 716, GAR 424 (“Unless FDA has issued an order denying or refusing to accept the submission, products for which timely premarket submissions have been submitted will be subject to a continued compliance period for 12 months after the initial compliance period described previously. For such products, FDA does not intend to initiate enforcement for failure to have premarket authorization during this continued compliance period.” (quoting 81 Fed. Reg. at 29, 011)). The “compliance policy did not apply to any new tobacco product that was not on the market on August 8, 2016 ” Aug. 2017 Guidance 3, ECF No. 48-1, at 716, GAR 424.

         In May 2017, the FDA extended the compliance deadline by three months. Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule: Guidance for Industry (May 2017), GAR 206, ECF No. 48-1, at 687. Specifically, it provided that . the “compliance period for manufacturers to submit a substantial equivalence exemption request” was November 8, 2017;

• the “compliance period for manufacturers that have submitted substantial equivalence exemption requests by November 8, 2017 (unless they have received an order denying, or FDA has refused to accept their submission)” was one year later, November 8, 2018;
• the “compliance period for manufacturers to submit a substantial equivalence report” was May 8, 2018;
• the “compliance period for manufacturers that have submitted substantial equivalence reports by May 8, 2018 (unless they have received an order denying, or FDA has refused to accept their submission)” was one year later, May 8, 2019;
• the “compliance period for manufacturers to submit a premarket tobacco product application (PMTA)” was November 8, 2018;
• the “compliance period for manufacturers that have submitted PMTAs by November 8, 2018 (unless they have received an order denying, or FDA has refused to accept their submission)” was one year later, November 8, 2019.

May 2017 Guidance 7-8, GAR 214-15, ECF No. 48-1, at 695-96.

         Then, in August 2017, without allowing for a notice and comment period, Pls.' Mem. 7, the FDA issued the August 2017 Guidance (which revised its May 2017 Guidance), “announcing] that it would further defer enforcement of the premarket review provision with respect to combustible products (like cigars) until 2021, and noncombustible products (like most e-cigarettes) until 2022-but only for products that were on the market when the deeming rule took effect in August 2016.” Defs.' Mem. 2; see Aug. 2017 Guidance 8, GAR 429, ECF No. 48-1, at 721. The August 2017 Guidance explained that the FDA had set “compliance date[s] matter of enforcement discretion, stating that it does not intend to enforce [] particular requirement[s] that [were] already in effect for a period of time in order to give industry more time to comply.” Aug. 2017 Guidance 4, ECF No. 48-1, at 717, GAR 425. Notably, pursuant to the August 2017 Guidance, “there will be a continued compliance period pending review of [certain] applications, ” and “[t]his compliance period will continue until the agency renders a decision on an application (i.e., issuance of: a Marketing Order; a No. Marketing Order; a Refuse to File; or Refuse to Accept) or the application is withdrawn.” Id. at 3, GAR 424, ECF No. 48-1, at 716 (emphasis added). The chart of compliance deadlines only identified the end of the compliance periods for manufacturers to make their submissions; it no longer included a deadline for the compliance period for manufacturers that had made their submissions. Id. at 8, GAR 429, ECF No. 48-1, at 721.

         During the compliance period, “the agency plans to issue regulations governing the information to be included in premarket applications, to develop standards that certain products must meet, and to publish additional guidance explaining what applications should contain and how they will be reviewed.” Defs.' Mem. 2.

         The effect of this deferred enforcement is that the products subject to the Act pursuant to the Deeming Rule may remain on the market until 2021 or 2022 without submitting an application or having it reviewed and approved. These products include e-cigarettes. As noted, youth use of e-cigarettes has reached epidemic proportions. Azar & Gottlieb Op. Ed. The FDA recognizes this and professes to be “deeply concerned about the risks that e-cigarettes pose for children, given how quickly teenage use of these products has accelerated.” Id. It also “believe[s] e-cigarettes can be an important off-ramp for adults who are addicted to combustible cigarettes, ” but asserts that “[t]he technology that might help adults end one addiction cannot [be permitted to] pull a generation of kids into a new one.” Id. In fact, the FDA has stated that it is “actively reconsidering our policy under which certain e-cigarettes - particularly the products with flavors that might appeal to children[5] - can remain on the market without submitting a premarket application to the FDA until 2022, ” noting that “products such as e-cigarettes need to be put through an appropriate regulatory process. Under the most likely path for marketing authorization, they must show that their marketing is appropriate for protecting the public health, taking into account their risks and benefits to the population as a whole, ” and that “[r]ising e-cigarette use by children makes the marketing of this product especially deserving of close attention.” Id.

         Standard of Review

         Defendants challenge this Court's subject matter jurisdiction based on Plaintiffs' purported lack of standing and their view that the August 2017 Guidance is not subject to judicial review because it was an action within agency discretion and not a final agency action.[7] They also move to dismiss under Fed.R.Civ.P. 12(b)(6) for failure to state a claim. When a defendant moves to dismiss pursuant to Fed.R.Civ.P. 12(b)(1) for lack of subject matter jurisdiction, asserting a facial challenge that “a complaint simply fails to allege facts upon which subject matter jurisdiction can be based, ” as Defendants do here, “the facts alleged in the complaint are assumed to be true and the plaintiff, in effect, is afforded the same procedural protection as he would receive under a 12(b)(6) consideration.” Adams v. Bain, 697 F.2d 1213, 1219 (4th Cir. 1982); see Lujan v. Defs. of Wildlife, 504 U.S. 555, 561 (1992) (noting that, on a motion to dismiss, a plaintiff's pleading of the elements of standing are “presum[ed] [to] embrace those specific facts that are necessary to support the claim” (quoting Lujan v. Nat'l Wildlife Fed'n, 497 U.S. 871, 889 (1990))). But when, as here, a motion is styled in the alternative as one for summary judgment, both parties file their briefs along with evidence that is not integral to the pleadings, and the Court considers that evidence in reaching a decision, the Court must treat the motion as one for summary judgment. See Fed. R. Civ. P. 12(d); Laughlin v. Metro. Wash. Airports Auth., 149 F.3d 253, 261 (4th Cir. 1998) (observing that, while the parties must have notice that a motion will be treated as one for summary judgment, the styling of a motion in the alternative, as well as the filing of evidence in support of the parties' arguments, provides sufficient notice).

         Summary judgment is proper when the moving party demonstrates, through “particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations . . . admissions, interrogatory answers, or other materials, ” that “there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a), (c)(1)(A); see Baldwin v. City of Greensboro, 714 F.3d 828, 833 (4th Cir. 2013). If the party seeking summary judgment demonstrates that there is no evidence to support the nonmoving party's case, the burden shifts to the nonmoving party to identify evidence that shows that a genuine dispute exists as to material facts. See Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 585-87 & n.10 (1986). When considering cross-motions for summary judgment, “the court must view each motion in a light most favorable to the non-movant.” Linzer v. Sebelius, No. AW-07-597, 2009 WL 2778269, at *4 (D. Md. Aug. 28, 2009); see Mellen v. Bunting, 327 F.3d 355, 363 (4th Cir. 2003).


          This Court may “adjudicate only actual cases and controversies.” Zaycer v. Sturm Foods, Inc., 896 F.Supp.2d 399, 407 (D. Md. 2012) (citing U.S. Const. art. III, § 2; O'Shea v. Littleton, 414 U.S. 488, 493 (1974); Bishop v. Bartlett, 575 F.3d 419, 423 (4th Cir. 2009)). This “constraint of Article III” has two distinct but overlapping facets that must be satisfied for a federal district court to have subject matter jurisdiction: standing (which addresses who may sue and which is at issue here) and ripeness (which addresses when a party may bring a suit). See South Carolina v. United States, 912 F.3d 720, 730 (4th Cir. 2019) (quoting Scoggins v. Lee's Crossing Homeowners Ass'n, 718 F.3d 262, 269 (4th Cir. 2013)).

         A plaintiff has standing if

(1) [the plaintiff] has suffered an “injury in fact” that is (a) concrete and particularized and (b) actual or imminent, not conjectural or hypothetical; (2) the injury is fairly traceable to the challenged action of the defendant; and (3) it is likely, as opposed to merely speculative, that the injury will be redressed by a favorable decision.

Zaycer, 896 F.Supp.2d at 408 (quoting Bishop, 575 F.3d at 423)); see also Lujan, 504 U.S. at 560-61 (same). Notably, while a plaintiff must plead these elements to allege standing, these elements are more than “mere pleading requirements”; they are “an indispensable part of the plaintiff's case, ” and “each element must be supported in the same way as any other matter on which the plaintiff bears the burden of proof, i.e., with the manner and degree of evidence required at the successive stages of the litigation.” Lujan, 504 U.S. at 561. In response to Defendants' Motion for Summary Judgment, Plaintiffs cannot “rest on . . . ‘mere allegations'” of injury resulting from Defendants' conduct. Id. Rather, they have to “‘set forth' by affidavit or other evidence ‘specific facts.'” Id. (citing Fed.R.Civ.P. 56). If one of multiple plaintiffs has standing for a claim, then the claim can proceed. Kenny v. Wilson, 885 F.3d 280, 287 (4th Cir. 2018). Here, the three claims are each brought by all Plaintiffs. Compl. ¶¶ 92-118.

         Injury in Fact

         The Fourth Circuit has held that, where an organization's “efforts to carry out its mission” are impeded, that impediment is a concrete and particularized injury. Lane v. Holder, 703 F.3d 668, 674 (4th Cir. 2012). Likewise, “an organization suffers an injury in fact when it is deprived of information integral to its core activities.” Pub. Citizen Health Research Grp. v. Acosta, 363 F.Supp.3d 1, 12 (D.D.C. 2018) (finding that plaintiffs alleged injury in fact sufficiently by “alleg[ing] that [their] ‘activities [are] impeded' when [they] cannot rely on the information OSHA would ordinarily collect under the Electronic Reporting Rule”). The Supreme Court refers to this as an “informational injury.” Dreher v. Experian Info. Sols., Inc., 856 F.3d 337, 345 (4th Cir. 2017) (quoting Fed. Election Comm'n v. Akins, 524 U.S. 11, 24 (1998)).

         For a plaintiff to have standing based on an informational injury, the plaintiff must “lack access to information to which he is legally entitled and . . . the denial of that information [must] create[] a ‘real' harm with an adverse effect.” Id. (quoting Spokeo, Inc. v. Robins, __ U.S. __, 136 S.Ct. 1540, 1549 (2016) (internal quotation marks omitted)). Thus, “a plaintiff suffers a concrete informational injury where he is denied access to information required to be disclosed by statute, and he ‘suffers, by being denied access to that information, the type of harm Congress sought to prevent by requiring disclosure.'” Id. (quoting Friends of Animals v. Jewell, 828 F.3d 989, 992 (D.C. Cir. 2016) (emphasis supplied)). In Spokeo, the respondents' injury in fact “‘consist[ed] of their inability to obtain information . . . that . . . [a] statute require[d] [to be] ma[d]e public' where that information ‘would help them . . . evaluate candidates for public office.'” Id. (quoting Spokeo, 136 S.Ct. at 1548).

         The injury also must be “imminent, ” that is “not too speculative”; in other words, it must be “certainly impending.” Lujan v. Defs. of Wildlife, 504 U.S. 555, 564 (1992) (quoting Whitmore v. Arkansas, 495 U.S. 149, 158 (1990)). Injury cannot be predicted “at some indefinite future time” or expected to result from acts “partly within the plaintiff's own control.” Id.

         Six Plaintiffs are “Organizational Plaintiffs”: American Academy of Pediatrics (“AAP”), the American Cancer Society Cancer Action Network (“ACS CAN”), the American Heart Association (“AHA”), the American Lung Association (“ALA”), the Campaign for Tobacco-Free Kids (“CTFK”), and the Truth Initiative. Pls.' Rely & Opp'n 3. Plaintiffs assert that the Organizational Plaintiffs' “missions center on educating the public about the dangers of [new tobacco products]” and “advancing the public health.” Id. at 6, 7. To this end, the Organizational Plaintiffs “work daily on the front lines of a multi-faceted effort to eradicate tobacco addiction and to avert the creation of new generations of addicted children and adults.” Id. at 2.

         Plaintiffs offer evidence that,

[a]s implemented by the Deeming Rule, the Act would have enabled sustained progress toward that goal by subjecting hazardous and addictive products such as cigars and e-cigarettes to premarket review-requiring manufacturers to supply data and other information to FDA showing that the products they seek to market advance the public health, directing FDA to issue public orders determining whether the statutory public health standard has been met, and prohibiting the marketing of those products for which premarket orders have not been issued. . . .
. . . Were FDA performing its statutorily required premarket review responsibilities, FDA would be disclosing to the public significant information about new tobacco products that Organizational Plaintiffs would use to further their missions.

Id. at 2-3 (citing Myers (CTFK) Decl. ¶¶ 10-17, ECF No. 39-1); see also, e.g., Myers (CTFK) Decl. ¶ 11 (noting that one FDA “premarket review order disclosed a wealth of information that aid[ed] Tobacco-Free Kids in understanding and educating about the risks of tobacco products and the relative risk among products, ” such as “how standards in [one producer]'s manufacturing process help ensure lower levels of certain carcinogens; the relative disease risk of [its product] vs. cigarettes and other forms of smokeless tobacco; and the contribution of various harmful and potentially harmful constituents to disease risk”). Plaintiffs assert that they suffered informational injury because

FDA's suspension of premarket review requirements for approximately 25, 000 new tobacco products deprives Organizational Plaintiffs of access to vital scientific and health information necessarily generated as a part of that process-information Plaintiffs need to carry out their missions.

Pls.' Reply & Opp'n 3.

         Additionally, Plaintiffs argue, “the Guidance interferes with Organization Plaintiffs' missions of advancing the public health by allowing nearly 25, 000 unreviewed products to remain on the market-requiring Plaintiffs to expend more resources to monitor the marketplace and to counsel and educate the public about e-cigarettes, cigars, or both.” Id. at 7. Specifically,

Plaintiff AAP, for instance, has expended “approximately 2000 hours on e-cigarette work” since FDA issued the Guidance, AAP Decl. ¶ 15-hours spent updating and offering educational programs focused on e-cigarettes, id. ¶¶ 16-25; developing and issuing educational curricula and clinical materials, id. ¶¶ 30-34; and researching and publishing a policy statement on e-cigarettes, id. ¶¶ 35-44. The “massive increase in time that [AAP has] had to spend on e-cigarette work in light of the proliferation of products without premarket review” has required the organization to reduce staffing on other projects, postpone new initiatives, spend funds that it would not have otherwise had to, and forgo grant funding-all as a direct result of the Guidance. Id. ¶¶ 45-51. Other Organizational Plaintiffs attest to similar resource expenditures. See, e.g., ALA Decl. ¶¶ 11-14; ACS CAN Decl. ¶ 15; AHA Decl. ¶¶ 15, 17.

Id.; see also, e.g., Phillips (ACS CAN) Decl. ¶ 15, ECF No. 39-3 (“Without a prohibition on marketing newly deemed products until review is complete, hundreds of products in thousands of flavors are currently being sold without a decision from FDA on those products' effect on public health. This situation forces ACS CAN to invest considerably more resources in monitoring the market and the products in the market so that we can determine where the greatest risks to public health are arising. This work hinders ACS CAN from working on other priorities in our evidence-based tobacco prevention and control efforts.”).

         Notably, the Tobacco Control Act is quite clear that its purpose is, in part, “to ensure that consumers are better informed, ” and, to that end, it “require[s] tobacco product manufacturers to disclose research which has not previously been made available . . . relating to the health and dependency effects or safety of tobacco products.” Pub. Law. 111-31, at § 3(6), 123 Stat 1776, 1782. It recognizes that “the use of tobacco by young people and dependence on tobacco” are “of particular concern to public health officials.” Id. ยง 3(2), 123 Stat. 1776, 1781. And, the Act unambiguously established the public's right to the information by requiring the FDA to disclose ...

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