Am. Acad. Pediatrics v. Food & Drug Admin.

• Decision Date: 15 May 2019
• Docket Number: Case No.: PWG-18-883
• Citation: 379 F.Supp.3d 461
• Parties: AMERICAN ACADEMY OF PEDIATRICS, et al., Plaintiffs, v. FOOD AND DRUG ADMINISTRATION, et al., Defendants.
• Court: U.S. District Court — District of Maryland

379 F.Supp.3d 461

AMERICAN ACADEMY OF PEDIATRICS, et al., Plaintiffs,

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

Case No.: PWG-18-883

United States District Court, D. Maryland, Southern Division.

Signed May 15, 2019

Beth Christine Neitzel, Kevin Matthew Lamb, Lynn Eisenberg, Kelly Dunbar, Wilmer Cutler Pickering Hale & Dorr LLP, Dennis Henigan, Pro Hac Vice, Javier M. Guzman, Pro Hac Vice, Jeffrey B. Dubner, Pro Hac Vice, Washington, DC, Eve Lynne Hill, Brown Goldstein & Levy, LLP, Baltimore, MD, for Plaintiffs.

Eric B. Beckenhauer, Michelle Bennett, U.S. Department of Justice, Washington, DC, Kathleen Hoke Dachille, University of Maryland Carey School of Law, Baltimore, MD, for Defendants.

MEMORANDUM OPINION

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 children⁵ —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...