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Am. Acad. of Pediatrics v. FDA

United States District Court for the District of Maryland, Southern Division

May 15, 2019, Decided; May 15, 2019, Filed

Case No.: PWG-18-883

Opinion

 [*467]  MEMORANDUM OPINION

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 [**3]  (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 nonuser 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

 [*468]  To address public health concerns associated with [**4]  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 [**5]  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.

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379 F. Supp. 3d 461 *; 2019 U.S. Dist. LEXIS 81652 **; 2019 WL 2123397

AMERICAN ACADEMY OF PEDIATRICS, et al., Plaintiffs, v. FOOD AND DRUG ADMINISTRATION, et al., Defendants.

Subsequent History: Appeal dismissed by, As moot In re Cigar Ass'n of Am., 2020 U.S. App. LEXIS 14205 (4th Cir. Md., May 4, 2020)

Prior History: Am. Acad. of Pediatrics v. FDA, 2019 U.S. Dist. LEXIS 83904 (D. Md., Mar. 26, 2019)

CORE TERMS

FDA, tobacco, premarket, manufacturers, compliance, e-cigarettes, notice, deadlines, exempt, unreviewable, binding, newly, Organizational, addicted, bioequivalence, recommendation, Memorandum, missions, Reply, Electronic, announced, mandatory, flavors, vacated, cigars, youth, circumscribe, adhering, commerce, concrete

Civil Procedure, Responses, Defenses, Demurrers & Objections, Motions to Dismiss, Administrative Law, Judicial Review, Reviewability, Reviewable Agency Action, Subject Matter Jurisdiction, Jurisdiction Over Actions, Limited Jurisdiction, Preliminary Considerations, Justiciability, Standing, Summary Judgment, Burdens of Proof, Movant Persuasion & Proof, Nonmovant Persuasion & Proof, Motions for Summary Judgment, Cross Motions, Constitutional Law, The Judiciary, Case or Controversy, Ripeness, Standing, Elements, Antitrust & Trade Law, Consumer Protection, Tobacco Products, Particular Parties, Governments, Legislation, Interpretation, Legislation, Standards of Review, Deference to Agency Statutory Interpretation, Agency Rulemaking, Notice & Comment Requirements