Opinion ID: 6500930
Heading Depth: 1
Heading Rank: 1

Heading: Statutory & Regulatory Landscape

Text: To fully appreciate the events that gave rise to the petitions before us, we begin with a careful review of the statutory and regulatory background. Nearly a century ago, Congress passed the Food, Drug, and Cosmetics Act (“FDCA”), Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified at 21 U.S.C. 2 Case: 21-60766 Document: 00516397516 Page: 3 Date Filed: 07/18/2022 No. 21-60766 c/w No. 21-60800 § 301, et seq.), which established broad regulatory authority—such as a premarket “new drug” authorization requirement—to protect the public against the dangers of “adulterated and misbranded food, drugs, devices, and cosmetics.” 52 Stat. at 1040, 1052; see generally id. at 1040–59. The FDCA developed substantially over the next fifty-eight years, but tobacco remained unregulated through the Act and its accompanying regulations. That is, until 1996, when FDA determined that it could regulate tobacco given its existing authority to regulate drugs and devices. Nicotine in Cigarettes and Smokeless Tobacco Is a Drug, 61 Fed. Reg. 44,619 (Aug. 28, 1996). “Like the products that FDA traditionally regulates,” tobacco products are “placed within the human body; like many of these products, they deliver a pharmacologically active substance to the bloodstream; and like these products, they have potentially dangerous effects. Indeed, no products cause more death and disease . . . .” Id. at 44,628. On that basis, FDA determined that it had jurisdiction to regulate tobacco products. Id. The Supreme Court disagreed. In a landmark decision, the Court held that “Congress . . . precluded the FDA’s jurisdiction to regulate tobacco products.” FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133 (2000). The Court’s reasoning centered on Congress’s failure to amend the FDCA to give FDA that authority, Congress’s enactment of several tobacco statutes, and FDA’s prior assertion that it lacked jurisdiction. Id. at 155–57. Following Brown & Williamson Tobacco Corp., if Congress wanted FDA to regulate tobacco, it would have to grant the agency that authority expressly. So Congress did precisely that. In 2009, it passed the Family Smoking Prevention and Tobacco Control Act (“TCA”), Pub. L. No. 111-31, 123 Stat. 1776 (2009) (codified at 21 U.S.C. § 387, et seq.), which amended the FDCA to include the regulation of tobacco. Section 2 of the Act laid out myriad congressional findings, which pointed to the dangerous effects of tobacco on 3 Case: 21-60766 Document: 00516397516 Page: 4 Date Filed: 07/18/2022 No. 21-60766 c/w No. 21-60800 both adults and children. See, e.g., TCA § 2(34), 123 Stat. at 1779 (“Because the only known safe alternative to smoking is cessation, interventions should target all smokers to help them quit completely.”); id. § 2(1), 123 Stat. at 1777 (“The use of tobacco products by the Nation’s children is a pediatric disease of considerable proportions that results in new generations of tobaccodependent children and adults.”). “Obviously,” given the extensive congressional record, “the TCA’s purpose sounds in (1) protecting public health and (2) preventing young people from accessing (and becoming addicted to) tobacco products.” Big Time Vapes, Inc. v. FDA, 963 F.3d 436, 444 (5th Cir. 2020), cert. denied, 141 S. Ct. 2746 (2021) (mem.). Congress also found that FDA had the relevant “scientific expertise to . . . evaluate scientific studies supporting claims about the safety of products[] and to evaluate the impact of labels, labeling, and advertising on consumer behavior in order to reduce the risk of harm and promote understanding of the impact of the product on health.” TCA § 2(44), 123 Stat. at 1780. To that end, Congress gave FDA broad authority to regulate tobacco products, requiring that most “new tobacco product” receive authorization from the FDA prior to marketing. 21 U.S.C. § 387j(a)(2)(A). The TCA defines “new tobacco product” (in relevant part) as “any tobacco product . . . that was not commercially marketed in the United States as of February 15, 2007.” Id. § 387j(a)(1)(A). The Act lists specific categories of tobacco products subject to regulation—“all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco”—but it also provides that the Act will apply “to any other tobacco products that the Secretary by regulation deems to be subject to this subchapter.” Id. § 387a(b). 1 In 2016, FDA used that authority to deem e-cigarettes and their 1 We recently rejected the argument that this provision constitutes an unlawful delegation of congressional power. Big Time Vapes, 963 F.3d at 447. In reaching that 4 Case: 21-60766 Document: 00516397516 Page: 5 Date Filed: 07/18/2022 No. 21-60766 c/w No. 21-60800 component parts (including e-liquids) as tobacco products subject to the requirements of the TCA. Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, 81 Fed. Reg. 28,974 (May 10, 2016) (“Deeming Rule”). 2 Relevant here, the Deeming Rule subjected e-cigarette manufacturers to the TCA’s prior authorization requirement—manufacturers of “new tobacco product[s]” must submit premarket tobacco product applications (“PMTAs”). See 21 U.S.C. § 387j(a)(2). FDA reviews the PMTAs and is statutorily required to decline them if “there is a lack of a showing that permitting such tobacco product to be marketed would be appropriate for the protection of the public health.” Id. § 387j(c)(2)(A). In determining whether a product is appropriate for the protection of the public health (referred to as the “APPH” standard), FDA must consider “the risks and benefits to the decision, this court extensively examined the TCA’s purpose and relevant background. Id. at 444. 2 As Petitioners showcased at oral argument, e-cigarettes can come in various forms. FDA provided a helpful explanation in its briefing: Some devices have “pods” or “cartridges” that hold nicotine-containing liquid known as “e-liquid.” Some pods or cartridges (known as closed systems) come pre-filled with e-liquid and are replaced after the e-liquid is used up, while others (known as open systems) can be refilled by the user. Tank or “mod” (short for “modifiable”) devices can also be refilled by users and are also usually customizable. Disposable e-cigarettes come prefilled with the e-liquid, and the entire device is designed to be discarded after the e-liquid runs out. Collectively, these devices are referred to as electronic nicotine delivery systems (“ENDS”), but the term “ENDS” is sometimes used interchangeably with e-cigarettes. We mimic one of our sister courts in simply using the term “e-cigarettes” for ease of reference. See Nicopure Labs, LLC v. FDA, 944 F.3d 267, 273 n.1 (D.C. Cir. 2019) (“We use the term ‘e-cigarettes’ to refer to the full range of products that the Industry calls ‘vapor products’ and the FDA calls Electronic Nicotine Delivery Systems, or ENDS. They go by many other names as well . . . .”). 5 Case: 21-60766 Document: 00516397516 Page: 6 Date Filed: 07/18/2022 No. 21-60766 c/w No. 21-60800 population as a whole.” Id. § 387j(c)(4). This includes considering “the increased or decreased likelihood that existing users of tobacco products will stop using such products,” id. § 387j(c)(4)(A), as well as “the increased or decreased likelihood that those who do not use tobacco products will start using such products,” id. § 387j(c)(4)(B). The Deeming Rule was set to go into effect on August 8, 2016, but FDA delayed enforcement of the regulation as to existing e-cigarette manufacturers. 81 Fed. Reg. at 28,977. Instead, manufacturers would have a two- to three-year period to come into compliance. Id. at 28,977–78. In 2017, the FDA pushed that deadline to 2022. 3 But shortly after extending the deadline, the American Academy of Pediatrics sued the FDA for granting the extension. See Am. Acad. of Pediatrics v. FDA, 399 F. Supp. 3d 479 (D. Md. 2019). A federal court vacated FDA’s 2017 guidance and required FDA to set a new deadline at ten months after the issuance of its order. Id. at 480– 81, 487. The deadline shifted once again due to the COVID-19 pandemic, making the final deadline September 9, 2020.