Wages & White Lion Invs., L. L.C. v. Food & Drug Admin.

• Decision Date: 18 July 2022
• Docket Number: 21-60766,consolidated with No. 21-60800
• Citation: 41 F.4th 427
• Parties: WAGES AND WHITE LION INVESTMENTS, L.L.C., doing business as Triton Distribution, Petitioner, v. FOOD AND DRUG ADMINISTRATION, Respondent, Wages and White Lion Investments, L.L.C., doing business as Triton Distribution; Vapetasia, L.L.C., Petitioners, v. Food and Drug Administration, Respondent.
• Court: U.S. Court of Appeals — Fifth Circuit

41 F.4th 427

WAGES AND WHITE LION INVESTMENTS, L.L.C., doing business as Triton Distribution, Petitioner,

v.FOOD AND DRUG ADMINISTRATION, Respondent,Wages and White Lion Investments, L.L.C., doing business as Triton Distribution; Vapetasia, L.L.C., Petitioners,

v.Food and Drug Administration, Respondent.

No. 21-60766

consolidated with No. 21-60800

United States Court of Appeals, Fifth Circuit.

FILED July 18, 2022

Eric Heyer, Joseph Andrew Smith, Thompson Hine, L.L.P., Washington, DC, Anthony J. Hornbach, Esq., Thompson Hine, L.L.P., Cincinnati, OH, for Petitioner.

Lindsey E. Powell, Esq., Noah T. Katzen, U.S. Department of Justice, Washington, DC, Alisa Beth Klein, Esq., Hilary Keith Perkins, Esq., U.S. Department of Justice, Civil Division, Appellate Section, Washington, DC, Mark Raza, Chief Counsel, Wendy S. Vicente, U.S. Food and Drug Administration, Food and Drug Division, OGC, Silver Spring, MD, for Respondent.

Leane K. Capps, Esq., Polsinelli, P.C., Dallas, TX, for Amici Curiae American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Parents Against Vaping e-cigarettes, and Truth Initiative Foundation, doing business as Truth Initiative.

J. Gregory Troutman, Trotuman Law Office, P.L.L.C., Louisville, KY, for Amici Curiae Americian Vaping Association, Incorporated, American Vapor Manufacturers Association, Incorporated, Consumer Advocates for Smoke-Free Alternatives Association, Incorporated, Smoke-Free Alternatives Trade Association, Incorporated, and United Vapers Alliance, Incorporated.

Mary G. Bielaska, Zanicorn Legal, P.L.L.C., New York, NY, Michael D. Matthews, Jr., McDowell Hetherington, L.L.P., Houston, TX, for Amici Curiae David B. Abrams, Clive D. Bates, and David T. Sweanor, J.D.

Before Jones, Haynes, and Costa, Circuit Judges.

Haynes, Circuit Judge:

Petitioners Wages and White Lion Investments, LLC, d/b/a Triton Distribution ("Triton") and Vapetasia, LLC ("Vapetasia") sought to market flavored nicotine-containing e-liquids for use in open-system e-cigarette devices. To do so, Petitioners needed to submit premarket tobacco product applications as required by 21 U.S.C. § 387j —which the Food and Drug Administration ("FDA") deemed applicable to e-cigarette tobacco products in 2016. FDA denied the requested marketing authorizations, finding that Petitioners failed to offer reliable and robust evidence (such as randomized controlled trials or longitudinal studies) to overcome the risks of youth addiction and show a benefit to adult smokers.

Petitioners seek review of those marketing denial orders ("MDOs"), and prior to the consolidation of the two cases, Triton requested a stay pending that review. Without (of course) the benefit of full merits briefing, a prior panel of this court granted the stay, determining (as any court granting a stay application must determine) that there was "a strong likelihood of success on the merits." Wages & White Lion Invs., L.L.C. v. FDA , 16 F.4th 1130, 1136, 1144 (5th Cir. 2021). But having now had the opportunity to review the merits briefing followed by oral argument, we DENY the petitions for review.

I. Statutory & Regulatory Landscape

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. § 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, 120 S.Ct. 1291, 146 L.Ed.2d 121 (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, 120 S.Ct. 1291. 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 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 tobacco-dependent 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 , ––– U.S. ––––, 141 S. Ct. 2746, 210 L.Ed.2d 896 (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 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 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.

II. The Petitions

Waiting to file until the deadline date, on September 9, 2020, Petitioners submitted PMTAs in an effort to manufacture and sell various flavored e-cigarette products.⁴ Specifically, they sought approval for products that came in flavors like sour grape, pink lemonade, crème brulee, peachy strawberry, milk & cookies, and pound cake and with names such as "Jimmy The Juice Man Strawberry Astronaut" and "Suicide Bunny...