____________ FILED March 23, 2023 No. 23-60037 Lyle W. Cayce ____________ Clerk R.J. Reynolds Vapor Company; RJR Vapor Company, L.L.C.; Avail Vapor Texas, L.L.C.; Mississippi Petroleum Marketers and Convenience Stores Association,

Petitioners,

versus Food & Drug Administration; Robert Califf, in his official capacity as Commissioner of the United States Food & Drug Administration; United States Department of Health and Human Services; Xavier Becerra, in his official capacity as Secretary of the United States Department of Health and Human Services,

Respondents,

consolidated with _____________

No. 23-60128 _____________ R.J. Reynolds Vapor Company; RJR Vapor Company, L.L.C.; Avail Vapor Texas, L.L.C.; Mississippi Petroleum Marketers and Convenience Stores Association,

Petitioners,

versus United States Food & Drug Administration; Robert M. Califf, Commissioner of Food and Drugs; United States Department of Health and Human Services; Xavier Becerra, Secretary, U.S. Department of Health and Human Services,

Respondents. ______________________________

Appeal from the Food & Drug Administration Agency Nos. PM0000637, PM0000713, PM0000554, PM0000561 ______________________________ Before King, Jones, and Smith, Circuit Judges. Edith H. Jones, Circuit Judge: The Food and Drug Administration denied petitioners’ application to market menthol-flavored e-cigarettes. Petitioners seek a stay pending review of the denial order on the merits. We grant the stay. I. Background This court has become quite familiar with the legal and regulatory framework underpinning this case. See Big Time Vapes, Inc. v. FDA, 963 F.3d 436, 437 (5th Cir. 2020); Wages & White Lion Invs. v. FDA, 16 F.4th 1130 5th Cir. 2021) (stay order); Wages & White Lion Invs. v. FDA, 41 F.4th 427 (5th Cir. 2022) (merits decision), vacated 58 F.4th 233 (5th Cir. 2023). And the material facts resemble those in Wages & White Lion, with some notable differences. The Food and Drug Administration (“FDA”) has been regulating tobacco products since 2009 under 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.). And since 2016, the FDA has been in

2 23-60037 c/w No. 23-60128 the business of regulating e-cigarettes, 1 including those containing no tobacco flavoring. See 81 Fed. Reg. 28,974, 28,976 (May 10, 2016). In order to continue marketing e-cigarettes, manufacturers must submit to the FDA a premarket tobacco product application (“PMTA”). 21 U.S.C. § 387j. In June 2019, the FDA issued a “how-to” guide for submitting e-cigarette PMTAs. FDA, Guidance for Industry, Premarket Tobacco Applications for Electronic Nicotine Delivery Systems (June 2019) (“PMTA Guidance”), https://bit.ly/2R5TyYj. In it, the agency stated that it “does not expect that applicants will need to conduct long-term studies to support an application.” Id. at 13. The Proposed and Final Rules repeated this expectation. See Premarket Tobacco Product Applications and Recordkeeping Requirements,