Case: 21-60766 Document: 00516068813 Page: 1 Date Filed: 10/26/2021 United States Court of Appeals for the Fifth Circuit United States Court of Appeals Fifth Circuit FILED October 26, 2021 No. 21-60766 Lyle W. Cayce Clerk Wages and White Lion Investments, L.L.C., doing business as Triton Distribution, Petitioner, versus United States Food and Drug Administration, Respondent. Petition for Review of an Order of the Food and Drug Administration Before Elrod, Oldham, and Wilson, Circuit Judges. Andrew S. Oldham, Circuit Judge: The Food and Drug Administration denied Triton’s application to market flavored e-cigarettes. Triton moved for a stay pending disposition of its petition for review. We grant the stay. I. A. In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act (“TCA”) to regulate tobacco products. Pub. L. No. 111-31, 123 Stat. 1776 (2009). The TCA authorizes the Secretary of Health Case: 21-60766 Document: 00516068813 Page: 2 Date Filed: 10/26/2021 No. 21-60766 and Human Services to implement the Act through the Food and Drug Administration (“FDA”). See 21 U.S.C. §§ 387a(b), 393(d)(2). The TCA prohibits manufacturers from selling any “new tobacco product” without authorization. See id. § 387j(a). In 2016, the FDA deemed electronic nicotine delivery systems (“ENDS”)—colloquially called “electronic cigarettes” or “e-cigarettes”—a “new tobacco product.” 81 Fed. Reg. 28,973 (May 10, 2016) (“Deeming Rule”); see also Big Time Vapes, Inc. v. FDA, 963 F.3d 436, 443 (5th Cir. 2020) (“In the TCA, Congress delegated to the Secretary the power to ‘deem’ which tobacco products should be subject to the Act’s mandates.”). Thus, the TCA and the Deeming Rule generally prohibited the marketing of e-cigarettes. This created a serious and obvious problem because, by the time the FDA got around to issuing the Deeming Rule, manufacturers were widely marketing e-cigarettes throughout the United States. To avoid an overnight shutdown of the entire e-cigarette industry, the FDA delayed enforcement of the Deeming Rule. Then the FDA forced e-cigarette makers to meet a series of requirements and staggered deadlines to keep their products on the market. As relevant here, the FDA required e-cigarette manufacturers to submit premarket tobacco applications (“PMTAs”). The PMTA process is “onerous,” to put it mildly. See Big Time Vapes, 963 F.3d at 439 (“The PMTA process is onerous, requiring manufacturers to gather significant amounts of information.”). A manufacturer must submit to the FDA information on the product’s health risks, ingredients, and manufacturing process. The manufacturer also must include samples of the product and its proposed labeling. 21 U.S.C. § 387j(b)–(c). In the months and years following the Deeming Rule, the FDA moved its regulatory goalposts in at least two important ways. First, it moved the 2 Case: 21-60766 Document: 00516068813 Page: 3 Date Filed: 10/26/2021 No. 21-60766 PMTA deadline. Originally, the FDA demanded that all PMTAs must be filed within 24 months of the Deeming Rule—i.e., by 2018. The FDA later purported to extend the PMTA deadline to 2022. But then, in response to litigation from anti-smoking groups, the FDA moved the deadline up to September 9, 2020. …
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