Liquid Labs LLC v. U.S. Food & Drug Admin.
| Docket Number | 21-2883 |
| Decision Date | 27 October 2022 |
| Citation | 52 F.4th 533 |
| Parties | LIQUID LABS LLC, Petitioner v. UNITED STATES FOOD AND DRUG ADMINISTRATION |
| Court | U.S. Court of Appeals — Third Circuit |
Kevin T. Duffy, Jr., Duffy & Staab, 165 West Putnam Avenue, Suite 2B, Greenwich, CT 06903, Gary G. Staab, Duffy & Staab, 2 William Street, The Kennedy Building, Suite 302, White Plains, NY 10601, Counsel for Petitioner
Arun G. Rao, Gustav W. Eyler, Hilary K. Perkins, Jonathan E. Amgott, United States Department of Justice, Consumer Protection Branch, 450 5th Street, N.W., Suite 6400 South, Washington, DC 20001, Brian M. Boynton, Joshua Koppel, United States Department of Justice, Civil Division, 950 Pennsylvania Avenue, N.W., Room 7212, Washington, DC 20530, Daniel J. Barry, United States Department of Health & Human Services, 200 Independence Avenue, S.W., Washington, DC 20201, Wendy S. Vicente, Marci B. Norton, Food and Drug Administration, Office of the Chief Counsel, 10903 New Hampshire Ave., Silver Spring, MD 20993, Counsel for Respondent
James G. Troutman, Troutman Law Office, 4205 Springhurst Boulevard, Suite 201, Louisville, KY 40241, Counsel for Amicus Petitioners 38 National and State Electronic Nicotine Delivery System Product Advocacy Associations
Mary G. Bielaska, Zanicorn Legal, 845 Third Avenue, 6th Floor, New York, NY 10022, Counsel for Amicus Petitioners Dr. David B. Abrams, Clive D. Bates, and Professor David T. Sweanor, J.D.
William B. Schultz, Zuckerman Spaeder, 1800 M Street, N.W., Suite 1000, Washington, DC 20036, Counsel for Amicus Respondents Medical and Public Health Groups
Before: CHAGARES, Chief Judge, SHWARTZ and SCIRICA, Circuit Judges.
Liquid Labs LLC ("Liquid Labs") sought permission from the Food and Drug Administration ("FDA") to market products used in e-cigarettes. The FDA denied the request, and Liquid Labs petitions for review. Because the FDA's order was within its statutory authorities and the Administrative Procedure Act ("APA"), we will deny the petition.
E-cigarettes are electronic nicotine delivery systems ("ENDS") that vaporize e-liquids and allow for inhalation.1 See, e.g., Big Time Vapes, Inc. v. FDA, 963 F.3d 436, 439 n.11 (5th Cir. 2020), cert. denied, ––– U.S. ––––, 141 S. Ct. 2746, 210 L.Ed.2d 896 (2021). Liquid Labs manufactures and sells e-liquids that generally contain nicotine and flavoring.
Liquid Labs’ e-liquids qualify as "new tobacco product[s]" under the Family Smoking Prevention and Tobacco Control Act (the "Act"). See 21 U.S.C. §§ 387 - 387u. The Act applies to "all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to" the Act. 21 U.S.C. § 387a(b) ; see also 21 U.S.C. § 387j(a)(1)(A) (). In 2016, the FDA "deem[ed]" e-cigarettes and related components (such as Liquid Labs’ e-liquids) to be subject to the Act's requirements. See Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, 81 Fed. Reg. 28,974, 29,028 (May 10, 2016) ; see also Big Time Vapes, 963 F.3d at 440.
Because Liquid Labs’ e-liquids qualify as new tobacco products, they may not be introduced into interstate commerce without the FDA's authorization. See 21 U.S.C. § 387j(a)(2). One way to obtain authorization is by submitting a premarket tobacco product application ("PMTA"). See, e.g., Big Time Vapes, 963 F.3d at 439 ; see also 21 U.S.C. § 387j(b) - (c).
Under the Act, the FDA "shall deny" a PMTA if the applicant fails to "show[ ] that permitting such tobacco product to be marketed would be appropriate for the protection of public health." 21 U.S.C. § 387j(c)(2)(A). "[T]he finding as to whether the marketing of a tobacco product ... is appropriate for the protection of the public health [is] determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product." 21 U.S.C. § 387j(c)(4). On this subject, the Act directs the FDA to "tak[e] into account" both "the increased or decreased likelihood that existing users of tobacco products will stop using such products," and "the increased or decreased likelihood that those who do not use tobacco products will start using such products." 21 U.S.C. § 387j(c)(4)(A)-(B).
In addition to the Act and the deeming regulation, the FDA took several related regulatory steps. For example, the FDA issued guidance in June 2019 ("June 2019 Guidance") and April 2020 ("April 2020 Guidance") that "help[ed] manufacturers prepare [PMTA] applications ahead of the [discretionarily delayed submission] deadline," and "set[ ] out the agency's enforcement priorities," respectively. Prohibition Juice Co. v. U.S. Food & Drug Admin., 45 F.4th 8, 13-15 (D.C. Cir. 2022). Among other things, these documents highlighted that flavored e-liquids’ had a "disproportionate appeal to children," id. at 13, and "noted the types of rigorous scientific evidence [the FDA] would accept in support of applications to market such products," id. at 15.
Liquid Labs submitted two PMTAs on September 4, 2020, covering twenty e-liquid products. The products spanned ten flavors, two of which are described as being tobacco flavored, and eighteen of which are described as having a "characterizing flavor" other than tobacco or menthol with names such as "OG Island Fusion," "Berry Au Lait," "OG Summer Blue," and "Shake."
In connection with the applications, Liquid Labs submitted evidence from a variety of sources, including an abuse liability study, a cross-sectional perception and intention study, a population modeling analysis, a clinical literature review, and "well-controlled non-clinical analyses of Liquid Labs’ Products." Pet. Br. at 20. Liquid Labs also submitted a marketing plan setting forth, among other things, various measures Liquid Labs planned to take to discourage youths from using its products.
In September 2021, the FDA denied Liquid Labs’ PMTAs.2 In connection with its denials, the FDA sent Liquid Labs several documents, including a Marketing Denial Order, a document titled "Technical Project Lead (TPL) Review of PMTAs," JA 62, and two documents titled "Review for Flavored ENDS PMTAs," JA 52, 57.
The Marketing Denial Order briefly explained why the applications "lack[ed] sufficient evidence to demonstrate that the marketing of the[ ] products [wa]s appropriate for the protection of public health." JA 1. It noted, for example, that "[i]n light of the known risks to youth of marketing flavored ENDS, robust and reliable evidence" was "needed regarding the magnitude of the potential benefit to adult smokers," and such evidence could have been provided through "randomized controlled trial[s] and/or longitudinal cohort stud[ies]," as well as through "other evidence[,] but only if it reliably and robustly evaluated the impact of the new flavored vs. tobacco-flavored products on adult smokers’ switching or cigarette reduction over time." JA 1. The FDA found that Liquid Labs’ cross-sectional survey was "not sufficient" because "it d[id] not evaluate product switching or cigarette reduction resulting from use of these products over time or evaluate these outcomes based on flavor type to enable comparisons between tobacco and other flavors." JA 1-2.
The Technical Project Lead Review further discussed the FDA's rationale for denying Liquid Labs’ applications. For example, it set forth the FDA's concern about youth use of flavored ENDS and regulatory actions the FDA has taken to address the issue. It also explained, among other things, (1) why the FDA focused "on the risk to youth nonusers as well as the potential benefit to adult smokers as current users," (2) why "only the strongest types of evidence" would be sufficient to show an adequate benefit to adult smokers, (3) why the FDA looked for "acceptably strong evidence that the flavored products have an added benefit relative to that of tobacco-flavored ENDS in facilitating smokers completely switching away from or significantly reducing their smoking," and (4) how it concluded that although Liquid Labs’ applications "contain other evidence regarding the potential benefit to adult users," the "other evidence [wa]s not adequate." JA 64.
The Technical Project Lead Review explained that Liquid Labs’ "internet-based cross-sectional survey" evidence "[wa]s not sufficiently strong to support the benefit to adult smokers of using these flavored ENDS because it d[id] not evaluate product switching or cigarette reduction resulting from use of these products over time or evaluate these outcomes based on flavor type to enable comparisons between tobacco and other flavors." JA 75. Accordingly, the FDA concluded that Liquid Labs had not shown that the benefits of the products sufficiently outweighed the risks they posed to youths.
In the Reviews for Flavored ENDS PMTAs, the FDA examined Liquid Labs’ submissions to see if they "contain[ed] evidence from a randomized controlled trial, longitudinal cohort study, and/or other evidence regarding the impact of the new ENDS on switching or cigarette reduction that could potentially demonstrate the benefit of [its] flavored ENDS over an appropriate comparator tobacco-flavored ENDS." JA 53, 58. The reviews noted that the PMTAs lacked both randomized controlled trials related to new product use and smoking behavior and longitudinal cohort studies on new product use and smoking behavior and one review specified that the "[o]ther evidence" submitted was "not sufficient to support the benefit to adult smokers of using these flavored ENDS ...." JA 54; see also JA 57 ( "[e]vidence is absent in PMTAs").
Liquid Labs petitions for review.3
Liquid Labs contends that the FDA acted arbitrarily and...
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