Flavored E-cigarette Manufacturers Face Regulatory Challenges

| Makoto Tsunozaki, Ph.D.Jane Dai, Ph.D.

Manufacturers of e-cigarettes find themselves in a challenging regulatory environment to obtain U.S. Food and Drug Administration (FDA) marketing approval of flavored products.  On October 12, 2023, the FDA denied premarket authorization of flavored e-cigarette products from R.J. Reynolds Vapor Company under its Vuse Alto brand.[1]  This follows on the heels of the U.S. Supreme Court’s denial of e-cigarette manufacturer Avail Vapor’s challenge to the FDA’s rejection of premarket authorization of Avail Vapor’s flavored e-cigarette products, which was affirmed earlier by the U.S. Court of Appeals for the 4th Circuit.[2]   This is the latest case in a series of legal setbacks for the vaping industry, which has ballooned into an $8.2 billion market in less than a decade.

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (TCA), which requires any new tobacco products to obtain premarketing authorization from the FDA.[3]  Compliance with the TCA requires tobacco product manufacturers to submit Premarket Tobacco Product Applications (PMTAs) and receive authorization from the FDA for marketing any products.[4]  A PMTA is denied if the FDA finds the manufacturer failed to show that permitting the tobacco product to be marketed “would be appropriate for the protection of the public health.”[5] In particular, the FDA considers the impact of marketing the tobacco product on the “likelihood that existing users of tobacco products will stop using such products” and the “likelihood that those who do not use tobacco products will start using such products.”[6]

The TCA does not explicitly grant the FDA jurisdiction to regulate e-cigarettes, and the FDA initially did not do so.  However, in response to a steady increase in use of e-cigarettes among youth, in 2016 the FDA deemed e-cigarette products to be subject to regulation under the TCA.[7]   

Avail Vapor submitted PMTAs for various fruit- and dessert-flavored e-cigarette products and the FDA rejected all applications.  The FDA reasoned that Avail Vapor’s PMTAs did not provide “robust and reliable evidence” needed to show that the benefit to adult smokers (such as switching or reducing cigarette use) outweighs the risks to youth, such as by comparing the fruit- and dessert-flavored products with tobacco-flavored products in randomized controlled trials or longitudinal cohort studies.[8] 

In its petition to the Supreme Court, Avail Vapor challenged the FDA’s denial of the PMTAs on grounds that the FDA acted arbitrarily and capriciously when the agency “secretly” changed its evidentiary standard to require applicants to submit long-term clinical studies.  A unanimous panel of the 4th Circuit had found that the FDA’s rejection of Avail Vapor’s PMTAs was not based on a failure to meet any new evidentiary standard, but rather was based on the lack of any scientific evidence that demonstrated benefits that would outweigh the known high risk to youth.[9]  The 4th Circuit panel had also found that the FDA acted within its statutory mandate in requiring the appropriate evidence.[10] The 4th Circuit panel also noted that similar outcomes were reached in other circuits, including the D.C. Circuit, 3d Circuit, and the 7th Circuit.

The Supreme Court’s refusal to hear Avail Vaper’s appeal is not surprising as there is no clear circuit split. However, the high court's decision not to get involved may not be the final word on the matter. There is another closely watched case at the 5th Circuit, in which R.J. Reynolds Vapor Company and e-cigarette retailers have successfully moved to stay FDA's marketing denial order, allowing the continued sale of menthol-flavored e-cigarettes while the case is pending or upon further order of the court.[11]  It is expected that the losing party will appeal to the Supreme Court.

Editor: Brenden S.Gingrich, Ph.D.

[2] Avail Vapor, LLC v. FDA, No. 21-2077 (4th Cir. 2022).

[3] See Pub. L. 111-31, § 910, 123 Stat. 1776, 1807–12 (2009) (codified at 21 U.S.C. § 387j(a)). 

[4] See § 910(a)(2)(A), 123 Stat. at 1807. 

[5] § 910(c)(2)(A), 123 Stat. at 1809. 

[6] § 910(c)(4)(A)–(B), 123 Stat. at 1810.

[7] See 21 U.S.C. § 387a(b); 81 Fed. Reg. 28,974 (May 10, 2016).

[8] Avail Vapor (No. 21-2077) at 13.

[9] Avail Vapor (No. 21-2077) at 21.

[10]Avail Vapor (No. 21-2077) at 32. 

[11] R.J. Reynolds Vapor Co., et al. v. FDA, No. 23-60037 (5th Cir. 2023)