Under the Family Smoking Prevention and Tobacco Control Act (the “Act”), the Federal Drug Administration (“FDA”), responsible for protecting and promoting public health and safety, regulates the manufacture and production of tobacco products, including e-cigarettes.[i] The Act provides the FDA with agency regulatory authority to approve the sale of tobacco products if the applicant demonstrates that the product would be “appropriate for the protection of the public health.”[ii] However, with the rise in consumption of e-cigarettes and vaping among Americans, especially among adolescents and young adults, the FDA in 2020 announced its enforcement against flavored e-cigarettes and issued guidance in the approval process for manufacturers to have flavored e-cigarette products approved.[iii] Specifically, the FDA considers the likelihood that current tobacco users will cease tobacco smoking and the potential for non-users to initiate tobacco use.[iv]  Additionally, the FDA requires e-cigarette companies to provide detailed plans guaranteeing their products are not marketed to young consumers or sold at retailers without age verification requirements.[v]

Since assuming regulatory authority over e-cigarettes, the FDA has denied more than 1 million applications for flavored e-cigarette products, citing compelling evidence that flavors particularly appeal to minors.[vi] The agency asserts that flavors present a substantial risk to public health by increasing the likelihood of young individuals consuming e-cigarettes and, in turn, transitioning to cigarette smoking.[vii] As a result of the stringent application approval process and the federal government’s heightened interest in protecting American youth from the risks of e-cigarette smoking, the FDA faces a legal battle against e-cigarette companies challenging their application denials that our nation’s highest court granted to decide.[viii]

Particularly, Wages and White Lion Investments (also known as “Triton Distribution”) and Vapetasia, manufacturers of flavored nicotine products for e-cigarettes, submitted applications to the FDA for the authority to market flavored liquids for use in e-cigarettes.[ix] However, the FDA rejected Triton Distribution and Vapetasia’s applications, stating that the flavored liquids posed a known and substantial risk to youth that would increase the likelihood of young people using e-cigarette products and, eventually, tobacco.[x] In all, the FDA found a lack of evidence that the companies’ flavored e-cigarette liquids would “provide a benefit to adult users that would be adequate to outweigh the risks to youth.”[xi]

Consequently, Triton Distribution and Vapetasia challenged the FDA’s denial of their applications to the U.S. Court of Appeals for the Fifth Circuit, alleging that the FDA changed its approval standards without notice and refused to consider their marketing plans.[xii] The Fifth Circuit ruled in favor of the e-cigarette companies, calling the FDA’s actions a regulatory “switcheroo” by providing the e-cigarette manufacturers with specific instructions, which they followed, only to later reject the applications, disregarding those instructions, and imposing new requirements without acknowledging the change.[xiii]

The FDA subsequently appealed the Fifth Circuit’s decision to the U.S. Supreme Court, where the Court will decide whether the FDA’s orders rejecting Triton Distribution’s and Vapetasia’s applications to market new e-cigarette products were “arbitrary and capricious.”[xiv] During oral arguments held on December 2, 2024, a divided Supreme Court bench presented differing perspectives in assessing the FDA’s actions while emphasizing the challenge of reconciling public health goals with regulatory responsibility.[xv] The liberal justices of the Court supported the FDA’s position, claiming that the risks of flavored e-cigarette products posed to young individuals were well-established and should have been apparent to the applicants from the outset.[xvi] On the other hand, some of the Court’s conservative justices raised concerns about whether the FDA had effectively communicated its standards or had changed its requirements during the process, potentially putting the companies at an unfair disadvantage.[xvii]

While a mere executive regulatory decision may not seem to have considerable influence, the upcoming decision in FDA v. Wages and White Lion Investments, L.L.C. bears significant implications for public health and safety concerning vaping and smoking and may set a precedent in the way the FDA regulates emerging e-cigarette products. For example, the Supreme Court overturning the Fifth Circuit’s decision and ruling in favor of the FDA would likely reinforce the FDA’s efforts to limit the appeal of flavored e-cigarettes, which are known to attract minors and increase the likelihood of nicotine addiction. This could result in a reduction in the number of young people experimenting with or regularly using e-cigarettes, helping to curb the rising rates of vaping among adolescents. Additionally, a stricter regulatory framework could contribute to broader public health benefits, such as a decrease in the future transition from e-cigarettes to traditional tobacco smoking. On a larger scale, this could support ongoing efforts to combat the tobacco-related health crisis, potentially saving lives and reducing healthcare costs over time.

However, if the Supreme Court upholds the Fifth Circuit’s ruling and decides that the FDA’s actions in denying the companies’ applications were arbitrary and capricious, the FDA may face stricter scrutiny in its approval processes and potentially be forced to revise its regulatory approach. This may pave the way for greater access to and consumption of e-cigarette products among young Americans.

Ultimately, the Supreme Court’s future ruling in Wages and White Lion Investments will significantly shape the regulatory landscape and the future trajectory of e-cigarette use within the United States, highlighting the ongoing challenge of balancing regulatory authority with industry interests and public health goals.

[i] See generally 21 U.S.C. § 387; see also Wages and White Lion Investments, L.L.C. v. Food & Drug Administration, 90 F.4th 357 (5th Cir. 2024).

[ii] See § 387j(c)(2)(A) (“The Secretary shall deny an application submitted under subsection (b) if . . . the Secretary finds that . . . 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[.]”); Wages and White Lion Investments, L.L.C., 90 F.4th at 363 (“The [Family Smoking Prevention and Tobacco Control Act”] directs FDA to review the PMTAs to determine whether ‘permitting such tobacco product to be marketed would be appropriate for the protection of the public health.’”).

[iii] See FDA Finalizes Enforcement Policy on Unauthorized Flavored Cartridge-based E-cigarettes that Appeal to Children, Including Fruit and Mint, U.S. Food & Drug Admin. (Jan. 2, 2020), https://www.fda.gov/news-events/press-announcements/fda-finalizes-enforcement-policy-unauthorized-flavored-cartridge-based-e-cigarettes-appeal-children.

[iv] See Wages and White Lion Investments, L.L.C., 90 F.4th at 363

FDA must consider “the risks and benefits to the population as a whole.” This includes considering (1) the “increased or decreased likelihood that existing users of tobacco products will stop using such products’ and (2) ‘the increased or decreased likelihood that those who do not use tobacco products will start using such products.”).

Id.

[v] See id. at 366.

[vi] See Supreme Court Hears FDA’s Flavored Vape Case, Baker & Hostetler LLP (Dec. 5, 2024), https://www.healthlawupdate.com/blogs/supreme-court-hears-fdas-flavored-vape-case/.

[vii] See id.

[viii] See Food and Drug Administration v. Wages and White Lion Investments, L.L.C., 144 S. Ct. 2714 (2024).

[ix] See Wages and White Lion Investments, L.L.C., 90 F.4th at 369.

[x] See id. at 370 (stating that on September 14 and 16 of 2021, the FDA issued marketing denial orders (“MDOs”) to Triton and Vapetasia on their applications).

[xi] Id.

[xii] Id. at 371.

[xiii] Id. at 386

It is perhaps possible that FDA did its part to give the regulated community clear guidance and that one million out of one million not only got it wrong but got it unreasonably wrong. But administrative law does not turn on such infinitesimal possibilities. It instead prohibits administrative agencies from saying one thing, pulling a surprise switcheroo, and ignoring the reasonable reliance interests engendered by its previous statements.

Id.

[xiv] Food and Drug Administration v. Wages and White Lion Investments, L.L.C., 144 S. Ct. 2714 (2024).

[xv] See FDA v. Wages and White Lion Investments Oral Argument, C-SPAN (Dec. 2. 2024), https://www.c-span.org/program/public-affairs-event/fda-v-wages-and-white-lion-investments-oral-argument/652488.

[xvi] See id.

[xvii] See id.