“Respondents take issue with the FDA’s explanation that it changed enforcement priorities based on evidence that youth demand shifted from cartridge-based products to disposable products. In respondents’ view, that evidence had nothing to do with products such as theirs that are intended for open-system e-cigarette products. See Brief for Respondents 45–46. And respondents cite evidence from a study finding that between 2020 and 2021 high-school student demand for devices compatible with flavored bottled e-liquids actually decreased. See id., at 46, and n. 32 (citing E. Park-Lee et al., Centers for Disease Control and Prevention, Notes From the Field: E-Cigarette Use Among Middle and High School Students—National Youth Tobacco Survey, United States, 2021, 70 Morbidity and Mortality Weekly Rep. 1387, 1387–1388 (2021)). This counterargument is not persuasive. Even though the FDA did not cite evidence that was specifically about increasing youth demand for open-system e-cigarette products, the FDA drew a reasonable inference based on the data before it: namely, that the rapid shift in youth demand from flavored cartridge-based products to flavored disposable products strongly suggested that youth were most strongly drawn by flavor rather than device type. We see no reason why the FDA could not extrapolate from that data and conclude that young people would be drawn to flavored products for open-system e-cigarettes. Regardless, we are not positioned in this arbitrary-and-capricious challenge to consider respondents’ evidence from a study that postdates the filing of their applications and is, in any event, outside “the administrative record already in existence.” Camp v. Pitts, 411 U. S. 138, 142 (1973) (per curiam). Nor is respondents’ evidence of sufficient heft to call into question whether the FDA’s “factual determinations” about the powerful effect of flavor is supported by “substantial evidence” in the “existing administrative record.” Biestek v. Berryhill, 587 U. S. 97, 102 (2019).”
FDA v. Wages and White Lion Investments, LLC, d/b/a Triton Distribution
FDA v. Wages and White Lion Investments, LLC, d/b/a Triton Distribution et al., 604 U.S. ___ (2025).
- United States
- Apr 2, 2025
- U.S Supreme Court
Parties
Legislation Cited
Related Documents
Type of Litigation
Tobacco Control Topics
Substantive Issues
Type of Tobacco Product
“One of the FDA’s longstanding responsibilities, dating back nearly a century, is to determine whether manufacturers may market new drugs. For much of that history, the FDA lacked jurisdiction to regulate tobacco products. By the time Congress conferred that authority in 2009, a new product was ascendant on the market: the e-cigarette. This product offers existing smokers a potentially safer alternative to traditional combustible cigarettes. But e-cigarettes carry their own health risks, and they come in a dizzying array of flavors, many of which, such as dessert, candy, and fruit flavors, are particularly appealing to the young. The surging youth demand for flavored products—and the prospect of a new generation of smokers—caught the FDA on its back foot. In 2016, the agency declared that manufacturers of e-cigarette products would need to obtain the same marketing authorization that is required for other “tobacco products.” The FDA’s regulatory efforts culminated in the 2021 denial of over a million applications for flavored e-cigarette products.”
The U.S. Supreme Court ruled unanimously that the FDA followed the law in denying marketing applications for certain flavored e-cigarette products. In September 2020, Triton Distribution and Vapetasia filed applications with FDA to sell nicotine e-liquids with kid-friendly flavors like “Jimmy the Juice Man Peachy Strawberry,” “Suicide Bunny Mother’s Milk and Cookies,” “Iced Lemonade” and “Killer Kustard Blueberry.” Their applications included existing studies on e-cigarettes and marketing plans to restrict youth access. In August 2021, FDA announced a new trial and study requirement specific to flavored products. Shortly thereafter, FDA denied the manufacturers applications, citing a lack of evidence. The manufacturers challenged this decision in a federal appeals court, which held the FDA had improperly changed its requirements without notice and refused to consider the submitted marketing plans.
The Supreme Court explained that under federal law, courts reviewing an agency’s actions can only set them aside if they are arbitrary and capricious, meaning they lack a rational basis or are unreasonable. The case was sent back to the federal appeals court to revisit whether it made a difference that FDA changed its position and failed to consider marketing plans submitted as part of their applications.
The Campaign for Tobacco-Free Kids and other public health groups filed an amicus brief urging the court to deny the marketing applications (see "Related Documents").