This educational guide is based on the linked primary sources. It is not a Court publication, is not affiliated with the Court, and is not legal advice.
In brief
Overview
Background and question before the Court
The FDA received applications from more than 500 companies covering over 6.5 million e‑cigarette products.
What each side argues
Respondents
Respondents argue that the FDA changed its guidance on required scientific evidence after they had relied on the original instructions.
Respondents contend that the FDA’s internal memoranda required them to submit evidence from a randomized control trial or longitudinal cohort study, a requirement not present in the original guidance.
Respondents state that they do not argue the TCA imposes an affirmative duty on the FDA to detail how new products should be compared with existing tobacco products.
Food and Drug Administration
According to Food and Drug Administration, the FDA explains that, under the Tobacco Control Act, a manufacturer may introduce a new tobacco product only with FDA authorization, and the agency must weigh both cessation benefits and the risk of initiating use among non‑users.
According to Food and Drug Administration, the FDA characterizes its guidance on the “well‑controlled investigations” and “valid scientific evidence” requirements as non‑binding, reflecting the agency’s current thinking.
Petitioner
Source-limited. The record does not yet support a complete account.
Mr. Gannon
According to Mr. Gannon, mr. Gannon states that the two requirements for a product are (1) it helps smoking cessation and (2) it does not create other problems; the second is irrelevant if the first fails.
Mr. Heyer
Source-limited. The record does not yet support a complete account.
What happened at oral argument
The case was argued before the Supreme Court at 10:03 a.m.
Justice Thomas asked whether the guidance was a moving target that changed over time.
Justice Barrett asked the Court to distinguish the case from D.C. Circuit precedent on airwaves.
According to Justice Gorsuch, justice Gorsuch questioned whether due‑process notice and a hearing were required.
Justice Jackson asked what remedy the Court might fashion.
According to Justice Kavanaugh, justice Kavanaugh inquired about the practical relief available, noting that companies could reapply.
Chief Justice Roberts asked how much guidance must be provided when an agency proceeds case‑by‑case.
- [1] 19dd9295e4bc6977799a-r1-c30ba8c1efdf0d15.pdf, p. 2
- [2] 19dd9295e4bc6977799a-r1-c30ba8c1efdf0d15.pdf, p. 6
- [3] 19dd9295e4bc6977799a-r1-c30ba8c1efdf0d15.pdf, p. 14
- [4] 19dd9295e4bc6977799a-r1-c30ba8c1efdf0d15.pdf, p. 16
- [5] 19dd9295e4bc6977799a-r1-c30ba8c1efdf0d15.pdf, p. 25
- [6] 19dd9295e4bc6977799a-r1-c30ba8c1efdf0d15.pdf, p. 26
- [7] 19dd9295e4bc6977799a-r1-c30ba8c1efdf0d15.pdf, p. 79
What the Court decided
The Court held that respondents failed to show that the FDA changed its position regarding the scientific evidence supporting pre‑market tobacco product applications.
According to Justice Alito, judge Haynes, joined by four other judges, dissented.
Justice Sotomayor wrote a concurrence vacating the Fifth Circuit judgment and remanding for further proceedings consistent with this opinion.
Why it matters
The Tobacco Control Act vests the Secretary of Health and Human Services, acting through the FDA, with authority to regulate the manufacturing, marketing, sale, and distribution of tobacco products.
Terms to know
No glossary terms are available for this guide.
Primary sources
Read the source materials on the official site or open the immutable repository copy used for this guide.
- 19dd9295e4bc6977799a-r1-c30ba8c1efdf0d15.pdforal argument transcript
- 241aecc240bc7ac7e72b-r1-92a8a117541d1bfa.pdfopinion
Guide generated September 27, 2026. Automated validation accepted this version.