Supreme Court hears challenge to FDA denials of flavored e-cigarette marketing applications

The Supreme Court heard argument in case 231038 over whether the Food and Drug Administration lawfully denied marketing applications for flavored e-cigarette products. Government counsel, identified in the transcript as Mister Gannon, told the justices that the Family Smoking Prevention and Tobacco Control Act requires applicants to show ‘‘the marketing of [a] product would be appropriate for the protection of the public health,’’ a test that requires evidence both that existing users will stop using more harmful tobacco products and that nonusers (particularly youth) will not start. "They just did not have sufficient scientific evidence to bear out their claim that non‑tobacco flavors are ‘crucial to getting adult smokers to make the switch,’" Gannon said, urging reversal of the Fifth Circuit.

Respondents, represented in the argument by Mister Hyer, countered that FDA shifted course after applicants filed and that the agency effectively required longitudinal comparative‑efficacy studies (randomized controlled trials or cohort studies comparing flavored products to tobacco‑flavored products over time) without giving clear notice before the 09/09/2020 application deadline. Hyer told the Court that the agency enied orders applied a new litmus test to hundreds of applicants and that vacatur and remand were appropriate because reapplying is not a practical remedy for small companies facing business closure.

The justices focused on three legal questions: (1) fair notice and whether applicants were misled by prior guidance or instead had clear statutory notice about the required comparative showing; (2) the proper role of harmless‑error analysis versus ordinary Chenery remand practice when an agency may have failed to consider parts of the administrative record; and (3) the practical consequences of remanding or deciding the case now, including enforcement and any interim stays. Several justices pressed both sides to explain whether the alleged change was a true change in the agency—aseline or merely a disagreement over how much evidence the statute required. As Mister Gannon put it, the statute itself "gives the basic calculus" and applicants—urden to provide valid scientific evidence; as Mister Hyer replied, applicants lacked notice that the agency would treat single‑time surveys and marketing plans as categorically insufficient.

On harmless‑error and remand, the government urged the Court that this was not a typical Chenery situation because the agency's prior public statements and later denial orders showed what it would do, making a remand an "idle and useless formality" in some respects. Respondents argued the record lacks sufficient detail about what the agency actually reviewed or ignored (including marketing plans), and that the internal memoranda and standardized technical reviews show a prospective, rule‑like change that applicants did not have fair notice to meet.

The argument also touched on enforcement mechanics and factual points in the record: the 2020 guidance, internal FDA memoranda, the sequencing of reviews (fruit/candy/dessert flavors first, menthol later), and survey evidence such as a 6‑month study relied on by a menthol applicant the agency authorized. Counsel debated how many products and applications were implicated (Gannon observed a large universe of products but clarified it represented roughly 320 applications underlying decisions that covered many product variants). The government emphasized FDA's continuing concern that flavors are a strong driver of youth vaping, while respondents emphasized the absence of the specific longitudinal comparative evidence FDA later treated as decisive.

The Court concluded arguments after government rebuttal; Gannon reiterated that respondents had notice of FDA's concerns about flavors and failed to supply reliable comparative evidence, and the case was submitted. The justices will decide whether the Fifth Circuit correctly remanded the denials to FDA or whether the denials should be upheld (and whether harmless‑error review can be applied here).