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Supreme Court hears challenge to FDA denials of flavored e-cigarette marketing applications
Summary
At oral argument in case 231038, the government defended the FDA enials of flavored ENDS (electronic nicotine delivery systems) applications as based on insufficient scientific evidence that flavors produce a net public-health benefit for adults that would outweigh youth uptake risks; respondents contend FDA changed its guidance post-deadline and imposed a new longitudinal comparative-efficacy requirement without adequate notice.
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…
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