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Regulatory Intelligence Insights for December 9
Deep Dive - Postmarket Reporting Requirements
Jon Dice
December 09, 2024
On December 2, 2024, the Supreme Court heard oral arguments in the FDA v. Triton case, a pivotal dispute over the Food and Drug Administration's rejection of applications to market flavored nicotine vaping devices - as reviewed in the last issue of this newsletter.
The FDA argued that it had not changed its position on required evidence, stating that while certain studies weren't required, strong evidence was needed to prove products would benefit the population as a whole. Triton contended that the FDA had given specific instructions that were followed, only to ignore those instructions and impose new requirements without acknowledgment.
Justices Clarence Thomas and Samuel Alito seemed to lean towards the argument that the FDA didn't provide "fair notice". The three liberal justices (Elena Kagan, Kentanji Brown Jackson, and Sonia Sotomayor) appeared satisfied with the FDA's actions. Justices Kavanaugh and Gorsuch questioned whether Triton had made its fair notice case.
A decision on this case is expected by the end of the Supreme Court's term in June 2025.
Week of December 2 Regulatory Intelligence Recap
Rhode Island shop owners file lawsuit over flavor ban
Mexico's Lower House passes constitutional ban on vapes
FDA issues warnings to 115 retailers for illegal sales (see summary below)
Center for Experimental & Research-based Clinical Health (CoEHAR) releases study finding vapes are most effective quitting tool
EU countries push for stricter smoking rules including outdoor smoking/vaping bans
Supreme Court to examine FDA's denial of flavored vapes (Triton case)
Dallas, Texas considering public places vaping ban
Impact of e-cigarette vaping on cardiovascular function in young people (Scientific Reports)
Social epidemiology of dual use of electronic and combustible cigarettes (Global Journal of Cardiovascular Disease)
Study on biomarkers of exposure to nicotine in users (Cancer Epidemiology Biomarkers)
Research on household fuel use and smoking prevalence (Frontiers in Allergy)
One notable active trial: "A Study in a Human Laboratory Model of Smoking Behavior" by Janssen Research examining CERC-501 versus placebo for smoking interventions