The Supreme Court has largely affirmed the Food and Drug Administration’s rejection of two companies’ bids to sell flavored vaping liquids. In a unanimous decision, the court overturned a judgment by the U.S. Court of Appeals for the Fifth Circuit, which had previously claimed that the FDA performed a “regulatory switcheroo.” The appeals court argued that the agency had improperly altered its requirements after the companies, Triton Distribution and Vapetasia, complied with initial guidelines. Justice Samuel Alito’s 46-page opinion directs the lower court to re-evaluate the case, particularly focusing on whether the FDA reasonably considered, or failed to consider, the marketing plans submitted by the companies.
Under the Family Smoking Prevention and Tobacco Control Act of 2009, the FDA’s authority to regulate tobacco products includes premarket approval of new products. The law mandates that companies demonstrate that their products are “appropriate for the protection of the public health.” The FDA evaluates this on the basis of whether current tobacco users might quit and whether non-users might be enticed to start. In 2021, the FDA denied applications from the two companies, citing concerns that flavored liquids attract young users and lack evidence of benefit to adult smokers.
The Fifth Circuit had set aside the FDA’s denials, arguing that the agency ignored compliance with its own procedural guidelines by imposing new requirements without appropriate acknowledgment. However, the Supreme Court ruled that courts should defer to the agency’s expertise unless actions are deemed arbitrary and capricious. Under this framework, Alito noted that agencies like the FDA are allowed to shift their positions if they offer a reasonable explanation, recognize their shift, and consider reliance interests. Further, Alito pointed out that while the FDA’s approach was somewhat inconsistent, it hadn’t breached federal administrative law in its decision-making process.
However, the FDA’s treatment of marketing plans for keeping e-cigarettes from young users remains contentious. The FDA had labeled these plans as “critical” but seemingly neglected them in its decision-making. The Supreme Court has remanded this issue to the appellate court to determine whether this oversight requires reconsideration of the FDA’s denials or should be resolved by the court itself.
Justice Sonia Sotomayor added a brief concurrence to highlight that the FDA offered manufacturers some flexibility in evidence presentation, maintaining its obligation to approve only those products that are suitable for public health protection. Her comments aim to provide clarity on the agency’s position during the decision-making process, as the Court continues to navigate the complex intersection of regulatory rigor and administrative deference. For more detailed coverage, see the original article at SCOTUSblog.