Overview of the Ruling

The Supreme Court delivered a unanimous ruling affirming the Food and Drug Administration’s (FDA) decision to deny applications from two companies seeking to market flavored liquids for e-cigarettes. The justices overturned a prior ruling from the U.S. Court of Appeals for the 5th Circuit, which had argued that the FDA had enacted an unjust regulatory reversal, failing to honor its guidance to the companies.

Details of the Case

In a 46-page opinion authored by Justice Samuel Alito, the Court emphasized that procedural regulations concerning administrative agencies require courts to defer to the agency’s judgment unless its actions are deemed arbitrary or capricious.

The FDA’s stance is informed by the 2009 Family Smoking Prevention and Tobacco Control Act, mandating that manufacturers obtain FDA permission prior to introducing new tobacco products. This regulation includes the requirement that any introduced product must be “appropriate for the protection of the public health,” assessing both the cessation potential for current tobacco users and the risk of introducing new users.

Background of the FDA’s Decision

In 2021, the FDA rejected applications from Triton Distribution and Vapetasia to sell flavored e-liquid options such as “Rainbow Road” and “Crème Brulee.” The FDA concluded that these flavored products have a higher probability of attracting youth users, with insufficient evidence to indicate benefits for adult smokers.

Legal Proceedings and Court Findings

The 5th Circuit Court had previously set aside the FDA’s denials, citing the companies had adhered to the agency’s provided guidelines only to be met with unexpected new requirements during the FDA’s review process. However, the Supreme Court’s ruling clarifies the legal framework within which such agency determinations must be evaluated.

Justice Alito highlighted that agencies are permitted to amend their positions as long as they provide a sound rationale and acknowledge the change—key components in maintaining regulatory integrity.

Concurring Opinions and Future Directions

While the Court dismissed the 5th Circuit’s finding, it also pointed out that the FDA’s failure to account for a critical element—marketing plans outlining prevention strategies to deter youth tobacco usage—required further examination. The case has been remanded to the 5th Circuit for a re-evaluation of this aspect.

Justice Sonia Sotomayor, in her concurring opinion, aimed to clarify perceptions surrounding the FDA’s decisional processes, asserting that the agency was not merely uncertain, but rather sought to grant flexibility while adhering to its statutory responsibilities.