SCOTUS Grants Certiorari to Triton Distribution v. FDA: A New Era for PMTA Regulations – Matt Salter

After a protracted eight-year period since the United States Food and Drug Administration (FDA) implemented the deeming regulations, the vapour industry has reached a significant milestone with the United States Supreme Court.


Introduction to the Case

On March 19th, 2024, the FDA filed a petition with the US Supreme Court to review its appeal against the United States Fifth Circuit Court. This appeal stemmed from a decision by the Fifth Circuit to grant an injunction to Wages & White Lion Investment LLC concerning their PreMarket Tobacco Application (PMTA), which had been denied by the FDA. The Fifth Circuit agreed with Wages that the FDA had denied the application in an arbitrary or capricious manner, prompting the FDA to retract its marketing denial order and reinstate the application, allowing continued marketing activities.


The Surprise Switcheroo

This instance was not isolated, as the FDA had previously denied millions of vapor product applications, citing the absence of a “Longitudinal Cohort Study” to assess youth access and public health impacts. However, the FDA had earlier indicated that alternative studies or robust marketing plans could fulfill this requirement. This discrepancy became known as the “Surprise Switcheroo.”


Impact of Overturning the Chevron Doctrine

A pivotal development in this context is the recent overturning of the Chevron Doctrine by the Supreme Court on June 28th. Adopted in 1984, the Chevron Doctrine had mandated judicial deference to agency expertise in matters concerning their respective fields. Over time, this doctrine had increasingly empowered governmental agencies with considerable autonomy and limited judicial oversight.


Implications for the Vapor Industry

The acceptance of the Wages & White Lion Investment LLC case by the Supreme Court in this post-Chevron era holds profound implications. It marks a significant opportunity for the vapor industry to challenge governmental decisions in a more balanced judicial landscape, potentially setting a precedent across various legal domains.


Possible Outcomes if SCOTUS Upholds the Fifth Circuit Decision

We could see SCOTUS require the FDA to disregard the need for the longitudinal cohort study and force them to reexamine every application with a robust marketing plan being the only mandatory requirement. This could also force the FDA to abdicate all current MDO’s and allow the denied products back onto the market. At the very least, I see this forcing the FDA to abandon the current PMTA process, and provide clear cut, black and white guidance to the industry and lower the barrier of entry to the entire industry.


Conclusion: A Historic Juncture

The vapor industry finds itself at a historic juncture, presenting its case to the Supreme Court at a moment when fundamental principles of administrative law are being reevaluated.