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For the vape industry as a whole, monitoring the U.S. Food and Drug Administration’s (FDA) barrage of new rules between 2016 and 2021, reading thousands of pages of FDA positions, policies and guidance documents, and following the agency’s pathway for marketing authorization through the Premarket Tobacco Product Application (PMTA), only to then witness FDA simply toss aside millions of PMTAs was infuriating.
From regional brands to tens of thousands of small-scale local manufacturers, collectively, something just seemed off about the PMTA process; something didn’t smell right at FDA. Was FDA enforcing a secret (and unlawful) flavor ban? Was FDA even reviewing the PMTAs? Did FDA change the rules after accepting millions of PMTAs? Thousands of applicants read their marketing denial letters and thought, “Wait, you didn’t tell me my application required that!”.
… And then the lawsuits started.
From coast to coast, in virtually every state, and soon in almost every federal appeals court, the vape industry was calling out what it saw as a fundamentally unfair process. And perhaps to be expected, most federal appeals courts were siding with FDA – but not the Fifth Circuit Court of Appeals. In the now famous FDA v. Wages and White Lion Investments, L.L.C., dba Triton Distribution, et al. case (Triton Case), the Fifth Circuit Court of Appeals agreed with vape manufacturers; something was off about the PMTA process. According to the Fifth Circuit Court of Appeals, FDA had in fact changed the rules after accepting millions of PMTAs. According to the Fifth Circuit Court of Appeals, FDA was not reviewing many – most – of the PMTAs submitted. And in the world of administrative law, this is called arbitrary and capricious government action (a legal standard in which a federal regulatory agency has acted unreasonably or considered irrelevant factors).
All it takes is one. The Triton Case created a sufficient conflict between the courts of appeal that the U.S. Supreme Court would need to step in and resolve it. And that is indeed what will begin to happen, starting with oral arguments on Monday, December 2, 2024, where lawyers for FDA and lawyers for Triton will make their case to the justices in Washington DC.
While no one can predict which way this case may go, what can be said today is that this is the case – this is the case that the vape industry has been waiting for. For better or worse, the U.S. Supreme Court will consider – and answer – whether this whole process was unfair from the beginning.
It is also worth noting that the Triton Case could not have arrived at a better time, as FDA and even the states have begun tying ever more regulation to marketing authorization through the PMTA process. FDA recently published a Proposed Rule which would block imports of vape products coming from overseas unless the importer provides the FDA-issued Submission Tracking Number (STN) associated with its marketing authorization. Likewise, California just passed two laws which will take effect January 1, 2025, which empower the state’s Attorney General to maintain a state list of lawful tobacco products – and includes the power to exclude any product from California sales which do not have FDA marketing authorization.
We represent a wide array of vape industry operators across the United States and will be closely following the oral arguments in the Triton Case on December 2, 2024.
As part of our commitment to your business, we are hosting a virtual Town Hall on Tuesday, December 10th from 12:30 PM to 1:00 PM ET to discuss the potential impact of the U.S. Supreme Court’s upcoming decision on the future of the vape industry and what it could mean for your business. The Town Hall will feature Jacob Lundy, Legal Research Analyst at the Clark-Esposito Law Firm, P.C., who will provide insights into the Triton Case.
During this Town Hall, you will learn about FDA’s challenge to the Fifth Circuit’s decision to overturn marketing denial orders (MDOs) and how SCOTUS’s review could potentially reshape the FDA’s Premarket Tobacco Product Application (PMTA) process and regulatory authority. Jacob will discuss the arguments from both Triton and FDA, as well as the justices' reactions during oral arguments, which could provide clues to the ruling’s outcome. This case has far-reaching implications for vape and tobacco businesses, including compliance obligations, business operations, and product strategies. In just 30 minutes, gain essential insights that may help you prepare for potential changes to FDA’s regulatory framework under the Tobacco Control Act (TCA).
As a bonus for attending, you will receive our “10 Essential Tips for Legal Compliance in the Vapor Industry” guide, offering actionable steps to navigate complex regulatory landscapes and stay compliant in this evolving market.
For additional support, contact us today at (917) 546-6997 or visit www.clarkespositolaw.com. We’re here to help ensure that your business thrives in this rapidly changing regulatory landscape.
Get to know our presenter...
Jacob Lundy is a Legal Research Analyst at the Clark-Esposito Law Firm, P.C. His journey within the firm has been marked by notable advancement through two previous positions, reflecting his dedication and expertise in the legal field. Jacob's role involves conducting complex legal research, analysis, and document drafting, focusing on proactively guiding clients through legal complexities and potential business impacts across a variety of US regulatory agencies and foreign jurisdictions.
In addition, having joined the firm from a background in compliance, Jacob performs significant work on our client compliance projects, including preparing full suites of internal compliance programs with integrated workflows and decision trees in highly regulated sectors, which creates significant efficiencies for clients navigating otherwise complex compliance processes. Perhaps Jacob’s greatest skill in this arena is an innate appreciation for how clients actually use compliance products in daily business life and matching compliance requirements with workflow.
Jacob keeps abreast of frequent developments in the laws, regulations, and judicial decisions affecting our clients in a range of sectors, providing real-time updates with practical action plans for tackling changes in ways that minimize disruption to day-to-day operations. Jacob's unique ability to understand how clients actually use compliance products in their daily business operations and to tailor compliance requirements to fit those workflows stands out as one of his greatest skills. His progression from a legal administrative assistant to a key player in legal research and compliance underscores his value to our firm and our clients.
Have questions? Give our office a call today at (917) 546-6997, we would be happy to speak with you.
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