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A lot can happen in a summer. And this summer has been a busy summer for federal regulation generally, and for Food and Drug Agency regulation of tobacco and vape products, specifically.
The Supreme Court has spent a lot of time lately deciding how (and how far) federal regulators should apply their power – and soon – the Supreme Court is going to give some thought to how FDA has been applying its power to the vape industry. The Supreme Court’s recent and still-to-come actions have the potential to dramatically change how FDA has been regulating tobacco and vape products, and more specifically, how FDA has reviewed Premarket Tobacco Product Applications (PMTA) for millions of vape products.
The first case (already decided) was Loper Bright Enterprises v. Raimondo, Secretary of Commerce, in which the Supreme Court overruled its own prior decision in the 40 year old Chevron case. The Chevron case established a rule under which federal regulatory agencies were permitted to interpret laws which were unclear, and the courts were generally required to defer to those federal regulatory agency interpretations (thus, the rule became known as “Chevron deference”). The Chevron deference rule reflected a practical solution in the eyes of the Supreme Court in 1984 – not all laws are perfectly clear, however, federal regulatory agencies 1) have a job to do, and 2) these agencies employ experts in their fields who were believed to be in a better position than judges to interpret and apply laws covering technical areas of regulation (such as the environment, tobacco, medicines, and so on).
FDA and its review of PMTAs provides a clear example of how this works in the real world. Under the Tobacco Control Act of 2009, Congress granted FDA significant new powers to issue rules for tobacco and vape products, as long as FDA determined that its actions were “appropriate for the protection of public health” (APPH). However, Congress did not make perfectly clear what APPH actually meant, giving FDA extremely broad discretion. Therefore, in the time since, FDA has used its own interpretation of APPH to develop and apply rules (i.e., whatever rules it wanted) – with the understanding that, under Chevron deference, courts would largely defer to the agency’s interpretation of the Tobacco Control Act.
The problem with this Chevron deference is that regulatory agencies tend to expand their own power, branching farther and farther out into their fields and increasingly overstepping their authority – which many have argued is precisely what FDA has done in the tobacco and vape sector.
In June, with its decision in Loper Bright Enterprises v. Raimondo, Secretary of Commerce, the Supreme Court put an end to Chevron deference, and this has the potential to significantly affect FDA cases that come after this Supreme Court decision.
Enter the case, Wages and White Lion Investments, LLC, dba Triton Distribution v. FDA – or the Triton case as it is known. As everyone involved in the vape industry certainly knows, FDA’s review of vape PMTAs has been widely panned as flawed – even labeled as deeply unfair. The manufacturers at Triton certainly thought so, and they successfully proved as much to the United States Fifth Circuit Court of Appeals, who wrote a devastating opinion on the way in which FDA conducts PMTA review (leading vape manufacturers on a “wild goose chase” and pulling a “switcheroo” on industry was how the Court described FDA’s marketing approval process).
Naturally, FDA appealed the Triton decision to the Supreme Court – and the Supreme Court agreed to hear the Triton case, given all the uncertainty in the industry owing to lawsuits and differing court decisions throughout the country.
In October 2024, the Supreme Court will begin to consider whether FDA’s PMTA process is in fact flawed and unfair – and as noted above, FDA will no longer be able to rely on Chevron deference.
The Supreme Court’s eventual decision in the Triton case has the potential to significantly impact the way FDA has interpreted and applied its authority to the tobacco and vape sector. While it is impossible to predict how the Supreme Court may rule, the nature of the question presented to the Supreme Court means that it is possible that the Supreme Court unravels many of FDA’s marketing denials issued to thousands of vape manufacturers under similar circumstances to Triton’s.
At the very least, given all of the changes to administrative law made by the Supreme Court in recent years, it is difficult to imagine a scenario in which the Triton case has no impact on FDA’s tobacco and vape products marketing authorization pathways.
Whatever the impact – vape operators should be preparing now for an eventual Supreme Court decision which opens the door either to new marketing applications under clearer standards, or an opportunity to appeal previous denials based on a flawed and unfair review process.
Interested in influencing the US Supreme Court in the upcoming Triton case? Have questions in general about where you stand legally? Contact us! Give our office a call today at (917) 546-6997, we would be happy to speak with you.
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