On December 2, 2024, the Supreme Court will hear a case that could dramatically impact the future of the vaping industry. The case, FDA v. Wages and White Lion Investments, L.L.C., centers around the FDA’s premarket tobacco application (PMTA) process and its marketing denial orders (MDOs) issued to flavored vaping products. The decision, expected by spring 2025, could force major regulatory changes—or cement the FDA’s authority over vaping products, potentially eliminating flavored e-liquids and open-system devices from the U.S. market.
Key Stakes for the Vaping Industry
If Triton Wins
- The FDA may need to overhaul its PMTA process, making it more transparent and fair.
- All MDOs issued since 2021 could be invalidated.
- The FDA could be forced to abandon parts of its 2016 Deeming Rule, which brought vaping products under its regulatory authority.
If the FDA Wins
- The current regulatory framework will remain, favoring large tobacco companies with authorized menthol-flavored products.
- Flavored e-liquids and open-system devices could face an uncertain future, likely disappearing from the legal U.S. market.
This pivotal decision will shape the vaping industry’s trajectory for years to come.
What Led to This Case?
The case originated from the FDA’s rejection of PMTAs submitted by Triton Distribution (also known as Wages and White Lion Investments, LLC) and its partner Vapetasia. Triton challenged the rejection, arguing that the FDA acted in an arbitrary and capricious manner by shifting its PMTA requirements after the submission deadline.
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The Fifth Circuit Decision:
In January 2024, the Fifth Circuit ruled in favor of Triton, calling out the FDA for failing to follow proper procedures and issuing "cookie-cutter" MDOs based on unpublished standards. The court criticized the FDA’s approach as a regulatory “surprise switcheroo.” -
FDA’s Appeal to the Supreme Court:
After facing repeated losses in the Fifth Circuit, the FDA petitioned the Supreme Court to review the case, potentially reversing the lower court’s decision and preserving its current regulatory practices.
Core Issues to Be Decided
1. Shifting PMTA Standards
The FDA introduced new requirements for flavored products—such as randomized controlled trials—after the PMTA deadline. Triton argued this violated the Administrative Procedure Act (APA), as it essentially created new rules without public input.
2. Failure to Follow Rulemaking Procedures
The FDA bypassed APA-mandated notice-and-comment rulemaking, effectively imposing a de facto ban on flavored products through its PMTA denials. This shortcut circumvented the required process for implementing a formal flavor ban.
3. Marketing Plan Neglect
Although the FDA initially emphasized the importance of marketing plans to prevent youth usage, it later dismissed these plans, citing inefficiency. This inconsistency has been labeled a “harmless error,” but it highlights the agency's flawed decision-making process.
What to Expect at the Oral Arguments
- Triton Representation: Eric Heyer, a seasoned attorney for vaping businesses, will argue on behalf of Triton.
- FDA Representation: Curtis Gannon, Deputy Solicitor General, will represent the FDA.
During oral arguments, the justices will ask probing questions, offering insights into their views on regulatory overreach and administrative law. Observers can listen live or access recordings on the Supreme Court’s website.
What’s at Stake for Vapers and Businesses?
This case isn’t just about one company—it’s about the entire future of flavored vaping products and the regulatory landscape in the U.S.
- For Vapers: A ruling against the FDA could mean continued access to flavored products that many adults prefer as alternatives to smoking.
- For Small Businesses: An FDA loss could give independent vape manufacturers a fairer shot at navigating the PMTA process.
- For Public Health Policy: The case may set a precedent for how far regulatory agencies can go without proper rulemaking procedures.
Conclusion
The Supreme Court’s decision in FDA v. Wages and White Lion Investments, L.L.C. could reshape the vaping industry and the FDA’s role in regulating it. Whether the ruling favors Triton or the FDA, the case will have long-lasting implications for vapers, businesses, and the broader public health debate around vaping products.
For more in-depth analysis, visit Vape360, a trusted source for updates on vaping industry news and regulations.
