Vapetasia's Victory in the Court of Appeals

The recent decision by the U.S. Court of Appeals for the Fifth Circuit in the case against the Food and Drug Administration (FDA) marks a significant moment for the vaping industry, particularly for Vapetasia (Wages and White Lion Investments). In a decisive 10-6 vote, the court overturned the FDA's marketing denial orders (MDOs) for Vapetasia's products, addressing critical issues surrounding the FDA's handling of the premarket tobacco application (PMTA) process.

This is the Fifth Circuit's third Vapetasia (Wages & White Lion) opinion

"Initially, a panel of the court had intervened to halt the FDA's enforcement of its ban on the sale of unapproved vaping products, criticizing the agency's unexpected policy reversal as a 'surprise switcheroo.' However, this decision was later overturned by another panel which upheld the FDA's stance. Now, with the full court sitting en banc, the Fifth Circuit has once more positioned itself against the FDA. In this latest ruling, the court vehemently criticized the FDA for its inconsistent and arbitrary handling of the product applications submitted by Wages & White Lion, and, by extension, those from numerous other manufacturers in the industry."

The Challenge with PMTA

At the heart of this case was the FDA's approach to PMTAs, especially for flavored e-cigarette products. Vapetasia, like many other small businesses in the vaping industry, had to demonstrate that their products were "appropriate for the protection of public health" (APPH). However, the FDA's guidance on what constituted a successful PMTA was not only unclear but also seemed to shift unpredictably. This lack of clarity and consistency in the FDA's requirements posed significant challenges for companies attempting to comply.

Court's Opinion and Criticism of FDA

The court's opinion, authored by Judge Oldham, highlighted the capricious nature of the FDA's regulatory approach. Judge Oldham criticized the FDA's actions as a "regulatory 'bait and switch' of the highest order," and noted the complexity and frequent changes in the FDA's requirements, calling them "mindnumbing in their complexity."

Literary References in the Opinion

Interestingly, the opinion employed literary references to underscore its points. Judge Oldham quoted Shakespeare's "Romeo and Juliet" to emphasize the irrelevance of labels in the face of substantive regulatory issues. Additionally, referencing Mercutio's curse in the same play, he said:

"Like Mercutio's 'plague o' both your houses,' the FDA's arbitrary denial of PMTAs is a pox on all regulatory houses,"

criticizing the FDA for its indiscriminate approach.

The Impact of the Decision

The decision is a substantial victory for Vapetasia and its allies, such as Triton Distribution and Suicide Bunny, who have been instrumental in the case. It highlights the importance of regulatory clarity and fairness, particularly for small businesses that are major contributors to the vaping industry. The hope now is that the FDA will provide more concrete and consistent guidelines for PMTAs, offering much-needed clarity to the industry.

Conclusion

In conclusion, the Fifth Circuit's ruling not only overturns the FDA's MDOs for Vapetasia but also sets a precedent for how regulatory agencies should interact with industries under their purview. It underscores the necessity for clear, consistent, and fair regulatory processes, especially when they have significant implications for small businesses and public health. The decision is a reminder of the critical balance that regulatory bodies must maintain between enforcing standards and providing clear guidance to those they regulate.