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A potentially key but temporary legal win for a vaping company challenging the US Food and Drug Administration (FDA)’s review process for premarket tobacco product applications has been transformed into a resounding loss as a court rejected an appeal by Wages and White Lion Investments.
The company, doing business as Triton Distribution, had joined with Vapetasia to ask the US Court of Appeals for the Fifth Circuit to vacate the FDA’s marketing denial orders, arguing that the legal standard the agency used was “arbitrary and capricious”.
The company enjoyed an early win last October when the court stayed the FDA’s rejection of its two premarket tobacco product applications (PMTAs). But the stay was only temporary, pending the resolution of the full appeal, and the court’s eventual 2-1 ruling means Triton is running out of options to keep its products on the US market.
It can ask the Fifth Circuit to reconsider the case en banc, meaning with all judges weighing in instead of only three. If that fails, it can petition the US Supreme Court to review the circuit court’s decision – but the Supreme Court grants less than 1% of the approximately 7,000 petitions it receives each year, and has already declined vape manufacturer Breeze Smoke’s request to review its rejection by the FDA.
However, the 18th July decision by the Fifth Circuit did come with a potentially helpful caveat for Triton: a sharply worded dissent from a judge who said her colleagues wrongly relied on the FDA’s post-rejection justifications for ignoring the marketing plans submitted by Triton.
Judge Edith Jones said the marketing denial orders (MDOs) issued to Triton should be vacated and the case returned to the FDA “with instructions to allow these petitioners to develop and offer further evidence in support of the PMTAs”.
A Kafka-esque ‘mockery’
Jones called the FDA’s changing standards in its review process “a mockery of ‘reasoned’ administrative decision-making” and invoked the late novelist Franz Kafka, whose work depicted individuals struggling against impossible bureaucracies. “Even with the noblest of motives in mind, a federal agency does not have licence to run companies out of business without adhering to fixed rules of fair procedure,” Jones said.
Her dissent could strengthen any argument Triton’s lawyers might make to the Supreme Court urging review. It provides some refutation to the majority opinion by judges Catharina Haynes and Gregg Costa, who endorsed the FDA’s PMTA review process.
The majority judges decided heavily in the FDA’s favour – though with a number of caveats. They said it was not up to the court to say whether it agreed with the FDA’s decision nor was it their job to consider the scientific evidence put in front of the FDA as part of the PMTA.
They could only concern themselves with whether the FDA’s review of the PMTAs was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law”. In order for it to be considered so, the judges said, they would have to find that the FDA had “relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise”.
The judges emphasised that they were not there to reconsider the scientific decisions the FDA made during its review. “Moreover, where the parties disagree on the science, we owe the FDA deference. After all, Congress deemed only the FDA as the scientific expert here, not the federal courts,” the judges added.
In the main, they decided the FDA had not been arbitrary or capricious in denying the PMTA.
Dissenting judge ‘ignored evidence’
Lawyers for Triton had argued that the FDA “pulled a surprise switcheroo” by initially saying applicants were not required to provide a scientifically rigorous review of smoking cessation capability, such as a randomised controlled trial or longitudinal cohort study, in order to demonstrate benefits to adult smokers.
When Triton did not include this, instead providing only a cross-sectional survey conducted by Vapetasia, lawyers argued the FDA had pulled the rug out from under the applicants by saying the survey was not rigorous enough.
Judges disagreed. They said the FDA never said rigorous studies of cessation were required – only that they might help support applications where other evidence was weak.
“The FDA does not now – and has not ever – required studies of smoking cessation. Contrary to the motion panel’s determination that FDA made a ‘radical’ change, FDA has always suggested and continues to suggest that such studies might be useful, in particular where, as here, the evidence presented in an application is otherwise weak,” the judges said.
Haynes and Costa also cited the neighbouring Sixth Circuit’s rejection of Breeze Smoke’s petition that concluded the same thing. They said judge Jones’s dissent ignored evidence showing the FDA’s continuous use of conditional language.
For example, they said, “the dissenting opinion frames FDA as stating that longitudinal studies are ‘most likely’ to provide reliable and robust evidence to satisfy the APPH [appropriate to the protection of public health] standard.’ But the dissenting opinion ignores the next line…‘other types of evidence could be adequate…and will be evaluated on a case-by-case basis’.”
– Meghann Cuniff ECigIntelligence US legal correspondent
Photo: Wikimedia Commons
