In a landmark ruling the FDA's refusal to authorize new non-tobacco flavoured vaping products has been sharply criticized. We ask Will Godfrey of Filter Magazine if this could be a turning point for flavoured products in the United States, and how the FDA will now seek to reassert its authority in the aftermath.
Chapters:
0:00 - Intro with Joanna Junak 0:32 - FDA rebuked in landmark ruling 1:30 - Judges criticize FDA handling of vaping authorizations 2:59 - What does this mean for vapers in the USA? 3:59 - Closing remarksTranscription:
00:00:05 --> 00:00:37
Joanna Junak: Hello and welcome! I'm Joanna Junak and this is GFN News on GFN.TV. This week we'll be speaking with Will Godfrey of Filter about an important court ruling in the United States earlier this month. Hi Will. What was this case about?
00:00:37 --> 00:01:20
Will Godfrey: Hi Joanna. This was the long-running Triton case with two mid-sized vape manufacturers disputing the FDA's denial of authorisation under its PMTA process for their flavoured vaping products. The case has been seen as key to hopes of ultimately seeing an effective range of harm reduction products authorised in the US. To date, the FDA hasn't authorized a single flavored vaping product, options that are critical to many people who switch from cigarettes. The agency implausibly denies that this amounts to a de facto flavor ban. In early 2023, this case was referred to a panel of judges at the Fifth Circuit Court of Appeal.
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Joanna Junak: And what was they ruling?
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Will Godfrey: As Kieran Sidhu reported for Filter, the majority decision by the judges this month, reversing a 2022 ruling by the same court, amounted to a scathing rebuke for the FDA. The court overturned the FDA's marketing denial orders against the two companies, ordering the agency to review their applications again. And the judges quite brutally condemned the FDA's handling of its vape authorization process. Their ruling agreed with the plaintiffs that the FDA's decision-making was arbitrary and capricious. It said that the agency sent manufacturers on a wild goose chase and pulled regulatory switcheroos only to arrive at preordained outcomes. The FDA promulgated hundreds of pages of guidance documents and hosted public meetings, the judges noted, all with the false promise that flavored vapes might get authorized. After receiving applications for months, the judges continued, the FDA turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all 1 million flavored e-cigarette applications for failing to predict the agency's volte face. Worse, the ruling added, after telling manufacturers that their marketing plans were critical to their applications, FDA candidly admitted that it did not read a single word of the one million plans.
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Joanna Junak: So what are likely to be the consequences of this decision?
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Will Godfrey: It's undoubtedly a humiliation for the FDA's Center for Tobacco Products, long accused of obstructing harm reduction. But the real world impact is harder to assess. Will the FDA, for example, just find new pretexts to deny flavors that it thinks will stand up in court? This opinion could be a catalyst for meaningful reforms that would benefit both small business manufacturers and adult consumers, Greg Conley of American Vapor Manufacturers told Kieran. However, he continued, do not expect positive changes to happen overnight. CTP director Brian King has spent the majority of his adult life advocating for flavour prohibition. Moreover, the Department of Justice holds considerable power in deciding what the next steps in litigation will be, and the department hates to be told no. It's a battle won, in other words, but the legal war continues. Still, most observers agree, Kieran wrote, that the future of US tobacco harm reduction looks brighter than it did before the decision.
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Joanna Junak: Thank you, Will. That's all for today. Tune in next time here on GFN TV or on our podcast. You can also find the descriptions of each episode on the GFN TV website. Thanks for watching or listening. See you next time.