0:00 - Intro with Joanna Junak
0:24 - Alex Norcia of Filter discusses recent USA vape battle developments
1:41 - Why is the battle for flavoured vapes so important?
2:11 - Flavoured vape applications denied by FDA
3:27 - Closing remarks
Joanna: Hello and welcome. I'm Joanna Junak, and this is GFN News on GFN.TV. In today's program, Alex Norcia will discuss e-cigarette legal battles in the United States. Thank you, Alex, for joining us today. Can you tell us what legal battles have recently caught people's attention?
Alex: Sure. So, two weeks ago here, there was a major development on a much watched legal case. The Fifth Circuit Court of Appeals ordered that the cases of both Triton and Factasia to US-Based vapor companies who had filed petitions for review against the Food and Drug Administration, be reheard en banc. The FDA had originally denied their pre-market tobacco applications for their products, and they were among the first to file a petition in the US Appeals court, which had sided with the agency initially. In a two to one decision last July, the new hearing will happen in the spring, though, and other legal appeals for other companies remain active in appeals courts throughout the rest of the country.
Joanna: What exactly does en banc mean?
Alex: Sure. So, en banc hearings, which basically requires that a stable of judges weigh in on a case, are incredibly rare. In the fifth Circuit, for instance, fewer than I think it's 1% of cases. Are reheard rather in this action. So here, 16 judges ultimately voted on whether to rehear Triton and Factasia’s case, meaning at least nine of them must have voted in favor.
Joanna: And why is this case so important?
Alex: Yeah. So in many ways, it's seen essential tobacco harm reduction advocates hope that flavored Vapes, which of course most adults find Critical acquitting smoking, but none of which have received FDA authorization, will remain available throughout the US. Additionally, there are many who urge that the market not be restricted to just a handful of, let's say, large, well money companies that have so far received authorizations, again just for tobacco flavored products. And that open system vapes, which are not popular with youth, be judged differently.
Joanna: Can you explain how treatment and Vape Asia got here?
Alex: Sure. So, as I mentioned, triton and Vape. Asia submitted their PMTAs as was required by September 2020. And then the applications had to show in short, that they would be appropriate for their protection of public health, which has essentially become shorthand here for more likely helping adults to switch from smoking rather than introduce a new generation to nicotine. So in the next year. September 2021, the FDA had denied all their applications. October, though, the Fifth Circuit had granted Triton and Factasia a full stay as the case went through the judicial process, meaning they could continue selling their products and three judges included a scathing 20 page review, which they did not have to do. That argued the agency had essentially ignored their marketing plans and had demanded the inclusion of long term like behavioral studies. That Trident Factasia didn't know were required. Some surprisingly, though, following oral arguments in. July, the court ended up siding with the FDA. All that, however, is negated now, and that the scene being presented is one. In which the agency is sort of constantly shifting priorities. That has not provided anything close to what you might call a level playing field.
Joanna: Thank you, Alex. That's all for today. Tune in next time here on Gfn.tv or on our Gfntv podcast. You can also find transcriptions of each episode on the Gfn.tv website. Thanks for watching or listening. See you next time.