On Oct. 11th, the judge heard the arguments from both sides in the Nicopure Labs / Right 2 Be Smoke Free Coalition vs FDA lawsuit. Arguments were heard for three hours.
Judge Ann Jackson asked nearly 100 questions, which Abboud says were fairly balanced among both parties, although the VTA believes the plaintiffs received more time overall.
The questions that were asked were focused on:
- The FDA’s authority over non-nicotine containing parts and devices
- FDA Authority on Non-tobacco E-liquids
- FDA Authority on synthetic nicotine
- If the court would be able to review the Administrative Procedure Act of the deeming rule
- If the court should consider that FDA had to engage in a cost-benefit analysis
- If the FDA could or should have moved the predicate date
- and First amendment issues such as: if free samples are protected speech and about first amendment implications of the Modified Risk Tobacco Products provision of the Tobacco Control Act. That focuses on misleading claims (in the eyes of the FDA), such as vaping being smoke free, no ash, free of certain substances, etc.
The VTA also reported that a recurring theme during proceedings were about the FDA’s misguided characterization of the vaping products market. A specific example Tony Abboud mentioned was that the FDA claimed that 2/3 of the market is comprised of closed systems made by Big Tobacco companies, which isn’t correct.
The FDA also tried to justify their regulations due to the vape industry operating as if it was the “wild west.” The FDA also claimed that they were not regulating any vape products as long as it would not be used with a tobacco product.
Abboud stated that the lawyers raised all of the issues that they needed to bring up, so the judge should have everything she needs to know to make a decision on the case.
I’ve read some summaries from other sources who say that judge seemed skeptical of the vapor companies arguments and that she seemed misinformed of the industry. Dimitris Agrafiotis of the Tenessee Smoke Free Association said that the judge didn’t even know the difference between open and closed system products and that she had the typical outsider’s view of the vapor industry.
The judge also stated that the FDA does not have the authority to change the 2007 predicate date, since it’s part of the Tobacco Control Act. This makes it all the more important to continue supporting the Cole-Bishop amendment to get the predicate date changed.
Judge Jackson has several months to rule and can make a judgement at any time, so there’s really no telling when we might hear an update. Some people are saying it’s unlikely to happen before the end of the year. All we can do now is wait and see what happens.