Below is the email I received from Vapor Technology Association about the court hearing the other day if you would like to read more about it.
FROM THE TRENCHES
Washington, D.C. - Yesterday, Judge Ann Jackson heard oral arguments in the Nicopure Labs, LLC, et al. v. FDA, et al. lawsuit. Plaintiff Nicopure Labs was represented by Covington & Burling, and plaintiff Right 2 Be Smoke Free Coalition was represented by Keller & Heckman. The FDA was represented by the Department of Justice. The proceedings lasted for three hours.
Judge Jackson opened the proceeding by stating that she was going to ask a series of specific questions of both parties. She must have asked almost 100 questions, fairly balanced among the plaintiffs and government, although somehow it seems she gave more time to the plaintiffs overall.
The judge's questions focused on the following topics:
* FDA's authority over non-nicotine containing parts, devices, non-tobacco liquids and synthetic nicotine;
* Whether the court could undertake Administrative Procedure Act review of the deeming rule;
* Whether the court should consider that FDA had to engage in a cost-benefit analysis and what level of deference it should give the Agency;
* the Regulatory Flexibility Act analysis and whether the FDA could or should have moved the predicate date;
* Due Process Clause analysis; and
* First Amendment issues such as:
o are free samples protected speech and, if so, what kind of scrutiny should the court apply; and
o what are the First Amendment implications of the MRTP issues.
Recurring themes were a mistaken characterization by the FDA of the vaping products market. For example, FDA had stated that 2/3 of the vapor market is comprised of closed systems made by tobacco companies, which is not accurate. Further, the FDA made statements that this industry is the "wild west" as a basis for justifying their regulation. Also, youth access to products came up even though it was not relevant to the legal arguments before the Court. The government also repeated its position that it does regulate all parts, components, non-nicotine liquids if it?s reasonably foreseeable that they would be used with a tobacco product. The government further repeated that it intended to enforce against businesses who make modified exposure claims, including references such as no ash, no smoke, free of a certain substance.
All in all, it was a balanced hearing and the plaintiffs? lawyers clearly raised all the issues and made all the points they needed to make during the limited time that was available. As with any other like hearing, no predications can be made as to any outcome of the litigation based on the judge's questions. The judge can take several months to rule. We wish the plaintiffs the best of luck with this courageous effort to save our industry.
FROM THE TRENCHES
Washington, D.C. - Yesterday, Judge Ann Jackson heard oral arguments in the Nicopure Labs, LLC, et al. v. FDA, et al. lawsuit. Plaintiff Nicopure Labs was represented by Covington & Burling, and plaintiff Right 2 Be Smoke Free Coalition was represented by Keller & Heckman. The FDA was represented by the Department of Justice. The proceedings lasted for three hours.
Judge Jackson opened the proceeding by stating that she was going to ask a series of specific questions of both parties. She must have asked almost 100 questions, fairly balanced among the plaintiffs and government, although somehow it seems she gave more time to the plaintiffs overall.
The judge's questions focused on the following topics:
* FDA's authority over non-nicotine containing parts, devices, non-tobacco liquids and synthetic nicotine;
* Whether the court could undertake Administrative Procedure Act review of the deeming rule;
* Whether the court should consider that FDA had to engage in a cost-benefit analysis and what level of deference it should give the Agency;
* the Regulatory Flexibility Act analysis and whether the FDA could or should have moved the predicate date;
* Due Process Clause analysis; and
* First Amendment issues such as:
o are free samples protected speech and, if so, what kind of scrutiny should the court apply; and
o what are the First Amendment implications of the MRTP issues.
Recurring themes were a mistaken characterization by the FDA of the vaping products market. For example, FDA had stated that 2/3 of the vapor market is comprised of closed systems made by tobacco companies, which is not accurate. Further, the FDA made statements that this industry is the "wild west" as a basis for justifying their regulation. Also, youth access to products came up even though it was not relevant to the legal arguments before the Court. The government also repeated its position that it does regulate all parts, components, non-nicotine liquids if it?s reasonably foreseeable that they would be used with a tobacco product. The government further repeated that it intended to enforce against businesses who make modified exposure claims, including references such as no ash, no smoke, free of a certain substance.
All in all, it was a balanced hearing and the plaintiffs? lawyers clearly raised all the issues and made all the points they needed to make during the limited time that was available. As with any other like hearing, no predications can be made as to any outcome of the litigation based on the judge's questions. The judge can take several months to rule. We wish the plaintiffs the best of luck with this courageous effort to save our industry.
