Judge Amy Berman Jackson began to hear oral arguments yesterday in the historic lawsuit filed by Florida-based e-liquid manufacturer Nicopure Labs just days after the May 5, 2016 announcement of the FDA deeming regulations. Several other companies followed suit shortly thereafter, including the Right 2 Be Smoke Free Coalition. As a result, Judge Jackson decided earlier this year to order the consolidation of eleven similar cases into one big lawsuit, which is now officially underway.
The question at hand is whether the FDA has the legal authority to regulate the vaping industry with the same protocols used to oversee tobacco products. Yesterday’s proceedings lasted approximately three hours, and Judge Jackson opened by asking a series of pointed questions to the set of plaintiffs as well as to the FDA defendants. While the number of questions were somewhat evenly balanced between both sides, more time was given to the plaintiffs’ responses overall.
Judge Jackson’s questions largely focused on the following issues:
- Does the FDA have the legal authority to regulate vaping devices, parts, and related technology regarding zero-nicotine e-liquids?
- Should the court take into consideration the Administrative Procedure Act when reviewing the FDA deeming regulations?
- Should the court take into consideration whether the FDA engaged in a cost-benefit analysis and how important is this information to the final ruling?
- Should the FDA have considered or should consider moving the predicate date as per the Regulatory Flexibility Act?
- Was due process provided in regards to the FDA deeming regulations?
- Are any First Amendment Rights being violated?
- Is the ban of free samples a violation of free speech?
- If so, what sort of scrutiny should the court apply?
- What are the First Amendment implications of the MRTP issues?
Judge Jackson also questioned the accuracy of certain facts supplied by the FDA. For example, the FDA has stated on several occasions that approximately two-thirds of the e-cigarette market is comprised of closed-systems products, which is less than truthful. She also questioned previous FDA statements that the vaping industry is essentially the “wild west,” which lends support for the need for government oversight, if accurate.
It is important to note that no substantive predictions can be made from the Judge’s questions or the possibly inferred line of questioning. Furthermore, Judge Amy Berman Jackson could take several months before issuing her final ruling.
(Related Article: FDA RESPONDS TO NICOPURE LABS AND R2B SMOKE-FREE LAWSUITS)
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