The historic lawsuit over the newly announced FDA deeming regulations is officially underway as Judge Amy Berman Jackson listened to opening arguments just last week. The proceedings lasted for approximately three hours and covered a wide range of topics. Covington & Burling represented the plaintiff Nicopure Labs and Keller & Heckman is arguing for a second plaintiff, the Right 2 Be Smoke Free Coalition. The FDA was represented by the U.S. Department of Justice.
The basis of the case is whether the FDA has the legal authority to regulate the vaping industry as tobacco products. The plaintiffs argue that e-cigs are essentially 100% tobacco-free. So how can the FDA force manufacturers to adhere to a Pre-Market Tobacco Products application process that costs in upwards of $1 million per product? Furthermore, did the FDA even research just how financially devastating the deeming regulations would be to thousands of small business owners?
Judge Jackson asks a wide range of questions to both sides
During opening arguments, Judge Jackson asked a series of very pointed questions to both the FDA and the plaintiffs. An even balance of questions was asked to both parties, but she seemed to spend more time on the plaintiffs’ responses overall. Among the questions asked include the following:
- Does the FDA have the constitutional authority to regulate electronic cigarettes, including technological devices and individual parts?
- Was due process followed regarding the release of the FDA deeming regulations?
- Does the FDA have the constitutional authority to regulate electronic cigarettes containing zero-nicotine e-liquids?
- How relevant is the Administrative Procedure Act in regards to the FDA deeming regulations?
- Did the FDA conduct a cost-benefit analysis in regards to the deeming regulations’ economic effects on small business owners?
- How relevant is this information in determining the final ruling?
- Should the FDA consider changing the predicate date as per the Regulatory Flexibility Act?
- Does the banning of free e-liquid samples in vape shops violate the First Amendment?
- And several others.
Judge Jackson also seemed to question the accuracy of some of the specific facts stated by the FDA and its representatives. For example, on several occasions, the FDA has made claims that over 66 percent of the vaping industry consists of closed systems products. The judge seems to believe these statements to be gross misrepresentations of the facts. She also showed concern about the FDA’s claim that the vaping industry is the “wild west” of nicotine replace therapies.
While no one can predict the court’s ultimate decision from this short list of preliminary questions, Judge Jackson seems to be taking the case very seriously by taking the time to hear both sides of the argument. No word yet on how long it will take to get a final ruling.