When the FDA deeming regulations were first announced on May 5, 2016, the very first lawsuit filed in the U.S. District Court of Washington, D.C. was aptly named, Nicopure v. FDA. The Tampa-based e-liquid manufacturer filed the lawsuit just four days after the FDA’s stunning announcement, and several other companies followed its lead. Within weeks, there were so many lawsuits pending against the U.S. Food and Drug Administration that Judge Amy Berman Jackson took the unusual step of consolidating eleven separate cases into a single litigation proceeding.
Judge Berman Jackson together with the legal team for the combined plaintiffs also required the FDA to answer a long series of pre-trial questions. The first FDA response was released on August 16, 2016 and resulted in a very lengthy and hard-to-understand legal document of some 102-pages. Last Friday, another round of responses was released. While considerably shorter in length at only 34-pages, both documents contained the same condescending and somewhat arrogant tone of voice. Among the many assertions that the FDA claims include:
- Electronic cigarettes and all associated components are being properly regulated by the FDA.
- The deeming regulations are to be managed “AT THE FULL DISCRETION OF THE FDA.”
- The FDA has the right to implement, change, or delete any deeming regulations “IN ANY EVENT REASONABLE” and at any time.
- The FDA deeming regulations are in full compliance with the Regulatory Flexibility Act of 1980.
- The FDA deeming regulations do not violate the first amendment in any way.
- And perhaps most alarming, “THERE IS NO BASIS TO SECOND-GUESS THE FDA’S DETERMINATION THAT THE BENEFITS OF THE DEEMING RULE JUSTIFY ITS COSTS.”
Nicopure Labs’ biggest complaint
The FDA deeming regulations are being met with disgust across the entire vaping industry, but for very different reasons. For example, Nicopure Lab’s biggest complaint is the new requirement to adhere to a Pre-Market Tobacco Applications (PMTA) process that was typically only previously reserved for Big Tobacco products. But the other numerous lawsuits that were eventually combined with Nicopure’s argued other points of contention, including the legality of a predicate date of February 15, 2007. According to the FDA, any products released to the public after this date, which is essentially 100% of the entire industry, must adhere to the new FDA deeming regulations.
Other lawsuits are fighting the new ban on free samples of e-liquids to customers, the constitutionality of the FDA being given authority over the vaping industry in the first place, and violations of free trade by FDA deeming regulations that threaten to run millions of small vape shops out of business within the next two years. But if this latest legal document submitted to Judge Amy Berman Jackson is any indication, the FDA has no plans of backing down. The case of Nicopure v. FDA could get very ugly before it’s all over.