Just two short days after the FDA deeming regulations were first announced in May of 2016, e-liquid manufacturer Nicopure Labs immediately filed a lawsuit in federal court. Vaping advocacy groups around the world have been watching the case travel through the judicial process, eagerly awaiting the outcome. Last Friday, Judge Amy Berman Jackson published her ruling.
According to the resulting 93-page decision, the FDA deeming regulations which now categorize e-cigarettes as ‘tobacco products’ still stand, even though Nicopure Labs is essentially arguing that e-cigs are 100% tobacco-free (nicotine is NOT tobacco, after all). But the Judge did not stop there. Berman Jackson struck down each of the numerous allegations put forth by the plaintiffs in the historic lawsuit, including but not limited to the following points of contention.
- Does the FDA have the legal authority to backdate the regulations over ten years to a predicate date of February 2007?
- Does the inclusion of a predicate date violate the Regulatory Flexibility Act?
- Do the FDA deeming regulations violate any areas of the First Amendment to the U.S. Constituion?
- Does the FDA have the legal authority to require vaping and e-juice manufacturers to adhere to a Pre-Market Tobacco Application (PMTA) that may cost in upwards of $1 million dollars per product and with no guarantee of approval?
- Does the FDA have the legal authority to prohibit vape shops from giving away free samples of e-liquids?
- Does the FDA have the legal authority to tax an entire industry so aggressively that it threatens its very existence?
- Was a cost-benefit analysis conducted prior to the rollout of the FDA deeming regulations?
- Was due process provided regarding the creation and implementation of the FDA deeming regulations?
Nicopure Labs was not the only vape-friendly organization to file a lawsuit, but it was the first. Shortly thereafter, numerous additional cases were also filed in the U.S. judicial system. In July of 2016, Judge Berman Jackson decided to consolidate the Nicopures lawsuit with several others to save time and – presumably – money.
At that time, the Nicopure case was combined with lawsuits filed by eleven other plaintiffs, including those by such prestigious advocacy groups as NotBlowingSmoke.org, the Smoke-Free Alternatives Trade Association (SFATA), and the Consumer Advocates for Smoke-free Alternatives Association (CASAA), just to name a few. Unfortunately, the July 21 ruling applies to all.
Even though the judge’s decision can be perceived as a crushing blow to the American vaping industry, it does not come as a complete surprise. Like Mr. Didak, many legal experts have long suspected that the case would ultimately be won in the U.S. Court of Appeals. So, while the ruling is disappointing, all hope is not lost. The battle will continue…
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