Nicopure Labs’ Arguments in FDA Lawsuit Detailed

Motion for summar judgement spells out Halo’s case against the deeming ban

Nicopure FDA

Nicopure Labs laid out its arguments in its lawsuit against the FDA’s deeming regulations in a filing in the US District Court in Washington, DC, on Friday. Nicopure has filed a motion for summary judgement, which means it is requesting the court rule against the FDA without a trial. The “Memorandum of Points and Authorities” details the strong case against the ban, with citations of existing law as support. Nicopure is the maker of Halo E-Liquids.

The memorandum is is 45 pages long, and includes 63 citations of case law, and many references to statutes. Since the Nicopure suit has now been combined by the court with the suit brought by the Right to be Smoke-Free Coalition, we will soon see additional arguments from the attorneys representing the alliance of vaping groups responsible for that effort. They will only be arguing points not addressed in the Nicopure filing.

“We strongly believe that this rule violates the Constitution and the process by which it was put into effect is fundamentally flawed and not legally grounded,” said Jeff Stamler, Nicopure CEO in a press release. “Further, we object to the vaping industry being subjected to greater restrictions than traditional tobacco companies, with which Nicopure Labs has no affiliation. We trust that the U.S. District Court will see the merit of our arguments.”

"This court should set aside the deeming rule"

Law Books

The suit is based on four main claims:

  1. Non-nicotine containing products are not “tobacco products”
  2. The deeming rule violates the Administrative Procedure Act
  3. The rule is based on an “arbitrary and capricious cost-benefit analysis”
  4. The rule violates the First Amendment to the Constitution

The Rule exceeds FDA’s statutory authority in regulating non-nicotine containing products such as batteries, software, tanks, vaporizers, and non-tobacco, non-nicotine-containing e-liquids. Congress expressly defined “tobacco product” as a product made or derived from tobacco and intended for human consumption. The majority of Nicopure’s products are neither. The Deeming Rule also fails “hard look” APA scrutiny. The Rule is fundamentally inconsistent, purporting to regulate vaping products to protect the public health, while simultaneously conceding that FDA does not know enough about vaping to determine its effect on public health. The Rule also turns Congress’s intent on its head by subjecting vaping products to an insurmountable premarket authorization pathway while allowing cigarettes and other conventional tobacco products to either be grandfathered or eligible for far less-burdensome pathways. Furthermore, the Rule’s cost-benefit analysis violates the APA by failing to quantify the Rule’s benefits and grossly understating its costs. Finally, the Rule violates the First Amendment. Its ban of free samples of vaping devices or e-liquids flunks the Sorrell and Central Hudson tests. Its restrictions on making truthful, non-misleading statements about vaping products (such as that they do not contain tar, or ash, or that they are smokeless) are unconstitutional for the same reasons. This Court should set aside the Deeming Rule.

Jim McDonald
I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.