Breaking News Legal Update on E-Juice Manufacturer Nicopure's Lawsuit against the FDA

***LEGAL UPDATE - Nicopure Lawsuit***
Nicopure Labs Vape Company Sues the FDA & Right 2 Be Free Coalition

Tampa-based Nicopure Labs, LLC, an industry-leading American E-Juice Manufacturer established in 2009, with absolutely zero affiliation with any tobacco company, filed a lawsuit against the FDA four days after the announcement of the FDA deeming regulations on May 5, 2015. The court filings state the FDA violated the Administrative Procedure Act when making the rules and even violated the First Amendment. Jeff Stamler, CEO and co-founder of Nicopure Labs, stated the lawsuit goal is to "ensure the voices of all vapers are heard and that vapers are treated fairly and not with a single stroke of a broad brush by the FDA"

Yesterday, Federal Judge Ann Jackson from the District Court in Washington D.C heard oral arguments in the landmark Nicopure Labs, LLC, et al. v. FDA, et al. lawsuit. Plaintiff Nicopure Labs was represented by Covington & Burling, and plaintiff Right 2 Be Smoke Free Coalition was represented by Keller & Heckman. The FDA was represented by the Department of Justice. The proceedings lasted for three hours.

Judge Jackson opened the proceeding by stating that she was going to ask a series of specific questions of both parties. She must have asked almost 100 questions, fairly balanced among the plaintiffs and government, although somehow it seems she gave more time to the plaintiffs overall.

The judge's questions focused on the following topics:

  •  FDA's authority over non-nicotine containing parts, devices, non-tobacco liquids and synthetic nicotine;
  • Whether the court could undertake Administrative Procedure Act review of the deeming rule;
  • Whether the court should consider that FDA had to engage in a cost-benefit analysis and what level of deference it should give the Agency;
    • the Regulatory Flexibility Act analysis and whether the FDA could or should have moved the predicate date;
    • Due Process Clause analysis; and
    • First Amendment issues such as
      •  Are free samples protected speech and, if so, what kind of scrutiny should the court apply; and
      • What are the First Amendment implications of the MRTP issues.

Recurring themes included a mistaken characterization by the FDA of the vaping products market. For example, FDA had stated that 2/3 of the vapor market is comprised of closed systems made by tobacco companies, which is not accurate. Further, the FDA made statements that this industry is the "wild west" as a basis for justifying their regulation. Also, youth access to products came up even though it was not relevant to the legal arguments before the Court. The government also repeated its position that it does regulate all parts, components, non-nicotine liquids if it's reasonably foreseeable that they would be used with a tobacco product. The government further repeated that it intended to enforce against businesses who make modified exposure claims, including references such as no ash, no smoke, free of a certain substance.

All in all, it was a pretty balanced hearing and the plaintiff's lawyers clearly raised all the issues and made all the points they needed to make during the limited time that was available. As with any other like hearing, no predictions can be made as to any outcome of the litigation based on the judge's questions. The judge can take several months to rule.

Several other lawsuits with similar allegations against the FDA have also been filed throughout the country. We will keep the vape community updated as more information from these historic lawsuits are made available.

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