NicoPure Labs LLC v. U.S. Food & Drug Administration

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No. 1:16-cv-878 (D.D.C. 2016)

No. 17-05196 (D.C. Cir. 2017)

On May 10, 2016, Nicopure Labs, a Florida manufacturer of e-cigarette devices and liquid nicotine, filed suit in the District Court of the District of Columbia, requesting that the court permanently strike down the rule and in the meantime, enjoin enforcement of the rule while the litigation proceeds. Six weeks later, on June 20, 2016, eleven e-cigarette trade groups, Right To Be Smoke-Free (RSF), American E-Liquid Manufacturing Standards Association, American Vaping Association, Electronic Vaping Coalition of America, Georgia Smoke Free Association, Kentucky Vaping Retailers Association, Inc., Louisiana Vaping Association, Maryland Vape Professionals, LLC, New Jersey Vapor Retailers Coalition, Ohio Vapor Trade Association, and Tennessee Smoke Free Association (collectively the RSF Plaintiffs), also filed suit in the District Court of the District of Columbia, requesting that the court issue a preliminary injunction barring enforcement of the rule while the litigation proceeds and asked the court to permanently strike down the rule.

In an effort by the court to streamline proceedings, these two lawsuits were consolidated because they were based on the same agency action, had the same defendant, and raised some of the same claims. Nicopure filed a motion for summary judgment2 on July 8, 2016. The RSF Plaintiffs filed their own motion for summary judgment related to unique claims on July 25, 2016. The FDA filed a cross-motion for summary judgment on August 17, 2016 and public health groups filed a supporting amicus curiae brief on August 19, 2016. The plaintiffs’ consolidated reply was filed on August 26, 2016. The FDA’s reply was filed on September 9, 2016, and a hearing on the motions was held on October 11, 2016.

Nicopure’s complaint alleged that:

  1. the FDA’s interpretation of the term, “tobacco product” was “not in accordance with the law” and was “in excess of statutory jurisdiction,” a violation of the APA;
  2. the enforcement of premarket review against e-cigarette companies would be costly and stifle innovation, rendering the FDA’s action “arbitrary and capricious,” a violation of the APA;
  3. the FDA’s cost-benefit analysis for the rule overstated the benefits and understated the costs, an action that was “without observance of procedure required by law,” a violation of the APA; and
  4. e-cigarette manufacturers would be prohibited from making truthful and non-misleading statements and other forms of protected expression, an action that was “contrary to [the] constitutional right” to free speech protected by the First Amendment, a violation of the APA.

RSF Plaintiffs’ complaint alleges that:

  1. the FDA’s refusal to select a new grandfather date, later than February 15, 2007 for e-cigarettes rendered the Substantial Equivalence premarket review pathway inaccessible, an action that was “arbitrary and capricious,” a violation of the APA;
  2. the FDA’s imposition of the rigorous Premarket Tobacco Product Application process was too expensive and difficult, an action that is a violation of the APA;3
  3. the FDA’s treatment of e-cigarettes in a way that is similar to combustible cigarettes violated the equal protection clause of the Fourteenth Amendment by way of the due process clause in the Fifth Amendment.
  4. the FDA has prohibited the distribution of free samples, an action that was “contrary to [the] constitutional right” to free speech protected by the First Amendment, a violation of the APA.
  5. e-cigarette manufacturers would be prohibited from making truthful and non-misleading statements, an action that was “contrary to [the] constitutional right” to free speech protected by the First Amendment, a violation of the APA.
  6. the FDA’s interpretation of the term, “tobacco product” was “unreasonable and unlawful under the APA;”4
  7. the FDA’s Final Regulatory Flexibility Analysis did not properly quantify the costs of the rule or identify significantly less costly alternatives to the rule, a violation of the RFA; 8) the FDA’s cost-benefit analysis for the rule overstated the benefits and understated the costs, an action that is a violation of the APA.5

On July 21, 2017, the court granted the FDA’s motion for summary judgment, finding that the promulgation of the deeming rule did not violate the APA and that the rule did not infringe on any of the plaintiffs’ constitutional rights. The plaintiffs’ motion for summary judgment was dismissed. The plaintiffs filed an appeal to the Court of Appeals for the D.C. Circuit.

On September 8, 2017, the American Academy of Pediatrics, the American Lung Association, the American Heart Association, the American Cancer Society Cancer Action Network, the Campaign for Tobacco-Free Kids, and the Truth Initiative filed a motion to intervene as defendants to ensure that the deeming rule is adequately defended, after the government had filed several requests to delay motions in this and other cases, as well as delaying some of the enforcement dates implementing the deeming rule. The plaintiffs and the defendant filed responses to this motion on September 28, 2017, and the potential intervenors filed their reply on October 5, 2017. On March 30, the potential intervenors filed a motion to withdraw their motion to intervene and participate as amicus curiae.6

The appellants’ brief was filed on February 12, 2018. The FDA filed its brief on May 2, 2018. Four amicus curiae briefs in support of the FDA were filed on May 9, 2018. The appellants’ reply was filed on May 16, 2018, and final briefs were filed on June 6, 2018. Oral arguments were held on September 11, 2018.

Public Health Law Center Amicus Brief