Nicopure Labs, LLC v. Food and Drug Administration

Nicopure, an e-cigarette manufacturer, and Right To Be Smoke-Free Coalition, an e-cigarette industry group, raised three challenges to the district court's decision:

  1. The FDA violated the Tobacco Control Act (TCA) and the Administrative Procedure Act (APA) by not providing an easier premarket authorization pathway for e-cigarettes.
  2. The premarket review standards applicable to modified risk tobacco products, contending that the standards impermissibly burden what they say are truthful, non-misleading statements about e-cigarettes.
  3. The ban on distribution of free samples of tobacco products, including e-cigarettes, as suppression of constitutionally protected expressive conduct.

The DC circuit court affirmed the district court’s judgment sustaining the TCA and its application to e-cigarettes. The court found because of the public health risks associated with nicotine and increasing rates of e-cigarette use in adolescents and adults, the decision to subject e-cigarettes to the TCA was rational and not arbitrary. Further, the First Amendment does not bar the FDA from preventing the sale of e-cigarettes as safer than existing tobacco products until their manufacturers substantiate those claims. Finally, the court found that the rule did not violate the manufacturers’ First Amendment rights because free samples are not expressive conduct and preventing their distribution is unrelated to the suppression of expression.

In an amicus brief, the Campaign for Tobacco-Free Kids and other public health groups argued that appellants exaggerate the scientific evidence of claimed health benefits of e-cigarettes relative to conventional cigarettes and ignore real health risks posed by e-cigarettes. They also argue that FDA review of modified risk claims for e-cigarettes is necessary to determine whether e-cigarettes, as actually used, benefit the health of individuals and the public and is consistent with the First Amendment (see “Related Documents”).


Nicopure Labs, LLC v. Food and Drug Administration, No. 17-5196, U.S. Court of Appeals, District of Columbia (2019).

  • United States
  • Dec 10, 2019
  • U.S. Court of Appeals for the District of Columbia



  • Nicopure Labs, LLC
  • Right to be Smoke-Free Coalition
  • American E-Liquid Manufacturing Standards

Defendant Food and Drug Administration

Legislation Cited

Related Documents

Type of Litigation

Tobacco Control Topics

Substantive Issues

Type of Tobacco Product