Nicopure Labs, LLC v. Food and Drug Administration, et al. / Right to be Smoke-free Coalition, et al. v. Food and Drug Administration, et al. (2016) (2018)

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Status: Open

Legal Issue

Does the U.S. Food and Drug Administration’s regulation expanding its regulatory authority over cigars, e-cigarettes, and other tobacco products violate the Administrative Procedures Act, the Regulatory Flexibility Act, or the First Amendment?


On May 10, 2016, the U.S. Food and Drug Administration published its final deeming rule, extending the agency’s regulatory jurisdiction over tobacco products to e-cigarettes, cigars, hookah, and other products that had not yet been regulated by the FDA. On the same day, NicoPure Labs filed a lawsuit challenging the legality of the FDA’s action, alleging that the decision to regulate e-cigarettes, including the implementation of premarket review for all new products introduced after February 15, 2007, violated the APA, the Regulatory Flexibility Act, and the First Amendment.

On August 19, 2016, the Tobacco Control Legal Consortium and seven other public health and medical organizations joined an amicus brief organized by the Campaign for Tobacco-Free Kids, arguing that the deeming rule is a rational regulatory response to the short- and long-term public health effects of e-cigarettes and thus does not violate the APA.  The brief contends that even if the deeming rule implicates First Amendment issues, any restrictions on commercial speech materially and directly advance substantial public health interests, and are therefore permissible under the commercial speech regulation test set out in Central Hudson Gas and Electric Corp. v. Public Service Commission of New York, 447 U.S. 557 (1980).  The brief points out that 1) prohibiting free samples is necessary to meet the critical public health goal of limiting access to e-cigarettes by young people; and 2) FDA review of proposed modified risk claims is essential to protect against the serious public health consequences of unsubstantiated reduced risk claims.

On July 21, 2017, the court granted the government’s motion for summary judgment, finding that 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 at the Court of Appeals for the D.C. Circuit.

On May 9, 2018, the Public Health Law Center filed an amicus brief arguing that the FDA’s regulation of modified risk claims is a necessary and legal activity that does not offend the First Amendment, primarily because the tobacco industry has a long history of perpetuating deception about the health effects of its products. The brief also argues that the prohibition on free samples is a restriction on conduct, rather than speech and that if the prohibition is evaluated as a speech restriction, the proper level of judicial scrutiny is the O’Brien test.


On December 10, 2019, the United States Court of Appeals for the D.C. Circuit upheld a lower court decision dismissing a challenge to the FDA’s 2016 deeming rule, allowing the agency to regulate e-cigarettes, cigars, and other previously unregulated tobacco products. The court ruled that the FDA’s imposition of premarket review on newly-regulated products was lawful, that the regulation of modified risk claims did not violate the First Amendment, and that the prohibition on free samples regulated conduct, not speech, which does not implicate First Amendment speech protections.

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