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

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No. 266 F.Supp.3d 360 (D.D.C. 2017)

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

The FDA’s deeming rule does not violate the first amendment or the Administrative Procedure Act.


On May 10, 2016, the FDA issued a final rule, deeming e-cigarettes, cigars, pipe tobacco, hookah, and all other previously unregulated products to be subject to the agency’s authority. Several lawsuits were filed challenging the FDA’s rule. One suit was filed in District Court for the District of Columbia by NicoPure Labs, LLC on the same day the final rule was issued. Six weeks later, on June 20, 2016, eleven e-cigarette trade groups, including the Right To Be Smoke-Free Coalition, also filed suit challenging the FDA’s rule in the same district. The two cases were consolidated. Both challenges allege that the FDA’s action violates the Administrative Procedure Act (APA) and that some of the new requirements violate the First Amendment. Both sides filed motions for summary judgment.

The District Court’s Decision

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.

Litigation Status

The plaintiffs filed an appeal to the Court of Appeals for the D.C. Circuit.

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