Nicopure Labs, LLC v. FDA, No. 17-5196 (D.C. Cir. 2019)Annotate this Case
The DC Circuit affirmed the district court's judgment sustaining the Tobacco Control Act and its application to e-cigarettes. The court held that e-cigarettes are indisputably highly addictive and pose health risks, especially to youth, that are not well understood. Therefore, the court held that it is entirely rational and nonarbitrary to apply to e-cigarettes the Act's baseline requirement that, before any new tobacco product may be marketed, its manufacturer show the FDA that selling it is consistent with the public health.
Furthermore, the First Amendment does not bar the FDA from preventing the sale of e-cigarettes as safer than existing tobacco products until their manufacturers have shown that they actually are safer as claimed. The court explained that this conclusion was amply supported by nicotine's addictiveness, the complex health risks tobacco products pose, and a history of the public being misled by claims that certain tobacco products are safer, despite disclaimers and disclosures. Finally, the court held that nothing about the Act's ban on distributing free e-cigarette samples runs afoul of the First Amendment where free samples are not expressive conduct and, in any event, the government's interest in preventing their distribution is unrelated to the suppression of expression.