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Nicopure Labs, LLC v. Food and Drug Administration

In a final rule issued in May 2016, the Food and Drug Administration (FDA) deemed e-cigarettes to be tobacco products subject to the requirements set forth in the Family Smoking Prevention and Tobacco Control Act. Nicopure Labs, a manufacturer of e-cigarettes, challenged the rule, claiming that the FDA lacked authority to deem e-cigarettes tobacco products subject to various requirements and that the rule violated the First Amendment. The district court held in favor of the FDA, and Nicopure appealed.

On appeal, Public Citizen filed an amicus brief in support of the FDA. The brief explained that Nicopure’s challenge was not properly viewed as a First Amendment issue. Even if it were, Nicopure’s position that strict scrutiny should apply was incorrect. A long line of Supreme Court and federal appellate court cases hold that the standard for assessing First Amendment challenges to regulation of whether products may be marketed as providing health benefits is the intermediate scrutiny standard applicable to commercial speech.

In a decision issued in December 2019, the court of appeals agreed that the FDA’s e-cigarette rules are constitutional. The court explained that the FDA’s premarket authorization requirement for e-cigarettes is not speech restriction and, further, passes intermediate scrutiny if viewed as a commercial speech restriction. The court noted that its holding is 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. The court likewise held that a ban on distributing free samples is a conduct restriction, not a speech restriction.