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Cigar Ass’n of America v. FDA

The Family Smoking Prevention and Tobacco Control Act authorized the Food and Drug Administration (FDA) to require health warnings on cigar packaging and advertising similar to the health warnings that have traditionally been required for cigarettes. In 2016, the FDA exercised that authority to require cigar packaging and advertising to carry warnings that advise consumers of the health risks associated with tobacco use.

The cigar industry, acting through three industry associations, brought this action seeking to invalidate the FDA’s regulations. Among other things, the industry argued that the health warnings violated the First Amendment rights of the cigar industry due to the warnings’ size and design elements. The district court rejected the cigar industry’s First Amendment claims and ruled in favor of the FDA.

When the cigar industry appealed to the D.C. Circuit, Public Citizen filed an amicus brief supporting the FDA. The amicus brief addressed the issue of the appropriate level of First Amendment scrutiny that the court should apply. Traditionally, a commercial disclosure requirement is subject to deferential review, and will be upheld if it is not unduly burdensome and rationally related to the government’s interest. The cigar industry argued, however, that heightened review – either intermediate scrutiny or strict scrutiny – should be the standard. Public Citizen’s amicus brief refuted that argument. Our brief also addressed the cigar industry’s arguments that the FDA could not require warnings simply to inform consumers of the health risks of tobacco, as well as their argument that the FDA could only require disclosures if it were the least restrictive alternative available.

In July 2020, the D.C. Circuit invalidated the FDA’s regulations because the FDA had failed to consider how its warnings would likely affect the number of smokers, which the court held was required under the Tobacco Control Act and the Administrative Procedure Act.  The court did not reach the industry’s First Amendment arguments.