The cigar industry has found some official support for its challenge to the Deeming Regulations. That official support has come from the State of Arizona, whose Attorney General has filed a brief as amicus curiae, supporting the cigar industry’s position in Cigar Association of America, et al. v. FDA, et al., No. 18-5195 (D.C. Cir.).
The appeal involves challenges against the large health warnings required by the FDA, see 21 C.F.R. §§ 1143.3 and .5, as violating the First Amendment to the U.S. Constitution; the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C. § 387, et seq. (the “TCA”); and the Administrative Procedure Act, 5 U.S.C. § 500, et seq. (the “APA”). On May 15, 2018, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia ruled in the FDA’s favor, holding that these warning label requirements are lawful, but later entering an injunction against those warnings. The challengers noticed their appeal on June 27, 2018, and the case is pending before the U.S. Court of Appeals for the D.C. Circuit.
Arizona filed its amicus brief on May 5, 2019. Although “Arizona welcomed the passage of the” TCA, it sees the Deeming Regulations’ cigar warning label requirements as “contrary to the purpose and structure of the” TCA. “Arizona agrees with the [challengers] that this warning label regime is excessive, arbitrary, and unconstitutional and that this Court should reverse the judgment below and remand for further proceedings.”
While Arizona supports the challengers’ position in the appeal, it narrowed the focus of its brief “to a single issue: The District Court erred in holding that FDA made the factual findings regarding the effect of the new warning requirements on the manufacture and retail of premium cigars that the [TCA] requires.” Arizona’s argument boiled down to the following main points:
- the FDA failed to make any “finding” as to how the warning requirements would affect tobacco use, instead vaguely claiming that the warning helped consumers “appreciate the risks” and resolving to further study the issue;
- the FDA failed to justify the warning requirements under the purposes of the TCA, in that the cost-benefit analysis focuses on the reduction of tobacco use by youths and premium cigars constitute a de minimis portion of youth tobacco use (approx. 0.001% of 12-to-17-year-olds even under the study cited by the FDA);
- the FDA’s having taken such action without reference to the guiding principles of the TCA amounts to an unlawful delegation of Congress’ authority to the FDA; and
- the FDA failed to consider less costly alternatives to the warning requirements, such as the Federal Trade Commission’s existing (and less-intrusive) warning requirements and/or foregoing the extension of the warning requirements to cigar retailers.
Arizona also recognized that the “health warnings must cover 30 percent of the two most prominent panels of any package—an amount destructive of the aesthetic appeal of cigar boxes” and that regulatory and compliance “costs will fall disproportionately on the small, family-owned businesses that dominate the premium cigar industry.”
It is encouraging that the Attorney General of Arizona has added his voice to those recognizing the regulatory imbalance the Deeming Regulations have taken with respect to premium cigars.
More is yet to come in this case. Stay tuned for further developments.