## Facts

- Congress, through the Family Smoking Prevention and Tobacco Control Act, authorized the FDA to regulate tobacco products and to require warnings when “appropriate for the protection of the public health.”
- The statute directs that the “public health” determination be made from a population-wide view, including users and nonusers, and requires the FDA to take into account whether a regulation will likely increase or decrease the number of tobacco users.
- The FDA issued a rule requiring large, textual health warnings on cigar and pipe-tobacco packaging and advertising, substantially expanding existing warnings and imposing compliance costs the agency estimated at over $100 million.
- In the rulemaking, the FDA stated that the warnings would help communicate smoking-related health risks, but did not analyze whether the warnings would likely change tobacco-use prevalence in the population (e.g., initiation or cessation rates).
- Cigar and pipe-tobacco industry associations challenged the rule as contrary to the Tobacco Control Act and arbitrary and capricious under the Administrative Procedure Act (APA).
- The district court granted summary judgment to the FDA; the industry appealed.

## Issues

1. Whether the Tobacco Control Act required the FDA, when imposing cigar and pipe-tobacco warnings, to consider whether the rule would likely increase or decrease the number of tobacco users.
2. Whether the FDA’s failure to address that statutorily required factor rendered the warnings rule unlawful under the Tobacco Control Act and arbitrary and capricious under the APA.
3. Whether vacatur (rather than remand without vacatur) was the proper remedy.

## Decision

- The D.C. Circuit reversed the district court’s judgment for the FDA.
- The court held the FDA violated the Tobacco Control Act by failing to take into account how the warnings would likely increase or decrease the number of tobacco users.
- The court further held the rule was arbitrary and capricious under the APA because the agency omitted an important factor Congress expressly required it to consider.
- The court vacated the cigar and pipe-tobacco warning requirements and remanded for further proceedings consistent with its opinion.

## Legal Principles

- When a statute conditions agency action on a “public health” finding and expressly requires consideration of specified population-level effects, the agency must meaningfully address those effects in its rulemaking analysis.
- Under the APA, an agency acts arbitrarily and capriciously when it fails to consider an important aspect of the problem, including factors Congress has made mandatory.
- General assertions that a regulation improves risk communication do not substitute for analysis of the particular statutorily required question (here, likely effects on tobacco-use prevalence).
- Vacatur is warranted when the agency’s error is central to the statutory standard and the rule rests on a legally inadequate record, especially where compliance burdens are substantial.

## Conclusion

The D.C. Circuit set aside the FDA’s cigar and pipe-tobacco warning rule because the agency did not perform the statutorily required analysis of whether the warnings would likely increase or decrease tobacco use in the population, making the rule unlawful under the Tobacco Control Act and arbitrary and capricious under the APA.


Cigar Ass'n of Am. v. U.S. Food & Drug Admin., 964 F.3d 56 (D.C. Cir. 2020)