All Smoking is Not Created Equal

In a landmark development for the premium cigar industry, the U.S. Court of Appeals for the District of Columbia has reaffirmed that the FDA acted “arbitrarily and capriciously” in its attempt to regulate premium cigars under the 2016 Deeming Rule. This appellate decision upholds U.S. District Judge Amit P. Mehta’s earlier ruling vacating the FDA’s authority over premium cigars.

The appellate opinion, Cigar Association of America et al. v. U.S. Food and Drug Administration, confirms that the FDA failed to consider critical evidence submitted during the rule-making process—especially studies showing that premium cigar smokers almost universally smoke infrequently and that occasional cigar smoking presents no statistically significant increase in all‑cause mortality. These data, central to the dispute, had been cited in the district court and were acknowledged by the appellate judges.

The court agreed that the FDA had improperly dismissed or ignored evidence, such as findings from Monograph No. 9 1998 (National Cancer Institute), a major federal research publication detailing cigar usage patterns, health risks, and consumption trends. This monograph concluded that most premium cigar smokers consume cigars infrequently—far less often than consumers of other tobacco products.

The decision represents a major affirmation of the district court’s findings that the FDA misrepresented the existence of data submitted during commentary periods—specifically studies showing that premium cigar users do not engage in habitual, inhalation-based smoking patterns seen with cigarettes and other tobacco products. The district court’s earlier opinions, including Judge Mehta’s 2022 ruling and his 2023 final order vacating FDA authority over premium cigars, set the stage for this outcome.
Judge Mehta’s District Court Opinions:
Summary & background: https://cigarrights.org/mehta_dec/ [cigarrights.org]

Another key piece of research underlying both the district and appellate court conclusions is the federally commissioned National Academies of Sciences, Engineering and Medicine (NASEM) study, which found that:

• Most premium cigar smokers are nondaily or occasional smokers,
• Youth usage rates are extremely low, and
• Overall public health impact of premium cigars is comparatively modest.
  
  The 2022 NASEM research concluded that there was little or no

“HEALTH EFFECTS OF PREMIUHEALTH EFFECTS OF PREMIUM CIGARS, if cigar smoke is inhaled and cigars are smoked regularly, the risks are likely to be qualitatively similar to those of cigarette smoking. There is insufficient evidence to determine if occasional or nondaily exclusive cigar use in general is associated with increased health risks.

There is insufficient evidence to draw conclusions on the health effects of premium cigars on

• Youth or young adults,

• Racialized and ethnic populations,

• Pregnancy,

• Those with underlying medical conditions,

• People with occupational exposures to premium cigars (e.g., cigar lounges, manufactur ing), and• Health effects compared to other cigar types.

Conclusion 5-4. There is insufficient evidence to determine if occasional or nondaily exclusive cigar use in general is associated with increased health risks.

Conclusion 5-5. There is strongly suggestive evidence that health consequences of premium cigar smoking overall are likely to be less than those smoking other types of cigars because the majority of premium cigar smokers are nondaily or occasional users and because they are less likely to inhale the smoke.

Conclusion 5-7. There is moderately suggestive evidence that the health risks among primary cigar users in general (those who were never established cigarette users) are generally lower than among secondary cigar users (those who were former users of cigarettes) because secondary cigar users may be more likely to inhale the smoke. Likewise, concurrent users of premium cigars and other combustible tobacco products would experience greater health risks than those smoking only premium cigars.

Conclusion 5-9. Based on the extensive literature on the effects of flavors on cigars and other tobacco products, there is moderately suggestive evidence that adding characterizing flavors (that is, flavors added to the product that are not inherent to the tobacco itself) to premium cigars could result in a greater appeal to nonusers and lead to more frequent use with potentially increased nicotine intake, increased addiction potential, and increased exposure to harmful and potentially harmful constituents present in premium cigar smoke.

Conclusion 5-10. There is sufficient evidence that premium cigars generate considerable levels of secondhand smoke; however, there are insufficient data on the health risks associated specifically with exposure to premium cigar secondhand smoke. It is plausible that since the constituents emit ted from premium cigars are similar to constituents from other tobacco products, the health risk might be the same, but the extent of secondhand premium cigar exposure is unknown.

While the appeals court upheld the vacatur of the Deeming Rule as applied to premium cigars, it remanded one issue back to Judge Mehta: establishing a definitive legal definition of what constitutes a “premium cigar.” This step is crucial for any future regulatory attempts, as ambiguity surrounding the category has long complicated oversight efforts. [law.justia.com]

Additional legal context reinforces that the ruling does not forbid the FDA from regulating premium cigars in the future. Instead, the agency must restart the process entirely—grounding any new attempt in evidence‑based rulemaking and correcting failures identified in the judicial opinions.
Further Legal Background (Deeming Rule Vacatur):
https://natlawreview.com/article/federal-court-vacates-fda-deeming-premium-cigars-subject-to-tobacco-control-act [cigar-coop.com] [natlawreview.com]

As the case returns to the district court for definition‑setting, the premium cigar industry, both in the U.S. and Canada, benefits from strengthened legal clarity and reduced regulatory risk—at least for now.