Cigar Association of America v. U.S. Food and Drug Administration
Plaintiffs, cigar trade associations, challenged the decision of the Food and Drug Administration (FDA) to regulate, or “deem”, premium cigars subject to the agency’s regulatory authority under the Family Smoking Prevention and Tobacco Control Act of 2009. As background, the FDA issued a Final Rule on August 8, 2016, deeming all products meeting the statutory definition of a “tobacco product” to be subject to its regulatory authority, including premium cigars (the “Deeming Rule”).
Plaintiffs challenged the Deeming Rule alleging that the FDA did not consider comments provided in the rulemaking phase regarding usage patterns- asserting that premium cigars did not pose the same public health concerns as other tobacco products. The Court found that FDA’s failure to consider the data was a significant error.
The FDA argued that vacating the Deeming Rule would leave premium cigars unregulated at the federal level and maintaining the status quo would not impose significant burdens on premium cigar manufacturers. The Court recognized the importance of these consequences but found that they were not disruptive enough to warrant remand without vacating the decision.
The Court vacated the FDA’s decision to deem premium cigars, concluding a seven-year conflict between the cigar industry and FDA. The Court defined premium cigars as those that: (1) are wrapped in whole tobacco leaf; (2) contain a 100 percent leaf tobacco binder; (3) contain at least 50 percent (of the filler by weight) long filler tobacco; (4) are handmade or hand rolled; (5) have no filter, non-tobacco tip, or non-tobacco mouthpiece; (6) do not have a characterizing flavor other than tobacco; (7) contain only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) weigh more than 6 pounds per 1,000 units.
Cigar Association of America, et al. v. U.S. Food and Drug Administration, et al., No. 16-cv-01460, U.S. District Court for the District of Columbia (2023)
Tobacco companies or front groups may challenge any legislative or regulatory measure that affects their business interests. Unlike public interest litigation, these cases seek to weaken health measures. These cases frequently involve the industry proceeding against the government. For example, a group of restaurant owners challenging a smoke free law as unconstitutional.
Measures to regulate the marketing on tobacco packages. This includes both bans on false, misleading, deceptive packaging, as well as required health warnings on packaging.
(See FCTC Art. 11)
A violation of the right to the enjoyment of the highest attainable standard of health. Public health advocates may claim the public’s right to health is violated by weak tobacco control measures, industry tactics, or an organization’s or smokers’ actions.
A violation of the right to procedural fairness. For example, a party may claim that a government agency did not consult with public or stakeholders when issuing regulations.
The court might consider procedural matters without touching the merits of the case. These might include: improper joinder, when third parties, such as Health NGOs or government officials, seek to become parties to the suit; lack of standing, where a plaintiff fails to meet the minimum requirements to bring suit; lack of personal jurisdiction, where the court does not have jurisdiction to rule over the defendant; or lack of subject matter jurisdiction, where the court does not have jurisdiction over the issue at suit.
Any combustible tobacco product that is designed to be smoked – other than cigarettes – including cigars, cigarillos, little cigars, blunts, and bidis or beedis (small, flavored filterless Indian cigarettes).
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
"With respect to impact on public health, the FDA starts with the fact that vacatur would mean premium cigar sales to youth under the age of 21 will no longer be unlawful under federal law. But this concern is mitigated by the fact that existing state laws limit sales to youth and minors. Pls.’ Br. at 8. For example, all 50 states prohibit the sale of premium cigars to persons under 18 years old. Pls.’ Reply in Supp. of Pls.’ Mot. for Summ. J., ECF No. 256, at 30 n.10. Additionally, all but 12 states and four territories prohibit their sale to 18- to 20-year-olds.6 Although state laws will not bar sales to all young adults under 21, vacatur will make premium cigars newly legally available to only a small segment of the population. As for the availability of machine vending and free samples of premium cigars, the FDA has not shown to what extent premium cigars are distributed in those ways, particularly to reach young adults and minors. See 81 Fed. Reg. at 29,054 (stating that restricting free samples of premium cigars “will eliminate a pathway for youth to access tobacco products”). Given the higher individual cost of a premium cigar, it is unlikely that premium cigars are commonly sold through vending machines. And, presumably, the same state laws that restrict sales of tobacco products to youth under 18 or 21 also prohibit giving those products away for free as samples to youth. Finally, although limiting the FDA’s ability to enforce the law as to false or misleading labeling of premium cigar products is a legitimate concern, the agency has not shown that there is a history of mislabeling products in the premium cigar industry. The FDA has given the court no reason to think that its inability to police false or misleading labeling is likely to open the floodgates to mislabeled premium cigars. Additionally, in a different context, the FDA has said that premium cigars are its “lowest [enforcement] priorit[y]” relative to other tobacco products used with greater frequency by youth. See FDA’s August 2020 Notice to Court, ECF No. 209, at 3 (stating that premium cigars were the agency’s lowest enforcement priority with respect to the premarket authorization requirement). The agency has not said otherwise with respect to the labeling of premium cigars."
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
Plaintiffs, cigar trade associations, challenged the decision of the Food and Drug Administration (FDA) to regulate, or “deem”, premium cigars subject to the agency’s regulatory authority under the Family Smoking Prevention and Tobacco Control Act of 2009. As background, the FDA issued a Final Rule on August 8, 2016, deeming all products meeting the statutory definition of a “tobacco product” to be subject to its regulatory authority, including premium cigars (the “Deeming Rule”).
Plaintiffs challenged the Deeming Rule alleging that the FDA did not consider comments provided in the rulemaking phase regarding usage patterns- asserting that premium cigars did not pose the same public health concerns as other tobacco products. The Court found that FDA’s failure to consider the data was a significant error.
The FDA argued that vacating the Deeming Rule would leave premium cigars unregulated at the federal level and maintaining the status quo would not impose significant burdens on premium cigar manufacturers. The Court recognized the importance of these consequences but found that they were not disruptive enough to warrant remand without vacating the decision.
The Court vacated the FDA’s decision to deem premium cigars, concluding a seven-year conflict between the cigar industry and FDA. The Court defined premium cigars as those that: (1) are wrapped in whole tobacco leaf; (2) contain a 100 percent leaf tobacco binder; (3) contain at least 50 percent (of the filler by weight) long filler tobacco; (4) are handmade or hand rolled; (5) have no filter, non-tobacco tip, or non-tobacco mouthpiece; (6) do not have a characterizing flavor other than tobacco; (7) contain only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) weigh more than 6 pounds per 1,000 units.