TOBACCO CONTROL LAWS

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.

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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)

  • United States
  • Aug 9, 2023
  • U.S. District Court for the District of Columbia

Parties

Plaintiff Cigar Association of America

Defendant U.S. Food and Drug Administration

Legislation Cited

Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 90 (May 10, 2016)

Family Smoking Prevention and Tobacco Control Act, Public Law 111-31, June 22, 2009

Federal Food, Drug, and Cosmetic Act, Tobacco Products, 21 USC §§ 387 - 387u

Related Documents

None

Type of Litigation

Challenge to Government Policies Relating to Tobacco Control/Public Health
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.

Tobacco Control Topics

Packaging and Labeling Measures
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)
Advertising, Promotion and Sponsorship
Measures restricting any form of direct or indirect tobacco advertising, promotion and sponsorship. (See FCTC Art. 13)

Substantive Issues

Right to Health
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.
Right to Procedural Due Process
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.
Procedural Defect
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.
Ultra Vires Regulation
Subsequent regulations exceed the scope of the originating law.

Type of Tobacco Product

Cigars, cigarillos, bidis, and other similar products
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).
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