Case Summaries

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The passage of the Family Smoking Prevention and Tobacco Control Act, granting the U.S. Food and Drug Administration regulatory authority over tobacco products has ushered in a new era of tobacco litigation.

Many of the cases below are centered on the tobacco industry’s attempts to stop the Tobacco Control Act from being implemented and to prevent effective FDA regulation. The industry has also attempted to use the Tobacco Control Act’s narrow preemption provision to stamp out local tobacco control policies. In addition, public health groups have also filed lawsuits against the FDA seeking to stop attempts to roll back important regulation and to push the agency to regulate more effectively. Click the links under each dropdown menu below for information about each case.

Lawsuits Related to the 2016 Deeming Rule

On May 10, 2016, the U.S. Food and Drug Administration published its final deeming rule, extending the agency’s regulatory jurisdiction over tobacco products to e-cigarettes, cigars, hookah, and other products that had not yet been regulated by the FDA. For more information about the FDA’s action, see the Public Health Law Center's other deeming rule resources.

After the change in administration in January 2017, the government sought extensions of deadlines “to allow new leadership personnel at the Department of Health and Human Services to more fully consider the issues raised” in the lawsuits. On May 1, 2017, the FDA extended all future enforcement deadlines for portions of the deeming rule that have not yet been enforced. In addition, on July 28, 2017, the FDA announced a new regulatory plan that included extending deadlines for premarket review to 2021 and 2022. Following this change, several industry plaintiffs agreed to suspend their lawsuits. However, because the new plan effectively allowed for products to remain on the market indefinitely, public health groups filed their own challenge to the 2017 guidance.

The public health groups ultimately succeeded in their challenge to the FDA’s 2017 regulatory plan, obtaining a court-ordered, expedited premarket review application timeline. The industry appealed the ruling, but the district court’s order was upheld by a three-judge panel of the Fourth Circuit Court of Appeals on May 4, 2020. In light of the global Covid-19 pandemic, however, the deadline to submit premarketing applications has been postponed until September 9, 2020.

American Academy of Pediatrics et al v. Food and Drug Administration et al. (2018)
FDA’s 2017 guidance indefinitely extending the premarket review application deadline is unlawful.

NicoPure Labs LLC v. U.S. Food & Drug Administration (2016​)
It is within FDA’s authority under the Tobacco Control Act to require e-cigarettes to receive premarketing authorization. Additionally, neither the pre-marketing authorization requirement applicable to modified risk products nor the free sample ban violate the First Amendment.

Lost Art Liquids, LLC v. U.S. Food and Drug Administration (2016)
A California manufacturer of e-cigarette devices and liquid nicotine filed suit against the FDA alleging various violations of the Administrative Procedure Act in the adoption of the deeming rule.

Enrique Fernando Sanchez Icaza and Global Premium Cigars, LLC v. U.S. Food and Drug Administration (2016)
A manufacturer of cigars challenged various aspects of the deeming rule as it applies to premium cigars.

Larry W. Faircloth v. U.S. Food and Drug Administration (2016)
A consumer of e-cigarettes challenges the deeming rule under the APA and First Amendment.

Cyclops Vapor 2, et al. v. U.S. Food and Drug Administration (2016)
Several Alabama-based manufacturers and distributors of e-cigarettes challenge the deeming rule. The case is dismissed after the Nicopure decision resolves the issues raised by the plaintiffs.

Cigar Association of America et al. v. U.S. Food and Drug Administration (2016)
The FDA’s regulation requiring health warning labels as applied to cigars and pipe tobacco is unlawful. The FDA’s user fee provision is legal. Litigation of additional claims brought by industry trade associations is ongoing.

En Fuego Tobacco Shop LLC, et al. v. U.S. Food and Drug Administration (2018)
Cigar trade organizations challenge several aspects of the deeming rule under the First Amendment and the APA.

Moose Jooce, et al. v. U.S. Food and Drug Administration (2018)
FDA”s prohibition on unauthorized modified risk claims does not violate the First Amendment, and the deeming rule was not issued in violation of the Appointments Clause of the Constitution.

Rave Salon Inc., et al. v. U.S. Food and Drug Administration (2018)
Suit brought by e-cigarette manufacturer and retailer in Texas alleging First Amendment and Appointments clause violations is consolidated with Moose Jooce case.

Hoban, et al. v. U.S. Food and Drug Administration (2018)
Suit brought by e-cigarette manufacturer and retailer in Minnesota alleging First Amendment and Appointments clause violations is consolidated with Moose Jooce case.

Vapor Technology Association et al. v. U.S. Food and Drug Administration (2019)
E-cigarette trade group and manufacturer’s challenge to premarket review compliance requirements under the APA and Fifth Amendment of the Constitution is dismissed.

Big Time Vapes, Inc., et al. v. U.S. Food and Drug Administration (2019)
E-cigarette manufacturer and trade association’s challenge to the Tobacco Control Act’s delegation of authority under Article I of the Constitution is dismissed.

Lawsuits Related to Federal Laws and FDA Regulations

African American Tobacco Control Leadership Council et al. v. U.S. Dept. of Human Services et al. (2020)
Public health organizations sue the FDA for its failure to prohibit menthol as a characterizing flavor in cigarettes.

Philip Morris USA Inc. and Sherman Group Holdings, LLC v. U.S. Food and Drug Administration et al. (2020)
The tobacco industry challenges the 2020 graphic warning label rule under the First Amendment and Administrative Procedure Act.

R.J. Reynolds Tobacco Company et al. v. U.S. Food and Drug Administration et al. (2020)
The tobacco industry challenges the 2020 graphic warning label rule under the First Amendment and Administrative Procedure Act.

American Academy of Pediatrics v. U.S. Food & Drug Administration (2016)
Public health groups sue the FDA to compel the agency to require graphic warning labels on cigarette packages and advertisements.

R.J. Reynolds Tobacco v. U.S. Food & Drug Administration (2011)
The tobacco industry’s challenge to the composition of the Tobacco Products Scientific Advisory Committee and its report on menthol is not ripe for judicial review.

Philip Morris USA, Inc. v. U.S. Food and Drug Administration (2016)
The FDA’s authority to review packaging and labeling changes as a part of the premarket review process is limited and the agency’s previously issued guidance is struck down.

U.S. v. Philip Morris USA, Inc. (1999)
The remedies correcting the tobacco industry’s racketeering behavior must still be imposed even though the Tobacco Control Act imposes a comprehensive federal regulatory scheme on the tobacco industry.

R.J. Reynolds Tobacco Co. v. U.S. Food & Drug Administration (2011)
The FDA’s rule requiring graphic warnings on cigarette packages and advertisements is unconstitutional. For information, on reconciling the rulings in the two different graphic warning cases refer to our factsheet: Cigarette Graphic Warnings and the Divided Federal Courts

Discount Tobacco City & Lottery, Inc. v. United States (2009)
In the industry’s challenge to the Tobacco Control Act, the graphic warning requirement, prohibition on free samples, prohibition on branded non-tobacco merchandise, and prohibition on tobacco-branded event sponsorship are upheld. The prohibition on the use of color in tobacco advertising is struck down.

Sottera Inc. v. U.S. Food and Drug Administration (2009)
The FDA may regulate e-cigarettes as drug-delivery devices only when a therapeutic claim is made. In the absence of such a claim, they may only be regulated as tobacco products.

Lawsuits Related to Federal Preemption

R.J. Reynolds Tobacco Company et al v. County of San Diego (2020)
Tobacco industry files a lawsuit challenging San Diego County’s flavored tobacco product ordinance, alleging that the ordinance is preempted by the Tobacco Control Act.

R.J. Reynolds Tobacco Company et al v. County of Los Angeles et al. (2020)
Industry groups' challenge to the County of Los Angeles’ ordinance prohibiting the sale of flavored tobacco is dismissed, as the industry failed to allege any facts establishing that the ordinance is preempted by federal law.

CA Smoke and Vape Association, Inc. et al v. County of Los Angeles, et al. (2020)
Industry groups' challenge to the County of Los Angeles’ ordinance prohibiting the sale of flavored tobacco is dismissed, as the industry failed to allege any facts establishing that the ordinance is preempted by federal law or violates due process.

CA Smoke and Vape Association, Inc. et al v. City of Palmdale (2020)
Vape trade association challenges the City of Palmdale’s flavored e-cigarette sales restriction, arguing the ordinance is preempted by federal law. The Association voluntarily dismissed the case.

Neighborhood Market Association, Inc. et al v. County of San Diego (2020)
Industry trade association challenges San Diego County’s flavored tobacco product sales restriction, arguing the ordinance is preempted by federal law.

Cigar Association of America, et al v. City of Philadelphia et al. (2020)
The Cigar Association of America and other cigar manufacturers sue the City of Philadelphia over its flavored tobacco products sales ordinance, alleging that the ordinance is preempted by state law and is unconstitutional.

Independents Gas & Service Stations Associations, Inc. v. City of Chicago/5827, Inc. v. City of Chicago (2015)
Chicago is not preempted from prohibiting the sale of flavored tobacco products, including menthol cigarettes, within 500 feet of a school.

National Association of Tobacco Outlets, Inc. v. City of New York (2014)
New York City is not preempted from prohibiting the redemption of coupons or from establishing minimum prices for tobacco products.

National Association of Tobacco Outlets, Inc. v. City of Providence (2013)
Providence is not preempted from prohibiting the sale of flavored tobacco products or from prohibiting the redemption of coupons.

U.S. Smokeless Tobacco Manufacturing Company, LLC v. City of New York (2013)
New York City is not preempted from prohibiting the sale of flavored tobacco products.

23-34 94th St. Grocery v. N.Y.C. Board of Health (2012)
New York City is preempted from requiring tobacco retailers to display graphic posters depicting the health effects of smoking at the point-of-sale.

International Trade Dispute

United States – Measures Affecting the Production and Sale of Clove Cigarettes World Trade Organization, Dispute Settlement DS406
Indonesia’s challenge to the Tobacco Control Act’s prohibition on clove cigarettes could have seen the FDA prohibit menthol cigarettes but after a protracted challenge and arbitration, the two countries settled their dispute.

For more information on the FDA’s regulation of tobacco products, visit our FDA Tobacco Action Center.