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 on the links 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.
Enrique Fernando Sanchez Icaza and Global Premium Cigars, LLC v. U.S. Food and Drug Administration
Larry W. Faircloth v. U.S. Food and Drug Administration
Cyclops Vapor 2, et al. v. U.S. Food and Drug Administration
Cigar Association of America et al. v. U.S. Food and Drug Administration
En Fuego Tobacco Shop LLC, et al. v. U.S. Food and Drug Administration
Moose Jooce, et al. v. U.S. Food and Drug Administration
Rave Salon Inc., et al. v. U.S. Food and Drug Administration
Hoban, et al. v. U.S. Food and Drug Administration
Lawsuits Related to Federal Laws and FDA Regulations
American Academy of Pediatrics v. U.S. Food & Drug Administration
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
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
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.
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
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
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
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
Independents Gas & Service Stations Associations, Inc. v. City of Chicago/5827, Inc. v. City of Chicago
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
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
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
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
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.