In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), granting the U.S. Food and Drug Administration (FDA) the jurisdiction to regulate tobacco products. In response to the Tobacco Control Act and the FDA’s implementation of the Act, tobacco companies have brought multiple lawsuits challenging the constitutionality of the Act and of the FDA’s regulations, the composition of the FDA’s Tobacco Products Scientific Advisory Committee, and the preemptive scope of the Tobacco Control Act. Click on the links below for information about each case.
Lawsuits Related to Federal Laws and FDA Regulations
NicoPure Labs LLC v. U.S. Food & Drug Administration (2017)
The FDA’s deeming rule does not violate the first amendment or the 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 (2016)
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 (2015)
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. (2012)
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 (2012)
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 (2012)
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 (2011)
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 State and Local Laws and Regulations
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 (2012)
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.