The Campaign for Tobacco-Free Kids has an active litigation program, participating in tobacco control cases in federal and state courts. In federal courts, the Campaign has brought lawsuits against the U.S. Food and Drug Administration on behalf of public health organizations, seeking to compel the agency to more aggressively regulate the tobacco industry. In numerous other federal cases, Tobacco-Free Kids has filed briefs as amicus curiae (“friend of the court”), joined by various medical, public health, and community organizations, defending tobacco control measures against legal attack by tobacco companies. Below is a description of federal cases in which the Campaign has participated.
RICO Remedies Against Cigarette Companies
United States of America v. Philip Morris USA, Inc. et al. (U.S. District Court for the District of Columbia, 2006)
Case details: Civil No. 99-2496, 449 F. Supp. 2d 1 (D.D.C. 2006)
Key documents: Consent order, 2006 Opinion, 2023 Juul MDL document production opinion
In this historic case, filed by the Clinton Justice Department in 1999, a federal court found that the major cigarette companies had violated federal anti-racketeering laws by engaging in a massive conspiracy over several decades to defraud the American people by lying about the health effects of smoking and the marketing of cigarettes to children. As the trial was ending in 2005, Tobacco-Free Kids and five other public health groups successfully intervened in the case to argue for strong remedies to prevent future RICO violations by the defendant cigarette companies. Among the remedies ordered by the Court were corrective statements to be issued by the companies telling the truth about the hazards of cigarettes. The companies fought against the corrective statement requirement for eleven years, including four different appeals to the U.S. Court of Appeals for the District of Columbia Circuit. The companies exhausted their appeals in 2017 and corrective statements were implemented through required ads on three major TV networks (for 52 weeks starting November 2017), in full-page ads in the Sunday editions of 50 major newspapers (November 2017 to March 2018), in onserts on cigarette packs (for 12 weeks over a two-year period) and on company websites (indefinitely).
However, although the District Court had also ordered corrective statements to appear at the point of sale, the Court of Appeals reversed that remedy on the ground that the District Court had failed to adequately account for the interests of the retailers that would be required to display the statements. The case was remanded to the District Court for consideration of that issue and the Court set a trial for June 2022. As the trial date approached, the parties, including the public health intervenors, reached a settlement that would ensure that the corrective statements would appear at more than 220,000 retail establishments where cigarettes are sold for a period of 21 months. On December 6, 2022, the Court approved the settlement, in the form of a consent order.
In July 2023, the District Court also issued an order clarifying that Philip Morris’s IQOS HeatSticks, a heat-not-burn tobacco product, are considered cigarettes for purposes of the remedial order and thus subject to the court-ordered remedies. The court order, however, allows Philip Morris to make certain FDA-authorized modified exposure claims about its Heatsticks. Philip Morris initially appealed this decision before voluntarily dismissing its appeal in May 2024.
One of the other remedies ordered by the Court was a continuing obligation on the defendant companies, including Philip Morris, to post on a company website internal documents it produced in other litigation concerning “smoking and health, marketing, addiction, low-tar or low-nicotine cigarettes, or less hazardous cigarette research,” which had been the subject matters of the fraud. That obligation was to expire on September 1, 2021. Shortly before the expiration date, the public health intervenors filed a motion asking the Court to clarify that the 2006 document production order requires Philip Morris and its parent company Altria to post internal documents produced in discovery in the multidistrict litigation involving claims against Juul and Altria concerning fraudulent activity surrounding the marketing of Juul e-cigarettes. On June 19, 2023, the Court, noting the parallels between the fraudulent conduct at the heart of the DOJ’s RICO case on cigarettes and the allegations against Altria concerning its involvement with Juul e-cigarettes, ruled for the intervenors and ordered Altria to post on a website the internal documents it produced in discovery in the Juul multidistrict litigation and to maintain the documents on its website for one year, allowing others the opportunity to download the documents for more permanent retention.
Health Warnings and Other First Amendment Issues
Lawsuit Brought by Tobacco-Free Kids
American Academy of Pediatrics et al. v. FDA (U.S. District Court for the District of Massachusetts, 2016)
Case details: No. 1:16-cv-11985-IT, 330 F. Supp. 3d 657 (D. Mass. 2018)
Key documents: Complaint, motion for summary judgment, Court decision
Tobacco-Free Kids, joined by other public health groups and individual physicians, filed a lawsuit against the FDA seeking an order under the Administrative Procedure Act to require the agency to proceed with a rulemaking to require graphic warning labels on cigarette packages and advertisements following the agency’s years-long delay in issuing a new graphic health warnings rule, and to establish a firm deadline for issuance of a final rule. On September 5, 2018, Judge Indira Talwani issued a ruling in favor of the public health groups, finding that FDA had “unlawfully withheld” and “unreasonably delayed” issuance of a graphic warnings rule. The Court ordered the FDA to issue a graphic health warning proposed rule by August 15, 2019 and a final rule by March 15, 2020. FDA published the final rule on March 18, 2020.
Amicus Briefs Filed by Tobacco-Free Kids
Discount Tobacco City & Lottery, Inc. et al v. United States et al. (U.S. Court of Appeals for the Sixth Circuit, 2010)
Case details: Nos. 10-5234, 10-5235, 674 F.3d 509 (6th Cir. 2012)
District Court case details: Commonwealth Brands, Inc et al. v. FDA et al., No. 1:09-cv-117, 678 F. Supp. 2d 512 (E.D. Ky. 2010).
Key documents: Court of Appeals amicus brief, District Court amicus brief, Court of Appeals decision
Tobacco manufacturers and sellers challenged several provisions of the Tobacco Control Act, including the (1) requirement that tobacco manufacturers display health warnings, including graphic images, on the hazards of smoking, (2) restrictions on the commercial marketing of modified risk tobacco products, (3) ban on statements indicating a tobacco product has been approved by FDA or is safer because it is regulated by FDA, (4) limitation on most advertising of tobacco products to black text on a white background, and (5) prohibition on the distribution of free samples, brand-name sponsorship of athletic and social events, and brand-name merchandising of any non-tobacco product. Tobacco-Free Kids and other public health groups filed amicus briefs in both the district and appellate courts urging the courts to uphold the restrictions. The U.S. Court of Appeals for the Sixth Circuit upheld all of the challenged provisions, except the one limiting advertising to black text on a white background, finding that the restriction on the use of all color and imagery in most tobacco advertising was overly broad and violated the First Amendment. The Court determined that the other provisions did not violate the tobacco companies’ free speech or due process rights because they were not overly burdensome given the significant public health interests they sought to advance.
R.J. Reynolds Tobacco Company et al. v. FDA et al. (U.S. Court of Appeals for the District of Columbia, 2012)
Case details: No. 11-5332, 12-5063, 696 F.3d 1205 (D.C. Cir. 2012)
District Court case details: No. 11-1482, 823 F. Supp. 2d 36 (D.D.C. 2011); 845 F. Supp. 3d 266 (D.D.C. 2012)
Key documents: Court of Appeals amicus brief, District Court amicus brief, Court of Appeals decision
Five tobacco companies sued the FDA to challenge regulations requiring that cigarette packaging and advertising include one of nine text warnings along with “color graphics depicting the negative health consequences of smoking.” The tobacco companies also sought a preliminary injunction to prevent FDA from enforcing these requirements. Tobacco-Free Kids and our public health partners filed amicus briefs in both the district and appellate courts opposing the companies’ requested preliminary injunction, arguing that the warnings then in effect had failed to adequately inform consumers about the risks of tobacco use and that the government has a strong interest in more effectively informing consumers about these risks. The District Court granted the companies’ motion for a preliminary injunction and later struck down the warnings. On appeal, the U.S. Court of Appeals for the D.C. Circuit affirmed, finding that the government had not provided evidence demonstrating that the graphic warnings would directly advance the government’s interest in reducing the number of Americans who smoked.
R.J. Reynolds v. FDA (U.S. Court of Appeals for the Fifth Circuit, 2020)
Case details: No. 23-40076, 96 F.4th 863 (5th Cir. 2024)
District court case details: No. 6:20-cv-00176, 2022 WL 17489170 (E.D. Tex. Dec. 7, 2022)
Key documents: Court of Appeals amicus brief, District Court amicus brief, Court of Appeals opinion, District Court opinion
R.J. Reynolds filed a lawsuit in the U.S. District Court for the Eastern District of Texas to strike down FDA’s final rule mandating large, graphic health warnings on cigarette packs and advertising (the same rule is also being challenged in the U.S. District Court for D.C.). Tobacco-Free Kids filed an amicus brief, joined by other public health organizations, defending the warnings and arguing that the graphic warnings advance the governmental interest in enhancing public knowledge of the health hazards of smoking. After repeatedly postponing the effective date of the graphic warnings rule, the U.S. District Court for the Eastern District of Texas vacated the rule in December 2022, holding that it violated the First Amendment. Following an appeal from the FDA, and the filing of another amicus brief by Tobacco-Free Kids and other public health organizations, the U.S. Court of Appeals for the Fifth Circuit reversed the District Court, finding that the warnings were “factual and uncontroversial” and that they do not violate the First Amendment. The Court of Appeals remanded the case back to the District Court to consider Reynolds’ other claims that the warnings violate the Administrative Procedure Act and Tobacco Control Act. In August 2024, R.J. Reynolds filed a petition for a writ of certiorari with the U.S. Supreme Court requesting review of the Fifth Circuit’s decision on the First Amendment claims. That petition remains pending.
Philip Morris USA, Inc. v. FDA (U.S. District Court for the District of Columbia, 2020)
Case details: No. 1:20-cv-01181 (D.D.C.)
Key documents: Amicus brief
Philip Morris USA, Inc. filed a lawsuit in the U.S. District Court for the District of Columbia to strike down FDA’s final rule mandating large, graphic health warnings on cigarette packs and advertising (the same rule was also challenged in the Eastern District of Texas). Tobacco-Free Kids filed an amicus brief, joined by other public health organizations, defending the rule and arguing that the graphic warnings advance the governmental interest in enhancing public knowledge of the health hazards of smoking. The parties voluntarily dismissed the case after the Eastern District of Texas vacated the graphic warnings rule.
The Deeming Rule and Premarket Review
Lawsuit Brought by Tobacco-Free Kids
American Academy of Pediatrics et al. v. FDA (U.S. District Court for the District of Maryland, 2018)
Case details: No. PWG-18-883, 379 F. Supp. 3d 461 (D. Md. 2019) (merits decision); 399 F. Supp. 3d 479 (D. Md. 2019) (remedies decision)
Court of Appeals case details: In re Cigar Association of America, Nos. 19-2130, 19-2132, 19-2198, 19-2242, 812 F. App’x 128 (4th Cir. 2020)
Key documents: Complaint, summary judgment brief, remedies brief, Court’s merits decision, Court’s remedies decision
Tobacco-Free Kids along with a coalition of public health groups, sued the FDA to challenge a 2017 FDA Guidance that suspended, for several years, premarket review of e-cigarettes and cigars that were on the market prior to issuance of the Deeming Rule in August 2016. Our lawsuit charged that FDA acted arbitrarily and capriciously and that it lacked the authority under the Tobacco Control Act to suspend premarket review without a full rulemaking. After extensive briefing, federal District Court Judge Paul W. Grimm vacated the 2017 guidance and ordered the industry to submit applications by May 2020 (later pushed to September 9, 2020 due to the Coronavirus outbreak). Industry groups intervened and appealed the decision to the U.S. Court of Appeals for the Fourth Circuit, arguing that the ruling to vacate the 2017 guidance was incorrect. The Court of Appeals dismissed the appeal as moot, since FDA issued a new Guidance superseding the 2017 Guidance and adopting the application deadline previously ordered by the District Court.
Amicus Briefs Filed by Tobacco-Free Kids
Cigar Association of America et al. v. FDA (U.S. District Court for the District of Columbia and U.S. Court of Appeals for the District of Columbia, 2017)
Case details: No. 1:16-cv-1460 (D.D.C.)
Key documents: Court of Appeals amicus brief (Feb. 7, 2024); Court of Appeals amicus brief (February 22, 2021), Court of Appeals amicus brief (May 6, 2019), District Court amicus brief (April 16, 2021), District Court amicus brief (February 10, 2020), District Court amicus brief (August 8, 2019), District Court amicus brief (May 3, 2019), District Court amicus brief (October 31, 2017), Court of Appeals decision (2021), Court of Appeals decision (2020), District Court decision (2022)
Cigar and pipe tobacco trade associations challenged the FDA’s Deeming Rule’s assertion of FDA authority over cigars, including premium cigars, and also challenged other aspects of the Rule, including the requirement for new, larger health warnings. Tobacco-Free Kids and our public health partners have filed a total of eight amicus curiae briefs in the district and appellate courts in this case. In May 2018, the U.S. District Court for the District of Columbia upheld the required warning labels, FDA’s user fee rule, and its decision to regulate pipes, but the Court found that FDA’s rule designating tobacco retailers who blend pipe tobacco in-store as “manufacturers” was unreasonable under the Administrative Procedure Act. On appeal, however, the U.S. Court of Appeals for the D.C. Circuit struck down the warning labels as applied to all cigars, finding that the Deeming Rule did not contain evidence that the cigar warnings would actually reduce smoking, which the Appeals Court held was a required consideration under the Tobacco Control Act (TCA). In August 2020, the District Court decided several remaining issues. The Court found that: (1) FDA did not have the authority to adjust the grandfather date under the TCA, (2) the Deeming Rule’s August 2016 effective date was not based on faulty legal assumptions, (3) the deadline of September 9, 2020 for cigar and pipe tobacco manufacturers to submit substantial equivalence applications was reasonable, and (4) FDA’s cost-benefit analysis of requiring substantial equivalence reports for cigars and pipe tobacco manufacturers was reasonable. The District Court also considered challenges related only to premium cigars. The Court held that FDA had not adequately addressed industry comments urging the agency to create a separate, streamlined premarket review process for premium cigars. The Court remanded the Deeming Rule to FDA to determine whether such a process would be appropriate for premium cigars and enjoined FDA from enforcing the premarket review requirements on premium cigars. Following an appeal from the industry on the issues on which it had lost, the Court of Appeals affirmed the District Court’s August 2020 rulings on those issues in favor of the government. Finally, in July 2022, the District Court granted summary judgment to the industry on the claim that FDA arbitrarily and capriciously failed to exempt premium cigars from the Deeming Rule, and subsequently vacated the Deeming Rule as applied to premium cigars. FDA is currently appealing the July 2022 order and vacatur.
Nicopure Labs, LLC et al. v. FDA (U.S. Court of Appeals for the District of Columbia, 2018)
Case details: No. 17-5196, 944 F.3d 267 (D.C. Cir. 2019)
District Court case details: Nos. 16-0878 and 16-1210, 266F. Supp. 3d 360 (D.D.C. 2017)
Key documents: Court of Appeals amicus brief, District Court amicus brief, Court of Appeals decision, District Court decision
Nicopure Labs, an e-cigarette and e-liquid manufacturer, and various e-cigarette advocacy associations brought this lawsuit against the FDA in the U.S. District Court for the District of Columbia, claiming that the Deeming Rule imposed an undue and unfair burden on the companies by subjecting products on the market at the time to “premarket review” to determine if they were “appropriate for the protection of the public health.” In amicus briefs filed in the District Court and in the Court of Appeals, Tobacco-Free Kids countered that such premarket review is a powerful tool for FDA to understand what is on the market and to evaluate whether any of these products should be allowed to continue to be marketed, given their adverse impact on public health, particularly those that appeal to kids because of their fruit and candy flavors. The Plaintiffs also alleged that the Tobacco Control Act, through the Deeming Rule, violated the First Amendment by regulating claims about modified risk products and by banning free samples of e-cigarette devices and liquids. The District Court upheld the deeming rule and rejected Plaintiffs’ First Amendment claims. On appeal, the U.S. Court of Appeals for the D.C. Circuit affirmed the lower court’s decision in favor of FDA.
Vapor Technology Association et al. v. FDA (U.S. District Court for the Eastern District of Kentucky, 2019)
Case details: No. 5:19-cv-0330 (E.D. Ky.)
Court of Appeals case details: No. 20-5199, 977 F.3d 496 (6th Cir. 2020)
Key documents: District Court amicus brief, District Court decision, Court of Appeals decision
An e-cigarette manufacturer and trade association sued the FDA to challenge the premarket tobacco product application deadline established by the FDA in the Maryland District Court litigation brought by Tobacco-Free Kids and other public health groups. These same public health groups filed an amicus brief in support of the FDA, arguing that Plaintiffs’ lawsuit was a collateral attack on the Maryland order and that Plaintiffs’ requested relief would prevent FDA from taking actions recognized as necessary to address the unprecedented youth e-cigarette usage and addiction. The U.S. District Court for the Eastern District of Kentucky dismissed the action, supporting the FDA. Plaintiffs appealed to the U.S. Court of Appeals for the Sixth Circuit, which ruled that Plaintiffs did not have standing to challenge the deadlines because they were set by the Maryland District Court, not FDA.
Swisher International, Inc. v. FDA et al. (U.S. Court of Appeals for the Eleventh Circuit, 2021)
Case details: No. 21-13088, 2022 WL 320889 (11th Cir. 2022)
District Court case details: No. 21-cv-764, 2021 WL 4173841 (M.D. Fl. 2021)
Key documents: Court of Appeals amicus brief, M.D. Fl. District Court amicus brief, D.C. District Court amicus brief, Court of Appeals decision, M.D. Fl. District Court decision, D.C. District Court decision
Cigar manufacturer Swisher sued the FDA in the U.S. District Court for the Middle District of Florida, challenging the FDA’s Deeming Rule and seeking a preliminary injunction to prevent FDA from taking enforcement action against Swisher’s cigars while the agency considered the company’s marketing applications. The District Court denied Swisher’s motion, holding that an injunction would be premature because FDA was unlikely to take enforcement action against Swisher’s products in the immediate future. On appeal, the U.S. Court of Appeals for the Eleventh Circuit affirmed the lower court’s decision. Tobacco-Free Kids and our public health partners filed amicus briefs in both the Middle District of Florida and Eleventh Circuit opposing Swisher’s motion on the grounds that allowing Swisher’s cigars to remain on the market without marketing orders would harm the public health and undermine the order of the federal court in Maryland, which subjected all products without a marketing order to FDA enforcement beginning on September 9, 2021. The case was then transferred to the U.S. District Court for the District of Columbia to decide the merits of Swisher’s challenges to the Deeming Rule. Tobacco-Free Kids and our public health partners filed another amicus brief in the D.C. District Court that again emphasized that Swisher’s requested relief would harm public health and improperly undermine the District of Maryland’s order. On August 30, 2024, the D.C. District Court ruled in favor of the government on all counts, rejecting each of Swisher’s claims on the merits while also holding alternatively that Swisher was precluded from making many of its claims, which had already been rejected by other courts.
FDA Marketing Denial Order cases (2021-24)
Key documents: Sample amicus brief; Amicus brief in support of cert petition; Supreme Court amicus brief on the merits
Motion for stay decisions: Breeze Smoke, LLC v. FDA (6th Cir. 2021), Gripum LLC v. FDA (7th Cir. 2021), My Vape Order, Inc. v. FDA (9th Cir. 2021), 7 Daze, LLC v. FDA (9th Cir. 2022), Bidi Vapor LLC v. FDA (11th Cir. 2022), R.J. Reynolds Vapor Co. v. FDA (5th Cir. 2023) (menthol Vuse Vibe e-cigarette) , R.J. Reynolds Vapor Co. v. FDA (5th Cir. 2023) (menthol Vuse Solo e-cigarette)
Merits decisions: Prohibition Juice Co v. FDA (D.C. Cir. 2022), Wages & White Lion Invs., LLC v. FDA (5th Cir. 2022), Gripum LLC v. FDA (7th Cir. 2022), Bidi Vapor LLC v. FDA (11th Cir. 2022), Liquid Labs LLC v. FDA (3d Cir. 2022), Avail Vapor, LLC v. FDA (4th Cir. 2022), Magellan Technology, Inc. v. FDA (2d Cir. 2023), Lotus Vaping Technologies, LLC & Nude Nicotine Inc. v. FDA (9th Cir. 2023), Fontem US, LLC v. FDA (D.C. Cir. 2023), Logic Tech. Dev. LLC v. FDA (3d Cir. 2023), Wages & White Lion Invs., LLC v. FDA (5th Cir. 2024) (en banc); Electric Clouds v. FDA (10th Cir. 2024)
In September 2021, FDA began issuing marketing denial orders for flavored e-cigarettes, finding that the products were not “appropriate for the protection of public health” and thus may not be legally marketed in the US. Many companies that received denial orders sued FDA in federal courts of appeals across the country, challenging the orders as arbitrary and capricious and asserting that FDA exceeded its authority under the Tobacco Control Act. Some companies also sought to stay the denial orders while the courts decided the merits of the challenges. As of April 2024, Tobacco-Free Kids has filed a total of 27 amicus briefs, joined by other public health organizations, defending the agency’s denial orders and opposing stay requests. In two cases, Tobacco-Free Kids has also made filings requesting the unsealing of documents. The FDA has prevailed in the majority of the cases involving denial orders for flavored e-cigarettes, winning on the merits in 7 of the 9 courts of appeals that have ruled. Several companies have filed petitions for writ of certiorari, asking the Supreme Court to review one of these cases, and in March 2024, the FDA filed a cert petition in FDA v. Wages and White Lion Investments, LLC, D/B/A Triton Distribution et al. requesting Supreme Court review of a decision from the en banc 5th Circuit that struck down a denial order. Tobacco-Free Kids and our partners filed an amicus brief in support of FDA’s cert petition. In June 2024, the Supreme Court granted the government’s cert petition and, in August 2024 Tobacco-Free Kids and 10 other medical, public health and community groups filed an amicus brief on the merits urging reversal of the Fifth Circuit decision.
Menthol Cigarettes
Amicus Briefs Filed by Tobacco-Free Kids
R.J. Reynolds Tobacco Company et al. v. FDA (U.S. Court of Appeals for the District of Columbia, 2015)
Case details: No. 14-5226, 810 F.3d 827 (D.C. Cir. 2016)
District Court case details: Lorillard, Inc., et al v. FDA, No. 11-440, 56 F. Supp. 3d 37 (D.D.C. 2014)
Key documents: Amicus brief, Court of Appeals decision
Menthol cigarette producers challenged the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) in the U.S. District Court for the District of Columbia, alleging that three members of the committee had financial conflicts of interest that disqualified them from participating in the development of TPSAC’s menthol report. The District Court agreed with the tobacco companies and disqualified the TPSAC members because they had worked on smoking cessation products for pharmaceutical companies and/or had testified against the tobacco industry in liability cases. The District Court also enjoined the FDA’s use of the TPSAC menthol report. The FDA appealed the decision. Tobacco-Free Kids, joined by seventeen other public health and medical groups, filed an amicus brief urging reversal of the District Court decision and arguing that disqualifying TPSAC members because of such activity was not justified and would adversely affect FDA’s ability to appoint qualified and knowledgeable tobacco scientists in the future. The Court of Appeals reversed the lower court, on the ground that the Plaintiff tobacco companies did not yet have standing to challenge TPSAC’s membership because FDA had taken no action in reliance on the TPSAC menthol report that would adversely affect the companies’ interests. Thus, the companies were not at risk of imminent injury.
African American Tobacco Control Leadership Council (AATCLC) et al. v. HHS et al. (U.S. District Court for the Northern District of California, 2021)
Case details: No. 20-cv-04012 (N.D. Cal.), 4:24-cv-1992-HSG (N.D. Cal.)
Key documents: Amicus brief, Court decision
AATCLC and other public health organizations sued the FDA after it failed to respond to a Citizen Petition submitted in 2013 asking the agency to prohibit menthol in cigarettes. As a result of the lawsuit, FDA made an announcement on April 29, 2021 that it had plans to issue a proposed rule banning menthol cigarettes within the year. A proposed rule to ban menthol cigarettes was published in the Federal Register on May 4, 2022. Tobacco-Free Kids and other public health organizations filed an amicus brief arguing that the Court should exercise its jurisdiction in this case to set a firm timeline assuring completion of the rulemaking process with issuance of a final decision on whether the manufacture and sale of menthol cigarettes will be allowed to continue. Plaintiffs voluntarily dismissed the case after conferring with FDA and agreeing that the Citizen Petition had been granted when the FDA issued the proposed rule on banning menthol cigarettes. In 2024, plaintiffs filed a new complaint alleging that FDA has unlawfully withheld and unreasonably delayed promulgation of a final menthol rule.
Federal Preemption
Amicus Briefs Filed by Tobacco-Free Kids
23-24 94th Grocery Corp. et al. v. New York City Board of Health et al. (U.S. Court of Appeals for the Second Circuit, 2011)
Case details: No. 11-91-cv, 685 F.3d 174 (2d Cir. 2012)
District Court case details: No. 10-cv-4392, 757 F. Supp. 2d 407 (S.D.N.Y. 2010)
Key documents: Court of Appeals amicus brief, District Court amicus brief, Court of Appeals decision, District Court decision
In 2009, New York City’s Board of Health adopted a resolution requiring tobacco retailers to display signs next to their register or tobacco product display bearing graphic images depicting certain adverse health effects of smoking. Tobacco manufacturers, retailers, and trade groups challenged the resolution. Tobacco-Free Kids and other public health groups filed amicus briefs in both the district and appellate courts arguing that the resolution was narrowly tailored to advance the City’s compelling interest in alerting consumers to the adverse health effects of smoking, and that the resolution was not preempted by federal law. The U.S. Court of Appeals for the Second Circuit affirmed the lower court’s ruling striking down the warnings and holding that the warnings regulated the content of tobacco manufacturers’ promotional activities, which under the Federal Cigarette Labeling and Advertising Act is something only the federal government can regulate.
National Association of Tobacco Outlets, Inc. et al. v. City of Providence et al. (U.S. Court of Appeals for the First Circuit, 2013)
Case details: No. 13-1053, 731 F.3d 71 (1st Cir. 2013)
District Court case details: No. 12-96, 2012 WL 6128707 (D.R.I. 2012)
Key documents: Court of Appeals amicus brief, District Court amicus brief, Court of Appeals decision
Tobacco companies challenged two Providence ordinances that prohibited retailers from selling most flavored tobacco products except at a smoking bar, and from accepting discount coupons for tobacco products. Public health groups, including Tobacco-Free Kids, submitted amicus briefs in both the district and appellate courts defending the ordinances and the City’s authority to enact them. The U.S. Court of Appeals for the First Circuit affirmed the District Court’s ruling that neither ordinance was preempted by federal law or otherwise illegal. The Court held that the flavors provision related only to the sale of tobacco products, an area that the Tobacco Control Act expressly allows state and local jurisdictions to regulate, and that the coupon ban was not preempted by the Federal Cigarette Advertising and Labeling Act nor did it violate the First Amendment. The Court also concluded that neither ordinance violated state law or the Rhode Island Constitution.
R.J. Reynolds Tobacco Company et al. v. County of San Diego and Neighborhood Market Association, Inc. et al. v. County of San Diego (U.S. District Court for the Southern District of California, 2020)
Case details: R.J. Reynolds, No. 20-cv-1290, 529 F. Supp. 3d 1147 (S.D. Cal. 2021); Neighborhood Market Ass’n, No. 20-cv-1124, 529 F. Supp. 3d 1123 (S.D. Cal. 2021).
Key documents: Amicus brief in R.J. Reynolds, Amicus brief in Neighborhood Market, Court decision
R.J. Reynolds sued the County of San Diego after the County passed an ordinance banning the sale of flavored tobacco products, and quickly asked the court to enjoin enforcement of the ordinance. The lawsuit argued that the ordinance was preempted by the Tobacco Control Act because it constitutes a product standard that only FDA has the authority to adopt. Shortly before R.J. Reynolds filed its lawsuit, a vape shop and retail association sued the County challenging the same ordinance in the same court. That case was transferred to the judge deciding the R.J. Reynolds case, who issued identical opinions in each of the cases upholding the County’s flavor ordinance. Tobacco-Free Kids and our public health partners filed amicus briefs in both actions opposing the companies’ attempt to enjoin the ordinance and presented evidence to the Court that an injunction against San Diego County’s ordinance would be harmful to public health.
R.J. Reynolds Tobacco Company et al. v. City of Edina (U.S. District Court for the District of Minnesota, 2020)
Case details: No. 20-cv-1402, 382 F. Supp. 3d 875 (D. Minn. 2020)
Key documents: Court of Appeals amicus brief, District Court decision
The U.S. District Court for the District of Minnesota upheld the Edina, Minnesota flavor ban against a federal preemption challenge filed by R.J. Reynolds. The U.S. District Court for the District of Minnesota held that the local flavor ban did constitute a product standard, but that it was not preempted due to the “savings clause” of the Tobacco Control Act. The District Court’s decision was appealed to the U.S. Court of Appeals for the Eighth Circuit, where Tobacco-Free Kids joined an amicus brief arguing that state and local bans on the sale of flavored tobacco products constitute sales restrictions, not preempted product standards. The Court upheld Edina’s ordinance, stating that the Tobacco Control Act does not expressly or impliedly preempt Edina’s prohibition on selling flavored tobacco products.
R.J. Reynolds Tobacco Company et al. v. Becerra et al. (U.S. District Court for the Southern District of California, 2020)
Case details: No. 20-cv-1990 (S.D. Cal.)
Key document: Amicus brief
On August 28, 2020, the State of California enacted Senate Bill 793 to ban the sale of flavored tobacco products, including menthol cigarettes. R.J. Reynolds, Philip Morris USA, Neighborhood Market Association, and other industry groups filed a lawsuit in federal court seeking a preliminary injunction against the bill. The lawsuit alleges California’s law constitutes a product standard that is preempted by the federal Tobacco Control Act. Tobacco-Free Kids filed an amicus brief, joined by nineteen national and California public health and medical groups, supporting the position of the State and opposing the motion for a preliminary injunction. Because Senate Bill 793 was put on the November 2022 ballot to be approved or rejected by voters, the court dismissed the case on ripeness grounds since, at the time, enactment of the law was uncertain. In November 2022, California voters overwhelmingly upheld Senate Bill 793.
R.J. Reynolds Tobacco Company et al. v. County of Los Angeles (U.S. Court of Appeals for the Ninth Circuit, 2021)
Case details: No. 2:20-4880, 2020 WL 5405668 (C.D. Cal. 2020)
Court of Appeals case details: No. 20-55930, 29 F.4th 542 (9th Cir. 2022)
Key documents: Court of Appeals amicus brief, Court of Appeals decision
R.J. Reynolds sued the County of Los Angeles after the County passed a bill banning the sale of flavored tobacco products. The lawsuit argued that the ordinance was preempted by the Tobacco Control Act because it constitutes a product standard that only FDA has the authority to adopt. The U.S. District Court for the Central District of California ruled that the Tobacco Control Act reserves to states and localities the authority to impose restrictions on sales of tobacco products. R.J. Reynolds appealed the decision to the U.S. Court of Appeals for the Ninth Circuit, which upheld the District Court ruling. Tobacco-Free Kids and our public health partners filed an amicus brief in support of the County in the Court of Appeals. In October 2022, R.J. Reynolds filed a petition for a writ of certiorari asking the U.S. Supreme Court to review the Ninth Circuit’s decision. The petition for a writ of certiorari was denied in February 2023.
R.J. Reynolds et al. v. Bonta et al. (U.S. Supreme Court, 2022)
Case details: No. 22A474, 2022 WL 17576427 (U.S. 2022)
Supreme Court, Appellate, and District Court details: No. 23-207 (Supreme Court); No. 22-56052 (9th Cir. 2022); No. 22-cv-1755, 2022 WL 16986580 (S.D. Cal. 2022)
Key documents: Supreme Court amicus brief, Supreme Court order, District Court order granting motion to dismiss
Tobacco-Free Kids and 22 public health partners filed an amicus brief in the U.S. Supreme Court urging rejection of R.J. Reynolds’ request to Justice Elena Kagan for an emergency injunction against California’s law ending the sale of most flavored tobacco products (Senate Bill 793). R.J. Reynolds argued that the Tobacco Control Act preempted California from enacting its flavored tobacco law, which was overwhelmingly approved by state lawmakers in 2020 and, following an industry-sponsored effort to place the law on the ballot, upheld by 64% of the state’s voters in November 2022. Our brief explained why the California law is not preempted by the Tobacco Control Act and argued that an injunction delaying the implementation of the law would harm public health. On December 12, 2022, the Supreme Court denied the request, allowing California’s law to take effect on December 21, 2022. On March 15, 2023, the U.S. District Court for the Southern District of California dismissed the case, further finding that S.B. 793 did not violate the United States Constitution’s dormant Commerce Clause. Following an appeal from Reynolds, the U.S. Court of Appeals for the Ninth Circuit upheld the lower court’s order. On January 8, 2024, the Supreme Court denied Reynolds’ petition for a writ of certiorari, thus marking the end of the case.
FDA Regulatory Authority Over E-Cigarettes
Amicus Briefs Filed by Tobacco-Free Kids
Sottera, Inc. v. FDA et al. (U.S. Court of Appeals for the District of Columbia, 2010)
Case details: No. 10-5032, 627 F.3d 891 (D.C. Cir. 2010)
District Court case details: Smoking Everywhere Inc. v. FDA, No. 09-771, 680 F. Supp. 2d 62 (D.D.C. 2010).
Key documents: Court of Appeals amicus brief, Court of Appeals decision, District Court decision
Prior to the FDA deeming regulation that enabled the agency to regulate e-cigarettes (among other products) under its tobacco authorities, FDA attempted to regulate e-cigarettes using its drug and device authorities. In response, two e-cigarette companies sued FDA seeking to enjoin the agency from regulating e-cigarettes as drugs and/or devices. In their amicus brief, Tobacco-Free Kids and other public health groups argued that an injunction would harm the public health by allowing e-cigarettes to remain on the market free from FDA oversight. The U.S. Court of Appeals for the D.C. Circuit sided with the e-cigarette companies and affirmed the District Court’s injunction, finding that e-cigarettes that do not make therapeutic claims may only be regulated by the FDA as tobacco products.
Local Bans on Tobacco Price Discounting
Amicus Briefs Filed by Tobacco-Free Kids
National Association of Tobacco Outlets, Inc et al. v. City of New York et al. (U.S. District Court for the Southern District of New York, 2014)
Case details: No. 14-CV-00577 (S.D.N.Y. 2014)
Key documents: Amicus brief, Court decision
The tobacco industry challenged a New York City ordinance banning the discounting of tobacco products, including the redemption of discount coupons, asserting that the ordinance violated the First Amendment and was preempted by federal and state law. Tobacco-Free Kids filed a brief, joined by 11 national, state and local public health and medical organizations, urging the Court to uphold the New York City law as a necessary strategy to prevent tobacco companies from undermining the City’s efforts to maintain high tobacco prices to reduce tobacco use, particularly among young people. The Court upheld the ordinance, concluding that it did not violate the First Amendment, and that neither federal nor state laws preempted its enactment.
Delivery of Untaxed Cigarettes
Amicus Briefs Filed by Tobacco-Free Kids
State of New York et al. v. United Parcel Service, Inc. (U.S. Court of Appeals for the Second Circuit, 2018)
Case details: Nos. 17-1993-cv, 17-2107-cv, 17-2111-cv, 942 F.3d 554 (2d Cir. 2019)
District Court case details: No. 15-cv-1136, 253 F. Supp. 3d 583 (S.D.N.Y. 2017) (merits decision); 2017 WL 2303525 (S.D.N.Y. 2017) (damages decision)
Key documents: Court of Appeals amicus brief, Court of Appeals decision
Tobacco-Free Kids and our public health partners filed an amicus brief in the U.S. Court of Appeals for the Second Circuit supporting the affirmance of a District Court judgment of $247 million in damages and penalties against UPS for delivering untaxed cigarettes from Indian reservations in New York in violation of a previous consent agreement and state and federal laws. Our brief emphasized the public health importance of preventing cigarette tax avoidance, which undermines the State’s use of taxation to maintain high prices for cigarettes and thus diminish consumption, particularly among price-sensitive youth. The U.S. Court of Appeals for the Second Circuit affirmed the judgment of liability against UPS, although it ruled that the District Court had made several legal errors in calculating the penalties and reduced the total judgment to $97.6 million.
Last Updated Nov. 1, 2024