The U.S. Food and Drug Administration (FDA) cigarette graphic health warning saga continues. On August 18, 2026, the U.S. Court of Appeals for the Fifth Circuit issued a decision in R.J. Reynolds Tobacco Co. v. FDA, No. 25-40137, affirming the Eastern District of Texas’s order postponing the effective date of FDA’s 2020 cigarette graphic health warning rule pending a final decision on the merits. The decision delivers another significant setback for FDA’s long-running effort to require graphic images on cigarette packaging and advertisements — and provides clarity on the statutory limits of the agency’s authority under the Federal Food, Drug, and Cosmetic Act (FDCA) and the Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by the 2009 Family Smoking Prevention and Tobacco Control Act (TCA).
Advocacy Groups Sue FDA Over May 2026 Enforcement Guidance — What Industry Needs to Know
As our Tobacco + Nicotine team previously reported, FDA’s May 8, 2026 guidance (the 2026 Guidance or the Guidance) on enforcement priorities for certain unauthorized ENDS and nicotine pouch products created a path for products with pending premarket tobacco product applications (PMTAs) to remain on the market. That Guidance is now being challenged in federal court by advocacy organizations, threatening the viability of FDA’s enforcement discretion.
Ninth Circuit Upholds ATF’s PACT Act Authority Over Tribal Cigarette Sales
Over the last couple of years, we have written about a federal case brought by the Twenty-Nine Palms Band of Mission Indians (the Tribe) (here, here, and here) involving key issues related to the Bureau of Alcohol, Tobacco, Firearms and Explosives’ (ATF) authority to enforce the Prevent All Cigarette Trafficking Act (PACT Act) against federally recognized Indian tribes and ATF’s interpretation of key sections of the PACT Act. The Ninth Circuit Court of Appeals recently upheld a federal district court’s decision ruling against the Tribe.
Federal Court Finalizes Definition of FDA-Exempt Premium Cigars
For years, we have written (here, here, here, and here) about the decade-long effort to vacate the U.S. Food and Drug Administration’s (FDA) decision to “deem” premium cigars covered by FDA’s 2016 rule (the Deeming Rule), which swept all tobacco products under FDA authority. On April 15, the U.S. District Court for the District of Columbia issued an order that it characterized as “(hopefully) … the final chapter” in the litigation over how FDA regulates premium cigars. The parties have 30 days to appeal the order, but, if not, the order will stand.
North Carolina Court Affirms Sealed Container Defense in Vape Battery Malfunction Case
The North Carolina Court of Appeals recently issued a decision strengthening the “sealed container” defense available to non‑manufacturing sellers in products liability cases. In Weaver v. AMV Holdings LLC, the court found in favor of a vape retailer and distributor after a lithium‑ion battery malfunctioned in a customer’s pocket, causing serious burns. For retailers and distributors — particularly those dealing with lithium‑ion batteries — this decision underscores the continued viability of sealed container defenses.
Florida AG Sues Retailers for Alleged Violations of Nicotine Product and Consumer Protection Laws
The Florida attorney general (AG) recently initiated legal proceedings against several Florida smoke shops, alleging violations of state law related to the sale and marketing of illegal nicotine products, particularly vapor products, to minors. The action targets multiple businesses, including 27 Smoke Shop Inc., A&A Smoke Shop LLC, Alami 9 LLC, Alami 10 LLC, Epic Novelty LLC, and Fuego Smoke Shop LLC. The complaint, filed in the Fifth Judicial Circuit, accuses these retailers of selling, shipping, or failing to remove from their inventory nicotine products that are classified as illegal contraband under Florida law, with a particular focus on products marketed to children.
Court Rules That Ohio AG Cannot Enforce FDA Premarket Authorization Requirements
An Ohio appellate court recently affirmed the dismissal of a case brought by the Ohio attorney general (AG) against Central Tobacco & Stuff Inc. (Central Tobacco), an e-cigarette retailer, in which the AG alleged that Central Tobacco sold e-cigarettes lacking FDA premarket authorization and violated the state’s Consumer Sales Practices Act (CSPA) by failing to inform consumers about the lack of FDA authorization. See State ex rel. Attorney Gen. Dave Yost v. Cent. Tobacco & Stuff Inc., 2025-Ohio-4613 (Ct. App.). This appears to be a novel use of a state consumer protection law, which most states have, to attempt to enforce the Federal Food, Drug, and Cosmetic Act (FDCA). The court concluded that federal law preempts Ohio’s ability to enforce FDCA premarket authorization requirements through the CSPA. The court’s decision may be relevant in other cases involving a state’s attempt to enforce FDA premarket authorization requirements through their consumer protection laws.
Feds Seize Illegal E-Cigarettes Worth Millions
In May, we wrote about the Trump administration’s first major enforcement action involving the importation of unauthorized e-cigarettes, in which the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) seized products valued at nearly $34 million. FDA and CBP have once again seized unauthorized e-cigarettes in Chicago, but this time the estimated retail value was $86.5 million — the largest seizure of its kind. This enforcement action is consistent with a statement on FDA’s website: “[e]nforcing against unauthorized ENDS products, including unauthorized products popular with youth, are [sic] among our highest enforcement priorities.” FDA maintains that decisions about whether to take enforcement action will continue to be made on a case-by-case basis after considering youth use and other risk factors.
Court Denies Indian Tribe’s Injunction Request Pending Appeal in PACT Act Case
We recently wrote about a federal case here and here involving key issues related to the Bureau of Alcohol, Tobacco, Firearms and Explosives’ (ATF) authority to enforce the Prevent All Cigarette Trafficking Act (PACT Act) against federally recognized Indian tribes and ATF’s interpretation of key sections of the PACT Act. In addition to appealing the U.S. District Court for the Central District of California’s decision, we noted that the Twenty-Nine Palms Band of Mission Indians (the Tribe) asked the district court to require ATF to remove it from the agency’s PACT Act noncompliant list (NCL) and prevent ATF and the other defendant, the Department of Justice from taking action against it pending its appeal before the U.S. Court of Appeals for the Ninth Circuit. On July 30, the federal district court denied the Tribe’s request.
Indian Tribe Fights With ATF Over Applicability of PACT Act to Its Cigarette Sales
In 2023, the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) placed Twenty-Nine Palms Band of Mission Indians (Twenty-Nine Palms), a federally recognized Indian tribe that sells cigarettes on sovereign reservations in California, on the Prevent All Cigarette Trafficking Act’s (PACT Act’s) noncompliant list (NCL). The PACT Act generally prohibits common carriers from shipping products to or from companies on the NCL. After ATF placed Twenty-Nine Palms on the NCL, the tribe sued ATF and its parent agency, the Department of Justice (DOJ), in federal court. This case is worth following because it involves key issues related to ATF’s authority to enforce the PACT Act against federally recognized Indian tribes and ATF’s interpretation of key sections of the PACT Act.