Compliance

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On September 2, 2026, a group of tobacco product manufacturers and retailers filed a complaint in federal court, the U.S. District Court for the Northern District of Texas, challenging the U.S. Food and Drug Administration’s (FDA) 2021 premarket tobacco product application (PMTA) rule. Plaintiffs take aim at a regulation they say has made it virtually impossible for the FDA to authorize new tobacco products within the timeline Congress set more than 15 years ago. The case raises fundamental questions about whether a federal agency can adopt a regulatory process that, by design, cannot meet its own statutory deadlines.

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’ 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).

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.

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.

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.

On March 26, 2026, California Attorney General (AG) Rob Bonta filed a complaint in state court against six individuals and three organizations for allegedly creating and operating sham charities. According to the complaint, the defendants used the organizations to raise approximately $3.8 million, which they used for personal expenses. The complaint alleges that these actions resulted in violations of various state laws, including California’s Charitable Supervision Act.

What Happened

States including Texas, Utah, Louisiana, and California have begun shifting children’s online safety obligations from individual apps and websites to app stores and operating systems. These laws generally require centralized age checks, parental consent tracking, and tighter coordination between app stores and developers, and they are already generating litigation risk, including a pending First Amendment challenge to the Texas statute. For a deeper overview of these state approaches and the emerging legal challenges, see this article.

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.

California recently finalized changes to its Proposition 65 (Prop 65) warning rules that included significant changes to short-form warning statements for product labels. These changes directly affect nicotine‑containing products — including e‑cigarettes, e‑liquids, oral nicotine products, and other consumer goods that can expose consumers to nicotine.

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.