The U.S. Court of Appeals for the Fifth Circuit recently ruled in NicQuid, L.L.C. v. FDA, No. 24-60272 (5th Cir. Aug. 19, 2026), that the U.S. Food and Drug Administration’s (FDA) “comparative efficacy standard” is a substantive rule that was adopted in violation of the Administrative Procedure Act’s (APA) notice-and-comment rulemaking requirements.
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.
On August 31, the U.S. Securities and Exchange Commission (SEC) and the U.S. Food and Drug Administration (FDA) executed a Memorandum of Understanding (MOU) establishing a formal framework for sharing nonpublic information between the two agencies. The MOU takes effect immediately upon signature and reflects a significant step toward coordinated regulatory and enforcement activity at the intersection of public health and financial markets.
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.
In June, the U.S. District Court for the Middle District of Florida made public an order that stayed a Food and Drug Administration (FDA) refuse to file (RTF) determination, finding that the FDA likely violated the Regulatory Flexibility Act (RFA) and the Administrative Procedure Act (APA) when it promulgated its 2021 PMTA rule based on a small-business certification that the court described as “facially false.” The RTF letter is stayed pending final judgment.
On June 29, 2026, the U.S. Food and Drug Administration (FDA) published a notice of proposed rulemaking (NPRM) titled “Establishment Registration and Product Listing for Tobacco Products,” which would, for the first time, require foreign tobacco product manufacturers to register their manufacturing establishments and list their products with the agency. Domestic manufacturers are already subject to these registration and listing requirements; foreign manufacturers are not. This regulation, if finalized, would close that gap.
A New Jersey queso fresco manufacturer’s ignored U.S. Food and Drug Administration (FDA) warnings culminated in a federal guilty plea after its products were linked to a multistate listeria outbreak that hospitalized at least 13 people and killed one. The case of Abuelito Cheese Inc. illustrates how regulatory noncompliance, left unaddressed, can escalate from civil enforcement into criminal liability under the Federal Food, Drug, and Cosmetic Act (FDCA).
On May 8, the U.S. Food and Drug Administration (FDA) issued guidance that clarifies how the agency enforces premarket review requirements for certain electronic nicotine delivery system (ENDS) products and nicotine pouches with pending premarket tobacco applications (PMTAs).
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.