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.
This article was originally published on Law360 and is republished here with permission as it originally appeared on August 21, 2026.
On July 30, two federal appeals courts permitted the enforcement of state laws in Iowa and North Carolina conditioning the sale of electronic nicotine delivery systems, or ENDS, on a manufacturer’s certification of compliance with U.S. Food and Drug Administration premarket review requirements.[1]
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.
The Texas Supreme Court (the Court) recently issued an important tax decision for modern oral nicotine products, such as nicotine pouches. In Hancock v. RJR Vapor Co., LLC, the Court held in favor of Acting Comptroller Hancock, finding that RJR Vapor Co., LLC’s (RJR) VELO oral nicotine pouches are taxable as “tobacco products” under the Texas tobacco products tax, and reversed a lower court decision holding that they were not taxable “tobacco products.”
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.
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).
In April 2026, the U.S. Department of Justice (DOJ) and Drug Enforcement Administration (DEA) announced a significant shift in federal cannabis policy. Effective immediately, the following categories of marijuana have been rescheduled from Schedule I to Schedule III under the Controlled Substances Act (CSA): (i) U.S. Food and Drug Administration (FDA)-approved drug products that contain marijuana; and (ii) marijuana in any form covered by a state medical marijuana license.