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.
On April 14, Iowa Attorney General (AG) Brenna Bird, leading a coalition of 13 state AGs, sent a pointed letter to Visa, Mastercard, American Express, and Discover. Their message was clear: payment networks are expected to help shut down the U.S. market for unauthorized e‑cigarette products.
On March 9, the U.S. Food and Drug Administration (FDA) released a draft guidance document describing the agency’s perspective on premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS).
A recent decision of the U.S. Court of Appeals for the Third Circuit serves as a stark reminder to companies and individuals in the state-legal cannabis industry that the federal illegality of cannabis can jeopardize their ability to enforce contracts in federal court.