On March 9, the U.S. Food and Drug Administration (FDA) released a draft guidance document describing the agency’s perspective on premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS).
Third Circuit Ruling Highlights Unique Dynamics for Cannabis-Related Contract Disputes
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.
Circuit Split Emerges on State Marijuana Residency Rules, With Ninth Circuit Finding Dormant Commerce Clause Inapplicable
In January, the U.S. Court of Appeals for the Ninth Circuit ruled 3-0 that the Dormant Commerce Clause does not prohibit states from imposing residency requirements for obtaining marijuana business licenses. The court found that the federal illegality of marijuana renders Dormant Commerce Clause protections inapplicable, cementing a circuit split on the constitutionality of state residency rules for marijuana licenses.
Federal Court Bars Enforcement of Virginia Vapor Directory, Pending Fourth Circuit Ruling
We recently covered this case here, in which a small manufacturer and retailer sued the Virginia attorney general (AG) and tax commissioner in the U.S. District Court for the Eastern District of Virginia, seeking to enjoin enforcement of the vapor product directory law. See Nova Distro, Inc., et al. v. Miyares et al., No. 3:25-cv-857 (E.D.V.A.). There, we also noted another ongoing case challenging a similar law in North Carolina, for which oral argument is scheduled before the U.S. Court of Appeals for the Fourth Circuit on January 29, 2026. See Vapor Technology Association, et al. v. Wooten et al., No. 25-1745 (4th Cir.).
Congress Narrows Federal Definition of ‘Hemp,’ Effectively Banning Most Intoxicating Hemp Products
Congress has enacted H.R. 5371, the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026. Section 781 of the law substantially amends the Agricultural Marketing Act’s definition of “hemp,” tightening the THC threshold and explicitly excluding several categories of hemp-derived cannabinoid products from the definition. Because the Controlled Substances Act (CSA) excludes “hemp” by cross-reference to the Agricultural Marketing Act, narrowing the hemp definition will push many currently marketed intoxicating hemp products back into Schedule I status under the CSA once these changes take effect.
Virginia’s Vapor Product Directory Challenged in Federal Court
Earlier this fall, a small manufacturer and retailer (the plaintiffs) sued Virginia Attorney General (AG) Jason Miyares and Tax Commissioner James Alex (the defendants) in the U.S. District Court for the Eastern District of Virginia, seeking to enjoin their enforcement of Virginia’s vapor product directory regime, Va. Code Ann. §§ 59.1-293.14 to .21, which the General Assembly passed in 2024.
FDA Pilot Program Will Fast-Track Certain Nicotine Pouch PMTAs
In September, the U.S. Food and Drug Administration (FDA) announced the launch of a pilot program aimed at streamlining the agency’s review of certain premarket tobacco product applications (PMTAs) for modern oral nicotine pouches.
California Finalizes Unflavored Tobacco List Regulations
In August, the California Department of Justice (DOJ) finalized regulations to implement California’s unflavored tobacco list (UTL) law, enacted in 2024. The new regulations include detailed filing requirements for manufacturers and importers to have their tobacco products legally sold in California.
The deadline for applicants to be considered for the initial publication of the UTL is October 9.
FDA Sued Over Years-Long Internal Review of Flavored ENDS MDO
On August 21, 2025, NJOY, LLC (NJOY), a subsidiary of Altria Group, Inc., sued the U.S. Food and Drug Administration (FDA), alleging that the agency has unlawfully delayed rendering a decision on supervisory review of its June 2022 marketing denial order (MDO) for certain flavored, disposable electronic nicotine delivery systems (ENDS).
FDA Tobacco Civil Money Penalty Provisions Ruled Unconstitutional, but Not Enjoined Nationwide
In early August, the U.S. District Court for the Northern District of Texas ruled that the civil money penalty (CMP) provision in the Food, Drug, and Cosmetic Act (FDCA) for tobacco products, 21 U.S.C. § 333(f)(9), is unconstitutional. Specifically, the court found that the FDCA improperly allows the U.S. Food and Drug Administration (FDA) to bring an administrative action to collect CMPs because the Seventh Amendment guarantees the right to a jury trial in such cases.