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.
Nicotine Pouches Taxable as “Tobacco Products” in Texas, State Supreme Court Rules
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.”
FDA Issues Draft Guidance on Flavored ENDS PMTAs
On March 9, the U.S. Food and Drug Administration (FDA) released a draft guidance document describing the agency’s perspective on premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS).
The document, titled “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk: Draft Guidance for Industry,” available here (Draft Guidance), reflects FDA doubling down on its heightened expectations for flavored ENDS PMTAs.
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.).
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.
This litigation is a recent addition to the growing list of legal challenges to state vapor product directories around the country—and the second to arise in federal courts within the Fourth Circuit. Like these other ongoing challenges, the Virginia case raises the issue of whether these state directory regimes are preempted under the Federal Food, Drug, and Cosmetic Act (FDCA).
FDA Pilot Program Will Fast-Track Certain Nicotine Pouch PMTAs
In September, the U.S. Food and Drug Administration (FDA) announced that it has launched a pilot program aimed at streamlining the agency’s review of certain premarket tobacco product applications (PMTAs) for modern oral nicotine pouches.
The announcement notes that evidence suggests nicotine pouches can help adults switch away from more harmful tobacco products. Although nicotine pouch PMTAs will still be subject to the traditional case-by-case review, FDA says the pilot program will “increase efficiency by focusing review on the most critical elements for this product category to determine whether permitting the marketing of a product is appropriate for the protection of the public health.”
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, which the state 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, 2025.
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).
As we recently covered here, FDA has struggled to control the proliferation of ENDS products that are not in compliance with premarket authorization requirements. Flavored illicit disposable ENDS have been particularly dominant in the face of lacking federal enforcement. This litigation is significant because it highlights another key reason for the illicit products’ dominance: FDA’s failure to timely act on premarket submissions for flavored 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.
Sam’s Club Eyeing Appeal of Hefty Local Tobacco Tax Assessment
In June, the Appellate Court of Illinois upheld an assessment of over $314 million against Sam’s Club for unpaid county cigarette excise taxes, including a 10% late fee, a 25% penalty, and accrued interest. The assessment arose from Sam’s Club’s alleged failure to pay taxes on cigarettes that it sold to out-of-county retailers from 2009 to 2016. Following the June ruling, the company now appears poised to bring its arguments to the state’s highest court in a case illustrating the ambiguities of state and local excise taxation laws.