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On March 9, the U.S. Food and Drug Administration (FDA) released a draft guidance document describing the agency’s perspective on premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS).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“Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk: Draft Guidance for Industry,” available here (Draft Guidance), reflects FDA doubling down on its heightened expectations for flavored ENDS PMTAs.

Bryan Haynes and Agustin Rodriguez of Troutman Pepper Locke Tobacco + Nicotine team will attend the Total Product Expo show in Las Vegas, March 31 to April 2.

This show is a great opportunity for manufacturers, importers, distributors, retailers and other stakeholders in the nicotine and tobacco industry to connect…

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).

On October 27, FDA appealed a decision of the U.S. District Court for the Southern District of Georgia that vacated the agency’s 2020 rule requiring graphic health warnings on cigarette packaging and advertisements.  This appeal to the U.S. Court of Appeals to the Eleventh Circuit, along with a separate challenge pending before the Fifth Circuit, may determine whether FDA’s second attempt to impose graphic health warnings on cigarettes will be successful.[1]

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.”

Michael Jordan joined the “Product Compliance” panel at the Food & Drug Law Institute’s (FDLI) Introduction to Tobacco and Nicotine Law and Regulation course on October 8. The panel covered topics such as labeling and warning requirements, product registration and ingredient submission, user fees and tobacco taxation, marketing and advertising…

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.

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.

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.

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.