Photo of Agustin Rodriguez

Agustin is sought after by clients for his strategic counsel on their most challenging competitive and regulatory compliance issues, including tobacco Master Settlement Agreement issues, federal and state enforcement investigations, licensing and excise tax issues, developing compliance programs, and evaluating advertising and marketing practices. A partner in the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group as well as its Tobacco and Cannabis law practices, he represents manufacturers, distributors, retailers, and suppliers in all aspects of their businesses, including regulatory compliance, FDA requirements, administrative disputes involving federal or state governmental entities, mergers and acquisitions, commercial agreements, and taxation matters.

The Florida attorney general (AG) recently initiated legal proceedings against several Florida smoke shops, alleging violations of state law related to the sale and marketing of illegal nicotine products, particularly vapor products, to minors. The action targets multiple businesses, including 27 Smoke Shop Inc., A&A Smoke Shop LLC, Alami 9 LLC, Alami 10 LLC, Epic Novelty LLC, and Fuego Smoke Shop LLC. The complaint, filed in the Fifth Judicial Circuit, accuses these retailers of selling, shipping, or failing to remove from their inventory nicotine products that are classified as illegal contraband under Florida law, with a particular focus on products marketed to children.

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.).

In this episode of our special 12 Days of Regulatory Insights podcast series, Chris Carlson is joined by colleagues Bryan Haynes and Agustin Rodriguez — members of our Tobacco and Nicotine Practice and RISE Practice Group — to review the year’s most consequential developments in the tobacco and nicotine space and what they mean heading into 2026.

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.”

In May, we wrote about the Trump administration’s first major enforcement action involving the importation of unauthorized e-cigarettes, in which the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) seized products valued at nearly $34 million. FDA and CBP have once again seized unauthorized e-cigarettes in Chicago, but this time the estimated retail value was $86.5 million — the largest seizure of its kind. This enforcement action is consistent with a statement on FDA’s website: “[e]nforcing against unauthorized ENDS products, including unauthorized products popular with youth, are [sic] among our highest enforcement priorities.” FDA maintains that decisions about whether to take enforcement action will continue to be made on a case-by-case basis after considering youth use and other risk factors.

This article was originally published on August 29, 2025 on Law360 and is republished here with permission.

On June 20, in U.S. Food and Drug Administration v. R.J. Reynolds Vapor Co., the U.S. Supreme Court concluded that marketing denial orders issued by the FDA regarding new tobacco products can be challenged not only by the applicants — typically, the manufacturer or importer of the products — but also by retailers of such products.[1]