On March 9, the U.S. Food and Drug Administration (FDA) released a draft guidance document describing the agency’s perspective on premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS).
Reviewing, analyzing, and navigating compliance, enforcement, investigation, and litigation developments and trends in the state and federal regulatory landscape
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.
On March 9, the U.S. Food and Drug Administration (FDA) released a draft guidance document describing the agency’s perspective on premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS).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.
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.
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.
Troutman Pepper Locke is once again well represented on the Food and Drug Law Institute’s (FDLI) committees for 2026, underscoring the firm’s continued leadership on issues affecting FDA‑regulated industries, including tobacco and nicotine.
On January 5, 2026, Colorado Attorney General (AG) Phil Weiser announced that MC Global Holdings and affiliated persons and entities (collectively, MC) had been fined for allegedly violating the terms of a May 2025 assurance of discontinuance. The defendants, who are engaged in manufacturing, packaging, labeling, distributing, and/or selling industrial hemp products under the brand Vivimu, agreed to a fine of $575,000, of which $500,000 will be suspended as long as they comply with the terms of the new agreement.
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.
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.
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.
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