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Agustin Rodriguez

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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.

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In September, the U.S. Food and Drug Administration (FDA) announced that it would begin enforcing the agency’s cigarette graphic warning rule in December 2025, in an enforcement policy outlined in a short guidance document. Although a federal district court previously found the rule unconstitutional, an appeals court reversed that decision, and the final rule is now in effect. According to the guidance, FDA will not begin enforcement until December 2025 at the earliest, but we believe it likely that the rule might yet again be postponed or vacated, as it remains the subject of ongoing litigation.

In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN) to U.S. Customs and Border Protection (CBP) for imports of such products. This rule could result in the denial of entry for ENDS imports for which the manufacturer has not submitted a premarket tobacco product application (PMTA) to FDA.

On August 27, the New Jersey Attorney General (AG) and the Division of Consumer Affairs announced that the state had issued notices of violation and $4,500 civil penalty demands to 19 retailers across New Jersey for allegedly selling banned flavored vapor products. This is New Jersey’s first public enforcement of the state’s 2020 flavor ban, and New Jersey joins a number of other state AGs taking similar action across the U.S.

In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration (FDA) from requiring graphic warnings on cigarette packs. As we noted in prior coverage, the March 2020 FDA rule at issue would require new textual health warning statements alongside color, photorealistic images displayed on the top 50% of the front and rear panels of cigarette packs and the top 20% of cigarette advertisements.

In June, the Bureau of Alcohol, Tobacco and Firearms (ATF) argued in federal court that the federal Prevent All Cigarette Trafficking (PACT) Act requires tribal retailers to obtain state licenses to sell cigarettes on their own reservations. If accepted, ATF’s position would greatly expand the scope of state authority over tribal tobacco sales.

In May, the U.S. Department of Justice (DOJ) issued a notice of proposed rulemaking to transfer cannabis from Schedule I to Schedule III of the Controlled Substances Act (CSA), a change that could significantly affect current state cannabis programs. In response, the Cannabis Regulators Association (CANNRA) submitted a detailed comment letter to the DOJ requesting clarity on how rescheduling will impact these existing regulatory structures. An examination of CANNRA’s public comment offers insights for state-legal businesses into what the future may hold for the joint regulation of cannabis at the state and federal levels.

In late June, the U.S. District Court for the District of Montana held that federal law preempts the Montana Attorney General (AG) from removing the cigarette brands of Grand River Enterprises Six Nations, Ltd. (Grand River) from the state tobacco directory based on Grand River’s alleged violations of the Federal Food, Drug, and Cosmetics Act (FDCA). The FDCA preempts state law actions based solely on FDCA violations if the U.S. Food and Drug Administration (FDA) has not already found that such violations exist, the court explained.

In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened enforcement against sellers of unauthorized ENDS in 2023 and predicted that this pattern of enforcement would continue. A year-to-date review of 2024 shows that FDA is placing a high priority on action against unauthorized ENDS.

Across states, lawmakers often embrace “medical” marijuana as a precursor to establishing a “recreational” marijuana market. Although marijuana remains illegal at the federal level — and would remain illegal even under the proposed rescheduling — federal regulators also recognize the therapeutic potential of certain marijuana-adjacent substances. At the federal level, the U.S. Food and Drug Administration (FDA) has approved one drug product derived from the cannabis sativa L. plant and three synthetic cannabis-related drug products. At the same time, 38 states and Washington, D.C., have established legal frameworks for access to medical marijuana. Comparing these frameworks to FDA’s drug approval process reveals fundamental differences between state and federal approaches to determining whether cannabis is “therapeutic.”