State Regulatory

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An Ohio appellate court recently affirmed the dismissal of a case brought by the Ohio attorney general (AG) against Central Tobacco & Stuff Inc. (Central Tobacco), an e-cigarette retailer, in which the AG alleged that Central Tobacco sold e-cigarettes lacking FDA premarket authorization and violated the state’s Consumer Sales Practices Act (CSPA) by failing to inform consumers about the lack of FDA authorization. See State ex rel. Attorney Gen. Dave Yost v. Cent. Tobacco & Stuff Inc., 2025-Ohio-4613 (Ct. App.). This appears to be a novel use of a state consumer protection law, which most states have, to attempt to enforce the Federal Food, Drug, and Cosmetic Act (FDCA). The court concluded that federal law preempts Ohio’s ability to enforce FDCA premarket authorization requirements through the CSPA. The court’s decision may be relevant in other cases involving a state’s attempt to enforce FDA premarket authorization requirements through their consumer protection laws.

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.

Over the past two years, at least 14 states have enacted laws requiring manufacturers of electronic nicotine delivery systems (ENDS) to certify the status of their federal premarket tobacco product applications (PMTAs) in order to be sold in the state. This year, several of these laws have been challenged, and a clear split is beginning to emerge among state courts regarding whether the state laws are enforceable.

Effective July 1, Mississippi will require all cigarette and ENDS manufacturers to provide annual certifications and have their products listed on a state directory in order for their products to be sold in the state. The law, enacted through HB 916, creates separate directories for cigarettes, including roll-your-own (RYO) tobacco, and Electronic Nicotine Delivery Systems (ENDS) products, such as e-cigarettes and vapes.

In the first major enforcement action involving the importation of illegal tobacco products by the new administration, and on the heels of the appointment of the new acting director of the U.S. Food and Drug Administration (FDA) Center for Tobacco Products, FDA and U.S. Customs and Border Protection (CBP) seized illegal e-cigarettes valued at nearly $34 million. This operation underscores the ongoing efforts by federal agencies to combat the influx of unauthorized tobacco products into the U.S.

Our colleagues recently wrote about 14 memoranda from the new U.S. Attorney General (AG) Pam Bondi to Department of Justice (DOJ) employees framing the DOJ’s current policies and enforcement priorities. In a memorandum addressing DOJ’s general charging, plea bargaining, and sentencing policy, the AG stated the following: “To free resources to address more pressing priorities, the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) shall shift resources from its Alcohol and Tobacco Enforcement Programs to focus on matters relating to the other priorities set forth herein. No resources shall be diverted from the ATF’s regulatory responsibilities, such as federal firearms licenses and background checks.”

On December 17, 2024, Iowans for Alternatives to Smoking & Tobacco, Inc., Global Source Distribution, LLC, and others filed a complaint[1] and motion for a preliminary injunction[2] in federal district court against the Iowa Department of Revenue (the Department) challenging Iowa House File 2677 (HF 2677), a law imposing certification and directory requirements on vapor products sold in Iowa. A hearing on the plaintiffs’ motion for a preliminary injunction is scheduled for March 5. If the court rules in the plaintiffs’ favor, it could stay enforcement of the new law until the case is ultimately resolved. While the Department was previously scheduled to publish the vapor products directory on January 2 and begin enforcement on February 3, the Department has not published the directory, and its website indicates that it will not be enforcing the directory. The Department’s website states: “Publication and enforcement of Iowa’s vapor products directory is delayed until further notice. The Department will make an additional announcement before publication and enforcement of the vapor products directory begins. During the delay, manufacturers should continue to submit certification applications.”

Throughout 2024, the U.S. Food and Drug Administration (FDA) endeavored to curb sales of unauthorized electronic nicotine delivery systems (ENDS) in the U.S. In light of persistent demand for flavored ENDS — nearly all of which are unauthorized — there is little evidence that these enforcement efforts have reduced illicit sales. Indeed, some observers estimate that flavored ENDS account for more than 80% of all ENDS sales. With a new administration on the horizon, our team highlights two opportunities for FDA to step up its enforcement efforts: (1) focusing enforcement on imports and (2) authorizing premarket tobacco product applications (PMTAs) for flavored products.