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).

Virginia’s New Directory

Virginia’s directory regime requires manufacturers of “nicotine vapor products” and “liquid nicotine” to submit annual certifications that their products either: (1) received a marketing granted order from the U.S. Food and Drug Administration (FDA), or (2) were “marketed in the United States as of August 8, 2016, or the manufacturer timely submitted a premarket tobacco product application (PMTA) to the [FDA] … on or before September 9, 2020, and the application either remains under review by the [FDA] or a final decision on the application has not otherwise taken effect.” Va. Code Ann. § 59.1-293.16.A.2.

Interestingly, the second certification option above is more permissive under Virginia’s regime than in other states’ vapor directory regimes. Unlike many other states, Virginia’s statute appears to allow a certification that the product was on the market as of August 8, 2016, or that the product was the subject of a timely submitted PMTA that either remains under FDA review or pending the effect of a final decision. Conversely, this second certification option in other states typically requires manufacturers to attest that their product was both on the market as of August 8, 2016, and that the product was the subject of a timely submitted PMTA that either remains under FDA review or pending the effect of a final decision.

The law further directs the Virginia AG to establish a directory that lists all nicotine vapor products or liquid nicotine products and the manufacturers thereof that have completed the required certifications. Beginning December 31, 2025, the sale, distribution or importation for resale, or offer for sale of any liquid nicotine or nicotine vapor products not included on the directory will be prohibited. See Va. Code Ann. § 59.1-293.20.A.

The Plaintiffs’ Challenge

In Nova Distro, Inc., et al. v. Miyares et al., No. 3:25-cv-857 (E.D.V.A.),the Plaintiffs argue that the directory law (1) is preempted by the FDCA, (2) violates the Virginia Constitution’s prohibition on the enactment of “special laws,” and (3) violates the Equal Protection Clause of the Fourteenth Amendment to the U.S. Constitution.

Regarding federal preemption, the Plaintiffs’ argument is similar to those raised in other federal courts with respect to state vapor product directories. Virginia’s directory, the Plaintiffs argue, is merely an attempt by the Commonwealth to enforce the premarket review provisions of the FDCA—a role that Congress expressly delegated to FDA. As we discussed in July and October, the reactions of other federal courts to this argument have been mixed.

Regarding the Virginia Constitution, the Plaintiffs argue that the vapor product directory law is a prohibited “special law,” in that it has the special purpose and effect of establishing a “Big Tobacco” monopoly on vapor products in the Commonwealth. This is because, according to the Plaintiffs, only large manufacturers can shoulder the financial burden of obtaining FDA premarket authorization.

Regarding the Equal Protection Clause, the Plaintiffs argue that the vapor product directory interferes with private business, such that “the Virginia vape market will be accessible only to Big Tobacco.” They allege that the vapor product directory “impermissibly discriminates between Big Tobacco and Small Tobacco without a rational basis for such differential treatment.”

The Defendants’ Motion to Dismiss

In November, the Defendants moved to dismiss the Plaintiffs’ Complaint. They first assert that the case should be dismissed for lack of standing. The Plaintiffs, the Defendants argue, lack standing to sue because they have no legally cognizable interest in selling vapor products that lack FDA premarket authorization.

Second, the Defendants argue that Virginia’s directory law is not preempted by the FDCA because it falls within the Commonwealth’s police power to protect public health and welfare, and it does not conflict with federal law. Third, they argue that the Commonwealth’s sovereign immunity bars the Plaintiffs’ claim with respect to the Virginia Constitution. Fourth and finally, the Defendants argue that the vapor product directory law comports with the federal Equal Protection Clause because it easily passes the “rational basis” review standard.

What’s Next

In their Complaint, the Plaintiffs requested that the court (i) preliminarily and permanently enjoin AG Miyares and Tax Commissioner Alex from enforcing the directory law and (ii) issue a declaratory judgment that the directory law is unconstitutional under the U.S. Constitution and/or the Virginia Constitution.

In November, the Plaintiffs formally moved for a preliminary injunction against the directory law. A hearing on this motion is set for December 18, 2025.

Why It Matters

Notably, another case challenging North Carolina’s directory has already been briefed at the U.S. Court of Appeals for the Fourth Circuit, Vapor Technology Association, et al. v. Wooten et al., No. 25-1745 (4th Cir.). There, the Fourth Circuit will consider an appeal of the U.S. District Court for the Eastern District of North Carolina’s order denying a preliminary injunction of North Carolina’s vapor product directory law. Importantly, the appeals court’s ruling on this could include, among other things, an analysis of whether the plaintiffs were likely to succeed in their argument that the directory is preempted by the FDCA. Given that the U.S. District Court for the Eastern District of Virginia is also in the Fourth Circuit, a determination by the appeals court with respect to federal preemption or Equal Protection is highly likely to influence the Virginia case discussed here. Oral argument for the North Carolina case before the Fourth Circuit is scheduled for January 29, 2026.