Fourth Circuit upholds North Carolina vape product directory law

The U.S. Court of Appeals for the Fourth Circuit upheld a lower court’s denial of a preliminary injunction against North Carolina’s 2024 law creating a directory of electronic nicotine-delivery system products that may be sold in the state. Products missing from the directory cannot be sold in North Carolina.

The ruling leaves the certification requirement in place for manufacturers while the underlying case continues. The court found that the federal Tobacco Control Act preserves state authority over tobacco product sales and distribution.

Manufacturers must certify one of three qualifying routes

The law requires manufacturers to certify that a product holds FDA marketing authorization, was submitted for FDA review by specified federal deadlines, or qualifies for an exemption covering certain minor product modifications.

Those three routes set the bar for a state listing, not a federal authorisation alone. A product that is still under FDA review can meet the state test if the submission fell within the federal deadlines the law names.

Retailers in North Carolina cannot sell ENDS products absent from the directory. The ruling does not create a new filing window; it keeps the existing certification condition enforced.

The court split state sales conditions from federal enforcement

The Fourth Circuit held that North Carolina’s directory sets independent conditions for retail sales rather than enforcing federal law. It also rejected the argument that the restrictions conflict with congressional objectives, concluding the law falls within the state’s authority to regulate tobacco sales.

A coalition of vape manufacturers, retailers, an industry trade association and a consumer brought the challenge. They argued federal tobacco regulations preempted the state law.

The decision addresses a preliminary injunction, not a final judgment on the merits. The panel’s reasoning on preemption, however, will shape how the remaining case proceeds.

What the ruling changes for Shenzhen exporters and U.S. distributors

For manufacturers shipping into North Carolina, the directory is now the operative gate: a product without a listing cannot move through state retail channels, whatever its FDA status elsewhere. Analysis: exporters selling through U.S. distributors should confirm which party holds the state certification and when each SKU was submitted federally, because the submission date drives eligibility, not the launch date.

Analysis: distributors carrying brands that have not filed state certifications face a narrower assortment in North Carolina, and order timing for new SKUs now depends on directory listing ahead of shipment.

Other states are watching the preemption question

North Carolina is not the only state to build a product directory tied to federal authorisation or submission status. The Fourth Circuit’s reasoning gives those programmes a federal appellate footing on the preemption question.

The comparison below sets out the elements the ruling turned on.

No date is set for the next step in the case

The ruling resolves the appeal over the preliminary injunction. The case returns to the lower court, and no schedule for further proceedings appears in the record.

Manufacturers weighing a first North Carolina listing should treat certification as a precondition for shipment rather than a post-launch formality, since unlisted products cannot be sold in the state.

Questions readers ask

Can an ENDS product still under FDA review be sold in North Carolina?

The law allows a manufacturer to certify that the product was submitted for FDA review by specified federal deadlines, as an alternative to certifying that it holds FDA marketing authorization. Products not listed in the directory cannot be sold in the state.

Did the Fourth Circuit strike down North Carolina's directory law?

No. The court upheld a lower court's denial of a preliminary injunction, holding that the Tobacco Control Act preserves state authority over tobacco sales and distribution and that the directory sets independent conditions for retail sales.