This year, several state legislatures will consider bills to establish vapor product directories. Amid heightened scrutiny of illicit vapor products by the U.S. Food and Drug Administration (FDA), these product directory bills would create a mechanism for states to bar the sale of products that are not FDA-authorized or subject to a pending premarket application. Like state cigarette directories implemented in connection with the tobacco Master Settlement Agreement, these directories would specify which vapor products are permitted to be sold in the state.
Only three states currently have vapor product directories, including Alabama (with respect to “e-liquids” and “alternative nicotine products), Louisiana (with respect to “vapor products” and “alternative nicotine products), and Oklahoma (with respect to “vapor products). In January, legislatures in Florida, Indiana, Missouri, and Virginia introduced bills to establish their own vapor product directories.
The recently introduced bills are aimed at reducing the proliferation of illicit vapor products and have the following elements:
- A state administrative agency (typically the Department of Revenue, Office of the Attorney General, or alcoholic beverage authority) maintains a directory of vapor products permitted to be sold in the state, listed by brand and manufacturer. The responsible agency must publish and maintain the directory on its public website.
- Products not listed in the directory may not be sold in the state — whether by manufacturers, wholesalers, or retailers. The appropriate state agencies are authorized to take enforcement action against those dealing in noncompliant products.
- Manufacturers seeking to have their vapor products listed must file a certification for each product — affirming that their product is either the subject of an FDA marketing granted order or a premarket tobacco product application filed prior to September 9, 2020, which remains under consideration. Under the bills introduced in Indiana, Missouri, and Virginia, manufacturers must pay an initial filing fee and an annually recurring fee for each product sought to be listed.
Beyond garnering attention from state legislatures, illicit vapor products are increasingly in federal regulators’ crosshairs. As we recently reported, the FDA concluded 2023 with multiple rounds of enforcement action against sellers of illegal vapor products, including warning letters and civil money penalty complaints. We expect this pattern of federal enforcement to continue, regardless of state-level action.
It remains to be seen whether the state directory regimes, as proposed, will curb the prevalence of unauthorized products. However, these bills may signal a broader shift in the overall tobacco and nicotine regulatory environment — one in which FDA is no longer the only regulator patrolling the block for illicit vapor products. We will continue monitoring the introduction of state vapor product directory bills around the U.S., as more states may consider similar initiatives.