We recently reported that several state legislatures are considering bills to establish vapor product directories this year—namely Florida, Indiana, Missouri, and Virginia. Throughout January and early February, similar bills have been introduced in Arizona, Hawaii, Iowa, Nebraska, New York, South Carolina, South Dakota, Vermont, Washington, West Virginia. Additionally, a bill in Oklahoma would update the state’s existing directory framework to be consistent with the proposals of these recent bills. The directories would allow states to prohibit the sale of vapor products that are not authorized by the U.S. Food & Drug Administration (FDA) or subject to a pending premarket application. Like the proposals discussed in our previous coverage, these bills are intended to reduce the proliferation of illicit vapor products.
These bills typically have the following elements:
- A state administrative agency (typically the Department of Revenue/Tax Commission, 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 either: (i) that their product is the subject of an FDA marketing granted order; or (ii) that their product was on the market in the U.S. as of August 8, 2016, and is the subject of a premarket tobacco product application filed on or before September 9, 2020, which remains under consideration. The Florida bill would additionally allow a manufacturer to certify that its non-tobacco-derived vapor product was on the market in the U.S. as of April 14, 2022, and is the subject of a PMTA filed prior on or before May 14, 2022. Under the bills introduced in Hawaii, Indiana, Missouri, Nebraska, Oklahoma, South Carolina, South Dakota, Vermont, Virginia, Washington, and West Virginia, manufacturers must pay an initial filing fee and an annually recurring fee for each product sought to be listed. Conversely, the Iowa bill requires only an initial fee, while the Arizona and New York bills leave the determination of fees to state regulators. Only the Florida bill declines to impose such fees.
The consideration of these directory proposals signals a more intense interest on the part of state governments in keeping illicit vapor products off the market. For instance, a recent New Hampshire bill would not establish a directory. Instead, it would specifically prohibit retailers from selling alternative nicotine products, e-cigarettes, or e-liquids that are not FDA-authorized or subject to pending review.
Illicit vapor products will likely remain a focus of both state and federal regulatory attention this year. As we previously reported, the FDA’s Center for Tobacco Products’ strategic plan for 2024 reaffirms its commitment to “aggressive enforcement of the law and pursuing enforcement actions against manufacturers, distributors, importers, and retailers for violating the law.” The bills highlighted here may represent states’ interest in similar efforts. The adoption of these proposals would bolster states’ roles in regulating unauthorized vapor products. We will continue to monitor the consideration of these bills and the potential introduction of similar proposals in other states.