Lawsuit Challenges Kentucky PMTA Registry Law

A group of vape and hemp businesses has filed a lawsuit in state court challenging Kentucky’s recently passed PMTA registry law. The law is set to take effect Jan. 1, 2025, and will make it illegal to sell most vaping products that have not either received marketing authorization from the FDA, still be under review by the agency, or are currently under appeal to the FDA or a court.

The lawsuit was filed on April 12 in Franklin Circuit Court by four vaping companies, along with the Kentucky Smoke Free Association and the Kentucky Hemp Association. They are asking the court to declare the registry law unconstitutional, and to provide temporary and permanent injunctive relief that prevents the state from enforcing the law.

The petitioners charge the law violates the Kentucky Constitution by applying to more than one subject, and that the definition of vapor products in the law would also apply now to currently legal hemp-based vaping products and marijuana vaping products that are not under the FDA’s regulatory purview.

Vaping products that contain no nicotine—like zero-nicotine vapes or nicotine analog products, CBD vapes and other hemp-based cannabinoid vaping products—do not fall under the FDA’s regulatory authority, so they’re unable to apply for or receive authorization through the premarket tobacco application (PMTA) pathway. That makes them unable to qualify as legal products under Kentucky’s PMTA registry law.

“Unless the [hemp or marijuana] manufacturers are making a therapeutic claim—that is, they’re intended to cure, treat, mitigate disease—they’re not subject to an FDA regulatory process,” attorney Greg Troutman told the Kentucky Lantern. “So how can you condition market approval in Kentucky upon complying with a nonexistent process?”

Troutman represents the Kentucky Smoke Free Association and the other petitioners suing the state. He has represented other vaping industry businesses in multiple legal actions.

The bill that created the Kentucky PMTA registry law passed both houses of the state General Assembly on March 28. Governor Andy Beshear signed House Bill 11 into law on April 5.

Numerous other states have passed or are currently considering similar PMTA registry laws, which have been created and lobbied for by Big Tobacco companies, especially Marlboro manufacturer Altria Group.