Kentucky Vape Shops Fight Back Against PMTA Registry Bill

A coalition of vape and hemp enterprises has lodged a legal challenge in Kentucky's state court against the recently enacted PMTA registry law. Scheduled to come into force on January 1, 2025, the law will outlaw the sale of most vaping products unless they have obtained marketing authorization from the FDA, are still undergoing agency review, or are presently under appeal to the FDA or a court. 

The lawsuit, initiated on April 12 in Franklin Circuit Court, involves four vaping firms, alongside the Kentucky Smoke Free Association and the Kentucky Hemp Association. Their plea to the court seeks a declaration of the registry law's unconstitutionality and requests both temporary and permanent injunctions to halt the state from enforcing the law. 

The litigants argue that the law breaches the Kentucky Constitution by addressing more than one subject, and contend that the definition of vapor products in the law would also encompass currently legal hemp-based vaping items and marijuana vaping products not under FDA regulation. 

Vaping products lacking nicotine—such as zero-nicotine vapes, nicotine analog products, CBD vapes, and other hemp-based cannabinoid vaping goods—fall outside the FDA's regulatory purview. Consequently, they cannot seek authorization through the premarket tobacco application (PMTA) pathway, rendering them ineligible 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 informed the Kentucky Lantern. "So how can you condition market approval in Kentucky upon complying with a nonexistent process?" 

Troutman, representing the Kentucky Smoke Free Association and other petitioners, has been involved in multiple legal actions on behalf of the vaping industry. 

The bill instituting the Kentucky PMTA registry law cleared both chambers of the state General Assembly on March 28. Governor Andy Beshear signed House Bill 11 into law on April 5. 

Similar PMTA registry laws have been passed or are under consideration in numerous other states, often advocated for by major tobacco companies, particularly Altria Group, the manufacturer of Marlboro cigarettes. 

MiPod conversed with Troutman, inquiring about the rationale behind filing the lawsuit and their objectives moving forward.

 Troutman: “The suit was filed to challenge a bill which violated the Kentucky constitution in two respects. First, the bill violated the constitution’s “single subject” requirement. The bill is an act relating to nicotine products but its scope applies to more than nicotine products. Second, the bill is arbitrary in violation of due process because it requires FDA authorization for products like vapeable hemp for which there isn’t an FDA marketing pathway. The suit will also benefit the stakeholders of the upcoming medical marijuana products because vapeable marijuana products would also fall within the ban of HB 11.” 



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