Lawsuit Challenges Wisconsin’s PMTA Registry Law: A Battle Over Vaping Regulation

A coalition of vaping industry stakeholders, under the banner of Wisconsinites for Alternatives to Smoking and Tobacco, has launched a legal challenge against Wisconsin’s new PMTA (Premarket Tobacco Product Application) registry law, which took effect on July 1, 2025. The lawsuit, filed on June 30 in the U.S. District Court for Western Wisconsin, seeks to block enforcement of the law, with a preliminary injunction motion filed on July 7 and a hearing scheduled for July 30. With enforcement set to begin on September 1, the outcome of this case could have significant implications for the vaping industry in Wisconsin and beyond. 

The Legal Arguments: Supremacy and Equal Protection 

The lawsuit, spearheaded by attorney Eric Heyer of Thompson Hine LLC, argues that Wisconsin’s PMTA registry law violates the U.S. Constitution on two key grounds. First, it claims the law infringes on the Supremacy Clause by interfering with the federal government’s authority to enforce the Food, Drug, and Cosmetic Act as it pertains to tobacco and vaping products. Second, the suit alleges a violation of the Equal Protection Clause of the Fourteenth Amendment, asserting that the law unfairly discriminates against manufacturers based on the type of nicotine used in their products—specifically targeting synthetic nicotine products—without a rational basis. 

These arguments mirror those used in similar lawsuits in other states. Heyer, who has represented vaping industry plaintiffs in Iowa and North Carolina, saw success in Iowa, where a federal judge issued an injunction in May 2025 to block a similar registry law. However, a North Carolina federal judge rejected a temporary injunction in June, highlighting the mixed outcomes of these legal challenges. 

Wisconsin’s PMTA Registry Law: A Closer Look 

Wisconsin’s PMTA registry law, quietly passed in November 2023 as part of an unrelated bill, requires manufacturers to certify that their vaping products meet strict criteria to be sold in the state. These include: 

The product was on the market as of August 8, 2016. 

A PMTA was submitted to the FDA by September 9, 2020. 

The product has either been authorized by the FDA or is still under review. 

Manufacturers must pay a $500 annual fee per product to be listed in the state’s directory, maintained by the Wisconsin Department of Revenue. Retailers face steep penalties—$1,000 per day—for selling unlisted products after enforcement begins on September 1, 2025.Critics argue the law disproportionately harms smaller manufacturers, particularly those producing synthetic nicotine products, which are often newer and still under FDA review. The 2016 cutoff date effectively bans these products, fueling the equal protection challenge in the lawsuit. 

Big Tobacco’s Role in the Legislation 

The Wisconsin law, like similar PMTA registry laws across the U.S., was heavily influenced by Big Tobacco lobbyists. These registries are often promoted to regulate vaping products and protect public health, but opponents argue they serve to entrench the market dominance of large tobacco companies. By setting restrictive criteria—such as the 2016 cutoff date—the law limits competition from smaller, innovative manufacturers, particularly those offering synthetic nicotine products that have gained popularity as alternatives to traditional tobacco. 

The stealthy inclusion of the registry provision in an unrelated bill also drew criticism. Vaping advocates, caught off guard by the lack of transparency, had little opportunity to oppose the measure before it was signed into law by the governor in November 2023.The Bigger Picture: A Growing Trend in State RegulationWisconsin’s PMTA registry law is part of a broader wave of state-level regulations targeting the vaping industry. Similar laws have faced legal challenges in states like Iowa and North Carolina, with varying degrees of success. The Iowa injunction offers hope for Wisconsin plaintiffs, but the North Carolina ruling underscores the uncertainty of these cases. 

At the heart of the debate is the balance between state and federal authority over vaping products, as well as the fair treatment of manufacturers in an evolving industry. The outcome of the July 30 hearing could set a precedent for how states regulate vaping products and whether smaller players can continue to compete in a market increasingly shaped by Big Tobacco’s influence. 

What’s Next? 

As the September 1 enforcement date looms, the vaping industry in Wisconsin is bracing for impact. A favorable ruling on the preliminary injunction could pause the law’s implementation, giving businesses breathing room while the lawsuit progresses. However, a denial could force retailers and manufacturers to comply with costly and restrictive regulations, potentially driving smaller players out of the market. 

The Wisconsin case is a critical battleground in the ongoing struggle over vaping regulation. With similar fights playing out across the country, the outcome could ripple far beyond the state’s borders, shaping the future of the vaping industry in the U.S. 

Stay tuned for updates on the July 30 hearing and the broader implications for vaping regulation.