Health Law Daily Wrap Up, TOBACCO—W.D. Wis.: Wisconsin will start enforcing e-cigarette regulation over retailer’s objections, (Sep 12, 2025)

By Molly Platnick

The court rejected e-cigarette coalition’s claim Wisconsin regulatory scheme was preempted by the federal Food, Drug, and Cosmetic Act.

The federal district court for the Western District of Wisconsin denied a coalition of manufacturers, distributors, retailers, and users of e-cigarettes’ motion for preliminary injunction in a case against the Secretary of the Wisconsin Department of Revenue. The coalition’s complaint alleged a Wisconsin statute banning all e-cigarettes, even those compliant with federal regulations, violated the Supremacy Clause because the Federal Food, Drug, and Cosmetic Act (FDCA) impliedly preempts state laws that rely on FDA regulations to establish liability. Plaintiffs seeking a preliminary injunction must show their claim is likely to succeed on the merits, they would suffer irreparable harm absent the injunction, and that granting an injunction weighs in favor of the public interest. The court found the coalition’s preemption claim was not likely to succeed on their merits because the Tobacco Control Act expressly authorized states to regulate sales of tobacco product beyond what was in the FDCA. The court agreed enforcement of the Wisconsin statue would irreparably harm the coalition, but that coalition’s failure to show its claim would succeed also doomed their balance of harm argument (Wisconsinites for Alternatives to Smoking & Tobacco, Inc. v. Casey, No. 25-cv-552-wmc (W.D. Wis. Sept. 5, 2025)).

Background. The Family Smoking Prevent and Tobacco Control Act (TCA), added to the FDCA in 2009, requires FDA approval for “new tobacco products” to be sold on the market. To obtain TCA approval for a “new tobacco product,” manufacturers must submit a premarket tobacco product application (PMTA) and, if al requirements are met, the FDA will issue a marketing granted order. In 2016, the FDA issued a regulation stating e-cigarettes are subject to the TCA, but deferred enforcement until August 2019. The deadline was extended to September 2021 for products that were on the market before August 2016 if the manufacturer had submitted a PMTA by September 2020. Since September 2021, the FDA has reviewed the sale of unauthorized e-cigarettes on a case-by-case basis.

In 2023, Wisconsin put in place Wis. Stat. § 995.15, which directs the state department of revenue (DOR) to maintain a directory of all e-cigarette devices eligible for sale in the state. The regulatory scheme mandates all e-cigarette manufactures annually certify their product (1) has received marketing authorization from the FDA (2) was on the market as of August 8, 2016, or an PMTA was submitted to the FDA before September 9, 2020 (3) contains hemp, not nicotine. Retailers and manufacturers who do not satisfy these requirements are subject to fines and civil penalties by the Wisconsin Department of Agriculture, Trade and Consumer Affairs and Department of Justice. Additionally, individuals who have suffered a pecuniary loss based on a manufacturer or retailer’s failure to comply with state e-cigarette laws may be able to recover “twice that loss, together with costs, including a reasonable attorney fee.”

The § 995.15 directory limits retailers to selling 190 varieties of e-cigarette. The retail plaintiffs cross-examined in this case report they “will face a significant loss of business and revenues, likely causing them to downsize or completely close their businesses.” One retailer alleged this “reduction in its core business” would impact the sale of its other products; another reported a loss of over $200,000 in product inventory that would no longer be saleable. Plaintiffs also argued without nicotine-based e-cigarettes, their customers would resort to traditional cigarettes, which have more serious health consequences.

The coalition filed this action in June 2025, two months before Wisconsin was set to begin enforcing § 995.15. At the beginning of July, the coalition filed the instant motion for preliminary injunction based on preemption. The court granted the coalition permission to submit supplemental declarations after the state published its e-cigarette directory on August 1st.

Merits of the claim—implied preemption. The court determined the coalition did not meet its burden in pleading its claim would succeed on the merits because it could not show § 995.15 was inconsistent with the federal law. The “dispositive” issue was whether the FDCA’s statutory language and context implicitly preempt states’ historic authority to regulate sales of tobacco products. The rule from Buckman v. Plaintiff’s Legal Comm. (U.S. 2001) is § 337 implies Congress’ intent to preempt states’ authority to enforce the FDCA. When Congress enacted the TCA, however, it expressly reserved “substantial regulatory authority” to the states through the “Preservation,” “Preemption,” and “Savings” clauses. Taken together, these provisions, in the words of the Ninth Circuit, “broadly jettison the longstanding tradition of states and localities’ role in the regulation of sales of tobacco products when it enacted the TCA in 2009.”

Here, the court agreed with the coalition that § 995.15 puts burdens on e-cigarette manufacturers beyond what is imposed by the FDA but ruled this “is exactly the power preserved to the States in the TCA.” The court stated invalidating Wisconsin’s law would be ignoring Congress’ explicit intent for states to add tobacco-product restrictions, including “sales requirements.”

Irreparable harm. The court found the e-cigarette retailers were reasonably likely to suffer irreparable harm if § 995.15 takes effect. The court was persuaded by the “substantial evidence” members of the coalition presented that limiting their business to non-tobacco products would deplete their revenue and diminish their consumer base. The court emphasized if § 995.15 was ultimately found preempted the retailers would be unable to recover pecuniary losses because sovereign immunity prevented them from recovering money damages from the DOR, a state agency.

Balance of harms and public interest. The court concluded the coalition could not establish enjoining § 995.15 would be in the public interest because it had not shown the reasonable likelihood its claim would succeed on the merits Both sides conceded in a case where the constitutional rights at issue a balance of harms analysis must rely on the likelihood of success on the merits because “the public interest is not harmed by preliminarily enjoining the enforcement of a statute that is probably unconstitutional.” The court noted the coalition’s delay in bringing this action until two months before § 995.15’s start date cut against the argument extending enforcement would limit the alleged harm. Further, if enforcement ramped up in the intervening months, the coalition would have the opportunity to seek emergency relief from the Seventh Circuit.

The case is No. 25-cv-552-wmc.

Judge: Conley, W.

Attorneys: Eric Heyer (Thompson Hine LLP) for Wisconsinites for Alternatives to Smoking & Tobacco, Inc. Charlotte Gibson, Wisconsin Department of Justice, for David Casey.

Companies: Wisconsinites for Alternatives to Smoking & Tobacco, Inc.

Cases: CaseDecisions FDCActNews TobaccoNews WisconsinNews