In June, the U.S. District Court for the Middle District of Florida made public an order that stayed a Food and Drug Administration (FDA) refuse to file (RTF) determination, finding that the FDA likely violated the Regulatory Flexibility Act (RFA) and the Administrative Procedure Act (APA) when it promulgated its 2021 PMTA rule based on a small-business certification that the court described as “facially false.” The RTF letter is stayed pending final judgment.
On May 8, the U.S. Food and Drug Administration (FDA) issued guidance that clarifies how the agency enforces premarket review requirements for certain electronic nicotine delivery system (ENDS) products and nicotine pouches with pending premarket tobacco applications (PMTAs).
On April 14, Iowa Attorney General (AG) Brenna Bird, leading a coalition of 13 state AGs, sent a pointed letter to Visa, Mastercard, American Express, and Discover. Their message was clear: payment networks are expected to help shut down the U.S. market for unauthorized e‑cigarette products.
California recently finalized changes to its Proposition 65 (Prop 65) warning rules that included significant changes to short-form warning statements for product labels. These changes directly affect nicotine‑containing products — including e‑cigarettes, e‑liquids, oral nicotine products, and other consumer goods that can expose consumers to nicotine.
Troutman Pepper Locke is once again well represented on the Food and Drug Law Institute’s (FDLI) committees for 2026, underscoring the firm’s continued leadership on issues affecting FDA‑regulated industries, including tobacco and nicotine.
On October 27, the FDA appealed a decision of the U.S. District Court for the Southern District of Georgia that vacated the agency’s 2020 rule requiring graphic health warnings on cigarette packaging and advertisements. This appeal to the U.S. Court of Appeals to the Eleventh Circuit, along with a separate challenge pending before the Fifth Circuit, may determine whether the FDA’s second attempt to impose graphic health warnings on cigarettes will be successful.[1]
On September 22, a group of 28 state AGs led by Iowa filed an amicus brief in Vapor Technology Association v. Wooten in support of North Carolina’s state directory law that prohibits the sale of electronic nicotine delivery system (ENDS) products or e-cigarettes that lack Food and Drug Administration (FDA) marketing authorization. According to the brief, 15 states have already enacted laws similar to North Carolina’s ENDS directory law, and another 25 states are considering such legislation.
Importers of smoking tobacco products, particularly cigarettes, are increasingly saving millions in federal excise taxes by employing a refund mechanism known as the “drawback.”
Over the past two years, at least 14 states have enacted laws requiring manufacturers of electronic nicotine delivery systems (ENDS) to certify the status of their federal premarket tobacco product applications (PMTAs) in order to be sold in the state. This year, several of these laws have been challenged, and a clear split is beginning to emerge among state courts regarding whether the state laws are enforceable.
On June 20, the Supreme Court concluded that marketing denial orders (MDOs) issued by the Food and Drug Administration (FDA) can be challenged not only by the applicants (typically, the manufacturer or importer of the products), but also by retailers who would sell such products. As a result, more challenges to MDOs are likely to be brought before the U.S. Court of Appeals for the Fifth Circuit, where litigants have generally had greater success to date in challenging MDOs relative to other appellate courts.