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.
Val Fesenko*
Val Fesenko is a 2026 summer associate with Troutman Pepper Locke and not admitted to practice law in any jurisdiction.
FDA Proposes Foreign Manufacturing Establishment Registration and Product Listing Requirements
By Bryan Haynes, Agustin Rodriguez, Zie Alere & Val Fesenko* on
Posted in FDA
On June 29, 2026, the U.S. Food and Drug Administration (FDA) published a notice of proposed rulemaking (NPRM) titled “Establishment Registration and Product Listing for Tobacco Products,” which would, for the first time, require foreign tobacco product manufacturers to register their manufacturing establishments and list their products with the agency. Domestic manufacturers are already subject to these registration and listing requirements; foreign manufacturers are not. This regulation, if finalized, would close that gap.