On June 20, 2025, the U.S. Supreme Court issued a decision that allows manufacturers and other businesses adversely affected by a U.S. Food and Drug Administration (FDA) denial of a pre-market tobacco product application to file a lawsuit challenging the denial in any jurisdiction where the manufacturer or other businesses operate.
This decision was issued in response to a petition brought by the FDA against R.J. Reynolds Vapor Company, the Mississippi Petroleum Marketers and Convenience Store Association, and Avail Vapor, LLC. In the petition, the FDA claimed that only the manufacturer has the right to petition the courts when a marketing denial order is issued and that retail trade organizations and retailers are not adversely affected by such a denial order.
Originally, R.J. Reynolds Vapor Company, the Mississippi Petroleum Marketers and Convenience Store Association, and Avail Vapor, LLC, filed a lawsuit petition in a Texas federal district court seeking to overturn the FDA’s marketing denial order of pre-market tobacco applications for Vuse Alto electronic cigarette products. The Texas federal court venue was selected since Avail Vapor, LLC operates a retail store in Houston. Both Mississippi and Texas are located within the Fifth Circuit Court of Appeals.
The Family Smoking Prevention and Tobacco Control Act (TCA) authorizes “any person adversely affected” by an FDA marketing denial order to file a lawsuit for judicial review with a federal court in either the District of Columbia Circuit or “the circuit in which such person resides or has their principal place of business.”
In its decision, the Supreme Court held that: (1) the retailers also have the right to petition for review under the TCA “because Avail Vapor and the trade association have their principal places of business in Texas and Mississippi,” and (2) the retailers are adversely affected because “[i]f the FDA denies an application, the retailers lose the opportunity to profit from the sale of the new tobacco product—or, if they sell the product anyway, risk imprisonment and other sanctions.”
A full copy of the U.S. Supreme Court decision can be read
here.