Enorama Pharma Inc. filed a lawsuit against the U.S. Food and Drug Administration in federal court in Washington, D.C., alleging the agency unlawfully imposed costly premarket tobacco application (PMTA) requirements on its nicotine oral pouches. In a complaint filed Feb. 17, the company argues the FDA violated the Regulatory Flexibility Act and Administrative Procedure Act by subjecting pouches to the same regulatory framework as combustible tobacco without properly assessing the impact on small businesses. Enorama contends that although the FDA previously suggested publicly available data could support applications, it now requires product-specific scientific studies, dramatically increasing costs.
According to the filing, the FDA estimated bundled application costs between $181,686 and $2 million, but Enorama claims actual expenses range from $3 million to more than $15 million — forcing some manufacturers to exit the market. The company also alleges unequal treatment, asserting that larger competitors such as Philip Morris International and Altria Group have been allowed to market similar nicotine pouch products despite pending applications, while Enorama received a refusal-to-file letter. Attorney Eric N. Heyer of Thompson Hine LLP said the company plans to seek a preliminary injunction to halt the FDA’s action.
