Top Takeaways:

• PMTA fight expands: Enorama Pharma has filed suit in federal court in D.C., adding to a growing wave of litigation over the FDA’s handling of nicotine pouch applications.
• Standards disputed: The company argues that the FDA is imposing “arbitrary and capricious” regulatory demands on tobacco-free nicotine pouches under the PMTA framework.
• Category stakes high: With only a limited number of pouch authorizations granted to date, the outcome could affect competition and market access in the fast-growing oral nicotine segment.

Sweden-based Enorama Pharma Inc. has filed a complaint in the U.S. District Court for the District of Columbia, challenging the U.S. Food and Drug Administration’s handling of regulatory requirements for tobacco-free oral nicotine products.

At issue is how the FDA is applying the Family Smoking Prevention and Tobacco Control Act to nicotine pouches that do not contain tobacco leaf but are regulated as tobacco products because they contain nicotine. In its complaint, Enorama argues that the agency’s actions are “arbitrary and capricious” under federal administrative law and that they exceed the authority granted by Congress.

The lawsuit places Enorama alongside other nicotine pouch manufacturers that have recently turned to federal courts over the FDA’s premarket tobacco product application (PMTA) framework.

Enorama manufactures tobacco-free nicotine pouches sold under brands such as NIC-S. Although the FDA has authorized a limited number of nicotine pouch products through the PMTA pathway, most notably several ZYN products manufactured by Swedish Match USA, now part of Philip Morris International’s U.S. business, and Altria’s on! PLUS products. Many other pouch products remain under review or are at risk of enforcement.

The FDA is also likely to authorize several ZYN products as modified risk tobacco products (MRTPs). The MRTP designation will allow the nicotine pouch brand to claim that it is less harmful than combustible cigarettes.

On February 3, 2026, Enorama Pharma AB announced that its U.S. subsidiary, Enorama Pharma Inc., intended to appeal a Refuse-to-File (RTF) decision issued by the FDA for its nicotine pouch products. An RTF decision occurs when the FDA determines that an application is not sufficiently complete to permit a substantive review. There has been no public update on the status of that appeal.

Enorama’s claim states that although the FDA previously suggested that publicly available data could support applications, it now requires product-specific scientific studies, thereby 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.

The outcome of the case could have broader implications for how the FDA regulates tobacco-free nicotine pouches and for how smaller manufacturers navigate the costly and complex premarket process.

As of publication, the FDA has not publicly commented on the Enorama complaint.