
TAMPA, Fla., June 9, 2026 /PRNewswire/ -- Zest Brands LLC announced it has obtained a preliminary injunction from the United States District Court for the Middle District of Florida against the U.S. Food and Drug Administration (FDA), safeguarding Zest's ability to continue marketing its ZEO Universe nicotine pouch products in the United States.
The injunction stays the FDA's Refuse-to-File (RTF) decision related to the company's May 2022 Premarket Tobacco Product Applications (PMTAs), allowing the ZEO Universe products to remain on the market while the case proceeds.
The Court found that Zest Brands is likely to succeed on its claims under the Regulatory Flexibility Act and the Administrative Procedure Act because when FDA adopted its premarket tobacco product application regulations in 2021, the agency failed to conduct a complete regulatory flexibility analysis as to the impact of its regulatory requirements on small entities involved in the manufacture of novel tobacco products like nicotine pouches. The Court found that the FDA's actions may have been "arbitrary and capricious" and neither "reasonable [nor] reasonably explained."
Zest Brands is represented in the litigation by Thompson Hine LLP.
Zest Brands' CEO, Inga Nasi, stated: "Zest remains committed to working constructively with the FDA to complete the PMTA process and support greater regulatory clarity and long-term stability across the category."
The company is engaged in discussions with strategic and financial partners to support its next phase of growth.
About Zest Brands LLC
Zest Brands LLC is a U.S.-based, woman-owned company focused on next-generation nicotine alternatives. Its flagship brand, ZEO Universe, offers nicotine pouch products for adult consumers. ZEO Universe is distributed in 10,000+ retail locations nationwide.
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SOURCE ZEST Brands LLC
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