Core Facts: What Happened
Zest Brands LLC secured a preliminary injunction from the U.S. District Court for the Middle District of Florida on June 9, 2026, allowing its ZEO Universe nicotine pouch products to stay on the U.S. market while the company challenges the FDA’s refusal to review its PMTA applications. The court found the agency likely failed to assess the impact of its 2021 PMTA rules on small businesses under the Regulatory Flexibility Act, and described aspects of the FDA’s actions as potentially “arbitrary and capricious.”
The decision temporarily blocks the FDA’s Refuse-to-File (RTF) determination related to Zest’s May 2022 Premarket Tobacco Product Applications while the full case proceeds.
Key Legal Details
The court’s ruling hinges on two major issues. First, the FDA’s 2021 PMTA regulations may have violated the Regulatory Flexibility Act by not adequately accounting for the burden on small businesses like Zest. Second, the court signaled that the agency’s decision-making process had procedural problems that could invalidate the RTF determination.
Zest originally filed its PMTA for ZEO Universe nicotine pouches in May 2022, more than four years ago. The FDA issued a Refuse-to-File decision, meaning it determined the applications were insufficient to even begin formal review. The injunction now forces a pause while the court evaluates whether that determination was lawful.
The company said it remains committed to working with the FDA to complete the PMTA process and is currently in discussions with strategic and financial partners to support future growth.
Why This Matters: Broader Implications for Nicotine Pouches
This case is the latest in a growing pattern of court challenges to FDA tobacco regulation. The Regulatory Flexibility Act argument, that the FDA didn’t properly consider the impact of its rules on small manufacturers — has been raised in other contexts but rarely with success. A finding that the FDA acted arbitrarily could set a precedent affecting hundreds of pending PMTA applications from small and midsize nicotine product companies.
Nicotine pouches have become a major growth category in the U.S. market, led by Zyn from PMI. But the FDA’s slow and opaque PMTA process has left most pouch brands in legal limbo for years, with no clear path to authorization. The Zest case could force the agency to either speed up its review process or face more court-ordered injunctions.
Tobacco Reporter first reported the ruling.
Industry and Regulatory Context
The Zest injunction comes at a turbulent time for FDA tobacco regulation. In May 2026, the FDA released new enforcement discretion guidance allowing certain unauthorized e-cigarettes and nicotine pouches to remain on the market — a decision that blindsided the agency’s own tobacco center staff, according to PBS News. The agency has never authorized a nicotine pouch in any flavor except tobacco and menthol, and most PMTA applications remain unresolved years after submission.
Meanwhile, Ohio’s Supreme Court is hearing arguments on whether municipalities can restrict flavored tobacco and nicotine product sales, and at least 20 states introduced bills in 2025 to tax nicotine pouches, as Multistate reported.
Action Advice for Consumers
For nicotine pouch users: the Zest injunction does not change current market availability immediately — ZEO Universe products were already on shelves, and this ruling simply keeps them there. However, the case signals that the FDA’s PMTA backlog may face increasing judicial scrutiny. Watch for the court’s final ruling, which could affect how the FDA handles pending applications from other pouch brands. For now, the nicotine pouch market remains in the same regulatory gray zone it has been in since 2020.
继续阅读
- Nicotine Pouch Regulation: A Complete Guide to FDA and State Laws
- Best Nicotine Pouches in 2026: Full Review and Comparison
- Zyn vs On! vs Velo: Which Nicotine Pouch Is Right for You?
Kevin Li — Founder & Editor, VapeObservation.com Kevin reviews vape products hands-on, prioritizing real-world performance over manufacturer claims. His goal: honest, practical advice that helps everyday vapers make informed choices. Before launching VapeObservation, he was a longtime vaper frustrated by promotional content disguised as reviews. Every article on the site reflects his commitment to data-driven, reader-first testing.
