The U.S. Food and Drug Administration confirmed it will not block production or sales of Fontem US’s Zone nicotine pouches while a lawsuit over the product’s pending premarket tobacco product application proceeds, Law 360 reported. Fontem argued that the agency unlawfully delayed reviewing its application, leaving the product in regulatory limbo.
The FDA said it will not take enforcement action during the litigation, allowing the pouches to remain on the market. Fontem recently voluntarily dismissed its suit in Texas and plans to refile in Washington, D.C. The case underscores ongoing tension between regulators and manufacturers over PMTA backlogs and the treatment of newer oral nicotine products, which differ from traditional cigarettes and vapes.
According to Law 360, industry observers believe the court battle could set a precedent for how the FDA handles delayed applications and exercises enforcement discretion in the growing nicotine pouch sector.