FDA Says It Will Not Take Enforcement Action Against Zone Nicotine Pouches Until Lawsuit Is Resolved

Key Takeaways

• FDA said it has no present intention to take enforcement action against Zone products pending final judgment.
• The injunction hearing that had been scheduled for Friday was vacated.
• Fontem’s injunction motion will be converted into an expedited summary judgment motion.
• A hearing on the matter is set for June.
• If the government decides to take enforcement action, it must provide 15 days’ notice through a warning letter.

2Firsts, April 7, 2026

According to Law360, the U.S. Food and Drug Administration has told vape manufacturer Fontem US that it will not stop the production or sale of its Zone nicotine pouches before the company’s lawsuit over the agency’s handling of its application is resolved.

FDA says it has no present intention to take enforcement action before final judgment

Fontem US is a subsidiary of Dutch smokeless cigarette-alternative maker Fontem. The company had filed suit alleging that FDA waited more than three years before calling its application incomplete through a refuse-to-file letter.

The parties had originally been scheduled to appear in court Friday for a hearing on Fontem’s injunction motion. That hearing was later vacated after a status conference held a few days earlier, during which FDA said it had no current plans to prevent Fontem from continuing to sell the products even though they have not received formal authorisation.

In an order signed by U.S. District Judge Randolph D. Moss, FDA stated that, pending final judgment in the matter, it has “no present intention to take enforcement action against Fontem or any party based on the manufacture, sale, or distribution of the products identified.”

The injunction motion has been converted into an expedited summary judgment process

Under the terms agreed by the parties, Fontem’s injunction motion will be converted into an expedited summary judgment motion, and a hearing has been scheduled for June.

The court also said that if the government decides to take enforcement action relating to the products, it must provide 15 days’ notice beforehand in a warning letter.

As of Friday, neither FDA nor Fontem’s attorneys had immediately responded to Law360’s requests for comment.

Fontem says FDA issued a refuse-to-file letter after the statutory deadline

Fontem filed suit last week, alleging that FDA did not act within the 180-day statutory deadline after the company submitted its 2022 application, and instead issued a refuse-to-file letter in December 2025 saying the application was incomplete.

According to the report, after Fontem responded with a chart showing where the allegedly missing information had already been submitted, FDA withdrew its initial objection and issued a corrected refusal stating that Fontem had failed to submit ingredient lists for comparator products.

Fontem argues that the 2009 Smoking Prevention and Tobacco Control Act does not allow FDA to issue a refuse-to-file letter, and instead requires the agency to approve or deny a premarket tobacco product application. Fontem also said FDA must conduct a public health review and consider whether existing tobacco users are more or less likely to stop using such products.

Fontem says the Zone pouches are a less harmful alternative to cigarettes, and argued in its complaint that FDA is trying to avoid the statute’s required public health balancing inquiry by refusing even to file the PMTA.

Image source: Law360