For much of the past decade, the US nicotine and ENDS marketplace has operated in a state of regulatory imbalance. Thousands of products have remained on the market while their regulatory status was unresolved, enforcement was selective, and the infrastructure needed to support an authorised-only system was still under construction.
That is now changing.
As 2026 approaches, multiple regulatory strands are beginning to converge. PMTA decisions are accelerating, enforcement resources are increasing, and long-signalled rulemakings are moving closer to implementation. Taken together, these developments point to a clear direction of travel: the FDA is laying the groundwork for an authorised-only marketplace.
PMTA Decisions Are Finally Setting Market Direction
In September 2025, the FDA launched the Streamlined Nicotine Pouch Pilot, designed to review a defined subset of nicotine pouch PMTAs more efficiently while maintaining existing scientific standards. After years of limited decision-making in this category, the pilot marked a meaningful shift from concept to execution.
During recent industry forums, including the FDLI Tobacco Conference, FDA representatives indicated that applications selected for the pilot have progressed through streamlined scientific review, with initial decisions expected by the end of 2025 or early 2026. These decisions will be significant not just for the applicants involved, but for the wider market.
The first outcomes will establish practical benchmarks around scientific sufficiency, product characterisation, and manufacturing expectations. In effect, they will begin to define what an “authorisable” nicotine pouch PMTA looks like in today’s regulatory environment.
Enforcement Is Resetting Around PMTA Outcomes
At the same time, enforcement is becoming more central to FDA’s tobacco strategy. Recent Congressional appropriations have directed at least $200 million in tobacco user-fee funds toward enforcement against illicit and unauthorised ENDS products, including enhanced port-of-entry controls and a federal multi-agency task force focused on illegal disposables.
As more PMTA decisions are issued across nicotine pouches and other ENDS categories, enforcement in 2026 is expected to align more closely with regulatory outcomes. Marketing Denial Orders (MDOs) and Refuse-to-File (RTF) decisions are increasingly likely to be used as a roadmap for targeted enforcement activity, accelerating efforts to clear unauthorised products from the marketplace.
This represents a shift away from broad, reactive enforcement toward a more structured, data-driven approach tied directly to PMTA status.
Building the Infrastructure of an Authorised Marketplace
Crucially, FDA is not relying on enforcement alone. Several long-anticipated rulemakings are designed to hard-wire regulatory compliance into the system itself.
One of the most consequential is the proposed Automated Commercial Environment (ACE) Submission Tracking Number rule, which would require importers of ENDS products to provide a PMTA Submission Tracking Number at the time of entry. If finalised, this would directly link each shipment to a specific PMTA, making it significantly more difficult for unauthorised products to enter the US through legitimate customs channels.
Alongside this, FDA has signalled further rulemaking to formalise tobacco establishment registration and product listing requirements. Building on existing systems, a more enforceable framework would give the agency clearer visibility into who is manufacturing what, where products are being made, and how they move through the supply chain.
In parallel, the proposed Tobacco Product Manufacturing Practice (TPMP) rule continues to feature prominently in FDA communications. While still in proposed form, TPMP would introduce GMP-like expectations for design controls, manufacturing processes, quality systems, and product storage. Movement toward a final rule in 2026 would raise baseline manufacturing expectations across the industry.
Finally, FDA has also prioritised a proposed administrative detention rule specific to tobacco products. This would allow the agency to detain products encountered during inspections when there is reason to believe they are adulterated or misbranded, preventing distribution while enforcement decisions are made.
2026: Connecting the Dots
Individually, none of these developments is entirely new. What makes 2026 different is the way they are beginning to align.
PMTA decisions provide regulatory clarity. Enforcement resources give FDA the means to act on those decisions. Import controls, registration systems, manufacturing standards, and detention authority supply the infrastructure needed to sustain an authorised-only marketplace over time.
For manufacturers and brand owners, the message is clear: regulatory status, scientific robustness, and manufacturing quality are no longer abstract compliance concepts. They are becoming decisive commercial factors.
As the FDA moves from transition to execution, 2026 is shaping up to be the year when the authorised-only marketplace moves from aspiration to reality.
To find out how Broughton can support your regulatory submissions in 2026, use our PMTA price estimation tool here.