Since December, FDA actions have begun to define a more targeted and consequential regulatory landscape. This evolving posture reflects a dual track: improving transparency and efficiency in product review, while reinforcing expectations around enforcement, youth-risk mitigation, and product-specific evidence.
Nicotine Pouches: Efficiency Without Continuity—Yet
FDA’s authorization of six nicotine pouch products under its pilot program suggested a potential shift toward faster reviews. However, no additional authorization has followed since the on! PLUS decision, raising questions about whether this represents a scalable pathway or a one-time demonstration. At the same time, Refuse-to-File (RTF) decisions—now being challenged in court—highlight continued barriers at the filing stage. FDA has shown it can move quickly, but only for a narrow subset of applications.
ENDS: More Nuanced, Still High Bar
FDA’s recent actions between February and March 2026 reflect a coordinated shift toward greater transparency in expectations—particularly for ENDS products.
The February 10, 2026, roundtable provided small manufacturers with an opportunity to share their challenges with the PMTA process and offer feedback on improving efficiency. The overarching message was not that the evidentiary bar is being lowered, but that FDA is working to clarify how that bar is applied and where greater predictability may emerge. FDA's February Roundtable
That message was reinforced one month later through two closely aligned developments. On March 11, 2026, FDA issued its draft guidance, Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk, which further articulates the agency’s current framework. The guidance emphasizes that youth risk remains the central driver, reiterating concerns around fruit, dessert, and sweet flavors, while introducing a more refined “risk-proportionate, product-specific approach.”
Importantly, FDA acknowledges that flavored ENDS may provide adult benefits—such as switching, cessation, and reduction—but makes clear that these must outweigh youth risks. The guidance also introduces the concept of “differential youth appeal” across flavor categories, signaling that flavor-specific evidence will increasingly be required.
Consistent with this approach, FDA clarifies that Device Access Restrictions (DAR), including age-gating, may support an application—but cannot replace scientific evidence of adult benefit.
Just two days later, on March 13, FDA authorized the GLAS device—its first age-gated ENDS product—with a tobacco-flavored pod, developed by a small US based manufacturer. However, they did not issue a press release to announce the first authorization of an ENDS with Device Access Restriction, nor did they publish the Technical Project Lead {TPL) Reviews. Leaving many with questions about the remaining portfolio covered in the PMTA. More on FDA's GLAS Authorization
Enforcement: Early Impact of Congressional Direction
Congressional direction issued in late 2025 (through Section 772 of the FY2026 appropriations legislation) provided funding direction with the hope of kickstarting FDA’s enforcement posture. The provision requires $200M in user fees be directed toward ENDS enforcement, mandates updates to enforcement priorities (including flavored disposables), and introduces semiannual reporting to Congress. However, current activity has not yet reflected a meaningful increase—with 65 warning letters issued thus far in FY2026 (vs. 200+ in FY2025) and minimal civil money penalties to date. The required update to enforcement priorities guidance may serve as the inflection point, particularly as Congress has clearly signaled a focus on flavored disposable ENDS.
Looking Ahead:
Key Takeaway
FDA CTP’s Office of Science is showing signs of more consistent communication and greater efficiency in PMTA reviews, as reflected in the pouch‑pilot feedback. The question now is whether that momentum will hold as pilot programs expand to other product categories. For industry, success means submitting a high‑quality, product‑specific PMTA grounded in solid scientific evidence—and staying agile enough to adjust as FDA refines its expectations.
Written by
Lillian Ortega, MPH
WOW Solutions LLC- Founder & Chief Regulatory Compliance Strategist
Former Director of Enforcement and Manufacturing, FDA/CTP