By Lillian Ortega, WOW Solutions
Lillian Ortega, founder and chief regulatory compliance strategist of WOW Solutions, a regulatory consulting partner of the nicotine testing and research organization Broughton, explains the latest developments from regulators across pouches and electronic nicotine delivery systems (ENDS), as well as the latest enforcement actions in the United States.
Since December 2025, the Food and Drug Administration has started to develop a more targeted and consequential regulatory landscape to help improve transparency and efficiency in next generation nicotine and tobacco product review, while reinforcing expectations around enforcement, youth-risk mitigation and product-specific evidence.
Nicotine pouches
The FDA’s authorization of six nicotine pouch products under its pilot program suggested a shift toward faster product reviews and approvals. However, since the on! PLUS range was authorized, there have been no additional authorizations, leading to questions about whether it’s a scalable pathway or a one-time demonstration.
Simultaneously, Refuse-to-File (RTF) decisions—where an application is deemed insufficient or incomplete—are being challenged in court, which shows the challenges for the regulator at the filing stage of approval. The FDA has shown it can move quickly, but only for a narrow subset of applications. We’ll be keeping a close eye out for any additional nicotine pouch marketing decisions to see if the pilot expands.
ENDS
Following a roundtable on February 10, 2026, where small manufacturers shared their challenges with the PMTA process with the FDA, there is now a greater expectation of transparency, particularly with ENDS products. The overarching message was that the FDA is working to clarify what kind of evidence is required and how much, in turn helping predictability. This makes the process more nuanced and should not be confused with any lowering of standards.
The FDA’s draft guidance, ‘Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk,’ further reinforced this by emphasizing 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.’
The document acknowledges that flavored ENDS may provide benefits to adults, including switching, cessation and reduction, but makes clear these benefits 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.
Also, the FDA clarifies that Device Access Restrictions (DAR), including age-gating, can support an application but cannot replace scientific evidence of adult benefit.
This was followed by the first FDA authorization of an age-gated ENDS product—the GLAS device—which contains a tobacco-flavored pod, developed by a small U.S.-based manufacturer. However, the lack of detail via a press release and the absence of a published Technical Project Lead (TPL) review leaves some uncertainty about the remaining portfolio covered in the PMTA.
Like pouches, there is potential for a streamlined pilot review for ENDS to help combat illicit trade.
Enforcement
In late 2025, the U.S. Congress provided funding direction with the hope of kickstarting the FDA’s enforcement drive. The provision requires $200 million in user fees to be directed toward ENDS enforcement, mandates updates to enforcement priorities—including flavored disposable devices—and introduces semi-annual reporting to Congress.
However, with 65 warning letters issued so far in 2026 compared to over 200 at the same stage in 2025, along with minimal penalties, this suggests there hasn’t been a meaningful increase in enforcement. The required update to enforcement priorities guidance may serve as the inflection point, particularly as Congress has signaled a focus on flavored disposable ENDS.
Further enforcement priorities guidance should be available in the near future, so we’ll be looking for any initial reporting and whether enforcement activity materially increases.
To ensure your tobacco and nicotine products comply with the latest FDA regulations and guidance, it’s important to work with a trusted regulatory specialist so your product can navigate the PMTA pathway as smoothly as possible. Visit Broughton’s website to find out more about how working with a partner can bring your product to market.
Lillian Ortega is founder and chief regulatory compliance strategist of WOW Solutions. She is a former FDA regulator.
