Next Generation Nicotine Delivery Conference 2026

The Next Generation Nicotine Delivery Conference 2026 in Miami, opened with a noticeably more confident and operational update from FDA’s Center for Tobacco Products (CTP), signalling a shift from frustration over delays to clearer expectations about what makes a successful PMTA submission.

Cristi Stark’s update on CTP’s premarket review process was noticeably more operational, more structured and more confident in what is now working and opened two days of lively discussion across the latest developments, challenges, and breakthroughs in nicotine research and public health through keynote presentations, panel discussions, roundtable discussions and dynamic networking sessions.

Day 1 - Next Generation Nicotine Delivery Conference 2026

The clearest message from Cristi Stark’s presentation was that FDA is not rejecting applications because standards are impossibly high. More often, applications fail because they do not contain the information needed for review. Where submissions are complete and well supported, FDA can move quickly.

Acceptance review is now operating much faster, with a target of around 21 days. Applications are screened soon after receipt, with AI being used to help reviewers organise and triage information. At this stage, the focus is straightforward: correct forms, completed fields, and required supporting material such as environmental assessments. Missing basics still lead to Refuse to Accept outcomes.

Filing review remains the key route into substantive assessment. Here, the question is whether there is enough information to justify a full scientific review. Product characterization stood out as one of the most critical expectations, alongside evidence of manufacturing controls and abuse liability considerations.

Substantive scientific review continues to take longer than the statutory 180-day determination period, but the approach appears more focused. The emphasis is increasingly on the product-specific factors most relevant to an APPH determination, with greater willingness from FDA to clarify issues during review rather than to rely on formal deficiency letters.

The nicotine pouch pilot was referenced as an example of how more focused review can improve speed, even if it is not being formally expanded. Overall, the tone was less about rewriting policy and more about improving execution within the existing framework.

Benjamin Apelberg from CTP delivered a session that built on this theme by explaining what FDA expects to see in practice. The central issue was product characterization. If FDA cannot clearly understand what a product is, how it is made, and what it delivers, the rest of the application has limited value.

Three scientific pillars were highlighted. First, product characterization must be detailed and reliable, including design specifications, ingredient listings, HPHC testing, and validated analytical methods. Second, manufacturing consistency is essential. FDA wants evidence that the product repeatedly meets specification, remains stable over shelf life, and is supported by robust quality systems and in-process controls. Third, abuse liability remains central to understanding nicotine delivery and addiction risk. Clinical studies, especially crossover PK designs, remain the strongest evidence where needed.

FDA also made clear that not every SKU requires its own PK or abuse liability study. Bridging is acceptable, but only where applicants can justify that the tested product is representative. This requires detailed characterization of both products and a clear explanation of similarities and differences that could affect nicotine delivery. On marketing, the message was consistent. Authorization is not only about product risk, but also how the product is positioned and whether it is clearly targeted at adult users.

In the Q&A, FDA reinforced that in the case of ENDS products, the expectation for robust evidence remains highest, particularly where flavors are involved and where youth appeal risk is greater. The stronger the risk profile, the stronger the evidence required to demonstrate adult benefit. On abuse liability and PK, there was no suggestion that these requirements are being removed. While there is openness to different forms of evidence and potential future evolution, the clear message was that adult benefit must still be demonstrated.

AI use was also clarified. FDA is already using AI in acceptance and filing stages to triage and structure information, but every output is still subject to human review. AI supports efficiency, it does not replace regulatory judgment. The broader implication across the session was consistent. FDA is trying to increase speed and consistency, but within a framework that still relies heavily on detailed product understanding, robust characterization and evidence of adult benefit.

There was a discussion about how industry can work more effectively with CTP. Speakers stressed the value of early engagement, especially through pre-submission meetings, to build a productive dialogue before major studies are underway. That was particularly relevant for companies operating in newer categories such as nicotine pouches, where the regulatory framework is still evolving and evidence expectations continue to develop.

Panellists also discussed how communication from FDA could improve through town halls, webinars, and roundtable-style discussion, allowing more practical clarification than written guidance alone can sometimes provide.

The session on switching studies added another important layer. Drawing on recent experience, speakers highlighted how difficult these studies can be to design, execute, and interpret in a way that satisfies regulators. The key lesson was that strong study design is only part of the challenge; sponsors also need to communicate methods, limitations, and outcomes clearly so the findings can support regulatory decision-making.

By the end of Day 1, attention had shifted to enforcement. Panellists examined FDA’s updated enforcement priorities, including the publication of companies that will not currently be targeted. The new guidance marks a significant change in approach, but questions remain around omissions such as heated tobacco products and how the policy will work in practice.

One message came through strongly: companies can no longer rely on regulatory uncertainty as cover for weak submissions. The era of thin, placeholder-style PMTAs appears to be over, and businesses need both credible regulatory strategy and experienced legal support to navigate the environment effectively.

The final panel broadened the discussion to illicit products globally. Speakers noted that illicit trade raises more than commercial concerns; it increases the risk of youth access, product safety failures, tax losses, and wider criminal activity. For legitimate companies investing in quality and compliance, weak enforcement undermines incentives to do the right thing.

Taken together, the enforcement sessions underscored a simple principle: regulation only works if compliance is worth pursuing and non-compliance carries real consequences. The illicit market may never disappear entirely, but stronger and more consistent enforcement is essential to protect both public health and responsible operators.

Day 2 - Next Generation Nicotine Delivery Conference 2026

Day 2 moved from moved away from the higher-level regulatory discussions and into the detail behind the science. Presentations on toxicological risk assessment and switching data for the Breeze disposable ENDS range illustrated the level of evidence expected when FDA considers whether a product is appropriate for the protection of public health.

This discussion then returned to enforcement priorities, describing FDA’s emerging three-part framework: authorized products, unauthorized products that are a lower enforcement priority, and unauthorized products that are a higher enforcement priority. His review of the PMTA process reinforced a message repeated throughout the conference: applications must be complete, scientifically robust, and supported by detailed ingredient listings, validated HPHC data, manufacturing controls, and clear health risk information, particularly for flavoured ENDS where the evidentiary burden remains significantly higher. 

One of the more interesting aspects of the presentation was the discussion around unintended consequences of regulation. FDA’s 2020 focus on flavoured cartridge-based ENDS was followed by the growth of disposable products such as Puff Bar, as manufacturers responded to perceived gaps in policy. 

The obvious question is whether the new guidance could create similar unintended consequences. With FDA introducing a lower enforcement priority category for certain unauthorized products, industry will inevitably look closely at where the boundaries sit.

Overall this guidance has the ability to reshape policy for the better as long as implementation is effective and accompanied by the appropriate enforcement.