FDA Roundtable on ENDS PMTAs: More Clarity, Still No Clear Target

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On February 10, 2026, the U.S. Food and Drug Administration (FDA) hosted a Roundtable on Premarket Tobacco Product Application (PMTA) Submissions for Electronic Nicotine Delivery Systems (ENDS) Products, bringing together agency officials and industry representatives for a discussion about what the agency expects in today’s regulatory environment. The program covered product characterization, manufacturing controls, abuse liability, adult benefit for flavored ENDS, and toxicology. For vape manufacturers, especially small and mid-sized companies, the message was mixed. FDA offered more insight into how it evaluates applications, but industry continued to press for clearer benchmarks and more predictable standards.

One of the strongest themes of the day was completeness. FDA made it clear that product characterization remains the foundation of any successful PMTA. That means detailed design specifications, full ingredient disclosure, nicotine source information, measured Harmful and Potentially Harmful Constituents (HPHCs), stability data, and validated test methods. If basic product information is missing, the agency will not move forward with review. FDA also emphasized method validation and encouraged the use of Tobacco Product Master Files (TPMFs), particularly for proprietary flavor formulations and testing procedures.

Industry participants repeatedly asked whether FDA could define objective benchmarks such as specific measurable limits on the amount of harmful chemicals a device can emit during use, clear guidance on which materials or components may raise regulatory concerns, or temperature limits that would give manufacturers a clearer compliance target.

FDA’s response was consistent. An Appropriate for the Protection of the Public Health (APPH) determination is not based on a single number or chemical threshold. It is a multidisciplinary evaluation that considers chemistry, toxicology, behavioral science, and population-level impact together. For many small manufacturers, however, the lack of a defined target continues to create uncertainty, particularly when competing against unauthorized imports that are not navigating the same regulatory burden.

Bridging was discussed throughout the roundtable as a potential efficiency tool. FDA confirmed that bridging can be appropriate when product differences are minimal and well justified. However, the agency emphasized that bridging requires a clear scientific rationale explaining why differences in nicotine strength, flavor, device power, or formulation do not meaningfully change outcomes. In other words, bridging can help reduce duplication, but it is not a shortcut around generating product-specific evidence.

Manufacturing controls were another area of focus. FDA reiterated that the products consumers purchase must be the same products evaluated in PMTA studies. The agency expects documented quality systems, batch records, stability studies that support labeled shelf life, and risk analyses addressing potential product failures. FDA also highlighted device features that may mitigate risk, such as puff limits, temperature controls, low-voltage cutoffs, and child-resistant packaging. The underlying message was that product design and manufacturing decisions are central to the public health analysis.

Abuse liability and adult benefit for flavored ENDS products generated significant discussion. FDA explained that clinical studies measuring nicotine delivery and switching behavior provide the strongest evidence in this area. For flavored products, the agency reaffirmed that applicants must demonstrate an added benefit for adult smokers compared to tobacco-flavored ENDS. Because youth risk remains a substantial concern in FDA’s framework, flavored products face a higher evidentiary burden. Randomized controlled trials and well-designed observational studies remain the most persuasive types of evidence.

Industry representatives questioned whether declining youth use trends should recalibrate the risk-benefit threshold and emphasized the role that small manufacturers have played in helping adult smokers transition away from combustibles. They also raised concerns about investment challenges and the difficulty of planning product development without clearer regulatory guardrails. FDA acknowledged the concerns but maintained that its review process is grounded in statutory requirements and a case-by-case evaluation of risks and benefits to the population as a whole.

One of the more practical takeaways for manufacturers involved toxicology and risk modeling. FDA explained that cumulative cancer risk estimates consider not only HPHCs, but also ingredients and leachables from device materials. The agency emphasized that many toxicological risks are influenced by choices within the manufacturer’s control, such as material quality and ingredient selection. Better materials and more conservative formulation decisions can meaningfully affect overall risk estimates.

Throughout the discussion, FDA encouraged companies to use pre-submission meetings and to clearly explain the scientific rationale behind their study designs and product decisions. “Tell your story” was a consistent underlying theme. The agency signaled that transparency and justification matter, even if there is no universal checklist that guarantees authorization.

The broader tension remains. FDA views PMTA review as a holistic, multidisciplinary assessment. Industry continues to seek objective standards that provide predictability and support investment. The February roundtable did not resolve that tension, but it did offer greater visibility into how FDA is thinking in 2026.

For manufacturers preparing new or revised PMTAs, the practical message is straightforward. Ensure product characterization is complete and well documented. Use bridging strategically and justify it thoroughly. For flavored products, be prepared to demonstrate clear adult switching benefit relative to tobacco flavors. Pay attention to formulation and material choices that affect toxicological risk. And engage early with FDA whenever possible.

The pathway remains demanding. However, the agency’s expectations are more clearly articulated than in earlier phases of PMTA review. Companies that align their regulatory strategy with those signals may improve their position in an increasingly scrutinized marketplace.

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