FDA PMTA Roundtable: Ongoing Comprehensive Coverage by 2Firsts

On February 10, 2026, the U.S. Food and Drug Administration (FDA) convened a multi-session roundtable on Premarket Tobacco Applications (PMTAs) for electronic nicotine delivery systems (ENDS), bringing together senior agency officials and industry representatives to discuss scientific standards and regulatory expectations under the “Appropriate for the Protection of Public Health” (APPH) framework.

The discussions spanned product characterization, manufacturing controls, pharmacological assessment, studies of adult benefit, and toxicological review—offering rare public visibility into the agency’s current evaluation approach.

As of February 11, 2026 (Beijing Time), 2Firsts has published eight in-depth reports covering each panel session and key regulatory signals from the meeting. Together, these reports provide one of the most systematic and timely documentations of the event, examining scientific methodologies, review frameworks, and industry responses.

2Firsts will continue to follow developments related to FDA PMTA policy and review practice. Readers are invited to follow ongoing updates on the 2Firsts website and across our social media channels.

For professional inquiries or further discussion, readers are welcome to contact 2Firsts CEO Alan Zhao at alan@2firsts.com.

Below is the complete collection of our coverage to date.

Panel I: Product Characterization

2FIRSTS | FDA Highlights Product Characterization as a Foundational Requirement in ENDS PMTA Reviews

During its ongoing PMTA roundtable, FDA emphasized that product characterization is a foundational element in the review of electronic nicotine delivery systems (ENDS). The agency underscored the need for complete product identifying information, validation and verification of test methods on the specific product type, and the appropriate use of tobacco product master files (TPMFs) to support complex or proprietary ingredients in PMTA submissions.

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2FIRSTS | PMTA Roundtable Opens with Industry Questioning Product Characterization Standards, FDA Defends Regulatory Boundaries

At the opening of FDA’s PMTA roundtable, small ENDS manufacturers warned that unclear product characterization standards are limiting their ability to invest and raise capital. FDA officials acknowledged industry concerns but said regulatory flexibility is constrained by statutory and procedural boundaries.

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Panel II: Manufacturing Controls

2FIRSTS | FDA Outlines Manufacturing Requirements as Critical to ENDS PMTA Success

FDA officials said manufacturing consistency is a core prerequisite for ENDS PMTA reviews, not a procedural formality. During its February 10, 2026 roundtable, the agency outlined expectations for quality management systems, manufacturing documentation, nicotine control, stability studies, and risk mitigation, emphasizing that robust manufacturing evidence underpins determinations of whether products are appropriate for the protection of public health.

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2FIRSTS | PMTA Manufacturing Panel Sees Small Firms Warn “Unknown Is Death” as FDA Defends Review Boundaries

During FDA’s Feb 10 PMTA roundtable (manufacturing controls panel), small ENDS manufacturers warned that uncertainty in manufacturing expectations creates existential financial risk. FDA officials reiterated review flexibility is constrained by statutory and scientific boundaries. The panel debated testing standards, documentation requirements, open-system responsibility, supply chain changes, and software updates—highlighting unresolved PMTA challenges for small manufacturers.

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Panel III: Pharmacological Profile

2FIRSTS | Small ENDS Manufacturers Press FDA on Abuse Liability Standards as Agency Defines Pharmacological Review Framework

At the third session of its PMTA roundtable, the FDA outlined its framework for assessing abuse liability in ENDS products, emphasizing the role of nicotine pharmacokinetics and product-specific data in APPH determinations. Small manufacturers questioned the high cost of clinical PK studies and the absence of defined numeric thresholds, while raising bridging strategies and PBPK modeling as potential alternatives.

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Panel IV: Studies of Adult Benefit

2FIRSTS | FDA Says Flavored ENDS Must Show “Added Benefit” as Small Manufacturers Seek Clearer Switching Benchmarks

During the FDA PMTA roundtable session on “Studies of Adult Benefit,” officials said flavored ENDS must demonstrate “added benefit” over tobacco-flavored products under the APPH standard, including sustained complete switching evidence. Small manufacturers questioned switching benchmarks, study duration, and bridging expectations.

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Panel V: Toxicological Profile

2FIRSTS | FDA Details Carcinogenicity Tiering and ELCR Framework as Small Manufacturers Press for Predictability

During the “Toxicological Profile” session at FDA’s Feb 10 PMTA roundtable, officials outlined the carcinogenicity tiering system and Excess Lifetime Cancer Risk (ELCR) framework used in ENDS reviews under the APPH standard. Small manufacturers questioned database transparency, exposure assumptions, and the existence of clear compliance benchmarks. FDA reiterated toxicological risk is assessed case by case within a broader population-level determination.

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Summary, Closing Comments & Adjournment

2FIRSTS | FDA Commissioner Stresses “Predictability” as Science Chief Addresses Industry Uncertainty

FDA Commissioner Marty Makary briefly appeared at the February 10 PMTA roundtable, underscoring the importance of regulatory predictability. At the close of the session, Office of Science Director Matthew Farrelly responded to industry concerns over review uncertainty, stating the agency will issue a written summary of feedback, while reiterating that no fixed quantitative risk benchmark governs authorization decisions.

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