What Does it Take to Bring a Nicotine Pouch Product to Market?
Roundtable Discussion
Thursday, March 5 | 11 AM ET
Is Your Business Ready to Enter the Nicotine Pouch Market?
U.S. nicotine pouch sales grew ~6.5x in just three years (2019–2022), with continued growth expected following FDA’s Nicotine Pouch Pilot Program, launched in late 2025 to streamline PMTA reviews. One new marketing granted order (MGO) has already been issued for on! PLUS – and more may follow.
The opportunity is significant, but navigating the requirements can be challenging for new market entrants.
You Have Questions. We Have Answers.
This expert-led roundtable will help businesses understand the scientific, manufacturing, and regulatory expectations for developing a nicotine pouch product and bringing it to market today.
Complete the form to register. Can’t attend live? Register to receive the recording.
What We'll Discuss:
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How should manufacturers realistically view the nicotine pouch market today, and what have recent authorizations and the FDA nicotine pouch pilot program revealed about what is achievable?
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What does the FDA nicotine pouch pilot program change – and what does it not change – when preparing PMTAs?
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When should regulatory, legal, and scientific planning begin in the nicotine pouch product lifecycle, and how does early engagement affect PMTA outcomes?
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What are the first practical steps in building a high-quality nicotine pouch PMTA strategy?
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How should companies apply the APPH standard when designing nicotine pouch PMTAs, and what data categories are FDA evaluating?
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How can manufacturers use learnings from existing nicotine pouch market authorizations to inform decisions about toxicological and non-clinical data?
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What are the most common and preventable mistakes that delay or weaken nicotine pouch PMTA submissions?
-
What should companies consider when selecting nicotine pouch product portfolios for inclusion in a PMTA?
Join the Roundtable
Roundtable Discussion
Thursday, March 5 | 11 AM ET
Is Your Business Ready to Enter the Nicotine Pouch Market?
U.S. nicotine pouch sales grew ~6.5x in just three years (2019–2022), with continued growth expected following FDA’s Nicotine Pouch Pilot Program, launched in late 2025 to streamline PMTA reviews. One new marketing granted order (MGO) has already been issued for on! PLUS – and more may follow.
The opportunity is significant, but navigating the requirements can be challenging for new market entrants.
You Have Questions. We Have Answers.
This expert-led roundtable will help businesses understand the scientific, manufacturing, and regulatory expectations for developing a nicotine pouch product and bringing it to market today.
Complete the form to register. Can’t attend live? Register to receive the recording.
What We'll Discuss:
-
How should manufacturers realistically view the nicotine pouch market today, and what have recent authorizations and the FDA nicotine pouch pilot program revealed about what is achievable?
-
What does the FDA nicotine pouch pilot program change – and what does it not change – when preparing PMTAs?
-
When should regulatory, legal, and scientific planning begin in the nicotine pouch product lifecycle, and how does early engagement affect PMTA outcomes?
-
What are the first practical steps in building a high-quality nicotine pouch PMTA strategy?
-
How should companies apply the APPH standard when designing nicotine pouch PMTAs, and what data categories are FDA evaluating?
-
How can manufacturers use learnings from existing nicotine pouch market authorizations to inform decisions about toxicological and non-clinical data?
-
What are the most common and preventable mistakes that delay or weaken nicotine pouch PMTA submissions?
-
What should companies consider when selecting nicotine pouch product portfolios for inclusion in a PMTA?
Join the Roundtable
Meet Our Panelists
Pete Gibbons, PhD
Director of Business Development, Labstat
Pete Gibbons leads business development for Labstat International’s Reduced-Risk Products (RRP) sector, where he focuses on expanding advanced analytical testing services for nicotine products. With a background as Head of Reduced-Risk Product Analysis at Element Life Sciences EMEAA, Peter brings deep expertise in analytical science, product evaluation, and market development. He works closely with manufacturers and regulators to support science-driven, defensible approaches to nicotine product safety and performance.
Beth G. Oliva
Partner, Fox Rothschild
Beth Oliva is a Partner at Fox Rothschild LLP, who has advised tobacco and nicotine clients for nearly 20 years. Her practice focuses on advising nicotine and tobacco product manufacturers on FDA compliance, premarket review, and post-marketing requirements. She works closely with clients from product development through PMTA submission, drawing on deep experience before FDA and state agencies, as well as extensive collaboration with scientific and medical experts to support defensible regulatory strategies. She serves on the Board of Directors of the Food and Drug Law Institute (FDLI) and the Nicotine Resource Consortium (NRC).
Stanley E. Gilliland III, PhD
Senior Vice President of Chemistry and Material Science, Sapphire Sciences
As Senior VP of Chemistry and Material Science as Sapphire Sciences, Stanley E. Gilliland III leads regulatory science and strategic consulting services for FDA-regulated tobacco and nicotine products. He has worked extensively in the FDA-regulated nicotine and tobacco product space since 2018, supporting client companies from early product development through all phases of the PMTA process, with particular depth in nicotine pouch submissions.
Peter Joza
Vice President of Scientific Research and Commercialization, Labstat
Pete Joza brings more than three decades of scientific leadership in analytical and production laboratory environments, with deep expertise in analytical methods, instrumentation, and quality systems. He has led laboratory teams in method development, data integrity, and Total Quality Management, and is highly experienced in communicating complex scientific information in both regulatory and commercial settings.
Bonnie Coffa, PhD, DABT
Scientific Director of Toxicology, Labstat & ToxPharm LLC
Bonnie Coffa is a board-certified toxicologist with more than a decade of experience supporting nicotine and cannabis products across regulatory science, in vitro toxicology, and risk assessment. She works with manufacturers on toxicological evaluations, literature reviews, and FDA regulatory applications, delivering clear, science-based insights to support defensible product submissions.
About Certified Group
Certified Group partners with customers to deliver innovative scientific solutions and expertise – So The World Can Trust In What It Consumes™. As a leading provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries.