Deep Dive - Nicotine Pouch PMTAs: What It Really Takes to Enter the U.S. Market?

CEO Broughton Group Chris Allen is Chief Executive Officer and Co-Founder of Broughton. With more than 25 years of experience in analytical and regulatory science, he has worked across pharmaceuticals, medical devices, and nicotine products, including inhaled and solid dose formulations.

Chris has extensive expertise working with global regulatory authorities such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Under his leadership, Broughton has supported Medicinal Marketing Authorisation Applications (MAA), EU Tobacco Products Directive (TPD) submissions, US Premarket Tobacco Product Applications (PMTA), and other international regulatory pathways.

Co-Founder and Chief Strategy Officer Sanova 

Sarah has broad experience supporting clients through the full regulated product life cycle, including product development, regulatory submissions, and postmarket.  

Sarah works closely with clients to plan and submit premarket tobacco product applications (PMTAs) and modified risk tobacco product applications (MRTPAs) across various nicotine product categories, including novel, emerging delivery systems. She combines her extensive industry experience, scientific expertise, and business acumen to navigate the rapidly evolving regulatory landscape and provide practical solutions to regulatory challenges. Sarah supports regulatory strategy across all scientific areas including product design, manufacturing, and nonclinical and clinical study programs.  She specializes in helping clients create and navigate multi-product regulatory strategies and product line extensions. These strategies leverage existing scientific evidence through use of supplemental PMTAs (sPMTAs) and tobacco product master files (TPMFs) to minimize regulatory costs and timelines.  She also supports preparation for Tobacco Products Scientific Advisory Committee (TPSAC) meetings.

Beth G. Oliva represents manufacturers, distributors, retailers, and trade associations in regulatory, litigation and legislative matters and has spent nearly twenty years representing the tobacco and nicotine industry. She handles a wide range of regulatory issues before the Food and Drug Administration, as well as other U.S. federal and state agencies.  While she represents clients at all levels of the distribution chain, she specifically represents manufacturers from research and design through product commercialization as well as through their life cycle on the US market.  Beth also has extensive experience with state and federal government affairs and routinely drafts legislation, testifies in front of state legislatures and negotiates.  In addition, Beth has significant experience working with scientific issues. She has worked with scientific and medical personnel in the U.S., Canada, Europe and the Middle East to advise product manufacturers on regulatory and duty-of-care issues. Further, Beth has worked with scientific consultants, expert witnesses, and scientific literature both to support regulatory submissions and to prepare defenses in domestic and international product liability litigation. Beth serves on the Board of Directors for the Food and Drug Law Institute (FDLI), the Board of Directors of the Nicotine Resource Consortium (NRC), and the Organization of Women in Nicotine and Tobacco (OWNiT) and is the Chair of the Global Forum for Nicotine and Tobacco (GTNF).

Samuel ‘Sam’ Hampsher-Monk joined Applied Reaserch and Analysis Company (ARAC) in January 2025 as VP, Global Regulatory Strategy and Business Operations, having spent seven years as Managing Director of BOTEC Analysis where he led international, multidisciplinary research on cannabis, tobacco, and nicotine product regulation for state and municipal agencies, research institutions, and philanthropic foundations. 

His work has spanned consumer product regulation, taxation, illicit trade, policy reform, and social justice. His peer-reviewed research has been published in the Journal of Consumer Policy and the Journal of Health Communication and his commentary on tobacco and nicotine regulation has been published by the C. D. Howe Institute. He was the lead author of Clearing the Air on E-Cigarettes and Harm Reduction: Tobacco Control, Economics, and Public Health (Palgrave Macmillan, 2024).