【2Firsts-Shenzhen】On the afternoon of April 16, the leading global aerosol technology media and think tank 2Firsts successfully held a closed-door seminar in Shenzhen Qianhai, titled "2025 Insight Forum on Dual Challenges of U.S. NGP Regulation & Tariff Trends/ Closed-Door Forum on Nicotine Pouch PMTA Technical Analysis".
The forum was divided into two sessions, with the first session focusing on the technical analysis of nicotine pouches' PMTA, delving into the compliance pathway of nicotine pouches in the US market. The second session revolved around the interpretation of the trends of new tobacco regulations and dual tariff challenges in the United States in 2025, providing attendees with insights into the future regulatory and tariff policies of the US. The conference attracted representatives of dozens of nicotine pouch and e-cigarette companies in terms of technology and compliance, collectively discussing key industry development issues and providing valuable insights and strategies for addressing future challenges.
Dr. Andrea Patton, the head of epidemiological research at the Centre for Substance Use Research (CSUR), along with co-director Gabriel Barnard, were invited to attend this seminar and each gave a keynote speech.
Dr. Andrea Patton gave a speech titled "Use of Zyn Nicotine Pouches in the United States: Quantifying Population-Level Risk and Benefit in a PMTA Framework.
Using ZYN's PMTA (Premarket Tobacco Product Application) approval as a case study, she systematically introduced the public health standards that new tobacco products need to meet in order to be approved for market in the United States. She analyzed the key types of research involved in the PMTA framework, and detailed how to scientifically quantify the risks and benefits at the population and non-population levels.
Dr. Patton pointed out that the approval of ZYN provides a "reference benchmark" for future applicants to evaluate the "level of acceptable use" of products among different populations, demonstrating significant industry implications.
Gabriel Barnard gave a keynote speech titled "A Perception and Behavioral Strategy to Quantify the Public Health Impact of an Oral Nicotine Pouch Product in the United States".
During the speech, Gabriel Barnard provided a detailed analysis of the Pre-Market Tobacco Product Application (PMTA) review framework, outlining the specific types of research and key information requirements that nicotine pouch manufacturers need to focus on during the application process. He presented three recommended research directions to help applicants meet the public health assessment standards of PMTA.
·Actual Use Study
·Behavior Intent ions and Risk Perceptions Study
·Label Comprehension and Usability Study
Subsequently, Gabriel Barnard systematically explained the important role of these three types of research in PMTA applications from the dimensions of regulatory compliance and scientific basis, providing practical strategic guidance for the registration path of nicotine pouch products.
Dr. Andrea Patton and Gabriel Barnard's professional presentations were widely praised and enthusiastically received by attendees. Many delegates expressed that the insights and compliance guidance shared by the two experts provided them with valuable industry knowledge, helping them to gain a deeper understanding of key assessment criteria for PMTA applications, methods for quantifying product benefits and risks, and the application of multidisciplinary research in compliance processes.
At the same time, attendees also expressed sincere gratitude to the two organizers, believing that this forum has built a high-quality compliance communication platform, greatly promoting communication and collaboration among various industry participants, and playing a positive role in pushing the new tobacco industry to take solid steps on the path of compliant development.
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