[2Firsts, Shenzhen] — On April 16, 2Firsts successfully concluded the seminar "Eye of the Storm: 2025 Insight Session on Dual Challenges of U.S. NGP Regulation & Tariff Trends/ Closed-Door Seminar on Nicotine Pouch PMTA Technical Analysis" in Shenzhen.
The seminar was divided into two halves, with the first half focusing on the "Nicotine Pouch PMTA Technical Analysis," delving into the technical compliance pathway for nicotine pouches in the American market. The second half revolved around "2025 Insight Session on Dual Challenges of U.S. NGP Regulation & Tariff Trends," providing insights into the future direction of regulatory and tariff policies in the United States. The conference attracted representatives of dozens of nicotine pouch and e-cigarette companies focusing on technology and compliance, collectively discussing key industry development issues and providing valuable insights and strategies to address future challenges.
In the opening speech, Alan Zhao, co-founder and CEO of 2Firsts, stated that nicotine pouches, a popular category within new tobacco products, are attracting numerous companies and becoming the new engine of industry development. This seminar will delve into various perspectives to share compliance strategies for nicotine pouches, providing solid guidance for businesses on the path to compliance.
Alan Zhao mentioned that in the past month, there have been significant changes in market regulation in the United States, with strengthened enforcement, legislative trends, and adjustments to tariff policies, all of which have far-reaching impacts on the e-cigarette industry. Faced with these unprecedented challenges, how should e-cigarette companies accurately position themselves and calmly respond to these changes? This not only concerns the survival and development of companies, but also the future direction of the entire industry. He hopes that through in-depth exchanges and collisions of ideas at this seminar, everyone can gain inspiration and contribute more to the promotion of the healthy development of the new tobacco industry.
Focus on Nicotine Pouch PMTA Application: Experts Provide In-Depth Analysis and Strategic Insights
At the "Nicotine Pouch PMTA Technology Analysis" closed-door seminar in the first half, 2Firsts partnered with several senior compliance experts to conduct an in-depth analysis of the technical solutions, policy details, and market dynamics of nicotine pouches.
American compliance expert and CEO of Accorto, Tom Beaudet, was invited as a special guest to come all the way from the United States to share valuable insights on the American market for nicotine pouches and PMTA application strategies with attendees.
As an authoritative expert in the field of nicotine product compliance, Tom has helped numerous well-known e-cigarette companies apply for PMTA, accumulating rich practical experience. His insights not only offer practical operational guidance but also provide valuable wisdom and direction for companies to find their positioning and achieve compliant development in the complex and ever-changing US market.
Dr. Andrea Patton, the director of research on behavioral trends at the American research and consulting firm CSUR, gave a presentation titled "Study on the Use of ZYN Nicotine Pouches in the US: Quantitative Analysis of Group Risks and Benefits within the PMTA Framework." Using ZYN Nicotine Pouches as the research sample, she systematically analyzed the public health standards that new products must meet during the PMTA application process, detailed the types of research required for PMTA, and explored how to accurately quantify the risks and benefits at the population level.
Dr. Patton's speech not only revealed the core elements of PMTA applications, but also provided industry professionals with valuable scientific evidence and practical guidance, helping companies move forward steadily on the path of compliance and innovation.
Gabriel Barnard, co-director of CSUR, delivered a speech titled "Assessing the Impact of Nicotine Pouch Products on Public Health in the United States Through a Perceptual and Behavioral Strategy Model," in which he delved into research strategies on the perception and behavior of nicotine pouch products. He emphasized that this strategy is a core component of research programs currently being implemented by multiple manufacturers of nicotine pouches in the United States, either already on the market or planning to launch. The goal of this program is to comprehensively evaluate the public health impact of nicotine pouch products in practical use through a scientifically rigorous approach, providing strong evidence for policy-making and corporate decisions.
Dr. Jessica Zdinak, Chief Research Officer/CEO of the American Behavioral Research Institute (ARAC), delivered a speech on "Nicotine Pouch PMTA Technology Analysis and US Regulatory Trends." During the presentation, she provided an in-depth technical analysis of the evaluation content of ZYN nicotine pouch PMTA and the Technical Project Lead (TPL) responsible for reviewing PMTA within the FDA. She focused on key modules in the PMTA application: Module 5 (impact of clinical products on individual health) and Module 6 (impact of clinical products on public health), and distilled a series of key points.
After the speech, she also connected with the audience on site and answered their questions in real time. Her speech provided clear insights and scientific evidence for attendees to navigate the complex regulatory environment, helping companies move steadily forward on the path of compliance and innovation.
Kurt Yang, Senior compliance expert at 2Firsts, conducted a thorough and detailed analysis of the PMTA application materials for ZYN nicotine pouches. He shared five key findings from his research and comprehensively deconstructed the application materials from multiple dimensions including product introduction, review process, competitor analysis, and scientific scrutiny. The presentation provided attendees with an insightful and professional sharing experience.
Kurt Yang's speech, with its outstanding professionalism, rigorous systematic approach, and high practicality, received high praise from the attendees. Some participants exclaimed on site: "This is the most comprehensive and thorough analysis I have encountered in the field of ZYN PMTA application cases.
In addition, Kurt Yang, along with 2Firsts Co-Founder and Chief Operating Officer Echo Guo, delivered a presentation titled "Strategic Recommendations for Nicotine Pouch Companies Applying for PMTA and Supply Chain Companies' TPMP Layouts." In their talk, they began by defining the TPMF and its functions, offering an in-depth analysis of the application and referral process. Drawing on industry insights and practical experience, they carefully crafted and shared five strategic recommendations. These strategies are designed to help nicotine pouch and supply chain companies navigate the PMTA and TPMF application processes, accurately align with regulatory requirements, and efficiently integrate resources, ultimately standing out in a highly competitive market and achieving high-quality development.
2025 U.S. Novel Tobacco Regulatory and Tariff Challenges: Trend Analysis and Strategic Responses
In the second half of the "2025 Insight Session on Dual Challenges of U.S. NGP Regulation & Tariff Trends" session, several U.S. compliance experts, 2Firsts specialists, and senior legal experts took the stage. Drawing on their deep expertise and extensive practical experience, they provided in-depth analysis of the regulatory and tariff challenges facing the industry from multiple perspectives, sharing a series of actionable strategies and future opportunities. Their insights offered participants forward-looking, practical professional guidance.
U.S. compliance expert and CEO of Accorto, Tom Beaudet, gave a detailed presentation on nicotine product registration methods across various U.S. states, including Kentucky, Virginia, Utah, and Iowa. He explained how different states regulate novel tobacco products. For example, in Kentucky, MGO is the only way for vaping products to enter the market, while in Virginia, distributors and retailers are required to complete forms such as TT-10/TT-10a.
Tom's presentation provided invaluable operational guidance, helping businesses navigate the complex and ever-changing state-level regulatory landscape in the U.S., ensuring compliance and smooth operations.
Lu Qiuying, Non-Equity Partner at Beijing Zhonglun (Shenzhen) Law Firm, delivered a presentation titled "Interpretation of U.S. Tariff Policies and Response Strategies for Novel Tobacco Companies" at the seminar. She provided an in-depth analysis of the complex U.S. tariff system and strategies for businesses to navigate it.
Lu systematically reviewed key U.S. tariff laws, including anti-dumping and countervailing duties (AD/CVD), Section 232 and 301 clauses based on national security or trade actions, global safeguard measures (Section 201), and anti-circumvention investigations. She also offered a detailed analysis of recent U.S. government actions, such as "benchmark tariffs" and "reciprocal tariffs," providing forward-looking, practical recommendations for novel tobacco companies to effectively respond.
Echo Guo, Co-Founder and Chief Operating Officer of 2Firsts, delivered a presentation titled "U.S. Nicotine Pouch Market Dynamics, Regulatory Trends Overview, and Future Forecasts." Drawing on her deep industry insights, she provided a thorough analysis of the latest developments in the U.S. nicotine pouch market, offering a precise interpretation of current U.S. novel tobacco regulatory policies. With rich data and cutting-edge market analysis, she made scientific, forward-looking predictions on the future development of the U.S. novel tobacco industry. Her presentation provided invaluable industry insights, helping businesses navigate the complex and changing market environment, seize opportunities, and address challenges.
2Firsts Senior Compliance Expert Kurt Yang provided an in-depth exploration of the critical applications of age verification technology and ELCR (Lifetime Cancer Risk Assessment) in PMTA (Pre-market Tobacco Product Application) submissions. He detailed the definition and function of ELCR in PMTA applications, highlighting its central role in assessing the long-term health impacts of products. Additionally, Kurt Yang analyzed the importance of age verification technology in PMTA applications, demonstrating its key value in ensuring product compliance and market safety.
Following the guest speeches, attendees expressed high praise and positive feedback. They unanimously agreed that the event was not only rich in content and highly professional, but also forward-looking and practical. It provided valuable references and guidance for their compliance strategies in the complex and ever-changing U.S. market.
Attendees mentioned that through the seminar, they gained a deeper understanding of the regulatory policies of the U.S. novel tobacco market, the PMTA application process, and industry development trends. They also acquired invaluable practical experience and strategic advice. These insights will greatly assist them in positioning their companies, seizing opportunities, addressing challenges, and achieving sustainable growth in future market competition.
2Firsts is a global media and research platform focused on the novel nicotine and tobacco industry. With correspondents and partners in Asia, Europe, and the Americas, we are committed to providing timely industry intelligence, in-depth analysis reports, and compliance insights to support evidence-based policy making, responsible technological innovation, and sustainable market development. Currently, the 2Firsts platform has an average daily traffic of over 30,000 visits, making it one of the most influential voices in the global novel tobacco sector.
As a leading global media and think tank for the novel tobacco industry, 2Firsts has launched 2Firsts Compliance Solutions, which has become one of the most influential U.S. compliance service platforms. It currently provides U.S. compliance services to multiple international novel tobacco brands and manufacturers.
2Firsts Compliance Solutions offers a comprehensive compliance service system covering the full PMTA process, tailored for e-cigarettes, heated tobacco, nicotine pouches, and other novel tobacco products. This helps businesses enter the U.S. market in a more efficient and professional manner.
We have exclusively launched several standardized core module products covering key PMTA stages, including:
·SMART Acceptance+: The minimum compliance threshold for entering the U.S. market. A beginner-level compliance assessment and acceptance preparation package to help products quickly obtain the FDA Acceptance Letter.
·SciAsset Filing: Scientific asset-level submission material construction service, creating "regulatory assets" through high-quality documentation.
·PMTA Booster Pack: A PMTA upgrade package, the "magic tool" for Acceptance. A lightweight ELCR cancer risk assessment module to reinforce scientific support for submitted applications.
·ELCR-S Full: Full version of toxicology and carcinogenic risk summary reports, providing the in-depth analysis required for FDA scientific review.
·TPMF Filing Service: The optimal compliance path for supply chain companies, with the best interfaces for connecting with large companies. TPMF+TPMP, supporting cross-brand references and accelerated submissions.
2Firsts has established strategic partnerships with several top international compliance organizations, including former FDA expert consultants, pharmacokinetics (PK) and abuse potential research labs, clinical research organizations (CROs), human behavior research institutions, compliance consulting firms, and more. We have built an all-in-one submission platform to support novel tobacco compliance upgrades and transformation.
To learn more about 2Firsts Compliance Solutions, please contact us at: info@2firsts.com.
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