Issue link: https://read.dmtmag.com/i/1531857
32 tobaccoasia Issue 1, 2025 January / February SPONSORED CONTENT China manufactures approximately 90% of the world's e-cigarette hardware. However, the US re- mains the largest market for e-cigarettes in terms of revenue, making FDA authorization to market reduced-risk nicotine products (RRPs) a highly sought-after achievement. For manufacturers of RRPs in Asia and beyond, FDA's pre-market to- bacco product authorization (PMTA) process has often appeared costly and unpredictable. Two re- cent announcements from FDA have provided greater clarity on the regulator's position on RRPs, sparking renewed confidence in the PMTA process. In the closing hours of the Biden Adminis- tration, FDA announced that it will move forward with a proposed rule establishing a maximum nic- otine level for combustible tobacco products sold in the US. The proposed rule, first announced in 2018, would cap nicotine levels at 0.7mg per gram of tobacco – about one twentieth of the amount that is in cigarettes currently on the market. The agency intends to render cigarettes no-longer able to create or sustain addiction, thereby accelerating smoking cessation among the 28 million Ameri- cans who currently smoke and decrease cigarette uptake among current and future generations. If the rule goes into effect two years from now, FDA's population health model projects that, by 2100, 48 million fewer people would start smoking and 4.3 million deaths would be prevented. Almost 13 million people might be expected to quit smoking within 1 year of the rule being implemented, and 19.5 million people would quit within 5 years. As Dr. Brian King highlighted at FDA's press conference, these cessation projections in- clude 'about 50% of smokers' transitioning to saf- er alternative nicotine products including PMTA SAMUEL C. HAMPSHER-MONK {BIO} Samuel 'Sam' Hampsher-Monk joined 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 FDA's Proposed Rule on Very Low Nicotine Content: A Path to Harm Reduction? Author: Samuel C. Hampsher-Monk VP, Global Regulatory Strategy & Business Operations, Applied Research and Analysis Company international, multidisciplinary research on cannabis, tobacco, and nicotine product regulation for state and municipal agencies, research institutions, and philanthropic foundations. He has authored technical reports, case studies, white papers, policy briefs, and academic papers on topics such as consumer prod- uct 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. He is also the lead author of Clearing the Air on E-Cigarettes and Harm Reduction: Tobacco Control, Economics, and Public Health (Palgrave Macmillan, 2024). About Applied Research and Analysis Company (ARAC): Applied Research and Analysis Company (ARAC) is a leading US-based, global behavioral science research firm that designs, executes, and presents Module 6 studies to support manufacturers, regulato- ry agencies, and industry consultants in their PMTAs, MRTPAs, and SEs. Their expertise also includes con- sumer-focused research services in product develop- ment and innovation. ARAC specializes in MODULE 5 & 6 studies including: label/claim development and comprehension, human factors/usability testing, and clinical/behavioral studies, such as switching studies to assess the benefit to the US population, including randomized experimental longitudinal, actual use, and cohort studies, tobacco product perceptions and Intentions (TPPI), and post-market surveillance sys- tems. Learn more: ARACscience.com