Tobacco Asia

14 tobaccoasia FRONT PAGE NEWS 卷首新闻 FDA to Review PMTA Framework The US Food and Drug Administration (FDA) plans to evaluate its regulatory framework for premarket tobacco product applications (PMTA), including the possibility of replacing the current system through new rulemaking. The agency announced the move on September 28, citing its experience implementing the 2021 PMTA rule, the develop- ment of an illicit and unregulated market, and the pace of new tobacco product introductions. FDA said it wants a modern regulatory framework that reflects current market conditions while providing greater clarity and predictability for the industry. The announcement does not change the current PMTA process. FDA will continue processing applications, conduct- ing premarket reviews, and issuing regulatory decisions under existing statutory requirements. The agency will also continue applying the statutory "appropriate for the protection of the public health" (APPH) standard when reviewing PMTAs. FDA did not provide a timetable for a potential new rule. It said any future changes would comply with applicable law and include opportunities for public input. FDA has separately moved to simplify some regulatory procedures. On September 28, it launched a redesigned Form FDA 3741 that consolidates establishment registration and product-listing submissions for regulated tobacco products into a single form. The revised form covers cigarettes, e-ciga- rettes, smokeless tobacco, heated tobacco products and oral nicotine products, including nicotine pouches. FDA said the change eliminates the need for manufacturers to determine which of two previous forms applied to their products or submit separate forms for different product categories. Manufacturers can use a submission checklist to identify the sections relevant to their applications, while companies updating existing registrations can update specific information without resubmitting unchanged sections. Koplow Appointed CTP Director Bret Koplow, Ph.D., J.D., will serve as the director of the US Food and Drug Administration's Center for Tobacco Products (CTP), the Department of Health and Human Services (HHS) announced on September 8. Koplow had served as CTP's acting director before the appointment. HHS included his selection among four senior FDA leadership appointments, alongside Michael Davis as director of the Center for Drug Evaluation and Research, Karim Mikhail as director of the Center for Biologics Evalua- tion and Research, and Jared Seehafer as FDA's first deputy commissioner for technology and artificial intelligence. Koplow joined FDA in 2011 and has held senior legal, policy, and leadership positions across the agency. Before taking over CTP, he served as senior counselor to the FDA commissioner, focusing primarily on regulatory, policy, and operational matters involving tobacco products. He previously worked in FDA's Office of the Chief Counsel and Office of Legislation. Before joining FDA, Koplow practiced food and drug law as a partner at international law firms in Washington, DC. He graduated with honors from the University of Chicago Law School and holds a Ph.D. in clinical psychology. Before attending law school, he worked as a clinical psychologist and directed the Divisions of Child and Adolescent Psychiatry at Case Western Reserve University School of Medicine and University Hospitals of Cleveland. HHS said Koplow's priorities as CTP director will include promoting innovation and access to less harmful alternatives for adults who smoke, while taking action to protect youth and minors from tobacco and nicotine products. Zhang Xiaotang Named STMA Deputy Director China has appointed another tobacco industry veteran to the top ranks of its monopoly regulator. The State Council appointed Zhang Xiaotang as deputy director of the State Tobacco Monopoly Administration (STMA) as part of a broader set of government personnel changes announced on September 20. STMA has also named Zhang a member of its Party leadership group. Zhang assumes the national leadership position after serving as Party secretary and general manager of Hebei China Tobacco Industry Co. Before joining Hebei China Tobacco, Zhang held senior positions in STMA's financial management and supervision department. He was appointed deputy director of the department in December 2018 and later served as its director. Chinese records from 2020 identify Zhang as the head of the STMA department. His appointment brings an executive with experience on both the regulatory and operational sides of China's state tobacco system into STMA's senior leadership. At Hebei China Tobacco, Zhang emphasized brand development, digitalization, and operational efficiency. During a 2024 national tobacco industry meeting, he called for improvements to the industry's integrated production and operations management platform and for greater use of data in tobacco-sector management. The appointment follows another significant change at the top of China's tobacco administration earlier this year. Yao Laiying was appointed director of STMA in April, succeeding Zhang Jianmin. Yao also serves as a member of the Party leadership group of China's Ministry of Industry and Informa- tion Technology and as Party secretary of the STMA. Before taking the tobacco post, Yao served as deputy commissioner at China's State Taxation Administration. Bret Koplow takes the helm at CTP, with innovation, adult access to potentially less harmful alternatives, and youth protection among his priorities. Credit: FDA

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