Week of January 13 Regulatory Intelligence Recap

Regulatory Summary:

• FDA Authorization of ZYN: The FDA authorized the marketing of 20 ZYN nicotine pouch products, marking them as the first FDA-authorized nicotine pouches in the US. (Analysis below)

• FDA Nicotine Reduction Proposal: The FDA issued a proposed rule to limit nicotine levels in cigarettes, representing a potentially landmark change in tobacco regulation. (Analysis below)

• UK Vaping Industry Changes: Significant regulatory shifts occurred in 2024 with more changes expected in 2025, as discussed by Vape Globe's Markus Lindblad regarding industry adaptation strategies.

• Norway's Smokefree Progress: Report indicates Norway is moving toward smokefree status with snus effectively substituting for cigarettes.

• Cardiopulmonary Effects: "Vape Check" - University of Wisconsin secured a $5.7 million NIH grant for research examining the long-term impact of vaping on heart and lung health.

• Supreme Court: Hears case on FDA v R.J. Reynolds Vapor Co on January 21.

Publications Summary:

• Barrier Systems Study: "Assessing the impact of e-cigarettes on human barrier systems: a systematic review" Published in Translational Research, January 14, 2025 Citation: Transl Res. 2025 Jan 14:S1931-5244(25)00011-8 doi: 10.1016/j.trsl.2025.01.001

• Canadian Vaping Study: "Use of nicotine vaping products during an attempt to quit smoking by Canadian adults" Published in Health Promotion and Chronic Disease Prevention in Canada Citation: Health Promot Chronic Dis Prev Can. 2025 Jan;45(1):54-60 doi: 10.24095/hpcdp.45.1.04

• Latin American E-cigarette Review: "E-cigarette use among adolescents in Latin America: A systematic review of prevalence" Published in Preventive Medicine Reports Citation: Prev Med Rep. 2024 Dec 19;49:102952 doi: 10.1016/j.pmedr.2024.102952

• Cardiopulmonary Effects: "The Growing Body of Literature on The Effect of Vaping on Cardiopulmonary Health" Published in Vaping Post Note: This appears to be news coverage of a grant award rather than a direct publication, specifically discussing the University of Wisconsin's $5.7 million NIH grant for research.

• Aerosol Chemistry: "Effect of electronic cigarette atomising power and flavour on aerosol size-segregated" Published in Tobacco Control Citation: Tob Control. 2025 Jan 15:tc-2024-058915 doi: 10.1136/tc-2024-058915

Clinical Trials:

• Stroke Prevention Study: New trial examining effectiveness of telephysical therapy for secondary stroke prevention, including lifestyle factors.

• Passive Smoking Effects: Study on the impacts of passive smoking on vital signs, anxiety, and recovery times in children during dental procedures.

• Deep Breathing Exercise Study: Investigation of deep breathing exercises' effects on pulmonary function and stress in smokers.