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[67] On 16 January 2025, the FDA authorised several ZYN nicotine pouch products, including flavoured varieties, through the Premarket Tobacco Product Application (PMTA) pathway

Noting that there are no long-term studies on the safety of these devices and insufficient evidence of their benefit as tools for smoking cessation, the WHO and some national health authorities, such as the Australian National Health and Medical Research Council (NHMRC) and the US National Academies of Sciences, Engineering, and Medicine (NAS), have recommended a precautionary approach and action to minimize harm to users and bystanders and to protect vulnerable groups such as young people, until clear evidence of safety, quality and efficacy are produced

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