Spree Bar, a vaping system delivering a synthetic nicotine analogue, marketed in the USA as ‘PMTA exempt

Background

In February 2021, the popular vaping company, PuffBar, started selling disposable e-cigarettes in the USA containing synthetic nicotine, claiming to be exempt from federal and state laws regulating products containing tobacco-derived nicotine.1 US lawmakers responded to the emerging synthetic nicotine market by clarifying that synthetic nicotine products are subject to the US Food and Drug Administration’s (FDA) regulatory regimen for tobacco products.1–3 As of 14 April 2022, the FDA has been authorised to regulate tobacco products containing nicotine from any source, including laboratory synthesis, requiring manufacturers to submit a premarket tobacco product application (PMTA).3 In October 2022, the FDA sent a warning letter to the company, alerting the owners that its products are ‘marketed unlawfully and are subject to enforcement action at FDA’s discretion’.4 5 Currently, the company appears to be selling Puffbar-branded e-cigarette products…

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