Regulatory report: synthetic nicotine in the US – ‘tobacco product’ or not?



1 Executive summary
2 Synthetic nicotine – the regulatory gap
3 Is synthetic nicotine within the FDA’s regulatory scope?
4 Policy considerations
5 Where are we headed?



Synthetic nicotine, created from chemicals in a lab, not derived from tobacco, is not a specifically regulated product in the US so its legal status is subject to interpretation, as outlined in detail in this report.