E-Cigarette Regulatory Report: Synthetic Nicotine in the US – ‘Tobacco Product’ or Not?
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.
Synthetic Nicotine falls in a regulatory gap since it is not included within the definition of “tobacco product” in the Federal Food, Drug, and Cosmetic (FD&C) Act, nor expressly regulated by any other regulatory instrument.
This regulatory gap applies to those products not derived from the tobacco plant (or that can be connected to the plant) and for which no medical claims are made. This leaves an opening in the market that may be seen as an advantage, while there is no express regulation on the matter.
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