As highlighted in our previous post, “What is TFN (Tobacco Free Nicotine)?,” it is nicotine which is not derived from the tobacco plant.
Although the U.S. Food & Drug Administration (FDA) has not made a decision on how it will regulate synthetic nicotine products, non-tobacco products like TFN have raised questions on whether they should be regulated as tobacco products or drugs.
To date, the FDA regulates all nicotine products and different regulatory schemes apply depending on where the nicotine came from. For example, the Center for Tobacco Products reviews products containing tobacco or tobacco-derived nicotine. Meanwhile, nicotine products that aren’t derived from tobacco are generally considered drugs and would typically go through the Center for Drug Evaluation and Research group for approval and review for safety and effectiveness.
Until a decision by the FDA is made on how to regulate these products, synthetic nicotine products remain on the market.