The Importance of Synthetic Nicotine Testing for ENDS, Vape and Smokeless Tobacco Products
All nicotine is not created equal. In fact, there are now two sources of nicotine finding their way into vape and smokeless tobacco products: natural nicotine, obtained from a plant source – typically from the tobacco plant, and synthetic nicotine, which is created via chemical synthesis. Synthetic Nicotine is synthesized using a variety of chemicals including sulfuric acid, niacin, and ethanol. Synthetic Nicotine is also referred to as tobacco-free nicotine (TFN), an important distinction within the vaping industry that speaks directly to the FDA oversight, with respect to the definition of nicotine in e-liquids and electronic nicotine delivery systems (ENDS).
Even though Synthetic Nicotine has the same molecular formula as the natural version, there is debate and some uncertainty as to whether Synthetic Nicotine will eventually come under FDA’s vaping regulations and the premarket tobacco application (PMTA) guidance. At this time, Synthetic Nicotine products appear to fall into a regulatory gap, as they do not seem to fit the Federal Food, Drug, and Cosmetic Act’s (FDCA) definition of a tobacco product. Furthermore, FDA has defined nicotine as any nicotine “made or derived from tobacco,” which seemingly leaves a regulatory loophole for nicotine that is not derived from tobacco plants, keeping Synthetic Nicotine just outside the reach of current regulations.
It is important to note that there is speculation that FDA could potentially regulate Synthetic Nicotine as a drug under the FDCA, but the Agency must be able to show that the product is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or “intended to affect the structure or any function of the body…” Regulating Synthetic Nicotine products as drugs would allow FDA to treat in a similar way to natural, tobacco-derived nicotine products. Currently, when nicotine serves a therapeutic use, such as when nicotine is used in smoking cessation products (e.g. nicotine patches), it is considered to be a pharmaceutical and is regulated by FDA accordingly.
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