The launch of the new product line of puffbar, a popular disposable e-cigarette brand, contains Synthetic Nicotine in advertisements, which has aroused people’s attention to the increasing use of Synthetic Nicotine in commercial products and its uncertain regulatory status.

A search of the truth tobacco industry documents showed that the industry had considered the use of synthetic nicotine as early as the 1960s, but abandoned these efforts due to high cost and insufficient purity. Recent patents have revealed new efforts to develop more effective nicotine synthesis strategies. Nicotine exists in the form of two stereoisomers, s-nicotine and r-nicotine.

Although s-nicotine is a popular (> 99%) nicotine form in tobacco, the market leading Synthetic Nicotine form contains the same amount of two stereoisomers, raising concerns about inaccurate labeling and little knowledge of the health effects of r-nicotine. Other manufacturers, including leading suppliers of pharmaceutical grade nicotine, have developed a stereotactic strategy to synthesize pure s-nicotine, which has now been added to e-cigarette products sold in the United States and the United Kingdom.

Although s-nicotine and r-nicotine can be distinguished by enantioselective high performance liquid chromatography (HPLC), the distinction between synthetic (fossil derived) and tobacco derived s-nicotine requires the development of methods for measuring carbon isotopes (14C or 13C).

Suppliers claim that FDA has no right to regulate Synthetic Nicotine as a tobacco product, so that they can avoid the application process of pre-market tobacco products. However, legal analysis shows that FDA may have the right to regulate Synthetic Nicotine as a drug. Alternatively, Congress needs to include nicotine from any source in the legal definition of tobacco products.

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Synthetic NicotineSynthetic Nicotine is used for Medical and Drug
The launch of the new product line of puffbar, a popular disposable e-cigarette brand, contains Synthetic Nicotine in advertisements, which has aroused people's attention to the increasing use of Synthetic Nicotine in commercial products and its uncertain regulatory status. A search of the truth tobacco industry documents showed that the...