Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina, USA
Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.
Tob Control. 2023 Apr;32(e1):e113-e117. doi: 10.1136/tobaccocontrol-2021-056626. Epub 2021 Sep 7.
The introduction of a new product line of the popular disposable electronic cigarette brand Puffbar, advertised as containing synthetic nicotine, has drawn attention to the increasing use of synthetic nicotine in marketed products and its uncertain regulatory status. A search of the Truth Tobacco Industry Documents revealed that the industry considered using synthetic nicotine already in the 1960s, efforts that were abandoned due to high costs and insufficient purity. Recent patents revealed renewed efforts to develop more efficient strategies for the synthesis of nicotine. Nicotine exists as two stereoisomers, -nicotine and -nicotine. While -nicotine is the prevalent (>99%) form of nicotine in tobacco, a market-leading form of synthetic nicotine contains both stereoisomers at equal amounts, raising concerns about inaccurate labelling and the poorly understood health effects of -nicotine. Other manufacturers, including a leading vendor of pharmaceutical grade nicotine, developed stereospecific strategies to synthesise pure -nicotine, now added to electronic cigarette products marketed in the USA and UK. While -nicotine and -nicotine can be differentiated by enantioselective High Performance Liquid Chromatography (HPLC), differentiation of synthetic (fossil-derived) from tobacco-derived -nicotine will require development of methods to measure carbon isotope (C or C) content. Vendors claim that the FDA has no authority to regulate synthetic nicotine as a tobacco product, allowing them to circumvent the premarket tobacco product application process. However, legal analysis suggests that FDA may have the authority to regulate synthetic nicotine as a drug. Alternatively, Congress needs to include nicotine from any source within the legal definition of tobacco products.
一次性电子烟品牌 Puffbar 推出了一款新的产品线，其中含有合成尼古丁，这引起了人们对市场上销售的产品中越来越多地使用合成尼古丁及其不确定的监管地位的关注。对 Truth Tobacco Industry Documents 的搜索显示，该行业早在 20 世纪 60 年代就考虑使用合成尼古丁，由于成本高和纯度不足，这些努力最终被放弃。最近的专利揭示了重新努力开发更有效的尼古丁合成策略。尼古丁有两种立体异构体，即-α-尼古丁和-β-尼古丁。虽然-α-尼古丁是烟草中尼古丁的主要存在形式（>99%），但一种市场领先的合成尼古丁形式含有等量的两种立体异构体，这引起了人们对标签不准确和对-β-尼古丁的健康影响了解甚少的担忧。其他制造商，包括一家领先的制药级尼古丁供应商，开发了合成纯-α-尼古丁的立体专属性策略，现在已添加到在美国和英国销售的电子烟产品中。虽然-α-尼古丁和-β-尼古丁可以通过对映选择性高效液相色谱（HPLC）来区分，但要区分合成（化石衍生）尼古丁和烟草衍生的-α-尼古丁，需要开发测量碳同位素（C 或 C）含量的方法。供应商声称，FDA 无权将合成尼古丁作为烟草产品进行监管，这使他们能够规避上市前烟草产品申请程序。然而，法律分析表明，FDA 可能有权将合成尼古丁作为药物进行监管。或者，国会需要将任何来源的尼古丁纳入烟草产品的法律定义。
