Synthetic nicotine has arrived.
Synthetic nicotine has arrived.
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DOI：
10.1136/tobaccocontrol-2021-056626
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发表时间：
2023-04
期刊：
影响因子：
5.2
通讯作者：
Jordt SE
中科院分区：
文献类型：
--
作者：
Jordt SE
广受欢迎的一次性电子烟品牌Puffbar推出了一个新产品线，广告中宣称含有合成尼古丁，这引起了人们对市场产品中合成尼古丁越来越多的使用及其不确定的监管地位的关注。对烟草行业真相文件的搜索显示，该行业早在20世纪60年代就考虑使用合成尼古丁，但由于成本高且纯度不足而放弃了这一努力。最近的专利表明，人们正在努力开发更有效的合成尼古丁的策略。尼古丁以两种立体异构体存在，s -尼古丁和r -尼古丁。虽然s -尼古丁是烟草中普遍存在的（约99%）尼古丁形式，但市场上领先的一种合成尼古丁形式含有等量的这两种立体异构体，这引起了人们对标签不准确和r -尼古丁对健康影响的担忧。其他制造商，包括制药级尼古丁的主要供应商，开发了立体定向策略来合成纯s -尼古丁，现在添加到美国和英国销售的电子烟产品中。虽然s -尼古丁和r -尼古丁可以通过对映选择性HPLC区分，但要区分合成（化石来源）和烟草来源的s -尼古丁，需要开发测量碳同位素（14C或13C）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，这使得他们可以绕过上市前烟草产品申请（PMTA）程序。然而，法律分析表明，FDA可能有权将合成尼古丁作为一种药物进行监管。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。
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, S-nicotine and R-nicotine. While S-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 labeling and the poorly understood health effects of R-nicotine. Other manufacturers, including a leading vendor of pharmaceutical grade nicotine, developed stereospecific strategies to synthesize pure S-nicotine, now added to E-cigarette products marketed in the US and UK. While S-nicotine and R-nicotine can be differentiated by enantioselective HPLC, differentiation of synthetic (fossil-derived) from tobacco-derived S-nicotine will require development of methods to measure carbon isotope (14C or 13C) 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 (PMTA) 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.
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影响因子：
5.2
作者：
Robichaud, Meagan O.;Seidenberg, Andrew B.;Byron, M. Justin
通讯作者：
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影响因子：
4.1
作者：
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影响因子：
3.3
作者：
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影响因子：
5
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影响因子：
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作者：
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