Finished nicotine, smokeless tobacco, vape and ENDS products on the market, as well as the raw materials used to create those products, can be analyzed to determine whether the nicotine within the product is, in fact, from a synthetic source. There appears to be a consensus as to what analytical tests of nicotine are required in order to confirm whether nicotine is synthetic or naturally-derived. This includes:

Nicotine Isomer Optical Rotation Testing
At the core of lab testing, and the primary chemical differences between synthetic and natural nicotine, is the ratio of R- and S-stereo isomers. Tobacco-free, Synthetic Nicotine is a mixture of R- and S-stereo isomers of nicotine , although only the S-stereo isomer can be fully metabolized and absorbed by the end user. Natural nicotine, on the other hand, is only comprised of the S-stereo isomer. The typical ratio of isomers in synthetic, tobacco-free nicotine is 1:1 of R- and S-stereo isomers. R-stereo isomers have a positive optical rotation, while S-stereo isomers have a negative optical rotation, and in the 1:1 ratio, they cancel one another out, resulting in no observable optical rotation. If optical rotation is observed, scientists may conclude that the nicotine is either a mix of synthetic and natural nicotine, or the nicotine present in the e-liquid has been derived from a natural source. In both scenarios, due to the presence of natural nicotine, even if it is blended with synthetic nicotine, the product would be subject to FDA oversight and must comply with the PMTA regulatory pathway.

Scientists may choose to pursue additional confirmatory analyses, employing chiral HPLC, to separate the R- and S-stereo isomers within the nicotine with a chiral column. Once separated, the relative amounts of each isomer can be observed, and a determination can be made as to whether the nicotine being analyzed is synthetic or naturally-derived.

Testing of Nicotine for the Presence of Tobacco Specific Nitrosamines (TSNAs)
Synthetic Nicotine, being chemically-derived through synthesis, is free from tobacco-specific impurities, including tobacco specific nitrosamines (TSNAs). Tobacco specific nitrosamines are considered to be some of the most potent carcinogens in tobacco products, and they are created during the curing and processing of naturally-derived tobacco as a result of a nitrosation reaction. Two of the eight identified TSNAs, N-nitrosonornicotine (NNN) and 4-methyl-N-nitrosamino-1-(3-pyridyl)-1-butanone (NNK), have been classified as Group 1 cancer-causing carcinogens. Tobacco specific nitrosamines can be quantified in nicotine and nicotine-containing products by liquid chromatography mass spectrometry (LC-MS). Avomeen’s team of expert scientists have developed and validated an LC-MS method to quantitate four tobacco specific nitrosamines (NAB, NAT, NNN, and NNK) in nicotine-containing products.

When nicotine-containing products and/or the nicotine itself is analyzed by a validated method for TSNAs, the confirmed presence or absence of TSNAs, in conjunction with the results of optical rotation testing, can confirm whether the nicotine has been derived from a natural source or chemical synthesis.

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Finished nicotine, smokeless tobacco, vape and ENDS products on the market, as well as the raw materials used to create those products, can be analyzed to determine whether the nicotine within the product is, in fact, from a synthetic source. There appears to be a consensus as to what...