Insights Blog

Nicotine is a chiral compound, meaning that there are two enantiomers or different forms of nicotine: (S)-Nicotine and (R)-Nicotine. (S)-Nicotine is the naturally occurring enantiomeric form of nicotine in plants from the Solanaceae family. Tobacco-derived nicotine contains predominantly (S)-Nicotine (~99.3%) and less than 1% (R)-Nicotine, with a small amount of (R)-Nicotine formed during combustion. Tobacco-derived nicotine is regulated under the FDA Center for Tobacco Products and has the CAS# 54-11-5.

Synthetic nicotine on the other hand does not come from the tobacco plant. It is synthesized using either a chemical or an enzymatic process. This is then often followed by a chemical or enantiomeric purification. There are multiple forms of synthetic nicotine. Synthetic nicotine can be identical to tobacco derived nicotine and be >99% (S)-nicotine, or can be a racemic mix of (R)- and (S)- (50/50 with the CAS # 22083-74-5) or vary in the ratios of (R)- and (S)-nicotine.

Currently there is no FDA regulatory requirement to determine the enantiomeric composition of synthetic nicotine or verify that the synthetic nicotine is indeed synthetic and not mislabeled or adulterated with tobacco derived nicotine.

Is Synthetic Nicotine regulated by FDA?

In 2009, the Family Smoking Prevention and Tobacco Control Act, also known simply as the Tobacco Control Act (TCA), granted FDA broad jurisdiction over tobacco products. The TCA requires that the regulation of tobacco products use a population-level health standard demonstrating appropriate for the protection of public health. In 2016, FDA finalized what is known as the “deeming rule”, that deems any product meeting the statutory definition of a tobacco product, which included e-cigarettes, under the scope of FDA’s regulatory authority. However, this rule only applies to e-cigarettes containing nicotine that are “made or derived from tobacco”, and therefore tobacco products containing synthetic nicotine fall outside of FDA jurisdiction, but on a “case by case basis” can be regulated by FDA as illustrated in FDA Commonly Asked Questions about the Center for Tobacco Products.

“The product I manufacture contains no substance made or derived from tobacco, e.g. is zero-nicotine, or has synthetic nicotine or nicotine made from tomatoes. Is my product subject to FDA regulation?

The definition of “tobacco product” includes any product made or derived from tobacco, including any component, part, or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to FDA’s tobacco control authorities.

However, it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product, if it is not intended or reasonably be expected to be used in such a fashion. FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.” Check out the full list of commonly asked questions here.