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 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.”
In addition, the FDA Center for Drug Evaluation and Research (CDER), which currently regulates nicotine replacement therapy products, also does not have authority over Synthetic Nicotine and therefore Synthetic Nicotine is currently seen as a regulatory loophole.
The lack of regulatory oversight enabled companies to bring products back onto the market by replacing the tobacco-derived nicotine with Synthetic Nicotine. In July 2020, FDA notified companies via warning letters to remove flavored disposable e-cigarettes from the market for marketing unauthorized tobacco products and we have seen companies pivot to Synthetic Nicotine.
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