What is the FDA’s regulatory view on synthetic nicotine?
The Governor of California, Gavin Newsom, recently signed into law a new bill passed by both houses of the state congress which will ban the sales of all favored vapor products statewide effective January 1, 2021. Other states are attempting to follow suit by implementing vaping bans of their own. As more and more anti-vaping legislation is enacted at the local, state, and federal levels, can a transition to synthetic nicotine help save vaping from complete annihilation?
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On a section of the FDA website entitled Commonly Asked Questions: About the Center for Tobacco Products, the FDA provides a rather obscure answer to this very question.
“Q: 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?”
“A: 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.”
The second paragraph is perhaps the most noteworthy. At first glance, the FDA seems to suggest that the agency’s current view is that the FDA should not be involved with the regulation of tobaccoless nicotine. But in the same sentence, they acknowledge that they reserve the right to change their mind in the future, “on a case-by-case basis.”
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