Regulations Impacting Synthetic Nicotine Products
There are currently no regulations, at least on the federal level, regarding Synthetic Nicotine. This is because there is no formal mention prohibiting the use of non-tobacco products in the Tobacco Control Act. The Act only states that “any product made or derived from tobacco and intended for human consumption, including any component, part, or accessory of a tobacco product.” is considered a tobacco product.
Since the Tobacco Control Act is the act that created the definition of a tobacco product, any vaping product that uses Synthetic Nicotine would not fall in the scope of the definition, which would ultimately mean they technically would not have to submit PMTAs. This is why we believe its popularity has risen and why many companies have been attracted to it. It offers a solution to the PMTA regulations.
However, regulations for Synthetic Nicotine are expected to occur once it becomes more readily available. And the Food and Drug Administration is already aware of its existence. On the FDA website, we can find a FAQ that states the following regarding Synthetic Nicotine:
“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, the FDA might not want to regulate a disposable, closed system device containing an e-liquid with truly zero nicotine (or Synthetic Nicotine) as a tobacco product if it is not intended or reasonably expected to be used in a fashion. FDA wants to make these determinations on a case-by-case basis, based on a totality of the circumstances.”
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