Synthetic Nicotine: The End of a Regulatory Loophole in the United States

Since April 14, the U.S. Food and Drug Administration (FDA) has been able to regulate all forms of nicotine on the market. This change should put an end to the circumvention practices of some manufacturers, who have so far been able to evade FDA regulation by marketing synthetic nicotine.

To evade FDA oversight, companies are marketing lab-made nicotine, rather than natural nicotine derived from the tobacco plant. However, the U.S. National Spending Bill, signed into law on March 15, 2022, clearly states that the FDA has regulatory authority over nicotine from “any source.”[1].

FDA Authority Over Tobacco and Nicotine Products

With the National Spending Bill enacted on April 14, any entity that manufactures or markets nicotine, including tobacco-free nicotine, is required to comply with FDA regulations. Specifically, the agency prohibits the sale of these products to minors under the age of 21, the distribution of free samples, or the marketing of these products as reduced-risk products without first obtaining FDA approval. Finally, manufacturers are also required to register their products with the agency in order to submit a premarket application, which includes a review of their marketing strategies.

A regulatory loophole widely exploited by e-cigarette manufacturers

In 2020, the FDA had initiated a review process of all vaping products, many of which had been banned. This measure was motivated by an imperative to protect the younger generation, for whom these new nicotine products have proven particularly popular. According to the United States Centers for Disease Control and Prevention, sales of e-cigarettes increased by nearly 3,00% between November 2016 and August 2019. Synthetic nicotine, which is outside the FDA's prerogatives, has nevertheless constituted the blind spot of the agency's public health policy, and a major development axis for manufacturers. Thus, if Puff Bar electronic cigarettes were banned by the FDA in 2020, the manufacturer returned to the market in February 2021, now marketing an identical product, but with synthetic nicotine. The FDA's new prerogatives could thus have serious consequences on the development of these new products, and therefore on public health.

FT

[1] CNN Health, Vaping loophole closes as FDA can now regulate all forms of nicotine, 04/15/2022, (accessed 04/19/2022)