FDA authorizes its first nicotine vape, but only with tobacco flavors

Brittany A. Roston - Oct 13, 2021, 2:12pm CDT
FDA authorizes its first nicotine vape, but only with tobacco flavors

The US Food and Drug Administration has granted its first market authorization for a small batch of electronic cigarette (vape) products, the agency has announced. The approval underscores the agency’s intentions to target ‘appealing’ vape products amid growing public criticism over non-tobacco flavors and youth vaping trends.

With this announcement, a total of three electronic cigarette products have been granted marketing authorization under the agency’s Premarket Tobacco Product Application. The authorization was granted for the Vuse Solo vape, as well as its related tobacco-flavored 4.8-percent G1 and G2 original replacement cartridges.

The FDA says that it approved the products based, in part, on a study that found that users weren’t exposed to as many harmful substances compared to tobacco cigarettes. The agency says that considerations about youth — the topic driving cries for crackdowns — was also factored into its decision. Of note, the FDA rejected the same company’s applications for 10 flavored liquids.

In a statement about the authorization, FDA Center for Tobacco Products Director Mitch Zeller, J.D., said:

Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation. The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals

Though many studies have found that vaping nicotine liquid solutions are less harmful than smoking cigarettes, public health officials and critics have expressed concerns about the increasing number of teenagers who vape — including those who never smoked tobacco cigarettes. Surveys have found that teens are more likely to vape non-tobacco flavors, including candy and fruit, potentially leading to a ban on these flavors.

However, questions have been raised over whether banning non-tobacco flavors will lead to a decrease in teenage nicotine use. Earlier this year, Yale University published a study revealing that the 2018 San Francisco ban on flavored vape liquids simply resulted in more teenagers switching to regular — and more harmful — combustion cigarettes.


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