The Food and Drug Administration (FDA) authorized Juul e-cigarettes for the U.S. market, ending a lengthy standoff with regulators and lawmakers who accused the company of spurring a youth vaping epidemic.

The details: FDA authorized the e-cigarette system and the menthol- and tobacco-flavored cartridges.

The company was required to prove that the products were “appropriate for the protection of public health” under FDA rules. Juul said it did that in part by showing that its products had helped about 2 million adults quit smoking.

Reminder: Juul started selling its products before FDA had authority over e-cigarettes, so FDA has employed “enforcement discretion” to leave Juul on store shelves while FDA considered its application for authorization.

The broader context: Since Juul applied for authorization in 2020, the e-cigarette market has shifted drastically.

Juul’s e-cigarettes were popular with middle and high school students in 2019. But by mid-2019, the company stopped selling flavored vapes that were driving that popularity, amid backlash from parents and regulators.
After large e-cigarette makers in the U.S. stopped selling flavored vapes, flavored products poured in from China and are now among the most popular with young people. And overall rates of teen vaping have fallen sharply.
FDA has already approved a handful of other e-cigarette products (e.g., Vuse, NJOY) to help adult smokers quit cigarettes. Juul will be one of only two U.S. companies authorized to sell menthol-flavored vapes.

But: Some advocates still say FDA should not have authorized products from a company involved in fueling youth vaping and highlight the risks the products pose to youth.