FDA Authorizes First Fruit-Flavored Vapes After Study Shows Higher Cigarette-Switching Rates

Marking the agency's first approval of fruit-flavored vapes. A six-page memo released this week showed that smokers who used the products were more likely to switch completely from cigarettes during a three-month study, yet the data did not demonstrate statistically significant differences compared with adults using the company's tobacco-flavored option.

The memo stated that the flavored products “did not have to demonstrate added adult benefit” because young people were unlikely to use them.

Glas requires users to unlock each device with an age-verifying cellphone app. The agency had previously authorized menthol-flavored vapes from Juul and NJOY after those companies showed statistically significant increases in adults cutting down or quitting cigarettes compared with tobacco flavors. The Glas memo is shorter than prior FDA documents on vaping products.

Last year's authorization memo for Juul's menthol e-cigarettes exceeded 90 pages and drew on research involving 50,000 people. The Glas memo omitted the number of smokers studied and appeared on the FDA website more than a month after the products were authorized. The application from the small, Los Angeles-based company followed an extended review.

Glas submitted its marketing request in 2021. FDA scientists authorized several flavors in February, but a senior official reporting to then-Commissioner Marty Makary blocked that step, according to internal memos later released by the agency. The mango- and blueberry-flavored products were approved during Makary's final full week as commissioner.

Makary resigned after months of criticism from industry stakeholders, including tobacco companies that lobbied President Donald Trump's White House for looser vaping regulations. ” The FDA's authorization also departs from recent agency guidance that fruit and dessert flavors would face “a high evidentiary burden” for adult use because of their appeal to children.