FDA Memo Shows Fruit E-Cigarettes Did Not Outperform Tobacco Flavors in Quitting

A six-page memo from U.S. health regulators states that fruit-flavored e-cigarettes authorized last month did not show statistically significant differences in helping adult smokers quit compared with tobacco-flavored products. The memo was posted on the FDA website more than a month after the agency approved the mango and blueberry flavors from Glas Inc.

It notes that smokers using the company's vapes were more likely to switch completely from cigarettes during a three-month study, but the data did not meet the threshold of statistical significance required for some prior flavored-product approvals.

Background on the authorization The FDA had previously maintained that fruit and dessert flavors appeal to youth and would need to demonstrate extra adult health benefits to gain approval. The new memo states that the Glas products did not have to show added adult benefit because young people were unlikely to use them due to an age-verifying cellphone app requirement.

The document is shorter than previous FDA memos on vaping products and does not include certain details such as the number of smokers studied. It appeared on the agency website more than a month after the authorization decision.

Congressional response Ten Democratic senators sent a letter to the agency last month requesting more information about the authorization. The letter described the decision as shortsighted and reckless. The application from the Los Angeles-based company had been submitted in 2021, initially rejected, and later approved after internal review.

A company spokesperson could not immediately provide comment when reached Thursday morning.