FDA Memo Says 2 Fruit Vapes Weren't Better Than Tobacco at Helping Smokers Quit
Updated
Updated · The Associated Press · Jun 11
FDA Memo Says 2 Fruit Vapes Weren't Better Than Tobacco at Helping Smokers Quit
3 articles · Updated · The Associated Press · Jun 11
Summary
A six-page FDA memo said Glas's mango and blueberry e-cigarettes did not show statistically significant quit-smoking advantages over tobacco-flavored vapes, despite winning authorization last month.
FDA instead said the products did not need added adult benefit because teens were unlikely to use them, citing Glas's age-verifying phone-app unlock system.
That rationale departs from the agency's longstanding stance that fruit and dessert flavors face a high evidentiary bar because they appeal to children; menthol approvals for Juul and NJOY had shown stronger adult-benefit data.
The unusually brief memo omitted basic study details such as sample size and was posted more than a month after approval, fueling criticism from health groups and 10 Democratic senators who called the decision reckless.
The Glas application, filed in 2021, was first cleared by FDA scientists in February, then blocked by a senior official before the fruit flavors were approved during Marty Makary's final full week as commissioner.