The Food and Drug Administration (FDA) released a memo on its decision to authorize its first two flavored e-cigarettes last month.
- The main point: It is likely to stir more questions about the decision, as it says that the authorized fruit-flavored e-cigarettes were not significantly better at helping smokers quit than tobacco-flavored e-cigarettes.
Reminder: To meet standards for authorization, companies must show that their vape product benefits public health, meaning they must demonstrate that the vapes help adult smokers switch or quit cigarettes, while not attracting underage use.
- FDA has typically said that because flavored products appeal to children, they must show extra health benefits compared to tobacco-flavored products to warrant authorization. Even FDA’s recent guidance from earlier this year maintained that fruit/dessert flavors would have to meet “a high evidentiary burden” for authorization.
The details:
- The memo says that smokers who tried Glas vapes were much more likely to completely switch from cigarettes over the course of a three-month study.
- But: The data did not show “statistically significant differences” between adults using the mango and blueberry flavors and those using tobacco-flavored e-cigarettes.
- That means the new vapes failed to meet the same bar as other products previously authorized by FDA, including menthol-flavored vapes from Juul and NJOY. Those companies showed that adults who used menthol were significantly more likely to cut down or quit cigarettes compared with those vaping tobacco flavors.
- FDA explained that the Glas flavored vapes “did not have to demonstrate added adult benefit” because young people were unlikely to use them given that Glas requires users to unlock each e-cigarette with an age-verifying cellphone app.
- The memo contains far less detail than the memos accompanying e-cigarette authorizations usually do. Previous memos have typically run dozens of pages, but this one is only 6. And the memo does not include key details, such as how many people Glas studied. For comparison, last year’s memo for Juul’s menthol e-cigarettes was more than 90 pages long and included detailed scientific data from research involving 50,000 people. Plus, FDA has always posted such memos immediately after announcing an authorization, but this one appeared more than a month after authorization.
Meanwhile: KFF Health News reports that President Trump grew his stock holdings this year to as much as $1.64 million in Philip Morris, along with holdings in Altria and a third leading tobacco company. In 2025, tobacco interests donated $6 million to a super PAC that supports the president and to the inauguration, as well as additional donations to the ballroom project.
- The big picture: The stock trades and political contributions came as the administration pursued more pro-tobacco policies. FDA piloted a fast-track program to approve nicotine pouches, unveiled a program to allow vapes on the market more rapidly, and issued guidance waving through flavored e-cigarettes. The administration also withdrew a proposal to ban menthol cigarettes and cut public health staff focused on tobacco policy.
Read more: FDA’s e-cigarette authorization: Fruity vapes not significantly better than tobacco ones