Health groups and Washington lawmakers quickly condemned the decision and have called for an explanation.
Smokers who tried Glas vapes were much more likely to completely switch from cigarettes over the course of a three-month study, according to the memo.
But the data did not show “statistically significant differences” between adults using the company’s mango and blueberry flavors and those using a tobacco-flavored e-cigarette.
Elsewhere, FDA regulators explained that the Glas flavored vapes “did not have to demonstrate added adult benefit,” because young people were unlikely to use them. Glas requires users to unlock each e-cigarette with an age-verifying cellphone app.
The agency’s authorization also runs counter to recent FDA guidelines advising companies that fruit and dessert flavors would have to meet “a high evidentiary burden” for adult use, given their risks to children. Tobacco-flavored products are not popular with teens and generally face lower regulatory hurdles at the FDA.
The FDA document is also unusual in its brevity.
Previous FDA memos on new vaping products typically run dozens of pages. For example, last year’s document authorizing Juul’s menthol e-cigarettes was more than 90 pages and included detailed scientific data from research involving 50,000 people.
The short memo on Glas does not include key details, such as how many smokers the firm studied.
Previously, the FDA almost always posted such memos immediately after announcing an authorization. The document on Glas appeared on the agency’s website more than a month after regulators OK’d the products.
The agency has faced questions from members of Congress about the decision. Last month, 10 Democratic senators sent a letter to the agency requesting more information about the authorization, calling it a “shortsighted and reckless decision.”
The application from Glas, which also included menthol and tobacco-flavored vapes, followed a winding path to authorization. The small, Los Angeles-based company submitted a marketing request to the FDA in 2021.
The mango- and blueberry-flavored products were finally OK’d during Makary’s last full week leading the agency. He resigned the post after months of criticisms from industry stakeholders, including tobacco companies that have lobbied President Donald Trump’s Republican White House for looser regulations on vaping flavors.
A spokesperson for the company could not immediately provide comment when reached Thursday morning.
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