WASHINGTON – A newly released memo suggests that fruit-flavored e-cigarettes, which recently received authorization from the Food and Drug Administration (FDA), do not significantly outperform tobacco-flavored e-cigarettes in aiding smokers to quit. This revelation could spark further debate over the FDA’s controversial approval.
Last month, the FDA made headlines by granting approval to fruit-flavored vaping products, effectively promoting them as a potentially safer alternative to traditional tobacco products. This decision was surprising to many, given the agency’s established stance that such flavors could entice younger users and needed to demonstrate additional health benefits for adult users to gain approval.
The ruling quickly drew criticism from health advocacy groups and legislators in Washington, who demanded a clear justification from the FDA.
This week, a six-page FDA memo was released, shedding light on the reasoning behind the agency’s decision. In the document, FDA officials appear to downplay prior warnings about the dangers of sweet-flavored vapes. They also acknowledge gaps in the data provided by Glas Inc., the manufacturer of these vaping products.
To gain federal approval, companies must prove that their products offer a net positive to public health. Specifically, they must demonstrate that their e-cigarettes help adult smokers either switch from or quit traditional cigarettes, without drawing in underage users.
The memo indicates that participants who used Glas vapes were significantly more likely to transition completely away from cigarette smoking over a three-month period compared to those who did not use these products.
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.
That means the new vapes failed to meet the same bar as a handful of other flavored products previously sanctioned by the 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.
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, and regulators initially rejected it.
In February, FDA scientists changed course and signed off on several flavors. But that decision was blocked by a senior official reporting to then-FDA Commissioner Marty Makary, according to internal memos later released by the agency.
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.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
