A recent memo from the Food and Drug Administration (FDA) has cast doubt on the agency’s decision to authorize fruit-flavored e-cigarettes, revealing that these products were not significantly more effective at helping smokers quit than their tobacco-flavored counterparts.
The revelation is likely to intensify scrutiny of the FDA’s controversial approval last month, which marked the first time the agency endorsed fruit-flavored vapes as a less harmful alternative to traditional cigarettes.
The decision immediately drew condemnation from health groups and Washington lawmakers, who have demanded an explanation.
The FDA’s authorization came despite its long-held position that such flavors appeal to children and must demonstrate exceptional health benefits to justify approval for adults.
The six-page FDA memo, released this week, offers further insight into the agency’s reasoning.
It suggests that FDA regulators sidestepped previous concerns about the risks associated with sweet vaping flavors, even as they acknowledged deficiencies in the data provided by manufacturer Glas Inc.
Federal regulations mandate that companies prove their products benefit public health.
This typically means demonstrating that vapes help adult smokers transition away from or quit cigarettes, without attracting underage users.
While the memo indicated that smokers using Glas vapes were more likely to completely switch from cigarettes over a three-month study period, the data showed no “statistically significant differences” between adults using the company’s mango and blueberry flavors and those using a tobacco-flavored e-cigarette.
This finding means the newly approved fruit-flavored vapes failed to meet the same standard as other flavored products previously sanctioned by the FDA, such as menthol-flavored vapes from Juul and NJOY.
Those companies had successfully demonstrated that adults using menthol flavors were significantly more likely to reduce or quit cigarettes compared to those vaping tobacco flavors.
In a notable departure from its usual stance, FDA regulators stated in the memo that the Glas flavored vapes “did not have to demonstrate added adult benefit” because young people were deemed unlikely to use them.
This assessment was based on Glas’s requirement for users to unlock each e-cigarette with an age-verifying cellphone app.
However, this authorization also contradicts recent FDA guidelines, which advised companies that fruit and dessert flavors would face “a high evidentiary burden” for adult use due to their appeal to children.
Tobacco-flavored products, generally less popular with teens, typically encounter fewer regulatory obstacles at the FDA.
The FDA document itself is unusually brief. Previous memos detailing new vaping product authorizations often span dozens of pages; for instance, last year’s document for Juul’s menthol e-cigarettes exceeded 90 pages and included extensive scientific data from research involving 50,000 individuals.
The concise memo on Glas lacks crucial details, such as the number of smokers included in the firm’s study. Furthermore, the memo appeared on the agency’s website more than a month after the products were approved, a delay from the FDA’s usual practice of posting such documents immediately.
The agency has already faced questions from members of Congress regarding the decision. Last month, 10 Democratic senators sent a letter to the agency, requesting more information and labeling the authorization a “shortsighted and reckless decision.”
The application from Glas, which also included menthol and tobacco-flavored vapes, navigated a complex path to approval. The small, Los Angeles-based company initially submitted its marketing request to the FDA in 2021, only for it to be rejected.
In February, FDA scientists reversed course and approved several flavors, but that decision was subsequently blocked by a senior official reporting to then-FDA Commissioner Marty Makary, according to internal memos. The mango- and blueberry-flavored products ultimately received approval during Makary’s final full week leading the agency.
He resigned following months of criticism from industry stakeholders, including tobacco companies that had lobbied the Republican White House for looser regulations on vaping flavors.
A spokesperson for Glas Inc. could not immediately provide comment when reached on Thursday morning.