Key facts
- Fruit-flavored e-cigarettes authorized by the FDA were not found to be significantly better at helping smokers quit than tobacco-flavored ones, according to a new memo.
- The FDA's decision to authorize fruit-flavored vapes faces criticism from health groups and lawmakers.
- Regulators stated that the fruit-flavored vapes from Glas Inc. did not have to demonstrate added adult benefit because young people were unlikely to use them.
- The authorization appears to contradict recent FDA guidelines that suggest fruit and dessert flavors would require a high evidentiary burden for adult use.
- The FDA's memo detailing the rationale for the authorization was unusually brief and released over a month after the products were approved.
The U.S. Food and Drug Administration (FDA) recently authorized fruit-flavored e-cigarettes, marking the first time such products received approval as a less harmful alternative to traditional cigarettes. However, a new FDA memo suggests these fruity vapes were not significantly more effective at helping smokers quit than tobacco-flavored e-cigarettes, a finding that has drawn condemnation from health groups and lawmakers.
The FDA's decision comes despite its previous stance that sweet vaping flavors appeal to children and require substantial health benefits for adult approval. The six-page memo released this week provides details on the agency's rationale, appearing to downplay previous concerns about sweet flavors while acknowledging data limitations from manufacturer Glas Inc. To gain federal approval, companies must demonstrate that their products aid adult smokers in switching or quitting cigarettes without attracting underage users.
According to the memo, smokers using Glas's mango and blueberry flavors were more likely to switch from cigarettes over a three-month study. However, the data did not show statistically significant differences compared to those using a tobacco-flavored e-cigarette. This falls short of the benchmark set by other authorized flavored products, such as Juul and NJOY's menthol vapes, which demonstrated significant benefits for adult smokers.
FDA regulators explained that Glas's flavored vapes did not need to prove added adult benefit because youth usage was deemed unlikely, citing the company's requirement for users to unlock e-cigarettes via an age-verifying cellphone app. This justification contrasts with recent FDA guidelines that advise companies seeking approval for fruit and dessert flavors to meet a high evidentiary burden due to their appeal to children.
The FDA document is notably brief, unlike previous memos for vaping products which often exceed dozens of pages and include extensive scientific data. The Glas memo lacks key details, such as the number of smokers studied, and was posted more than a month after the products' approval.
The decision has prompted scrutiny from Congress, with 10 Democratic senators sending a letter to the FDA calling the authorization "shortsighted and reckless." Glas's application, which also included menthol and tobacco flavors, followed a complex path, initially being rejected before FDA scientists changed their stance. This decision was reportedly blocked by a senior official but was ultimately approved during the final week of Marty Makary's tenure as FDA Commissioner. Makary resigned amid criticism from industry stakeholders advocating for looser regulations on vaping flavors.