FDA memo fuels questions over approval of fruit-flavored vapes
An FDA memo says Glas fruit-flavored vapes did not outperform tobacco flavors in helping adult smokers quit, the Associated Press reported.
By Daniel Okafor · Business Editor
3 min read
The Food and Drug Administration is facing new scrutiny after authorizing fruit-flavored e-cigarettes that its own memo says were not clearly better than tobacco-flavored vapes at helping smokers quit. The Associated Press reported that the six-page document, released this week, gives more detail on the agency’s first approval of fruit-flavored vaping products.
The FDA authorized mango- and blueberry-flavored devices from Glas Inc. last month, according to the AP. The decision marked a shift for an agency that has long treated sweet vaping flavors as a risk for youth use and required stronger evidence of adult public-health benefits before allowing them on the market.
Under federal rules, companies seeking to sell vaping products must show that the products are appropriate for public health, the AP reported. In practice, FDA reviewers weigh whether adult smokers are likely to switch from cigarettes against the risk that teens and other underage users will take up the products.
The FDA memo said smokers who used Glas vapes in a three-month study were more likely to move fully away from cigarettes, according to the AP. The memo also said the data did not show statistically significant differences between adults using Glas’ mango and blueberry products and adults using a tobacco-flavored e-cigarette.
That finding sets the Glas decision apart from some earlier FDA authorizations for flavored vaping products, the AP reported. In prior approvals for menthol products from Juul and NJOY, those companies showed adults using menthol were significantly more likely to reduce or stop cigarette use than those using tobacco-flavored vapes.
FDA reviewers said Glas’ fruit-flavored products did not need to show added adult benefit because youth use was unlikely, according to the memo cited by the AP. Glas requires each device to be unlocked through a cellphone app that verifies a user’s age, the AP reported.
The authorization also differs from recent FDA guidance that said fruit and dessert flavors faced a high evidentiary burden because of their appeal to children, according to the AP. Tobacco-flavored vaping products are generally less popular with teens and face lower regulatory hurdles at the agency, the AP reported.
The FDA memo is much shorter than many past agency reviews for vaping products, according to the AP. The AP reported that prior FDA memos often ran dozens of pages, including a more than 90-page document last year for Juul’s menthol e-cigarettes that described research involving 50,000 people.
The Glas memo did not include some details that often appear in FDA reviews, including the number of smokers in the company’s study, the AP reported. The AP also reported that the FDA posted the Glas memo more than a month after announcing the authorization, while the agency had usually released such documents immediately after approvals.
Health organizations and lawmakers in Washington criticized the decision after it was announced, according to the AP. Last month, 10 Democratic senators asked the FDA for more information and described the authorization as “shortsighted and reckless,” the AP reported.
Glas, a small company based in Los Angeles, submitted its marketing application in 2021 for menthol, tobacco and other flavored vapes, according to the AP. FDA scientists authorized several flavors in February, but an internal agency memo later released by the FDA showed that a senior official reporting to then-FDA Commissioner Marty Makary blocked that decision, the AP reported.
The AP reported that the mango and blueberry products received approval during Makary’s final full week leading the FDA. Makary resigned after months of criticism from industry stakeholders, including tobacco companies that had lobbied President Donald Trump’s Republican White House for less restrictive rules on vaping flavors, according to the AP.
A Glas spokesperson could not immediately comment when contacted Thursday morning, the AP reported.
This story draws on original reporting from Fortune.