FDA's e-cigarette authorization: Fruity vapes not significantly better
than tobacco ones
[June 12, 2026]
By MATTHEW PERRONE
WASHINGTON (AP) — Fruit-flavored e-cigarettes recently authorized by the
Food and Drug Administration were not significantly better at helping
smokers quit than tobacco-flavored e-cigarettes, according to a new memo
that’s likely to stir more questions about the agency’s decision.
The FDA last month gave its first OK to fruit-flavored vapes —
essentially endorsing them as a less-harmful alternative to traditional
cigarettes. The decision came despite the agency’s longstanding position
that such flavors appeal to children and must show extra health benefits
to warrant approval for adults.
Health groups and Washington lawmakers quickly condemned the decision
and have called for an explanation.
A six-page FDA memo released this week provides more details about the
agency's rationale. In it, FDA regulators appear to sidestep previous
statements about the risks of sweet vaping flavors while acknowledging
shortcomings in the data submitted by vape manufacturer Glas Inc.
To meet federal standards, companies must show that their products
benefit public health. In practice, that means demonstrating that their
vapes help adult smokers switch or quit cigarettes, while not attracting
underage use by teens.
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.
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.
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 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.
In February, FDA scientists authorized several of the 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.
___
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