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 The agency had been expected to make a decision by Thursday, a year
after Juul and other e-cigarette brands, including British American
Tobacco Plc's Vuse and Imperial Brands Plc's Blu, faced a deadline
to file applications showing their products provided a net benefit
to public health.
A federal judge set a September 2020 deadline for the e-cigarette
makers and gave companies a one-year grace period to remain on the
market without FDA enforcement, while the agency reviewed
applications.
The agency on Thursday said it continues to "work expeditiously on
the remaining applications," adding many are "in the final stages of
review."
It said products that have not been authorized by the FDA - a
category that now includes Juul after the one-year grace period -
"are subject to enforcement action at the FDA's discretion."
The agency said it will work "as quickly as possible to provide
regulatory certainty" and is prioritizing enforcement of e-cigarette
products that have not applied for FDA authorization.
The FDA's scientific review of e-cigarettes will decide whether they
are effective in getting smokers to quit and, if so, whether the
benefits to smokers outweigh the health damage to new users -
including teenagers - who never smoked.
REGULATORY GRAY AREA
E-cigarettes have operated in a regulatory gray area for years. The
products, which vaporize a nicotine-laced liquid, have been
available in the United States since at least 2007, but the FDA did
not formally get jurisdiction over the industry until May 2016.
During that time, Juul and dozens of competitors introduced products
that were grandfathered into the market because they were already
being sold before the regulation took effect.
The 2016 rule required e-cigarette makers to file extensive
applications to the FDA by August 2018 demonstrating the public
health benefits of their products, along with data on potential
toxins.
Under the administration of Donald Trump, the FDA pushed back the
application date to 2022, but public health groups sued in federal
court and succeeded in getting the deadline moved up to last year.
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 In June, FDA acting
Commissioner Dr. Janet Woodcock told a
congressional panel the agency had received
applications for 6.5 million products from more
than 550 companies, and said reviewing all
submissions by Sept. 9 "will be challenging."
In August, the agency denied marketing
applications for nearly 55,000 flavored
e-cigarette products from three small companies
for failing to provide evidence they
appropriately protect public health. The FDA has
so far denied applications from more than 100
companies, but has not made a decision on Juul
or other major tobacco industry players.
Teenage use of e-cigarettes has surged in recent
years, a trend that largely coincided with the
rise in popularity of Juul in 2017 and 2018.
E-cigarette use among high school students grew
from 11.7% in 2017 to 27.5% in 2019, before
declining to 19.6% last year, according to a
federal survey.
A Reuters investigation in 2019 detailed how
Juul’s developers used tobacco industry research
and patents to formulate a smooth but potent
blend of liquid nicotine that became a key
factor in its popularity among teenagers.
(https://reut.rs/3hgWDmI)
Facing a backlash from parents, teachers and
regulators, including state attorneys general,
Juul stopped selling its popular fruit- and
mint-flavored nicotine pods in 2019, ahead of an
FDA ban on such flavors in early 2020.
Over the last two years, Juul has tried to
repair its relationship with regulators and the
public by taking a lower profile. It stopped
print, TV and online advertising in 2019, and
pulled back on its international expansion plans
to focus on winning regulatory approval in the
United States.
Federal survey data from last year showed that
Juul’s popularity among teenagers declined
significantly from 2019, but was offset by
increases in teenage use of other brands. Juul
was still the most popular brand among
teenagers, according to the survey.
(Reporting by Ankur Banerjee in Bengaluru and
Chris Kirkham in Los Angeles; Editing by Anil
D'Silva and Bill Berkrot)
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