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Edited by
Jillian GoodmanThe Trump administration gave
e-cigarette makers room to
grow—then reports of vaping’s
risks began to emergesold in the U.S. as of December 2017. The compa-
ny’s sales increased 641% over that year, to 16.2 mil-
lion devices, according to data from the Centers for
Disease Control and Prevention.
Contributing to the surge are two things: the
belief that vaping is a safe and effective way for
adult smokers to quit their cigarette habits, and the
appeal to young people of candylike flavorings and
sleek technology available in the electronic devices.
Sales grew even as the regulatory schedule meant
there would be a huge gap in the public’s knowl-
edge about the safety of e-cigarettes.
For months, members of Congress had petitioned
for speedier regulatory action by the FDA. Gottlieb
drew up the plans, though few have been imple-
mented; he stepped down in April and is now on
the board of the pharmaceutical giant Pfizer Inc.,
which makes the smoking cessation drug Chantix.
Then, over the summer, a mysterious lung disease
linked to vaping killed six people, and U.S. health
officials are now investigating more than 380 con-
firmed and probable cases. In July a judge moved up
the regulatory deadline for e-cigs to May 2020. But
as the negative news surrounding vaping grew, con-
cern within the administration mounted.
On Sept. 11, President Donald Trump and Health
and Human Services Secretary Alex Azar said the
FDA will move to take all nontobacco-flavored
e-cigarettes off the market and make manufactur-
ers await regulatory review to determine whether
vapes are good for public health. On the same day,
the FDA released preliminary 2019 data from an
annual youth tobacco survey that found about 5 mil-
lion under-18 users vaped within a 30-day period.
That’s up from 3.6 million in 2018. Gottlieb hasn’t
yet been officially replaced at the FDA, which is led
by acting Commissioner Ned Sharpless, previously
the head of the National Cancer Institute.
Back in 2017, Gottlieb said he delayed e-cigarette
reviews because the agency wanted “to make cer-
tain that the FDA is striking an appropriate balance
between regulation and encouraging development
of innovative tobacco products that may be less
dangerous than cigarettes.” The regulatory lapse,
Trump said in reversing the policy, “frankly, should
have been looked into a few years ago in a much
more advanced way.” Azar attempted to pin that
time frame on the Obama administration, saying it
“allowed these products to go onto the market in an
unregulated way.” Congress had given the Obama
administration the power to regulate e-cigarettes
in 2009. But, while it was slow to do so, it was
Trump’s FDA that pushed back the deadline.
Just before stepping down, Gottlieb told the audi-
ence at a forum hosted by the Brookings Institution ILLUSTRATION BY ARNE BELLSTORF, *PRELIMINARY FIGURES. DATA: FOOD AND DRUG ADMINISTRATIONBloomberg Businessweek September 23, 2019A Big U-Turn
On Vaping
Something was buried in the press release the
U.S. Food and Drug Administration put out on
July 27, 2017. The agency was making an historic
announcement: the initiation of “a multi-year road-
map to better protect kids and significantly reduce
tobacco-related disease and death.” It quoted FDA
then-Commissioner Scott Gottlieb: “Unless we
change course, 5.6 million young people today
will die prematurely later in life from tobacco use.”
While focusing on combustible cigarettes that
deliver nicotine via smoke particles, the FDA rec-
ognized that e-cigarettes needed regulation as well.
In the seventh paragraph, it announced coming
“revised timelines” that would require e-cigarette
makers to apply for approval by Aug. 8, 2022—a long
extension from the then-existing FDA deadline of
August 2018. “The FDA expects that manufactur-
ers would continue to market products while the
agency reviews product applications,” it said.
And that’s what the industry did. In the past
two years, the market for vaping—which uses fla-
vored vapor, not smoke, to deliver nicotine—
has almost doubled, to an estimated $8.8 billion,
in 2019. Leader Juul Labs Inc., which last year got a
$13 billion investment from Marlboro maker Altria
Group Inc., accounted for nearly 1 in 3 e-cigarettes