Fortune USA - 11.2019

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FORTUNE.COM // NOVEMBER 2019

ards of both e-cigs and heat-not-burn products

run deeper. One thing both systems share is the

use of propylene glycol and vegetable glycerins

as “humectants” that keep other ingredients

moist. Both vape pods and the heat sticks in

an IQOS contain these compounds, and users

inevitably inhale them.

Glycols and glycerins are recognized as

safe in food, but early research suggests that

inhalation is a different story. One study

by Baylor College of Medicine research-

ers, published in September, examined the

impact of e-cigarette vapor in mice. It found

that exposing mice to vapors that contained

propylene glycol and vegetable glycerin led to

lung damage and the buildup of certain lipids,

or fats, in the lungs that could disrupt their

function. Some scientists have speculated that

lipid buildup is playing a role in the current

vaping-illness epidemic, although there are

many other factors in play. If further studies

strengthen a link between these substances

and lung damage, it won’t bode well for heat-

not-burn. “IQOS has much, much higher

May of 2016 before the Obama administration
instituted the first regulations, including a
ban on sales to minors and a requirement that
manufacturers disclose ingredient lists.
More significant, those new rules pushed
e-cigarettes closer to full regulation, requiring
manufacturers to prove that their products did
more good than harm in order to keep them on
the market. In 2017, new FDA commissioner
Scott Gottlieb, an advocate of e-cigarettes as an
alternative to combustible ones, delayed those
requirements, giving manufacturers until Au-
gust 2022 to submit so-called marketing appli-
cations. But a cohort of doctors, public-health
advocacy groups, and anti-tobacco organiza-
tions sued to block that extension, arguing that
tighter oversight was needed now, not later.
This July, a federal judge ruled for the
plaintiffs. Companies must now submit public-
health reviews by May 2020. After that, regula-
tors could take another year to determine if the
devices are kosher for consumers, but the in-
dustry will face a ticking clock: If manufactur-
ers can’t prove that their products don’t make
the public any worse off, they could face more
strict control of sales, or even an outright ban.
Representatives for Gottlieb, who stepped
down this April, did not respond to Fortune’s
requests for comment. The FDA directed For-
tune to an agency statement from July wherein
acting commissioner Ned Sharpless said,
“FDA stands ready to accelerate the review of
e-cigarettes and other new tobacco products.”
PMI and Altria may be rooting for a review.
They’ve been trying to get the FDA to classify
the IQOS and other products as definitively
less harmful than combustible cigarettes—a
potential marketing bonanza. This process
involves something called the “Modified Risk
Tobacco Product” protocol, and it’s a bar that
current e-cigarettes haven’t cleared. But some
investors think the IQOS could qualify. “We
believe the science supports the application
for a modified risk claim,” says Lavery.

DESPITE THE RECENT controversies, there’s a
strong possibility that vaping-style e-ciga-
rettes will stay on the market for years—per-
haps alongside heat-not-burn. If the current
spate of illnesses is eventually tied exclusively
to illicit THC and nicotine products, main-
stream e-cig makers may escape further re-
strictions. Modest adaptations could increase
their odds: For instance, manufacturers may
be able to create new models that make it
harder to modify and interchange pods.
But some critics say the fundamental haz-

FEEDBACK [email protected]

levels of glycols than a regular cigarette,” says

Stanton Glantz, a professor at the University

of California, San Francisco.

In a statement, PMI says that the IQOS

“emits significantly lower number and levels”

of the harmful compounds and none of the

carbon-based solid particles found in tradition-

al cigarettes. “No tobacco- or nicotine-contain-

ing product is risk-free,” the company notes.

Put another way: The new smokeless ciga-

rettes may not be good for you, but they could

be worse. That may be Big Tobacco’s winning

argument, even as today’s controversies test it.

The industry has survived such tests before.

After all, combustible cigarettes are undeniably

bad for you—and in case you haven’t noticed,

you can still buy them if you want them.

Research has linked

glycols —a key

e-cigarette ingredient—

to lung damage in mice.