Only two years ago, electronic cigarettes were viewed as a small
industry with big potential to improve public health by offering a path
to steer millions of smokers away from deadly cigarettes.
That promise led U.S. regulators to take a hands-off approach to
e-cigarette makers, including a Silicon Valley startup named Juul Labs,
which was being praised for creating “the iPhone of e-cigarettes.”
Today Juul and hundreds of smaller companies are at the center of a
political backlash that threatens to sweep e-cigarettes from store
shelves nationwide as politicians scramble to address two separate
public health
crises tied to vaping: underage use among teenagers and a mysterious
and sometimes fatal lung ailment that has affected more than 1,000
people.
New restrictions at the local, state and federal level are poised to
wipe out thousands of fruit-, candy- and dessert-flavored vapes that
have attracted teens. But experts who study tobacco policy fear the
scattershot approach of the clampdown could have damaging, unintended
consequences, including driving adults who vape back to cigarette
smoking, which remains the nation’s leading preventable cause of death.
“This could take us from potentially the single biggest improvement
in public health in the United States toward a public health disaster in
which cigarettes continue to be the dominant nicotine product,” said
Jonathan Foulds, an addiction researcher and tobacco specialist at Penn
State University.
Foulds and many other experts continue to view e-cigarettes as a
potential “off-ramp” for smokers, allowing them to continue using
nicotine—the addictive chemical in cigarettes—without inhaling all the
toxic byproducts of burning tobacco.
But they warn the vaping backlash could do irreparable harm to the
public perception of e-cigarettes, while ignoring the riskiest products
that are most likely to blame for the recent outbreak.
Federal investigators say that nearly 80 percent of people who have
come down with the vaping illness reported using products containing
THC, the high-inducing chemical found in marijuana. They have not traced
the problem to any single product or ingredient. But investigators are
increasingly focused on thickeners and additives found in illegal THC
cartridges sold on the black market.
On Friday, the Food and Drug Administration specifically warned the
public not to vape THC or purchase any vaping products off the street.
THC vapes are separate from the legal, nicotine-filled e-cigarettes
being targeted by President Donald Trump and politicians across the
country.
Democratic governors in New York, Michigan, Washington, Rhode Island
and Oregon have followed the president’s plan to ban flavored
e-cigarettes nationally with their own state-level flavor restrictions.
Massachusetts’ Republican governor has gone even further, placing a
four-month moratorium on sales of vaping products of any kind.
“The problem here is we have convinced adult America that vaping is
as dangerous as smoking—and nothing could be further from the truth,”
said Kenneth Warner, professor emeritus at the University of Michigan’s
school of public health.
E-cigarettes generally heat a flavored nicotine solution into an
inhalable aerosol. There is little research on the long-term effects of
inhaling the chemicals in vaping, such as vegetable glycerin. Despite
those unknowns, most experts agree e-cigarettes pose a much smaller risk
than cigarettes, which cause cancer, lung disease and stroke and
account for some 480,000 U.S. deaths each year.
Even before the current uproar over vaping, most adults considered
e-cigarettes dangerous. A 2017 government survey found 55 percent of
Americans considered e-cigarettes as harmful as regular cigarettes.
And while the flavor bans are likely to curb teen vaping, Warner and
others point out that those policies won’t prohibit flavors in
traditional tobacco products. That means both teens and adults could
wind up switching to deadlier menthol cigarettes or flavored cigars,
which come in coffee, raspberry, chocolate and hundreds of other
varieties.
WALKING A POLICY TIGHTROPE
The policy debate underscores the challenge of finding the right
regulatory scheme for e-cigarettes, products for which there is little
high-quality research.
More than 30 countries prohibit vaping products. In contrast, the
United Kingdom has fully embraced them as a public health tool, urging
doctors to promote them to help smokers quit.
The U.S. FDA has been struggling to find the right approach since it gained authority over e-cigarettes in 2016.
The agency repeatedly delayed its deadline to begin reviewing
e-cigarettes, a step that critics say allowed products like Juul to
catch on with teenagers. At the same time, e-cigarette companies and
proponents say the agency’s new review deadline of next May is too
aggressive and will force most companies out of business.
Now the agency is trying to walk a tightrope between keeping
e-cigarettes away from teens but preserving them for an estimated 10
million adults who use them, most of whom also smoke.
Further complicating the picture is the fact that no e-cigarette
brand has yet been shown to help smokers quit in rigorous studies. But
large-scale surveys suggest smokers who use e-cigarettes daily are up to
six times more likely to quit than those who don’t use them.
RISK OF SMOKING RELAPSE
The statistics favoring e-cigarettes are bolstered by the experiences of people like Laura Adams, 52, of Battle Creek, Michigan.
A smoker since age 16, Adams was rushed to the hospital in April when
a coughing fit left her struggling to breathe. Doctors diagnosed her
with chronic obstructive pulmonary disorder, or COPD, and told her she
needed to quit cigarettes.
For more than 25 years previously, Adams had smoked clove-flavored
cigarettes. When the government banned those in 2009, she switched to
flavored cigars.
“I always liked the flavors better than regular tobacco,” Adams said.
After her medical emergency, Adams tried a series of e-cigarettes at a
local vape shop before settling on a large, refillable device that
allowed her to switch between flavors like blueberry, watermelon and
peach.
“As far as I’m concerned, flavored vaping juice saved my life,” Adams
said. “It gave me the option of continuing with my nicotine but without
destroying my lungs.”
As Michigan stores pull their flavored products to comply with the
state ban, Adams has been researching out-of-state suppliers and even
do-it-yourself kits for mixing flavors.
But some public health advocates fear less motivated ex-smokers will
simply return to cigarettes. Even with the success of Juul, e-cigarettes
remain a tiny slice of the U.S. tobacco market, accounting for $8.6
billion in sales compared to $95 billion for cigarettes, according to
Euromonitor.
Industry analysts point to early indicators that e-cigarette sales
are beginning to flag amid the bans and negative headlines. E-cigarette
sales slowed by 11 percent over the four weeks ended Sept. 22, according
to retail data tracked by Nielsen.
The trend “could result in improved combustible cigarette” sales “as
vapers potentially return” to smoking, Wells Fargo analyst Bonnie Herzog
told investors in a recent note.
That’s exactly the opposite of what public health officials have been
trying to achieve, noted former FDA Commissioner Scott Gottlieb, who
stepped down in April.
As FDA chief, Gottlieb outlined an ambitious anti-smoking plan
intended to shift most of the nation’s 34 million smokers away from
cigarettes and toward less risky products. The unprecedented plan
involved a two-step process: cutting nicotine in traditional cigarettes
to make them virtually nonaddictive and then promoting FDA-sanctioned,
lower-risk alternatives, such as e-cigarettes.
But the agency has yet to unveil its proposal for cutting nicotine.
And a separate proposal to ban menthol cigarettes is still in regulatory
limbo.
So as the agency begins sweeping flavored e-cigarettes off the market
in coming months, Gottlieb fears smokers may revert to regular
cigarettes and cigars, which will still have nicotine levels and flavors
designed to addict users.
“This was always a package deal, and it’s become even more critical than ever to advance that entire policy agenda,” he said.
The FDA says it remains committed to Gottlieb’s vision of
lower-nicotine cigarettes and less-harmful alternative products. The
agency’s regulatory calendar lists this month as the target date to
release its proposal for regulating nicotine. But that effort will take
years to implement and will almost certainly face lawsuits from tobacco
companies.
Meanwhile, it remains unclear which e-cigarettes—if any—will survive the FDA review process set to begin in May.
Under agency standards, only vaping products that represent a net
benefit to the nation’s public health are supposed to be permitted.
Proving that standard will require companies to submit detailed analysis
of their ingredients and population-level estimates of how their
products will impact both adult and underage users.
Industry observers say few, if any, of the thousands of vape shops
that mix their own custom flavors and solutions will be able to meet the
threshold.
“It’s ironic that the vape shops, who really championed e-cigarettes
for smoking cessation, are going to be out of business,” said Dr. Neal
Benowitz, a nicotine and tobacco researcher at the University of
California San Francisco.
That leaves a handful of industry heavyweights such as Juul, which
could benefit from billions in research funding from Marlboro-maker
Altria, the tobacco company that owns a 35 percent stake in the vaping
firm.
But Juul has been besieged by lawsuits and investigations into its
alleged role in triggering the explosion of teen vaping. That history
could block the company from ever winning FDA approval for its current
device, according to former FDA officials.
A THIRD WAY
The uncertainty swirling around vaping could clear the path for another product that is neither a traditional cigarette nor an
e-cigarette.
Earlier this year, the FDA authorized the sale of a first-of-a-kind
device, IQOS, that heats tobacco without burning it. The approach is
designed to mimic the experience of smoking while producing fewer toxic
chemicals than paper-and-tobacco cigarettes.
The battery-powered device is getting a preliminary launch this month
in Atlanta ahead of a wider rollout. But IQOS’s pedigree underscores
the persistence of Big Tobacco companies, even in a world increasingly
focused on vaping and other alternative products.
IQOS was developed by Philip Morris International, the global tobacco
giant that sells Marlboro cigarettes overseas. It will be sold in the
U.S. by the biggest American cigarette maker, Altria, which is also
Juul’s biggest investor.
