Electronic cigarettes will now be regulated much like tobacco
cigarettes and their sale to children banned, according to a new federal
rule issued Thursday.
Under the rule, the U.S. Food and Drug Administration
would have to approve all tobacco products not currently regulated that
hit stores after February 2007. The e-cigarette industry was virtually
non-existent before then.
Premium, hand-rolled cigars, as well as
hookah and pipe tobacco, are also included in the new regulation, which
federal officials call "historic." The rule prohibits selling "covered
tobacco products" to people younger than 18, and buyers must show photo
ID. It also requires health warnings be displayed on cigarette tobacco,
roll-your own tobacco, and covered tobacco product packages and in
advertisements; and bans free samples and the sale of covered products
in vending machines not located in adult-only facilities.
Tobacco Control Act of 2009 sets Feb. 15, 2007, as the latest date by
which all tobacco products would have to have to be grandfathered
in. Mitch Zeller, head of the FDA's Center for Tobacco Products, has
said publicly that he couldn't choose a later date, although industry
That means nearly every e-cigarette on the
market — and every different flavor and nicotine level — would require a
separate application for federal approval. Each application could cost
$1 million or more, says Jeff Stier, an e-cigarette advocate with the
National Center for Public Policy Research and industry officials.
An amendment to appropriations legislation working its way through
the House would change the date so more e-cigarettes would be
grandfathered in. White House Press Secretary Josh Earnest
said Thursday that President Obama "takes a very dim view of attaching
ideological riders to appropriations bills," but stopped short of
threatening a veto of any legislation.
The proposed rule was
released more than two years ago, in April 2014, and the final
rule gives the industry two additional years to comply. The industry
will have had "plenty of time to submit their applications," says Robin
Koval, CEO of the Truth Initiative, an anti-tobacco health group.
stores have to comply with the rule in about three months (90 days from
its publication May 10), and Zeller says contractors tasked with
enforcement will be ready to "hit the ground running" on Day 91.
Koval says "it's perfectly reasonable" that people should know what's in something that "you inhale into your lungs."
Ellen Hahn, a professor at the University of Kentucky College of Nursing
and co-chair of the UK Tobacco-free Task Force, said the new rule is a
good first step toward controlling e-cigarettes. "From a health
perspective, to reduce the social acceptance of them is good because
frankly, it's the wild, wild West out there," she says. "Vape stores are
She says so-called "vaping" can get kids hooked on
nicotine and threatens to prolong "the tobacco epidemic." E-cigarette
use has been rising steadily, especially among youth. According to the
U.S. Centers for Disease Control and Prevention,
e-cigarette use among high school students rose from 1.5% in 2011 to
16% in 2015. Federal health officials estimate that about 3 million
middle and high school students use e-cigarettes.
president of the Campaign for Tobacco-Free Kids, says the rule announced
Thursday falls short in protecting children because it doesn't restrict
the use of sweet e-cigarette flavors such as gummy bear and cotton
candy even though the FDA's own data show flavors play a big role in
Industry experts say treating e-cigarettes, which don't
contain tobacco, the same as cigarettes could lead to such onerous and
costly approval that all but the largest tobacco companies would be
forced out of the market — and possibly those companies, too. Zeller
says he expects consolidation in the number and type of products and
The Tobacco Control Act requires the FDA to use
science to weigh the potential benefits of e-cigarettes against any
potential health risk for both individual users and the whole
population, which Stier says would be all but impossible.
That could force e-cigarette smokers back to regular cigarettes, he says.
help people trying to quit smoking, says Patricia Kovacevic, general
counsel and chief compliance officer at e-cigarette manufacturer
Nicopure. She and other e-cigarette advocates cited a Royal College of Physicians' report last week that showed e-cigarettes' benefits.
Department of Health and Human Services Secretary Sylvia Burwell says, "There are many other cessation tools available."
Koval agrees that e-cigarettes "are dramatically less harmful" than regular cigarettes.
"But they're not without harm," she says. "It would be hard to make a product more harmful or toxic than cigarettes."
Contributing: Gregory Korte