| WASHINGTON, April 17
WASHINGTON, April 17 Complaints of injury linked
to e-cigarettes, from burns and nicotine toxicity to respiratory
and cardiovascular problems, have jumped over the past year as
the devices become more popular, the most recent U.S. data show.
Between March 2013 and March 2014, more than 50 complaints
about e-cigarettes were filed with the U.S. Food and Drug
Administration, according to data obtained through a public
records request. That is on par with the combined number
reported over the previous five years.
The health problems were not necessarily caused by
e-cigarettes. And it is not clear that the rate of adverse
events has increased. In 2011, about 21 percent of adult smokers
had used e-cigarettes, according to federal data, more than
double the rate in 2010.
Still, David Ashley, director of the office of science at
the FDA's tobacco division, said the uptick is significant,
especially in light of a recent report from the U.S. Centers for
Disease Control and Prevention showing an increase in the number
of e-cigarette-related calls to poison control centers.
"Both together does suggest there are more instances going
on," he said.
The FDA is poised to regulate e-cigarettes and other
"vaping" devices for the first time, potentially reshaping an
industry that generates roughly $2 billion a year in the United
States. Some industry analysts see e-vapor consumption outpacing
that of traditional cigarettes, now an $85 billion industry,
within a decade.
E-cigarettes are battery-powered cartridges filled with a
nicotine liquid that, when heated, creates an inhalable mist.
Little is known about the long-term health effects of the
products, which were developed in China and moved into the U.S.
market in 2007.
"Some evidence suggests that e-cigarette use may facilitate
smoking cessation, but definitive data are lacking," Dr.
Priscilla Callahan-Lyon of the FDA's Center for Tobacco Products
wrote in a recent medical journal article.
Contradictory findings from preliminary studies have become
ammunition in the lobbying campaign around the devices, which
allow users to inhale nicotine without the damaging tar produced
by conventional cigarettes.
Public health officials have said the devices may encourage
nonsmokers, particularly young people, to try conventional
cigarettes. E-cigarette advocates have argued that they provide
a safer alternative for smokers.
The FDA has sponsored research to try to answer safety
questions, and it is examining its database of adverse events
for any trends that might raise concerns.
The complaints from the public filed with the FDA cited
trouble breathing, headache, cough, dizziness, sore throat, nose
bleeds, chest pain or other cardiovascular problems, and
allergic reactions such as itchiness and swelling of the lips.
One person told the FDA that while eating dinner at a
restaurant a customer at the next table was smoking an
"The vapor cloud was big enough to come over my table and
the e-cig smoker was 'huffing' it voraciously," the person,
whose name was redacted, wrote. "I got dizzy, my eyes began to
water and I ended up taking my food to go because of the intense
heartbeat I began to develop."
One woman wrote that her husband began smoking e-cigarettes
liberally in his car and home after being told they were safe
and that the vapor was "just like water."
"My 4-year-old has had a raspy voice since he started but I
really didn't think anything of it till last night my husband
was just puffing away on that thing for hours and I woke up
wheezing and unable to breathe."
Miguel Martin, president of Logic Technology, one of the
biggest U.S. e-cigarette makers along with Lorillard Inc
and privately held NJOY, said the spike in adverse event reports
reinforces the importance of regulation, especially in areas
governing manufacturing practices and labeling, where standards
can vary dramatically.
"Clearly, because of the business opportunities, you have
companies in an unregulated environment that are importing
without checks and balances," he said, adding that while Logic
pays attention to quality control, "some other companies just
are not having the same diligence or focus."
MADE IN CHINA
Most e-cigarettes are made in China and sold under more than
300 brands in the United States, some through retail stores,
The quality of the products is inconsistent, however, making
it difficult to tease out the cause of any health problems.
One smoker began using e-cigarettes following dental surgery
after the dentist said quitting smoking would speed the healing
process, according to a report filed last October with the U.S.
Consumer Product Safety Commission that was forwarded to the
"It blew up in my mouth while inhaling, burning my stitches
and gum, lip and fingers," the report said.
Others complained of over-heating devices.
"The electric cigarette gets hot when you use it and alters
the taste buds," wrote one consumer. "I just recently realized
what was turning my taste buds black."
It is not possible to draw general conclusions from
individual case reports, but there is a growing recognition that
the inconsistent quality of the devices, aside from any risk
inherent in the inhalation of nicotine vapor, poses potential
In a bid to address quality concerns, some e-cigarette
makers are beginning to make them, either partially or wholly,
in the United States.
Reynolds American Inc, which began selling its Vuse
e-cigarettes in Colorado last July and expects to expand
nationwide this summer, makes its products in Kansas and North
Carolina, though it still imports its batteries from China.
The reason, Richard Smith, a Reynolds spokesman said, is
that inconsistent quality is turning off potential customers.
"There has been a high level of trial among adult consumers
but a low level of adoption," he said.
While the cost may be higher than sourcing ready-made
products from China, the pay-off, Reynolds is betting, will be
customer loyalty. If a quality problem arises during the
manufacturing process, Smith said, "we can identify and fix it."
(Reporting by Toni Clarke in Washington; Additional reporting
by Jilian Mincer in New York; Editing by Michele Gershberg)