The U.S. Food and Drug Administration is spending $270 million on
these and 45 other research projects to determine the risks of
e-cigarettes before millions more Americans become hooked on the
"They want data and they want it yesterday," said Dr Suchitra
Krishnan-Sarin of Yale University, who is leading four projects.
"Yesterday," however, is years away.
Final results may not be available before 2018, researchers leading
the FDA-funded projects told Reuters. That timetable, which has not
been reported before, underscores how the slow pace of science is
contributing to a regulatory vacuum, allowing e-cigarette makers to
sell their products virtually unchallenged.
To be sure, studies of e-cigarettes not funded by the FDA are also
under way, and the agency can factor those results into any action
it takes. But the FDA chose these 48 projects because they address
questions central to future regulations.
The e-cigarette industry, which Wells Fargo Securities estimates
will make $2 billion in global sales this year, says the FDA must
wait for the results of the research before it issues any
regulations, or manufacturers risk being driven out of business by
unproven fears about their products.
"There shouldn't be regulations akin to those for cigarettes without
evidence of similar health impact, especially since the preliminary
evidence is positive for the industry" when it comes to comparing
the contents of e-cigarette vapor to tobacco smoke, said attorney
Bryan Haynes. His Richmond, Virginia-based firm Troutman Sanders
represents e-cigarette manufacturers.
Backed by the world's biggest tobacco companies, the industry is
aggressively expanding its marketing across the country. More than
14 million U.S. adults and nearly 2 million teens and tweens have
used e-cigarettes, and the rate of use among high-schoolers doubled
from 2011 to 2012, the latest data available.
The FDA "will always make regulatory decisions based on the best
available science,” said an agency spokeswoman. “With regard to
e-cigarettes, the agency does not believe it will take many years to
create the regulatory framework” once the FDA has the basic
authority to regulate the products, which could happen next year.
The missing science includes basic questions such as what compounds
are in the vapor produced by e-cigarettes. It also includes
complicated ones like whether flavors such as butterscotch and
bubble gum entice children to vape, how e-cigarette displays in
online stores affect teenagers' desire to buy vaping liquid, and,
perhaps most crucial, whether e-cigarettes will reduce the number of
smokers or produce millions of new nicotine addicts.
The Yale team, for instance, will study whether menthol and flavors
such as chocolate and cherry increase the appeal of e-cigarettes,
especially to 16-to-18-year-old smokers or "dual users" who both
smoke and vape. If that turns out to be the case, the FDA would have
scientific support for regulating.
"We'll have the first results within two years" and complete ones in
four to five, Krishnan-Sarin said.
As an uncontrolled experiment in public health, the use of
electronic cigarettes is rivaled only by conventional tobacco
smoking, a habit adopted by half of American men and one-third of
women during its peak in the 1960s. The first Surgeon General’s
report on the health dangers of cigarettes was released in 1964,
when more than 40 percent of American adults were already hooked. To
date, more than 10 million Americans have died from illnesses tied
to smoking tobacco.
Research on e-cigarettes has moved more quickly, partly because
scientists can draw on regular tobacco research to establish the
biological effects of vaping.
The cartridge-like devices were first introduced in the United
States by start-up manufacturers in 2007. Now, the U.S. market is
dominated by blu, a brand owned by Lorillard Inc.
Other leading tobacco companies are making a big push for a share of
the growing market: R.J. Reynolds Vapor Co., a subsidiary of
Reynolds American, began selling its Vuse e-cigarette nationwide
last month and Altria's NuMark subsidiary plans to do so with its
MarkTen later this year.
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The FDA got authority to regulate tobacco products, both traditional
and novel, with the 2009 Tobacco Control Act. In April, the FDA
proposed banning e-cigarette sales to minors, angering public health
advocates who want more far-reaching prohibitions on online sales,
advertising and flavors.
The FDA began funding e-cigarette research in 2012. An FDA-funded
project at the University of Louisville in Kentucky illustrates why
the pace of science is slow.
Scientists there will look at three or four brands of e-cigarettes
and analyze their volatile organic compounds, flavorings and
particulate matter to see how they affect lung and other cells in
lab mice, said lead researcher Dr Sanjay Srivastata.
This spring, he began exposing the animals to e-cigarette vapor for
up to six months, with full results expected in 2015. While those
findings could help FDA quantify risks from vaping, results
extending the conclusions to humans are as much as five years away.
THE 'PLEASURES OF NICOTINE'
Another crucial question researchers are trying to answer is whether
e-cigarettes will be used mostly by nicotine newbies, including
adolescents; by ex-smokers craving a nicotine hit without the
carcinogens of tobacco; or by smokers trying to quit.
To get a handle on who is likely to use e-cigarettes, scientists at
Georgia State University School of Public Health will conduct online
surveys of 6,000 people to assess whether they perceive e-cigarettes
as less harmful than the traditional kind, why those who have
switched from the latter to e-cigarettes did so, and what influences
people's perceptions of the product's risk.
"This is the kind of research that is going to be informing the
FDA's regulatory process," said Michael Eriksen, dean of the School
of Public Health and leader of three FDA-funded projects on tobacco.
The FDA's proposed e-cigarette rules would give it the power to
regulate the ingredients in the vaping liquid, but are silent on the
plumes of vapor produced when the liquid is heated. According to
research at Virginia Commonwealth University, that may be a
dangerous oversight: a form of e-cigarettes called tank systems can
get so hot the vapor can contain the carcinogen formaldehyde and
other toxic compounds.
"We want to know what's in the emissions, not just the ingredients,"
said VCU toxicologist Robert Balster, who is helping to oversee four
To find out, VCU engineers are constructing mechanical vaping
devices to measure how temperature, voltage, and other parameters
affect the content of the plumes from e-cigarettes. They will next
comb through Facebook and blog postings to see whether vapers like
super-hot temperatures, for instance. Combining the results of the
mechanical vaper and real-life habits should show what emissions
people are exposed to.
"If it turns out that people are tinkering with the electronics to
increase the voltage of e-cigarettes, and FDA regulations limit the
maximum voltage, that's useful to know," since it may justify a
requirement that the devices be tinker-proof, said Balster.
Full results are years away, he said, "but we're mindful of getting
information to FDA in a timely manner. They're under a lot of
pressure to get moving."
(Reporting by Sharon Begley in New York and Toni Clarke in
Washington; Editing by Michele Gershberg and Ross Colvin)
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