FDA Proposes E-Cigarette Regulations04/24/14
THURSDAY, April 24, 2014 (HealthDay News) -- The U.S. Food and
Drug Administration is proposing long-awaited regulations governing
the fast-growing electronic cigarette industry.
The new rules, made public Thursday, would give the FDA the
authority to regulate e-cigarettes as tobacco products, placing
them under the same requirements as cigarettes. That would include
a ban on the sale to minors.
The new proposed regulations would also give the FDA oversight
of numerous tobacco products that up to now have had no federal
oversight. Those products include cigars, pipe tobacco, nicotine
gels and waterpipe (or hookah) tobacco.
"This proposed rule is the latest step in our efforts to make the next generation tobacco-free," U.S. Health and Human Services Secretary Kathleen Sebelius said in an FDA news release.
The proposed regulations would require makers of "newly deemed"
tobacco products such as e-cigarettes to:
- register with the FDA and report product and ingredient
- only market new products after an FDA review,
- only make claims of reduced health risks if the FDA confirms
that scientific evidence supports the claim and that marketing the
product will benefit public health,
- not distribute free samples.
In addition, the proposal would require minimum age and
identification restrictions to prevent sales to underage children;
require health warnings; and prohibit sales through vending
machines, unless they're in a facility that never admits
"Tobacco remains the leading cause of death and disease in this country," FDA Commissioner Dr. Margaret Hamburg said in the news release. "This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products. Science-based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth."
The FDA is basing its proposed regulations on the Family Smoking
Prevention and Tobacco Control Act, which was signed by President
Barack Obama in 2009 and gave the agency oversight of tobacco
The FDA said the public, the electronic cigarette industry and
others will have 75 days to comment on the proposed regulations.
Then the agency will review those comments before issuing a final
E-cigarettes are battery-operated devices that turn nicotine,
flavorings and other chemicals into a vapor that can be inhaled.
Most are designed to look like a tobacco cigarette, but some look
like pens, USB drives or other everyday objects.
The devices are advertised on TV and the Internet, and come in
sweet flavors like green apple, watermelon and bubble gum.
Erika Sward, the American Lung Association's assistant vice
president for national advocacy, applauded the FDA's proposal.
"It would give FDA authority over all unregulated tobacco products," she said. "That would be e-cigarettes, but it also would be cigars, little cigars, hookah-type tobacco and any other products that aren't currently under the FDA's authority now."
Such regulations would close a huge loophole that allows
children to freely purchase e-cigarettes and little cigars in many
parts of the country, according to proponents of stricter
E-cigarette use more than doubled among middle and high school
students from 2011 to 2012, with more than 1.78 million students
nationwide inhaling nicotine-laced vapor from the devices, the U.S.
Centers for Disease Control and Prevention reported last year.
"What's concerning is that high rate of rise," said Dr. Hilary Tindle, assistant professor of medicine and director of the tobacco treatment service at the University of Pittsburgh Medical Center. "Who knows where it will be next year, or the year after that? Everyone agrees that's not a good thing. The least amount of regulation has to close that hole, so children can't get access to them as easily."
The drive for regulation is also being fueled by a dramatic
increase in the number of calls to poison centers involving
nicotine poisonings from e-cigarettes, according to federal health
Calls related to poisoning from the liquid nicotine in the
devices rose from about one a month in 2010 to 215 in February this
year, the CDC reported in April.
Electronic cigarettes may be safer than conventional tobacco
cigarettes, in that people don't have to inhale harmful smoke. But
without regulation, it's impossible to know what people are
inhaling when they use an e-cigarette, Tindle said.
"There are so many manufacturers right now making e-cigarettes, and there have been multiple reports of contaminants in the vapor and in the e-liquids," she said. "People don't necessarily know what they are getting in their bodies, based on the label."
The new regulations would end the "Wild West" nature of the
e-cigarette market, Sward said.
"Once these companies come under FDA authority, it would require them to register with the FDA to disclose their products and ingredients. That's really important in understanding how these new products impact public health," she said.
Given the lack of federal action so far, some states and cities
have started pursuing e-cigarette regulations of their own. New
York City added e-cigarettes to the city's overall ban on smoking
in December, treating them the same as tobacco products.
Some argue that e-cigarettes can help people quit smoking, but
evidence supporting that claim has been mixed. Recent studies
JAMA Internal Medicinehave reported that e-cigarettes either
don't help people quit or are about as effective as a nicotine
For more on e-cigarettes, visit the
U.S. National Institute on Drug Abuse.
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