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BY Kendra Baker | NOV 18, 2013 11:59 AM
The U.S. Food and Drug Administration (FDA) shares George Jepsen’s concerns about electronic
cigarettes—and plans to step in to regulate them.
The FDA sent that message to Jepsen, Connecticut’s attorney general, and 39 of his colleagues in a
letter sent last week.
The attorneys general had asked the FDA to state its position on e-cigarette regulation in a Sept. 24
joint l etter . The group wanted to know where the feds stood before exploring whether to seek state
regulation of the sale of e-cigarettes to minors. Jepsen and the other attorneys general urged the
agency to regulate electronic cigarettes as “tobacco products” under the Tobacco Control Act and
prohibit their sale to minors.
E-cigarettes use a battery to heat liquid, turning it into a vapor. The liquid, or “e-juice,” comes in
disposable cartridges containing chemicals, vegetable glycerine, flavors and varying amounts of
nicotine. The consumer inhales the vapor instead of smoke.
Jepsen said he recognizes the positive benefits of e-cigarettes, such as helping regular cigarette
smokers wean off the habit, but said the lack of regulation and multitude of appealing flavors could
potentially create “a new generation of nicotine addicts.” According to the Centers for Disease Control
and Prevention (CDC), 1.78 million middle and high school students nationwide tried e-cigarettes in
2012.
“The FDA is where the action really is at the federal level. At the state level, we will be introducing
legislation that will outlaw sales of e-cigarettes to minors,” said Jepsen, who remained confident that
e-cigarette regulation changes would come despite the agency’s failure to meet the deadline. “I wish
they would have acted by now [but] the FDA’s going to act eventually.”
In the FDA’s response letter , dated
Nov. 14, Deputy Commissioner
Sally Howard wrote that like the
attorneys general, the FDA is
concerned about “the public health
impact and lack of existing clinical
studies on the potential health
risks posed by electronic cigarette
use, as well as the manufacture
and marketing of these products in
ways which could be appealing to
minors.”
The attorneys general referenced
recent data from the CDC in their letter to the FDA that showed a
dramatic rise in e-cigarette use by
youth.
The FDA acknowledged the
growing popularity of e-cigarettes
in its response. The CDC findings
“reinforce why FDA intends to
FDA Tells Jepsen It’s On Same E-Cigarette Page
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extend its authority over products
that meet the statutory definition of
‘tobacco products’, when it issues
the proposed deeming rule as a
first step toward establishing an
appropriate regulatory framework
to reduce the disease and death
from tobacco use,” the letter
stated.
The proposed deeming rule, which would expand the its authority to include products that meet the
statutory definition of “tobacco product,” is currently under review at the Office of Management and
Budget.
Finalization of the rule-making would automatically apply provisions in Chapter IX of the Federal Food,
Drug, and Cosmetic Act to all newly deemed products meeting the statutory definition of “tobacco
product.”
The FDA currently regulates electronic cigarettes only if they make a therapeutic claim.
“The attorney general appreciates that the FDA shares his concerns, particularly in terms of the sale
and marketing of electronic cigarettes to minors,” said Jaclyn Falkowski, director of communications
at the attorney general’s office. “While we cannot compel the FDA to take action, he appreciates the
FDA’s attention to this matter, in particular that it is seeking the authority to regulate e-cigarettes as a
tobacco product.”
Falkowski said if the FDA does not issue regulations, state-level legislation prohibiting the sale of e-
cigarettes to minors would be “the appropriate course.”
“Should the FDA issue regulations restricting the sale to minors, such legislation would not be
precluded but would not be critical to ensure a prohibition on the sale to minors,” she reported.
About two w eeks ago—before the FDA responded to the attorneys general—Connecticut state Sen.
Edward Meyer started researching e-cigarettes after discovering that his daughter and grandchild
were smoking them.
“I thought this is something that needs more public attention,” said Meyer, who learned that the
vaporized nicotine devices lack age regulation. “I called the Connecticut Department of Public Health
and asked them what their position is, and I got very upset when they told me they had no position. I
urged them to take a position and had a bit of a falling-out with them when they would not.”
Meyer said he intends to push and support legislation that puts public restrictions, including an age
limit, on e-cigarettes.
The fast-growing e-cigarette market offers smokers like him flavors ranging from creamy milk
chocolate, farm fresh cherry and juicy peach flavors, with a youth market in mind.
Share this story with others.
Tags: e-cigarettes, Geoge Jepsen, Food and Drug Administration
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