A proposal introduced on Tuesday by the Food and Drug
Administration could result in warning labels and child-resistant
packaging on bottles of liquid nicotine used in electronic
cigarettes.
It is the first regulatory action on e-cigarettes the U.S.
agency has announced since proposing regulations in April 2014 that
would allow it to assume oversight of the $3.5 billion industry.
The FDA is expected to complete those rules within the next two
months. As part of the rules, it is also expected to restrict sales
of battery-powered devices to anyone under 18 years old and require
manufacturers to submit their products for federal approval.
The agency said on Tuesday that it would seek public comment for
60 days about whether bottles of liquid nicotine should require
warning labels and childproof packaging in light of a recent
increase in nicotine exposure and poisoning incidents. A January
report by the California Department of Public Health said that
reports of e-cigarette-related nicotine poisonings in young
children in the state of California rose to 154 in 2014 from seven
cases in 2012.
The FDA will weigh those comments before potentially proposing a
rule and the agency would then take additional public comments
before a rule is issued. By soliciting comments before it has
oversight of the industry, the FDA is setting itself up to shorten
the time it takes to complete a rule, which can take more than a
year.
Federal and state lawmakers have urged the FDA this year to
accelerate its push to regulate e-cigarettes. They have expressed
alarm about nicotine poisonings and a report by the federal Centers
for Disease Control and Prevention in April that e-cigarette use
among teenagers tripled between 2013 and 2014.
In the absence of federal regulations, many states and cities
have pushed forward with their own rules. More than 40 states have
banned e-cigarette sales to minors and more than 100 cities have
banned e-cigarette use indoors.
The FDA said earlier this year that it needed time to complete
rules because e-cigarettes involve "complicated rule making." The
agency gained regulatory authority over cigarettes through the 2009
Family Smoking Prevention and Tobacco Control Act, but the act
didn't cover e-cigarettes and liquid nicotine products because they
were just being introduced to the market.
The e-cigarette industry isn't opposed to child-resistant
packaging or warning labels, but e-cigarette advocates criticized
the timing of the proposal because it came before the FDA has taken
oversight of the industry.
E-cigarette advocates oppose the FDA treating e-cigarettes as
tobacco products because they say e-cigarettes don't contain
tobacco leaf and they believe e-cigarettes can be used to help
smokers quit cigarettes.
"This seems premature," said Gregory Conley, president of the
American Vaping Association, an industry funded advocacy group.
"There are still numerous problems the FDA should be working out
with their proposed regulations from last year before they
contemplate new regulatory actions."
Write to Tripp Mickle at Tripp.Mickle@wsj.com
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