FDA Commissioner Margaret Hamburg told senators at a
Congressional budget hearing that it has taken too long to move the
rule forward and that she expects the proposal to be ready for
release "very soon."
The FDA's proposal is currently being examined by the White House's
Office of Management and Budget, which reviews potential regulations
to assess their economic impact. OMB, which has been reviewing the
proposal for roughly five months, has not said when it will be
finished with its assessment.
A growing chorus of public health advocates and lawmakers are
pressing for prompt release of the proposal, arguing that the delay
presents risks to children who may be attracted to the sweet flavors
often contained in e-cigarettes.
Senator Jeff Merkley, Democrat of Oregon, told Hamburg that the
agency's delays were "disgraceful" since makers of products such as
tutti-frutti flavored e-cigarettes and strawberry-flavored cigars
have "an insidious strategy to addict our children to nicotine."
"Four years and four months to get the first draft over to OMB is
unacceptable," he said. For OMB to sit on it for months, he added,
Hamburg said the criticisms were fair.
"I do believe that very soon I will be able to call you and say the
deeming rule is out," she said.
A law passed in 2009 gave the FDA the authority to regulate
cigarettes, smokeless tobacco and roll-your-own tobacco. It also
gave the agency the power to "deem" other tobacco products to be
within its jurisdiction but it must first issue a rule to that
E-cigarette companies believe they should be exempt from the full
spectrum of regulations, saying they would stifle innovation, damage
small business and hurt consumers trying to quit smoking.
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Hamburg also responded to concerns about an apparent rise in the
number of poisoning cases from liquid nicotine, the substance
contained in e-cigarettes that, when heated, forms an inhalable
On Thursday a report from the Centers for Disease Control and
Prevention showed that the number of calls to poison centers
involving e-cigarette liquids containing nicotine rose from one per
month in September 2010 to 215 per month in February 2014. The
number of calls per month involving conventional cigarettes did not
show a similar increase, the report said.
"We do feel that this in an area that requires greater attention,
action and concern," Hamburg said.
(Reporting by Ros Krasny; editing by Andrew Hay)
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