WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) is "pushing very hard" to release a proposed rule establishing its authority over electronic cigarettes, Commissioner Margaret Hamburg said today during a Congressional budget hearing.
She added that while it has taken too long to move the rule forward, she expects the proposal to be ready for release "very soon," Reuters reported.
The rule is currently being examined by the White House's Office of Management and Budget (OMB). The OMB, which reviews potential regulations to assess their economic impact, has had the FDA's rule proposal for approximately five months. It has not stated when it expects to finish its review.
Numerous lawmakers and public health advocates have been asking for a prompt release of the rule, citing potential dangers to children as a result of the delay.
"Four years and four months to get the first draft over to OMB is unacceptable," said Sen. Jeff Merkley (D-Ore.).
Hamburg acknowledged that such criticisms are fair. "I do believe that very soon I will be able to call you and say the deeming rule is out," she said at today's hearing.
The commissioner also commented on a recent report from the Centers for Disease Control and Prevention (CDC), which showed that the number of calls to poison centers regarding 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 traditional cigarettes did not show a similar increase, according to the CDC report.
"We do feel that this in an area that requires greater attention, action and concern," Hamburg said.
In 2009, the FDA gained the authority to regulate cigarettes, smokeless tobacco and roll-your-own tobacco, as well as other tobacco products, but it must first issue a deeming rule to that effect.