FDA Ready to Rule on Electronic Cigarettes

Commissioner Margaret Hamburg said she expects the agency to release its rule “very soon” on establishing FDA authority over e-cigarettes.

April 07, 2014

WASHINGTON – The U.S. Food and Drug Administration is "pushing very hard" to release a proposed rule that would establish the agency’s authority over electronic cigarettes, Reuters reports.

FDA Commissioner Margaret Hamburg told members of Congress during a Senate budget hearing last week that it has taken too long to move the rule forward, and that she expects the proposal to be ready “very soon.” The news source adds that FDA’s proposal has been under review by the White House's Office of Management and Budget (OMB) for about five months.

The news source notes that U.S. Sen. Jeff Merkley (D-OR) told Hamburg during the hearing the FDA’s delays were "disgraceful,” noting that "Four years and four months to get the first draft over to OMB is unacceptable and that for OMB to sit on the proposal for months is also unacceptable. 

Hamburg agreed that the criticisms were fair, notes Reuters. "I do believe that very soon I will be able to call you, and say the deeming rule is out," she said.

In 2009, the FDA was granted the authority to regulate the manufacture and retail of tobacco products. 

Meanwhile, the U.S. Centers for Disease Control and Prevention (CDC) is reporting that the number of calls to poison centers involving e-cigarette liquids containing nicotine is increasing, going from one call per month in September 2010 to 215 per month in February 2014. 

CDC also found that more than half (51.1%) of the calls to poison centers due to e-cigarettes involved children under age 5, and about 42% of the poison calls involved people age 20 and older.

In response to the CDC’s report, Reynolds American Inc. says that its Vuse e-cigarette is designed to “minimize chances for accidental exposure.” Jason Healy, president of Lorillard Inc.’s Blu eCigs, told ABC News that the CDC’s findings are “a weak argument” against e-cigarettes and evidence of “an on-going attack on the e-cigs industry by various anti-smoking groups,” reports the Winston-Salem Journal.

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