Proposal To Regulate E-Cigarettes Expected Soon, FDA Says

ecig
While critics of e-cigarettes raise concerns about everything from exploding devices to poisoning risks to marketing and advertising to minors, there are currently no specific federal regulations on these products. That is likely to change soon, says the head of the FDA.

U.S. Food and Drug Administration Commissioner Margaret Hamburg told senators at a Congressional budget hearing today that a proposed rule that would establish FDA authority over e-cigarettes should be ready for release “very soon,” Reuters reports.

Currently, the proposal is being examined by the White House’s Office of Management and Budget to assess its potential economic impact.

Public health advocates and lawmakers have been pressing for regulations since the products came on the market as an alternative to traditional cigarettes.

“Four years and four months to get the first draft over to OMB is unacceptable,” Sen. Jeff Merkley of Oregon says.

Hamburg told senators that criticism of the FDA’s slow response to establish regulations is fair.

“I do believe that very soon I will be able to call you, and say the deeming rule is out,” she said.

The FDA isn’t exactly known for its swiftness. In 1977, the agency proposed a ban on penicillin and other antibiotics in farm animals. It wasn’t until 35 years later and a court order that the agency got around to seriously considering that proposal.

Since 2009, the FDA has had authority to regulate cigarettes, smokeless tobacco and roll-your-own tobacco, as well as the power to deem other tobacco product within its jurisdiction.

Still, e-cigarette companies believe they should be exempt from FDA regulations, contending it would stifle innovation, damage small business and hurt consumer trying to quit smoking.

Those in favor of regulations say the delay presents a risk to children who may be attracted to the product’s sweet flavors.

Last month, the New York Times explored one of the deadliest attributes e-cigarettes pose: liquid nicotine. When ingested or absorbed even small amounts of the toxin could prove deadly.

The Centers for Disease Control and Prevention released a new report [PDF] today that show the number of calls to poison centers involving e-cigarette liquid containing nicotine rose from one per month in September 2010 to 215 per month in February 2014.

“We do feel that this in an area that requires greater attention, action and concern,” Hamburg says of the increased poisonings.

E-cig rule coming ‘very soon,’ U.S. FDA chief says [Reuters]