Health officials push Obama for release of e-cigarette regulation proposal

FDA submited regulation proposal six months ago

Six health organizations are urging President Obama to request the release of a proposal that would allow the Food and Drug Administration to regulate e-cigarettes and cigars.

The FDA's Center for Tobacco Products began regulating tobacco products in 2009. That regulation does not include e-cigarettes unless the device is used as approved for therapeutic purposes.

If the Center wants to regulate anything else as a "tobacco product," such as e-cigarettes, it has to propose a rule and solicit public comment to the Office of Management of Budget, Office of Information and Regulatory Affairs, OIRA. It did just that Oct. 1, 2013.

“There is no federal oversight of these products, nor restrictions in place to protect the public health against risks posed by these products, particularly to the health of our children,” the health organizations wrote in a letter to Obama.

The organizations also point out the proposal is two months overdue.

“This is the first step,” Erika Sward, Assistant Vice President for National Advocacy for the American Lung Association said. “We need that clock to start ticking.”

Sward said this is only a proposed regulation and there will still be a public comment period. The FDA will then review all of those comments and submit a final draft. Then the process begins all over again.

“We are very troubled that any further delay means we will not see any meaningful protection for consumers for years,” Sward said.

In January, through a federal freedom of information request, reporters for the E.W. Scripps Company asked the FDA for “any and all proposed rules submitted by the FDA to the Office of Management and Budget and the White House's Office of Information and Regulatory Affairs related to defining e-cigarettes.”

In early March, the FDA responded, saying:

“I cannot confirm or deny the existence of the records you are seeking. If such record did exist, the would be exempt from disclosure under the Freedom of Information Act, 5, USC 522(b)5, as well as FDA’s regulation at 21 CFR20.62, as such records would consist of internal, deliberative and pre-decisional information.”

In their letter, the six health organizations said regulation is overdue, citing new data from the National Poison Data System which reports poisonings caused by accidental ingestion of e-liquids tripled from 2012 to 2013.

“We urge you to do everything in your power to enable FDA to initiate the public comment period for this regulation. Further delays will continue to compound the serious public health and medical problems that are occurring as a result of these unregulated tobacco products,” they wrote.

The organizations also cited an increase in cigar consumption and the increase in the number of children who reported using e-cigarettes.

The American Academy of Pediatrics, American Cancer Society, Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Legacy are the health organizations behind the letter.

In 2003, a Chinese pharmacist invented the e-cigarette as an alternative to smoking. Instead of lighting up traditional tobacco-filled cigarettes, smokers use a battery-powered device to inhale nicotine in the form of a vapor.

The process known as “vaping” has been sold to consumers as a healthier alternative to regular cigarettes.

What do you think? Are e-cigarettes good or bad? Take our poll here.

NewsChannel5 Investigator Sarah Buduson reported on e-cigarettes earlier this year.

Our San Diego sister station found a highly specialized lab — one of the first in the country — to test e-cigarettes. Scientist Prue Talbot and her researchers at University of California Riverside conducted recent tests and tested an e-cigarette bought from a San Diego drugstore. Click here to see the complete investigation.

During the testing, the liquid that is heated and turns into a vapor is put inside a centrifuge and spun. The end product: a small metal pellet.

As more studies of vapor and its second-hand effects are conducted, more municipalities and states are considering bans. More than 40 states across the country do not currently include e-cigarettes in their smoke-free laws, according to research done by the American Lung Association.

The tobacco products that currently fall under FDA regulation are cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco products.

The FDA’s Center for Drug Evaluation and Research oversees regulation of e-cigarettes used for therapeutic purposes. So far none have been FDA approved.

Even though the FDA only currently regulates electronic cigarettes if they make a therapeutic claim, consumers may submit voluntary adverse event reports to the FDA for all electronic cigarettes through the HHS Safety Reporting Portal.

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