FDA extends its reach to e-cigarettes in proposal

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Five years in the making, the Obama administration’s move Thursday to regulate electronic cigarettes and other tobacco products left many anti-smoking advocates waiting to exhale.

Democratic lawmakers and the political arm of the American Cancer Society offered lukewarm praise for the Food and Drug Administration’s “long overdue” proposal, deeming it a first step that fails to crack down on flavored tobacco products favored by younger smokers.

E-cigarette manufacturers by and large welcomed the package of rules as a minor headache for the industry — an embrace that threatened to ramp up skepticism among anti-tobacco groups.

Senate Minority Whip Richard J. Durbin, Illinois Democrat and vocal critic of youth-oriented tobacco marketing, declared, “Shame on the FDA.”

“Faced with a responsibility to protect our children from an addiction to a product that can harm them, the FDA strained to create a political compromise,” he said. “Prohibiting sales to kids but doing nothing to protect children from candy-flavored marketing in children’s venues is an awful outcome. Parents across America lost their best ally in protecting their kids from this insidious product.”

The agency said critics of its proposal need to understand this is a step-by-step process. Additional tobacco products had to come under the FDA’s mantle before the agency could take on specific aspects of their promotion, sale and use, it said.

Products that would be subject to regulation include e-cigarettes, cigar and pipe tobacco, nicotine gels and water pipe (“hookah”) tobacco.

Manufacturers would have to register with the FDA, report product ingredients and submit their health claims for scrutiny.

Companies could not sell the newly regulated tobacco products to customers younger than age 18. They would have to put health warnings on labels, and their products could not be dispensed in vending machines at places where children might be present.

“We’re taking another important step toward the goal of a tobacco-free generation,” former Health and Human Services Secretary Kathleen Sebelius said.

The proposal branches from a tobacco-control law signed by President Obama in 2009, and the move to rope in e-cigarettes affects a burgeoning, unregulated market.

“When it comes to e-cigarettes, it’s the wild, wild west,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

E-cigarettes look like traditional cigarettes, but work by heating up liquid nicotine into an aerosol rather than burning tobacco. The FDA regulates the sale and marketing of tobacco products such as cigarettes and chewing tobacco, but until Thursday had not released a rule governing e-cigarettes and other tobacco-derived goods.

Use of e-cigarettes among middle- and high school-age Americans doubled from 2011 to 2012, government officials said, and some lawmakers worry that young e-cigarettes smokers are more likely to make the jump to traditional cigarettes.

Supporters of e-cigarettes say there is no evidence to support that claim and that many people use e-cigarettes as an alternative to smoking, not a steppingstone to tobacco.

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