FDA eases into regulating e-cigarettes

Proposed rules regulating electronic cigarettes, issued Thursday by the Food and Drug Administration, would ban sales to anyone under 18, add warning labels and require FDA approval for new products.
By MICHAEL FELBERBAUM, Associated Press Modified: April 24, 2014 at 8:54 pm •  Published: April 24, 2014
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The federal government’s move to regulate e-cigarettes is a leap into the unknown.

Most agree a ban on selling them to kids would be a step forward. But health and public policy experts can’t say for certain whether the electronic devices are a good thing or a bad thing overall, whether they help smokers kick the habit or are a gateway to traditional cigarettes.

The proposed rules, issued Thursday by the Food and Drug Administration, tread fairly lightly. They would ban sales to anyone under 18, add warning labels and require FDA approval for new products.

Some public health experts say a measured approach is the right one. They think the devices, which heat a nicotine solution to produce an odorless vapor without the smoke and tar of burning tobacco, can help smokers quit.

“This could be the single biggest opportunity that’s come along in a century to make the cigarette obsolete,” said David Abrams, executive director of the Schroeder Institute for Tobacco Research and Policy Studies at the American Legacy Foundation.

Still, some wonder whether e-cigarettes keep smokers addicted or hook new users and encourage them to move on to tobacco. And some warn that the FDA regulations could have unintended consequences.

“If the regulations are too heavy-handed, they’ll have the deadly effect of preventing smokers from quitting by switching to these dramatically less harmful alternatives,” said Jeff Stier, senior fellow at the National Center for Public Policy Research, a conservative think tank in Washington.

Scientists haven’t finished much research on e-cigarettes, and the studies that have been done have been inconclusive. The government is pouring millions into research to supplement independent and company studies on the health risks of e-cigarettes and other tobacco products — as well as who uses them and why.

“There are far more questions than answers,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

But he said the proposed rules “would result in significant public health benefits, including through reducing sales to youth, helping to correct consumer misperceptions, preventing misleading health claims and preventing new products from entering the market without scientific review by FDA.”

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Timeline

•Late 2006: Electronic cigarettes first marketed in U.S. via kiosks in shopping malls and online.

Early 2009: Sellers sue the Food and Drug Administration after the agency told customs officials to refuse shipments into the U.S.

June 2009: The Food and Drug Administration said testing of products from two leading electronic cigarette makers turned up several toxic chemicals, including a key ingredient in antifreeze.

January 2010: Federal judge rules that the FDA can’t stop those shipments, saying the agency had overstepped its authority.

December 2010: Federal appeals court rules e-cigarettes should be regulated as tobacco products by the FDA rather than as drug-delivery devices.

April 2011: FDA announces plans to regulate electronic cigarettes as tobacco products.

April 2012: Lorillard Inc., the nation’s third-biggest tobacco company, buys Blu Ecigs.

Summer 2012: No. 2 tobacco company Reynolds American Inc. begins limited distribution of first electronic cigarette under Vuse brand.

February 2013: The Centers for Disease Control and Prevention releases study showing increased awareness and use of electronic cigarettes in the U.S.

March 2013: Former U.S. surgeon general Dr. Richard Carmona joins board of directors for e-cigarette maker NJOY Inc.

July 2013: Reynolds American launches test market of revamped version of Vuse e-cigarette.

August 2013: Subsidiary of Altria Group Inc., owner of the nation’s biggest tobacco company, Philip Morris USA, launches test market first e-cigarette under MarkTen brand name.

September 2013: CDC releases study showing growing use of e-

cigarettes by middle and high school students.

End of 2013: Sales of e-cigarettes reach nearly $2 billion with more than 200 brands.

April 24: FDA issues proposed regulations for electronic cigarettes.

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