WASHINGTON— 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.”
The FDA has left the door open to further regulations, such as a ban on TV advertising and fruit- or candy-flavored e-cigarettes — measures that some anti-smoking groups and members of Congress are demanding.
“It is inexcusable that it has taken the FDA and the administration so long to act. This delay has had serious public health consequences as these unregulated tobacco products have been marketed using tactics and sweet flavors that appeal to kids,” the Campaign for Tobacco-Free Kids said in a statement.
The FDA said it wants more evidence before passing more regulations.
Any further rules “will have to be grounded in our growing body of knowledge and understanding about the use of e-cigarettes and their potential health risks or public health benefits,” FDA Commissioner Dr. Margaret Hamburg said.
Sales are estimated to have reached nearly $2 billion in 2013. Tobacco companies have noticed that e-smokes are eating into cigarette sales, and they have jumped into the business, too. Smokers like e-cigarettes because the nicotine-infused vapor looks like smoke but doesn’t contain the thousands of chemicals, tar or odor of regular cigarettes. Some smokers use e-cigarettes to quit smoking or to cut down.
“If the product as I use it now becomes illegal, I’m not sure what’ll happen. I’ll probably end up smoking again,” said 38-year-old Jason Todrick of Huntington Beach, Calif. He kicked a more than 20-year smoking habit two years ago using the device.
In addition to mandating warning labels that say nicotine is addictive, the rules would require e-cigarette makers to disclose ingredients. They would not be allowed to claim their products are safer than other tobacco products. They could only give out free samples or sell e-cigarettes in vending machines in a place open to adults, such as a bar.
The public and the industry will have 75 days to comment on the proposed rules.
•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.