E-cigarette sales regulations, warning labels proposed by FDA
Federal health officials say they will extend the government's tobacco authority to cover electronic cigarettes and a slew of other nicotine-containing products, including cigars, which have gone unregulated for decades.
Officials from the U.S. Food and Drug Administration called their plans historic Thursday as they revealed the framework for federal regulations, which call for a ban on e-cigarette sales to minors and warning labels on packaging.
The proposed regulations are contained in a document of more than 300 pages, which cites the need for scientific research on e-cigarettes and their chemical agents used in flavorings and vapors.
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In addition to electronic cigarettes and cigars, FDA Commissioner Margaret Hamburg identified several other products deemed subject to oversight: pipe tobacco, nicotine gels and water-pipe, or hookah, tobacco.
The American Lung Association has been a longtime opponent of flavored cigars, which the organization says lures teens.
"One of the things that will be extremely helpful as we go forward is to have the regulatory oversight of these products," Hamburg said during a news briefing Thursday.
Currently, the agency regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.
Reaction to the proposed regulations was swift, especially regarding e-cigarettes.
"Here's the good thing, they didn't ban flavors, which is very important," said Talia Eisenberg, co-founder of the Henley Vaporium in Manhattan, a business that sells e-cigarettes and allows sampling of e-liquids.
Eisenberg and Peter Denholtz, the other Henley co-founder, worried about the FDA's tobacco authority being used to regulate an emerging industry.
Many electronic products, they said, are nicotine-free.
"Some people just want that throat hit," she said of the vapor, "but they don't want the nicotine."
Dr. Michael Niederman, who chairs the department of medicine at Winthrop-University Hospital in Mineola, said regulations give consumers a sense of protection.
"This is a good idea, since we know there are adverse effects of nicotine, and it is important to control exposure to this potentially dangerous substance, in any delivery form," Niederman said.
Others wondered whether the proposed regulations go far enough.
"There's no regulation for [manufacturers] to disclose what's in the flavoring agents," said Dan Jacobsen, of the North Shore-LIJ Center for Tobacco Control in Great Neck. "Flavoring agents are something that people usually ingest, not inhale, so there are lot of questions about these products."
Miguel Martin, president of LOGIC, one of the largest e-cigarette manufacturers, said he's pleased with the proposed rules.
"We were hoping for regulations that are science-based and they have done that," said Martin, whose company is in Pompano Beach, Fla.
The proposed e-cigarette oversight would not ban television advertising, Hamburg said.
Television e-cigarette ads featuring Hollywood stars have helped spur the products' multibillion dollar sales. Some analysts predict the industry will reap $10 billion annually by 2017.
The proposed regulations would not take effect immediately, said Mitch Zeller, director of the FDA's Center for Tobacco Products. There is a 75-day period for public comment.
E-cigarettes are battery-powered and contain an atomizer that releases a vapor of propylene glycol or other compounds.
Four years ago the FDA attempted to regulate them as drug-delivery devices, but a federal judge ruled they could be deemed as such only if being used therapeutically.
Three years ago, the agency moved to have them regulated as tobacco products based on the fact that nicotine comes from tobacco leaves.
Zeller said the need for regulations is critical.
"When it comes to e-cigarettes, it's the wild, wild West," Zeller said Thursday.
He said the FDA is sponsoring dozens of studies to learn patterns of e-cigarette usage. He also said the agency is studying e-cigarettes' chemical agents.
Zeller added that consumers need information. Some rechargeable devices have exploded in home electrical sockets and car lighters, he said.