WASHINGTON — The Food and Drug Administration's move to regulate e-cigarettes drew criticism Thursday from some public health advocates, who said the regulations do not go far enough to protect young consumers.
The proposed rule would for the first time allow the government to limit the manufacture and sale of e-cigarettes, as well as cigars and pipe tobacco. Sales to minors would be banned and health warning labels required.
But the new rules would not ban online sales or restrict youth-friendly flavors such as watermelon and peppermint. Nor would it forbid television commercials. Public-health advocates had called for such additional restrictions.
“Shame on the FDA,” said Sen. Richard J. Durbin (D–Ill.), who called the rules a “political compromise.”
Earlier this month, Durbin and several House Democrats released a report accusing makers of e-cigarettes of targeting children through marketing strategies that would be illegal if used to promote traditional cigarettes.
“With cotton candy and gummy-bear flavors and the ability to purchase e-cigarettes online, our children are still very much at risk even with the FDA’s move to regulate,” said Rep. Jacquie Speier (D–Hillsborough). She added that she planned to introduce legislation to tackle these concerns in the coming weeks.
FDA officials say the proposed rule would lay the groundwork for future regulations, pending further scientific studies.
“This rule would represent a significant step in the agency’s ability to regulate tobacco products,” said Mitchell Zeller, director of the agency’s Center for Tobacco Products, adding that the current regulatory landscape looks like the “wild, wild West.”
Large e-cigarette companies generally expressed support for the FDA proposals and insisted that e-cigarettes are a safer alternative to traditional tobacco products that should not be overregulated.
“You really have to let science dictate the policies,” said Miguel Martin, president of LOGIC, the second largest e-cigarette company in the U.S. “To preempt the FDA … without science to back that up is misguided.”
But the Smoke-Free Alternatives Trade Assn., a group of almost 100 mostly smaller companies, said the rule would stifle small- and mid-sized producers by requiring them to submit to an expensive registration process.
“Treating these products like tobacco products basically hands the industry over to big tobacco,” said the group's executive director, Cynthia Cabrera.
In preparing to regulate e-cigarettes, which heat liquid nicotine to produce a vapor that users inhale, the FDA has faced more complicated decisions about health than it does in efforts to control traditional cigarettes.
Supporters of e-cigarettes say they can help people quit smoking. Beyond that, they say that "vaping" — inhaling nicotine from the devices — does not involve the health risks posed by smoke from burning tobacco, which contains tars and other chemicals that cause cancer.
Nicotine is addictive, but whether its use causes long-term health problems remains uncertain.
But health advocacy groups, including the American Heart Assn., Tobacco-Free Kids and the American Cancer Society Cancer Action Network, have expressed concern that any delay on additional regulations would allow the fast-growing industry, which already counts billions of dollars of sales, to target more children.
“The longer there is inaction, the more the public might interpret this to mean that these in fact are safe,” said Mariell L. Jessup, president of the American Heart Assn. “We learned the lessons about tobacco,” she added. “When cigarettes were first out, they were touted as being healthy as well.”
The Centers for Disease Control and Prevention reported last year that e-cigarette use among minors had grown rapidly, with the percentage of high school students who had tried vaping more than doubling from 4.7% in 2011 to 10% in 2012.
Public health advocates have also worried about a sharp increase in poisoning incidents caused by liquid nicotine. The CDC reported this month that calls to poison centers regarding nicotine had increased from just one in September 2010 to 215 this February. More than half the calls involved children under 5.
Without imposing guidelines on child-resistant packaging, the FDA would leave children at risk of “getting one of these e-juice containers and drinking from it,” said Lee Cantrell, director of the San Diego division of the California Poison Control System.
Another sticking point for anti-tobacco groups is the FDA’s intention to create a category of cigars that will escape regulation. So-called “premium cigars” would have to be above a certain price range and be made by hand, wrapped in whole tobacco leaf and include no fancy flavor, filter tip or mouthpiece.
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