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FDA's proposed e-cigarette regulations don't go far enough

It's still unknown how safe the devices are and if they help people give up regular cigarettes

Published: April 24, 2014 01:45 PM

The Food and Drug Administration finally took a first step toward regulating the fast growing market of e-cigarettes. Consumers, health advocates, and industry representatives will have until July 9 to comment on proposed regulations, which the agency made public today. “There’s a lot that's still unknown about e-cigarettes, including what’s really in them and how safe they are, so there’s a lot of work to do between now and then,” Marvin M. Lipman, M.D. Consumer Reports chief medical adviser, said. "And until more is known, think of every puff as a trip into the unknown with you as the guinea pig."

The FDA will regulate e-cigarettes as tobacco products, since the liquid nicotine in the devices comes from tobacco. Under the proposed rules, e-cig manufacturers would have to register with the FDA, provide a list of ingredients in the products, disclose scientific data and manufacturing processes, allow FDA inspectors into the plants, and put warning labels on products saying that they contain nicotine, an addictive substance. Manufacturers also would be prevented from marketing the products to people younger than 18 in person or online, sell them in vending machines in places where minors are allowed, offer free samples, or claim that the products are safer than cigarettes unless they get approval from the FDA by submitting scientific data.

“Those are all good things,” Lipman said. “But there are some important gaps. For instance, the proposed regulations don’t ban flavored e-cigs, like bubble gum and grape, which may act as a come-on for kids." Nor do the new regs restrict the marketing of e-cigarettes by, for example, banning ads for the products on TV, as is done for cigarettes.

Perhaps most important, the proposed regulations don’t make any judgment on the safety of the products or just how effective they are in helping people stop smoking. “Clearly, we need to know more about e-cigarettes, and what we do know isn’t reassuring,” Lipman said. For example, several recent studies have suggested that e-cigs may actually encourage smoking of cigarettes in teens. And poison control centers have reported a recent surge in calls linked to the devices.

Beginning on Friday, you can read the proposed FDA e-cig regulations and comment on them. (Search for Docket No. FDA-2014-N-0189.) And share your experience with us including any problems stemming from children coming into contact with liquid nicotine.

—Joel Keehn

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