FDA Issuing First Regs On E-Cigs

The Food and Drug Administration is exercising its authority to regulate e-cigarettes in an announcement today that will ban their sale to consumers under 18 and will require manufacturers to disclose their ingredients and to print a warning label that nicotine is addictive.

But this long-anticipated first step at controlling what FDA Commissioner Margaret Hamburg called a “wild, wild West” scenario will not contain any restrictions on television advertising or limit sales on the Internet, although it does prohibit handing out free samples.

“Thursday’s action is about expanding FDA’s authority to products that have been ‘rapidly evolving with no regulation whatsoever,’ in order to create a foundation for broader regulation in the future,” as Mitch Zeller, director of the FDA’s Center for Tobacco Products, indicated during a media briefing that included the Washington Post’s Brady Dennis yesterday. “It creates the framework. We’re calling this the first step ….”



The public will have 75 days to comment on the proposal. 

“The blueprint — which is hundreds of pages long — is sure to set off a frantic lobbying effort in Washington as affected industries try to head off the costliest, most restrictive regulations,” Sabrina Tavernise writes in the New York Times. “The industry has several trade associations, and a number of them have met with Obama administration officials about the regulations over the past several months …,” she continues.

“Once the proposed rules are finalized, manufacturers will have 24 months to submit an application to allow their products to remain on the market or submit a new product application,” writes CNN’s Saundra Young.

“Until we have the authority to regulate e-cigarettes, we cannot provide the information that the American public wants about the relative risk and safety of these products,” the FDA’s Hamburg told CBS News. “... We cannot put in place certain restrictions that might be appropriate with respect to how the products are made, the kind of flavorings, the kind of marketing, etc.”

E-cigarettes, as defined by the FDA, “are battery-operated products designed to deliver nicotine, flavor and other chemicals. They turn chemicals, including highly addictive nicotine, into an aerosol that is inhaled by the user,” in a process commonly called “vaping.”

To be sure, people have been using e-cigarettes to quit tobacco products and believe them to be relatively harmless.

“E-cigarette enthusiasts say vaping is far safer than smoking cigarettes, and some experts say that may well be the case,” as NBCNews’s Maggie Fox writes. But, said American Heart Association president Dr. Mariell Jessup in response, “It’s being marketed a lot that the smoke is harmless and we don’t know that. We shouldn't be fooled by the promises that these devices, these nicotine delivery systems, are safe.”

The briefing yesterday was conducted with the understanding that the press would not report on it until the “blueprint” was released today. That didn’t stop everybody else from having their say once details hit the Internet last night. There were already more than 70 comments to Tavernise’s story — reasoned, passionate and on all sides of the issue — early this morning.

“Twitter never sleeps,” writes the Washington Post’s Gail Sullivan in a story posted at 5:12 a.m. “So when the news broke in the dead of night that the Food and Drug Administration wants to regulate e-cigarettes, the response was swift.”

Most of the tweets Sullivan cites are negative about regulation, such as @TheBradBlog’s “Good news, teens! When FDA bans sale of #ecigs to ya, u can always bum a dangerous real cigarette from a friend!” But, says @aaronmfisher, “Selling death makes money and individuals sell their souls. #ecigarettes.”

“This is the year that e-cigs went completely mainstream,” writes “Jordan” on the Electronic Cigarette Brands Guide, citing “HUGE” technological advances that allow for more vapor, better taste and cheaper product. “The new electronic cigarettes on the market today make the ones from the beginning of 2013 look archaic.”

“There are more than 250 brands of e-cigarettes and an estimated 4 million Americans use them, according to the Tobacco Vapor Electronic Cigarette Association,” ABC News’ Gillian Mohney reports.

Wells Fargo Securities analyst Bonnie Herzog tells the Times’ Tavernise that “the [FDA] proposal would probably lead to consolidation” in the industry. “It benefits the entrenched players,’ she said, referring to the three big tobacco companies that produce e-cigarettes, Lorillard, R.J. Reynolds and Altria, the parent company of Philip Morris U.S.A., as well as larger e-cigarette producers, like Njoy and Logic,” Tavernise writes.

1 comment about "FDA Issuing First Regs On E-Cigs".
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  1. Dan Kim from Red Mango, Inc., April 24, 2014 at 3:04 p.m.

    The tremendous power, reach and influence of the tobacco industry truly amazes me.

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