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FDA’s proposed rules would snuff out small manufacturers of premium cigars
Electronic cigarettes will now be regulated much like tobacco cigarettes and their sale to children banned, according to a new federal rule issued Thursday.
Under the rule, the U.S. Food and Drug Administration would have to approve all tobacco products not currently regulated that hit stores after February 2007. The e-cigarette industry was virtually non-existent before then.
Premium, hand-rolled cigars, as well as hookah and pipe tobacco, are also included in the new regulation, which federal officials call "historic." The rule prohibits selling "covered tobacco products" to people younger than 18, and buyers must show photo ID. It also requires health warnings be displayed on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements; and bans free samples and the sale of covered products in vending machines not located in adult-only facilities.
The Tobacco Control Act of 2009 sets Feb. 15, 2007, as the latest date by which all tobacco products would have to have to be grandfathered in. Mitch Zeller, head of the FDA's Center for Tobacco Products, has said publicly that he couldn't choose a later date, although industry officials disagree.
That means nearly every e-cigarette on the market — and every different flavor and nicotine level — would require a separate application for federal approval. Each application could cost $1 million or more, says Jeff Stier, an e-cigarette advocate with the National Center for Public Policy Research and industry officials.
An amendment to appropriations legislation working its way through the House would change the date so more e-cigarettes would be grandfathered in. White House Press Secretary Josh Earnest said Thursday that President Obama "takes a very dim view of attaching ideological riders to appropriations bills," but stopped short of threatening a veto of any legislation.
The proposed rule was released more than two years ago, in April 2014, and the final rule gives the industry two additional years to comply. The industry will have had "plenty of time to submit their applications," says Robin Koval, CEO of the Truth Initiative, an anti-tobacco health group.
However, stores have to comply with the rule in about three months (90 days from its publication May 10), and Zeller says contractors tasked with enforcement will be ready to "hit the ground running" on Day 91.
Koval says "it's perfectly reasonable" that people should know what's in something that "you inhale into your lungs."
Ellen Hahn, a professor at the University of Kentucky College of Nursing and co-chair of the UK Tobacco-free Task Force, said the new rule is a good first step toward controlling e-cigarettes. "From a health perspective, to reduce the social acceptance of them is good because frankly, it's the wild, wild West out there," she says. "Vape stores are everywhere."
She says so-called "vaping" can get kids hooked on nicotine and threatens to prolong "the tobacco epidemic." E-cigarette use has been rising steadily, especially among youth. According to the U.S. Centers for Disease Control and Prevention, e-cigarette use among high school students rose from 1.5% in 2011 to 16% in 2015. Federal health officials estimate that about 3 million middle and high school students use e-cigarettes.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, says the rule announced Thursday falls short in protecting children because it doesn't restrict the use of sweet e-cigarette flavors such as gummy bear and cotton candy even though the FDA's own data show flavors play a big role in youth use.
Industry experts say treating e-cigarettes, which don't contain tobacco, the same as cigarettes could lead to such onerous and costly approval that all but the largest tobacco companies would be forced out of the market — and possibly those companies, too. Zeller says he expects consolidation in the number and type of products and vape shops.
The Tobacco Control Act requires the FDA to use science to weigh the potential benefits of e-cigarettes against any potential health risk for both individual users and the whole population, which Stier says would be all but impossible.
That could force e-cigarette smokers back to regular cigarettes, he says.
E-cigarettes help people trying to quit smoking, says Patricia Kovacevic, general counsel and chief compliance officer at e-cigarette manufacturer Nicopure. She and other e-cigarette advocates cited a Royal College of Physicians' report last week that showed e-cigarettes' benefits.
Department of Health and Human Services Secretary Sylvia Burwell says, "There are many other cessation tools available."
Koval agrees that e-cigarettes "are dramatically less harmful" than regular cigarettes.
"But they're not without harm," she says. "It would be hard to make a product more harmful or toxic than cigarettes."
Contributing: Gregory Korte
ProActive Sports and Aristo Cigars Signs New Distribution Agreement
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