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FDA proposing first rules for e-cigarettes

Some industry officials say the Food and Drug Administration’s proposal to require manufacturers to report the ingredients in their e-cigarettes could help consumers by providing users with a product that is more “consistent.”

As electronic cigarettes soar in popularity, the U.S. government Thursday is proposing historic rules to ban their sale to minors and require warning labels as well as federal approval.

Three years after saying it would regulate e-cigarettes, the Food and Drug Administration is moving to control not only these battery-powered devices but also cigars, pipe tobacco, hookahs and dissolvable tobacco products. Currently, the FDA regulates cigarettes, roll-your-own tobacco and smokeless products such as snuff.

The proposed rules won’t ban advertising unless the products make health-related claims nor will they ban the use of flavors such as chocolate or bubble gum, which public health officials say might attract children.

“This is an important moment for consumer protection,” said FDA Commissioner Margaret Hamburg, noting tobacco remains “the leading cause of death and disease in this country.” The rules will require manufacturers to report their ingredients to the FDA and obtain its approval. They also ban free tobacco samples and most vending-machine sales.

“Some of these regulations will be very restrictive,” said Ray Story, founder of industry group TVECA (Tobacco Vapor Electronic Cigarette Association). He said they could be costly for smaller businesses and slow the growth of a product that advocates say has helped many smokers kick the habit.

Still, Story said, consumers might benefit because “it provides them a product that will be consistent.” E-cigarettes contain varying ingredients and levels of nicotine that are heated into a vapor that users inhale in a practice known as “vaping.” Most look like conventional cigarettes, but some resemble everyday items such as pens and USB memory sticks.

The rules come as e-cigarette sales, buoyed by TV ads with Hollywood celebrities, have soared in recent year and debate has risen about whether the devices are more apt to lure kids toward tobacco or help adults quit smoking.

An increasing number of states have cracked down by extending indoor smoking restrictions to e-cigarettes. Last month, U.S. poison centers reported a surge in illnesses linked to the liquid nicotine used in the devices.

While they don’t contain many of the harmful chemicals of conventional cigarettes, the FDA found trace amounts of toxic and carcinogenic ingredients in several samples in late 2008 when the e-cigarette market was just beginning in the United States. It sought to regulate them as drug-delivery devices, but in 2010, a federal judge ruled it could only do so if they made therapeutic claims. So in April 2011, the agency said it would regulate them as tobacco products.

“It’s taken more than three years to issue a proposed rule, which we think is inexcusable,” said Vince Willmore of the Campaign for Tobacco-Free Kids, an anti-smoking group. “It’s allowed a Wild West marketplace with irresponsible marketing and no control over the product.” He said the FDA should quickly finalize the rules,.

Several dominant e-cigarette manufacturers, which now include the nation’s three largest cigarette makers – Philip Morris, R.J. Reynolds and Lorillard – have embraced limited regulation such as a ban on sales to minors.

© 2014 USA TODAY. All rights reserved.



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