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New Rules for E-Cigarette, Tobacco Products

The FDA released its long-awaited final “deeming” regulations on non-cigarette tobacco products Thursday, giving the agency authority over e-cigarettes, cigars, little cigars, pipe tobacco, hookah pipes, and other tobacco products.

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As the FDA reviews the applications of e-cigarette marketers, they are very likely to find evidence of unambiguous harm, said tobacco researcher Rebecca Williams of the University of North Carolina’s Lineberger Comprehensive Cancer Center.

“As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap”, said Health and Human Services Secretary Sylvia Burwell.

The FDA gained the power to regulate a wider range of tobacco products in 2009, with the passage of the Family Smoking Prevention and Tobacco Control Act.

The FDA action comes five years after the agency first announced its intent to regulate e-cigarettes and more than two years after it floated its initial proposal.

E-cigarettes have always been controversial; the lack of regulation meant that even youths, who otherwise wouldn’t be able to purchase cigarettes, could purchase these products. Unfortunately, the FDA and the Obama Administration have rejected and cast aside any rationally objective approach to developing this regulation.

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. The e-cigarette industry hardly existed at that time. More than 3 million teenagers used e-cigarettes regularly in 2015, up by more than 500,000 from 2014, the FDA said.

He noted there have been reports of people burned and disfigured by e-cigarette battery explosions.

Regulations for the e-cigarette industry have been in the works for years. The tar and other chemicals from burning tobacco are no less harmful to the lungs when inhaled through water, as in a hookah, or when flavored.

The multi-billion-dollar e-cigarette industry has at times been the subject of both praise, for helping people quit traditional cigarettes, and condemnation, for potentially sucking youngsters into the world of nicotine, and many have called for a more thorough examination of the potential health benefits and costs. “Today’s action by the FDA will do nothing to improve our nations’ public health objectives”, said Tony Abboud, national legislative director for the Vapor Technology Association in a statement. By 2007, vaping devices were marketed in Europe and the United States as a less harmful alternative to smoking. They act as a gateway to smoking with seductive flavorings and safety claims-or they divert a generation of would-be smokers from the dangers of burned tobacco.

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The rule has other omissions: It does not restrict e-cigarette marketing, which often mimics tactics long used to market regular cigarettes to kids, nor does it take strong steps to prevent online sales of e-cigarettes and refill liquids to youth, despite studies showing many online vendors have inadequate age verification.

Drug Administration Commissioner Dr. Robert Califf center accompanied by from left Health and Human Services Secretary Sylvia Burwell US Surgeon General Dr. Vivek Murthy and FDA Center for Tobacco Products Director Mitch Zelle