FDA Rolls Out Tough New E-Cig Regs

Industry claims it won't be viable for 99% of products to undergo regulatory approval
By Arden Dier,  Newser Staff
Posted May 5, 2016 11:44 AM CDT
FDA Rolls Out Tough New E-Cig Regs
A man holds an e-cigarette in Chicago.   (AP Photo/Nam Y. Huh, File)

The FDA regulations on e-cigarettes are here, and not everyone is happy. The agency plans to ban the sale of e-cigarettes, hookah and pipe tobacco, and premium cigars—all of which must carry warning labels—to anyone under 18 within 90 days, reports ABC News. Free samples will also be banned. Unregulated tobacco products that hit stores after February 2007 must be approved by the FDA, though this could take years. Experts say producers will need an FDA application for every e-cigarette boasting a unique flavor and nicotine level, with one e-cig advocate telling USA Today that each application will cost $1 million or more. The changes will allow the agency to review ingredients, scientific data, possible dangers, and claims that a product is "light" or "mild," reports the New York Times.

Health Secretary Sylvia Burwell calls it "an important step in the fight for a tobacco-free generation." Anti-tobacco groups are also applauding the move, though they had hoped for limits on the sale of flavored cigars and e-cigarettes favored by youth; those could still come. E-cigarette makers, however, say their products are safer than regular cigarettes and shouldn't be so heavily regulated, per NBC News. In a release, the American Vaping Association says the cost of FDA approvals "will be so high that approximately 99% of products on the market will not even be put through the application process." The FDA argues tobacco-free e-cigs—used by 16% of high school students, according to one study—can still get people addicted to nicotine and the regulations are "reasonable and balanced," per a release. (More e-cigarettes stories.)

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