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FDA Releases New E-Cigarette Guidance, Says All Current Products On Market Must Submit For Approval

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Federal health officials have released new final guidance for e-cigarette manufacturers, indicating that a premarket tobacco product application must be submitted to the agency, establishing how the products will be marketed without contributing to the continuing public health risk associated with use among teens.

The FDA issued a press release on June 11, outlining how e-cigarette manufacturers should seek official authorization to market Electronic Nicotine Delivery Systems (ENDS), such as e-cigarettes or vapes, and all liquids used with the devices.

The agency indicates that all past, current and future e-cigarette manufacturers will be required to get approval through a premarket tobacco product application (PMTA) if they want to continue to sell the products in the U.S.

The final guidance lists a series of recommendations for manufacturers to consider when submitting their application. This includes instructions on explaining how they intend to market their products in a way that discourages teen and underage use. The guidance also warns that manufacturers should provide details on how they intend to prevent lithium ion batteries used in e-cigarettes from exploding.

Both teen use and battery explosions have been major focuses of the agency, particularly the issue of underage use. Last year, the agency announced a plan to remove many of the flavored e-cigarettes products from store shelves, which are believed to be behind the increasing teen use of the tobacco products.The policy was directed at all flavors used in e-cigarettes except tobacco, mint or menthol-flavored products, as the agency recognized these flavors are typically used by adults transitioning away from traditional cigarette smoking.

E-cigarette use has quickly become the most popular form of tobacco use among teens, with rates jumping 78 percent from 2017 to 2018, according to the FDA. In 2011, when the FDA first said it would regulate e-cigarettes, only 1.5 percent of teens vaped, but now more than one-third of teens use e-cigarettes as they have become increasingly popular among all age ranges.

The Centers for Disease Control and Prevention (CDC) found nearly 14% of middle school students, and 38% of high school students reported having used e-cigarettes. Among use in the last 30 days from when the survey was taken, five percent of middle schoolers and 16% of high school students reported having used vaping devices.

In April 2019, the FDA warned that it had received at least 35 reports of seizures linked to electronic cigarettes since 2010, and believes many more may have gone unreported. The agency is currently investigating the problem, which preliminary indications suggest occur more often in younger users.

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