Flavored E-Cigarettes Must Seek FDA Approval, Some Likely To Be Removed From Market: FDA Commissioner

To help protect the nation’s youth from the potential health risks associated with vaing, federal regulators have announced a new plan to remove many of the flavored e-cigarettes products from store shelves, which are believed to be driving the increasing use of the tobacco products and causing an emerging epidemic in the U.S.

On Wednesday, FDA Commissioner Scott Gottlieb issued a statement announcing new policies that will tighten sales of electronic nicotine delivery systems (ENDS) to the nation’s youth.

The announcement also came with the release of a new draft guidance (PDF) for industry, which warns manufacturers that they will be required to submit premarket applications for all flavored ENDS products by August 8, 2021. The products will be scrutinized for their potential risk for minors to access them, and any which are not approved for sale will be banned.

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“In addition, we’re proposing to prioritize enforcement of unauthorized ENDS products that are targeted to minors or likely to promote use of ENDS by minors,” Gottlieb said in the statement. “Any efforts that entice minors to use tobacco products are of particular concern to the FDA. For example, the agency has already issued warning letters for products that resemble kid-friendly foods and drinks or that resemble other non-ENDS products that are often consumed by youth.”

The new policies will not affect tobacco, mint or menthol-flavored products, unless they appear to be targeted at minors.

Gottlieb indicates that the FDA anticipates the new policies will result in some flavored electronic cigarette and flavored cigar products no longer being sold.

The move was already anticipated to some degree, with the FDA ENDS policy putting off the need for premarket review requirements until August 2022 before the new changes were announced. This new policy moves the date up by one year and focuses on flavored products more frequently used by teens.

Vaping has quickly become the most popular form of tobacco use among teens, with rates jumping 78 percent in only one year, from 2017 to 2018. 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.

According to prior research, 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.

Earlier this year, FDA officials took action against retailers selling tobacco to minors. Officials found Walgreens was the top violator, with more than 1,800 instances where tobacco was sold to minors.

The agency also listed other top violators being gas stations convenience stores, including Marathon, Exxon, Sunoco, BP, Citgo, and Mobil gas stations, all of whom had violation rates between 35 percent and 44 percent at all their stores.

The FDA is accepting public comment on the draft guidance for the next 30 days. Comments can be submitted through http://www.regulations.gov.


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