- The Washington Times - Thursday, September 9, 2021

The Food and Drug Administration on Thursday said it denied applications for more than 946,000 flavored e-cigarettes and vaping products as part of a sweeping review.

While the agency ordered the removal of thousands of e-cigarettes, it has not made a decision on whether to allow vaping brand giant Juul to stay on the market, saying it needs more time to review the company’s products, The Associated Press reported.

The FDA said it was tasked with reviewing applications for more than 6.5 million new tobacco products, many that were already on the market, and has reviewed about 93% of applications. The thousands of rejected products lacked “sufficient evidence” that the benefit to adult smokers outweighed the public health threat of youth use of these new tobacco products.

“There’s more work to be done to complete our remaining reviews and ensure that we continue taking appropriate action to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes,” the agency said in a statement. More than 80% of e-cigarette users are between the ages of 12 and 17, according to the FDA.

Thursday signaled a court deadline for the FDA to issue decisions on marketing applications from Juul and other e-cigarette makers. A federal judge set the deadline after anti-tobacco groups had successfully sued the FDA to speed up its review of vaping and e-cigarette products.

Companies that submit product applications for market approval must show that their e-cigarettes benefit public health such as proving that they help adult smokers quit or reduce their smoking while not attracting youth.

“We respect the central role of the FDA and the required thorough science- and evidence-based review of our applications, which is key to advancing harm reduction and earning a license to operate,” said a Juul Labs spokesman. “We remain committed to transitioning adult smokers away from combustible cigarettes while combating underage use.“
Matthew Myers, president of Campaign for Tobacco-Free Kids, called the FDA’s rejections a “significant step in the right direction.”

“However, the FDA will leave our kids at risk unless it acts quickly on the remaining applications, including for products like Juul that have driven the youth e-cigarette epidemic, and eliminates all flavored e-cigarettes, including menthol-flavored products that are widely used by kids,” he said in a statement. “Every day these products remain on the market, our kids remain in jeopardy.”

• Shen Wu Tan can be reached at stan@washingtontimes.com.

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