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FDA misses deadline, leaving harmful e- cigarettes on the market

ACS CAN says allowing additional delays is "unconscionable."

On Sept. 9, the U.S. Food and Drug Administration (FDA) failed to meet its court-ordered deadline to rule on all e-cigarette and other tobacco product manufacturers’ applications to keep their harmful products on the market.

The Sept. 9 deadline was set as the result of a 2018 lawsuit filed by the American Cancer Society Cancer Action Network (ACS CAN) and numerous other public health groups challenging the FDA’s decision to delay reviewing products based on if they are “appropriate for the protection of the public health” until August of 2022.

A statement from Lisa Lacasse, president of ACS CAN follows:

“The FDA’s failure today to act on applications by JUUL, the manufacturer with the single biggest e-cigarette market share, is extremely disappointing and will allow the industry to further endanger public health and hook more kids on their highly addictive products. The FDA has had ample time to review the applications and allowing additional delays is unconscionable. There is overwhelming data to demonstrate the negative impact these kinds of flavored products have had on public health and their role in the youth e-cigarette epidemic. The time to act is now.

“If we are to reduce suffering and death from cancer, we must prevent youth tobacco initiation and FDA’s premarket review process must play an important role in that work. While we assess options for expediting this process in earnest and urge the FDA to move swiftly, federal, state, and local officials should continue their essential work regulating these highly addictive and harmful products.”

The FDA said on Thursday that it had so far denied the applications of 946,000 flavored e-cigarette products to remain on the market, mostly made by small companies. Still undecided is how the regulatory agency will rule on the applications of Juul Labs and other major e-cigarette companies.

Companies have to show that their vaping products are less harmful than traditional cigarettes, and that their usefulness in helping smokers quit outweighs the risk that some people will start using nicotine through the products.

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