September 9, 2021 – The FDA orders millions of e-cigarette products in the public market, while saying it needs more time to review vape products sold by leading retailers such as Juul, the largest e-cigarette maker. in the country.
The agency had a court deadline of Thursday to process more than 6.5 million applications for what are considered new tobacco products, most of which are e-cigarettes and liquids, none of which have passed. review by the FDA before.
The FDA has reviewed 93% of these applications in the past year, said Dr. FDA Commissioner Janet Woodcock, and Dr. Mitch Zeller, director of the FDA’s Tobacco Center.
Of those reviewed, the agency rejected more than 946,000 flavored vape products, “because their applications lacked sufficient evidence that they benefit adult smokers sufficient to address the public health threat posed by well-documented, alarming levels of youth use. of such products, ”said Woodcock and Zeller.
They said further work was needed to complete the reviews to “ensure that we continue to take appropriate action to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used.” youth tobacco products through the United States. “
No e-cigarette product has received official FDA approval for sale, which means that all e-cigarette products are technically on the market illegally, the agency said in 2020, but federal officials have only decided to start enforcing anti-flavoring rules. products that studies show are used more often by children. Tobacco and menthol-flavored e-cigarette products – which some adults use to quit smoking – have been released.
The American Cancer Society and other advocacy groups have criticized the FDA’s decision to suspend action against major e-cigarette manufacturers, including Juul.
The failure of the FDA to act today on the claims of JUUL, the manufacturer with the largest market share of e-cigarettes, is extremely disappointing and will allow the industry to further threaten public health and attract more children to their highly addictive products, “Lisa Lakase said. president of ACS CAN, said in a statement, according to CNN.
“The FDA has had ample time to review applications and the assumption of further delays is unintentional. There is ample evidence to prove the negative impact of these flavored products on public health and their role in the young e-cigarette epidemic. To act now.” , added Lakas.
E-cigarette use among high school students increased from 11.7% in 2017 to 19.6% in 2020, according to the American Cancer Society. Almost 5% of high school students reported using them in 2020.