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FDA orders Juul e-cigarettes and vaping products to be removed from US market

The U.S. Food and Drug Administration announced on Thursday that it is removing e-cigarettes and other Juul Labs products from the market.

It comes after the federal health agency completed a nearly two-year review of the manufacturer’s application to sell its tobacco and menthol flavored vaping device and pods.

Ultimately, the FDA decided to block Juul’s application.

“Today’s action is further progress in the FDA’s commitment to ensure that all e-cigarette and e-nicotine delivery system products currently marketed to consumers meet our public health standards,” FDA Commissioner Robert M. Califf said in a statement. “The agency has devoted significant resources to reviewing products from companies that represent the bulk of the U.S. market. We recognize that these represent a significant portion of available products and many have played a disproportionate role in the increase youth vaping.

Juul Labs said it would seek a stay of the decision and was “exploring all of our options under FDA regulations and law, including appealing the decision and engaging with our regulator.”

The company has long claimed that its product is important as a tool to quit smoking cigarettes.

“We remain committed to doing everything in our power to continue to serve the millions of American adult smokers who have successfully used our products to move away from combustible cigarettes, which remain available on market shelves nationwide. national,” said Juul Labs.

After hitting the market in the mid-2010s, Juul became the most popular e-cigarette brand available, largely due to its wide variety of flavors including cream, mango, and mint.

A man uses a Juul vaporizer in Atlanta on September 26, 2019.

Elijah Nouvelage/Reuters, FILE

Politicians and anti-tobacco advocates have accused the company of using these flavors — along with a sleek USB drive-like design — to market vaping to American children and teens.

More than 2 million US middle and high school students used e-cigarettes in 2021 — with 8 in 10 students reporting using flavored e-cigarettes, according to the FDA.

The 2020 National Youth Smoking Survey found Juul was the most popular e-cigarette brand used by teens, 25.4% of high school e-cigarette users and 35.1% of college users stating that Juul was their most used brand.

Exposure to nicotine from e-cigarettes can impair brain development in teens and young adults, which can continue into their mid-twenties, according to the Centers for Disease Control and Prevention.

A single Juul pod contains as much nicotine as a pack of 20 traditional cigarettes, the manufacturer said.

The CDC also states that e-cigarettes may contain heavy metals and carcinogenic chemicals that can damage the lungs.

The American Heart Association applauded the decision, saying in a statement: “We call on Juul to immediately comply with the FDA order so that these products no longer pose a threat to public health, and we urge the FDA to take action. swift and severe enforcement if the company defies the order.”

FDA orders Juul e-cigarettes and vaping products to be removed from US market

A JUUL device is held by a detective from the local police department’s School Resource Unit, May 3, 2018, during a town hall meeting in Arlington, Virginia.

Washington Post via Getty Images, FILE

Juul did not respond to ABC News’ request for comment.

Shares of tobacco major Altria Group, which owns a 35% stake in Juul, fell 9% on Wednesday morning after the Wall Street Journal reported an FDA decision was imminent.

Parent company Pax launched the Juul e-cigarette in 2015. After initial sales success, Juul spun off from Pax as a separate company in 2017.

In 2018, when Altria acquired its stake in Juul, the e-cigarette company accounted for 75% of the tobacco vaping market, according to a Wells Fargo analysis of Nielsen data. By 2021, Juul’s market share had fallen below 50%, The New York Times reported.

FDA orders Juul e-cigarettes and vaping products to be removed from US market

Packages of Juul electronic cigarettes are displayed in a store, November 7, 2019, in San Rafael, California.

Justin Sullivan/Getty Images, FILE

Juul CEO Kevin Burns resigned in 2019 as the company came under scrutiny over the health effects and addictive nature of its products. He was replaced by longtime tobacco executive KC Crosthwaite, who currently runs the company.

In 2009, Congress gave the FDA authority to regulate the manufacture, distribution, and marketing of tobacco products.

E-cigarette makers, including Juul, were required to submit their products to the FDA for review by September 2020, but were able to sell products while FDA review was ongoing.

ABC News’ Anne Flaherty contributed to this report.

ABC News

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