The FDA has ordered Juul Labs to stop selling e-cigarettes and vaping products on the U.S. market, the agency announced on Thursday.
The marketing denial order covers all the company's products in the U.S., which means Juul must stop distributing the products and remove everything on the market. That includes the Juul device and flavor replacement pods in the tobacco and menthol flavors.
"Today's action is further progress on the FDA's commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards," Robert Califf, MD, the FDA commissioner, said in the announcement.
"The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market," he said. "We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping."
The marketing denial order only covers the commercial distribution and retail sale of Juul's products and doesn't restrict consumer possession or use. The FDA "cannot and will not" enforce actions against consumers, the agency said.
The order comes after a 2-year review of the company's application seeking authorization to continue selling non-fruit-flavored products, such as menthol and tobacco. The FDA determined the application "lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health."
Some of Juul's study findings raised concerns due to "insufficient and conflicting data," the FDA said, including potentially harmful chemicals leaching from the Juul liquid replacement pods.
"To date, the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUUL pods," the agency said. "However, the [orders] issued today reflect FDA's determination that there is insufficient evidence to assess the potential toxicological risks of using the JUUL products."
Juul is expected to appeal the FDA's decision, according to The New York Times .
In recent years, the FDA has reviewed marketing applications from Juul and other e-cigarette companies as anti-tobacco groups have called for new rules to limit products that led to a surge in youth vaping during the past decade. At the same time, advocates of e-cigarettes and nicotine-delivery devices have said the products help adult smokers to quit cigarettes and other tobacco products.
Juul, in particular, has been blamed for fueling the surge in underage vaping due to fruity flavors and hip marketing, according to The Wall Street Journal . The company removed sweet and fruity flavors from shelves in 2019 and has been trying to repair its reputation by limiting its marketing and focusing on adult cigarette smokers.
In 2020, all e-cigarette manufacturers in the U.S. were required to submit their products for FDA review to stay on the market, the newspaper reported. The agency has been weighing the potential benefits for adult cigarette smokers against the harms for young people.
The FDA banned the sale of fruit- and mint-flavored cartridges and juice pods in 2020, but menthol and tobacco-flavored products were left on the market, according to USA Today . In September 2021, the agency also banned the sale of hundreds of thousands of vaping and e-cigarette products but didn't rule on Juul.
Meanwhile, the FDA has cleared Reynolds American Inc. and NJOY Holdings Inc. — two of Juul's biggest rivals — to keep tobacco-flavored products on the market. Industry experts expected Juul to receive similar clearance, the Journal reported.
Juul, which was at the top of the U.S. e-cigarette market in 2018, has moved to second place behind Reynolds's Vuse brand, the newspaper reported. The U.S. represents most of the company's revenue, though its products are also available in Canada, the U.K., France, Italy, and the Philippines.
Underage vaping has fallen in the U.S. since federal restrictions raised the legal purchase age for tobacco products to 21 and banned the sale of sweet and fruity cartridges, according to the Journal. Juul's popularity has also dropped among youth, with other products such as Puff Bar, Vuse and Smok becoming more popular among e-cigarette users in high school.
In a separate decision announced this week, the FDA is also moving forward with a plan to reduce the amount of nicotine in cigarettes. The decision, which has been years in the making, is aimed at prompting millions of cigarette users to quit smoking or switch to alternatives such as e-cigarettes, as well as limiting the number of users who pick up smoking at an early age.
FDA: "FDA Denies Authorization to Market JUUL Products."
The New York Times: "FDA Orders Juul to Stop Selling E-Cigarettes."
The Wall Street Journal: "FDA to order Juul E-Cigarettes Off U.S. Market."
USA Today: "Report: Federal ban on popular Juul products forthcoming amid youth vaping concerns."
WebMD: "Biden Moves to Limit Nicotine Levels in Cigarettes."
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Cite this: FDA Orders Juul to Stop Selling E-Cigarettes - Medscape - Jun 23, 2022.