The FDA order affects all of the company’s products on the market.
Photo: Juul Labs
The Food and Drug Administration (FDA) of USA announced this Thursday the withdrawal from the market of the electronic cigarettes from Juul Labs because the company had not addressed certain safety concerns about its products. The marketing denial order (MDO) to Juul Labs applies to all of its products that are currently being marketed in the country.
“As a result, the company must stop selling and distributing these products. Additionally, those currently on the US market must be removed or risk enforcement action,” the agency said in a statement. These products include the Juul device and four types of JuuLpods, which are Virginia tobacco- and menthol-flavored pods with concentrations of nicotine 5.0% and 3.0%. The affected company said it would appeal the FDA’s decision. (You can also read: Latin America trains to better detect monkeypox)
In its ruling, the Administration said Juul had provided insufficient and conflicting data about potentially harmful chemicals that could leak from the company’s proprietary liquid pods. This data gap prevented the drug agency from completing a toxicological analysis full of these capsules. The company’s premarket tobacco product applications (PMTAs) “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing the products would be appropriate for the protection of public health,” the statement said. FDA.
The order issued by the agency only applies to the marketing, importation and sale of the products, and does not affect the consumption or particular possession of the aforementioned electronic cigarettes or capsules. The FDA announced that it will also work with distributors and retailers to comply with the denial order issued by the agency. (You may be interested in: Not going to work due to menstrual cramps: a debate that opens in Colombia?)
This action “is a further advance in the FDA’s commitment to ensure that all currently marketed e-cigarette products and electronic nicotine delivery systems … meet our public health standards,” the commissioner said. of the entity, Robert Califf, in a statement. According to a study published by the United States Centers for Disease Control and Prevention (CDC), 11% of high school graduates in the country used electronic cigarettes in 2021.
In 2019, the FDA said that the Juul company had marketed its vaping products as a less harmful alternative to traditional cigarettes, which was not true. The agency issued a warning to the company, saying it violated federal regulations because it had not received approval to promote and sell its vaping products as a healthier option.
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