The U.S. Food and Drug Administration said Thursday it would rescind a 2022 order that briefly blocked the sale of Juul products, including its e-cigarettes.
The latest move comes a few months after Juul requested an FDA clearance for new menthol-flavored capsules intended for use with its e-cigarette device, which was under review by the agency.
The FDA had banned all four varieties of tobacco and Juul’s menthol-flavored pods and e-cigarette device after concluding that the company did not provide “sufficient evidence” that they were safe. He also expressed concern about potentially dangerous liquid in the products.
The ban was suspended a month after it was issued as a result of an appeal by the company.
The FDA said the rescission of orders preventing the products from being marketed is neither an authorization nor a denial of Juul’s marketing application. Revocation only returns the company’s applications to pending and under review status.
The U.S. Food and Drug Administration said Thursday it would rescind a 2022 order that briefly blocked the sale of Juul products, including its e-cigarettes.
The denial of marketing orders issued by the FDA have faced multiple challenges in different US states from e-cigarette manufacturers.
“Some of these court decisions establish new case law and inform the FDA’s approach to product review,” the FDA said.
The agency began regulating e-cigarette devices and vaporizers in August 2016. So far, it has authorized 23 e-cigarette products for sale in the United States.
The FDA said its continued review of Juul’s application does not alter the fact that all e-cigarette products need its authorization to be legally marketed.
There is no rule against owning or using a Juul device.
The FDA ban included JUULpods Virginia Tobacco five percent, Virginia Tobacco three percent, Menthol five percent, and Menthol three percent.
The vaping industry has been caught in the FDA’s crosshairs amid accusations that it has led to a rise in e-cigarette use among youth and is a gateway for people to start smoking.
But manufacturers claim their products are much safer than cigarettes because they don’t contain toxic smoke and can help people kick the habit.
The photo on the left shows their store in Union Square and on the right is a package of Juul e-cigarettes.
Last year, Juul Labs Inc. agreed to pay $462 million to six states and the District of Columbia, marking the company’s largest settlement yet for its role in the rise of youth vaping, they announced. on Wednesday the attorneys general of several states.
The settlement with New York, California, Colorado, Illinois, Massachusetts, New Mexico and Washington, D.C. came amid a series of legal settlements Juul reached to resolve lawsuits related to the way it marketed addictive nicotine products. Critics said Juul was trying to attract children too young to smoke.
Like other agreements reached by Juul, the agreement included restrictions on the marketing and distribution of the company’s vaping products. For example, you are prohibited from any direct or indirect marketing to young people, which includes anyone under 35 years of age. Juul would also limit the number of purchases customers can make in retail stores and online.
Juul shot to the top of the vaping market with the popularity of flavors like mango, mint, and crème brûlée. But the startup’s rise was fueled by use among teenagers, some of whom became addicted to Juul’s high-nicotine pods.
