Ban on controversial product is reversed in shock move by FDA

The U.S. Food and Drug Administration said Thursday it would reverse a 2022 order that briefly blocked sales of Juul’s products, including its e-cigarettes.

The latest move comes a few months after Juul applied for approval from the FDA for new menthol-flavored pods intended for use with its e-cigarette device, which was under the agency’s review.

The FDA had banned Juul’s four types of tobacco- and menthol-flavored pods and its e-cigarette device after concluding that the company had failed to provide “sufficient evidence” that they were safe. Concerns were also raised about potentially hazardous liquids in the products.

The ban was suspended a month after it was issued following an appeal by the company.

The FDA said rescinding orders preventing the products from being marketed is not an authorization or a denial of Juul’s marketing application. The withdrawal means that only the company’s applications will be placed in Pending status and will not yet be reviewed.

The FDA’s marketing denial orders have faced multiple challenges from e-cigarette makers in several US states.

“Some of these court decisions represent new case law and inform FDA’s approach to product review,” the FDA said.

The agency began regulating e-cigarette devices and vapes in August 2016. To date, 23 e-cigarette products have been approved by the agency for sale in the United States.

The FDA said continued review of Juul’s application does not change the fact that all e-cigarette products require approval 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 is in the FDA’s crosshairs amid accusations that it has led to a spike in e-cigarette use among young people and is a gateway for people to start smoking.

But manufacturers claim their products are much safer than cigarettes because they don’t release toxic smoke and can help people kick the habit.

On the left is his store in Union Square, and on the right is a pack of Juul e-cigarettes

Last year, Juul Labs Inc. voted. agreed to pay $462 million to six states and the District of Columbia, marking the largest settlement the company has reached to date for its role in the rise of youth vaping, attorneys general in several states announced announced on Wednesday.

The agreement with New York, California, Colorado, Illinois, Massachusetts, New Mexico and Washington, D.C. followed a series of legal agreements Juul reached to settle lawsuits related to the way it marketed addictive nicotine products. Critics said Juul was trying to lure children who were too young to smoke.

Like some other settlements reached by Juul, the agreement included restrictions on the marketing and distribution of the company’s vaping products. For example, it is excluded from any direct or indirect marketing aimed at young people, including anyone under the age of 35. Juul would also limit the number of purchases customers can make in stores and online.

Juul shot to the top of the vape market with the popularity of flavors like mango, mint and crème brûlée. But the startup’s rise was fueled by use among teens, some of whom became addicted to Juul’s nicotine capsules.