Ban on controversial product is reversed in shock move by FDA

The US Food and Drug Administration said on Thursday it would reverse a 2022 order that briefly blocked sale of Juul's products, including its e-cigarettes.

The latest move comes a few months after Juul sought an FDA authorization for new menthol-flavored pods meant to be used with its e-cigarettes device, which was under the agency's review. 

The FDA had banned Juul's four varieties of tobacco and menthol-flavored pods and the e-cigarette device after it concluded that the company failed to provide 'sufficient evidence' they were safe. It also raised concerns over potentially hazardous liquid in the products.

The ban was stayed a month after it was issued as a result of an appeal by the company.

The FDA said rescission of orders that prevent marketing of the products is not an authorization or a denial of Juul's marketing application. The revocation only returns company's applications to a pending and under-review status.

The marketing denial orders issued by the FDA have faced multiple challenges in different US states by the e-cigarette makers. 

'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 vapes in August 2016. So far, 23 e-cigarette products have been authorized by it for sale in the United States.

The FDA said 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 in place 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 cross-hairs of the FDA amid allegations it has led to a spike in e-cigarette use among youngsters and is a gateway for people to start smoking.

But manufacturers claim that their products are much safer than cigarettes because they do not have the toxic smoke and can help people kick the habit.

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

The agreement with New York, California, Colorado, Illinois, Massachusetts, New Mexico and Washington, D.C. came amid a string 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 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 barred from any direct or indirect marketing that targets youth, which includes anyone under age 35. Juul would also limit the amount of purchases customers can make in retail stores and online.

Juul rocketed 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 hooked on Juul’s high-nicotine pods.