乌鸦传媒

In yet another delay in FDA action to regulate electronic cigarettes, the agency it was rescinding its earlier denial of the marketing orders necessary for Juul to keep its vaping products on retail shelves.

The FDA had effectively ordered Juul off the market in June 2022, determining that the company's premarket tobacco product applications didn't show enough evidence that public health would be protected if the e-cigarettes and nicotine pods remained for sale.

At the time, the FDA pointed to "insufficient and conflicting data -- including regarding genotoxicity and potentially harmful chemicals leaching from the company's proprietary e-liquid pods -- that have not been adequately addressed."

Then in July 2022, the agency instituted an administrative stay that kept the marketing order denial from taking effect, citing a need for additional review of certain scientific issues.

Now, the FDA has officially taken denial off the table and put Juul's products back into an under-review status, during which they will all be allowed to remain for sale.

The agency hedged about the specifics, in part because its own regulations limit what it can say while applications are pending. However, it said the move came due to gaining "experience with various scientific issues regarding e-cigarette products," review of information from Juul, and because of new litigation outcomes with marketing denial orders for other manufacturers' e-cigarette products.

Last year, the Supreme Court from Avail Vapor challenging FDA's authority to deny approval of flavored e-cigarette products. However, in January, the U.S. Court of Appeals for the Fifth Circuit for rejecting marketing applications by Triton Distribution for its non-tobacco, flavored, open-system e-liquid products, and a .

The FDA said that rescinding Juul's marketing denial order didn't mean that the company's products are now authorized, nor does it indicate whether the applications are likely to be authorized or denied. Rather, it returns the applications to pending status, under substantive review by the FDA.

Juul issued a saying it would re-engage with the agency on the science and evidence, confident that full review would find its e-cigarette device and Virginia Tobacco and menthol pods in 5.0% and 3.0% nicotine concentration in compliance with the statutory standards.

The American Lung Association said in a statement to CNN that it was "deeply troubled" by the latest action by FDA and urged the agency to issue marketing denial orders for all Juul products.

"Juul is largely responsible for the youth e-cigarette epidemic from 2017-2019," said Erika Sward, the association's assistant vice president of nationwide advocacy. "These products and its manufacturer clearly do not meet the standard for protecting the public health. FDA must follow the law and not permit any Juul product or other tobacco product to be sold in the U.S. prior to it receiving a premarket authorization."

Comment