The FDA announced that its ban on Juul Labs’ products would be lifted while the e-cigarette maker appealed the agency's decision, allowing its ENDS products to return to store shelves.
A bit of background is necessary to
shed light on the ban itself. In August of 2016, the FDA’s Deeming Rule took effect, which applied many of the regulatory and statutory requirements that had been in place for manufacturers of cigarettes and tobacco to electronic nicotine delivery systems (ENDS) product manufacturers.
Prior to the deeming rule, vape and other ENDS products were virtually unregulated on a federal level. The Deeming rule subjects ENDS products to the Tobacco Control Act, including the requirement that a new tobacco product receive premarket authorization from the FDA prior to marketing. The FDA issued a compliance policy allowing manufacturers of existing ENDS products until September 9, 2020, to submit the necessary application for FDA review. Pursuant to the Tobacco Control Act, only ENDS products deemed "appropriate for the protection of public health" may be authorized by the FDA.
Last month, in response to Juul Labs’ applications, the FDA issued marketing denial orders (MDOs) for all of JUUL Labs products currently marketed in the U.S, citing a lack of sufficient evidence that they were safe. In short, the company was ordered to cease selling and distributing these products and remove those products currently on the market.
The next day, a federal appeals court granted Juul Labs a temporary stay of the order, and Juul filed to extend the stay during the appeal process. Juul had prior requested that the FDA stay its own order pending the appeal, which the FDA originally denied.
However, The FDA announced yesterday that its MDO on Juul Labs Inc. products would be lifted while the ENDS maker appealed the agency's decision. According to the agency, it had “determined that there are scientific issues unique to the JUUL application that warrant additional review." The administrative stay suspends the order temporarily during the additional review but does not rescind it.
The FDA has approved ENDS products from some of Juul's main competitors, such as NJOY Holdings Inc., and many industry participants expect that Juul will receive similar approval.