For the first time, the US FDA authorized four menthol e-cigarette products to pass the PMTA.

On June 21, the U.S. Food and Drug Administration (FDA) approved four NJOY products through the Premarket Tobacco Product Application (PMTA) path. The FDA issued a marketing authorization order to NJOY, a subsidiary of Altria, including two cartridges for use in its Ace closed e-cigarette device (approved in April 2022) and two disposable e-cigarettes-NJOY DAILY Menthol 4.5% and NJOY DAILY EXTRA Menthol 2.4%.
The two authorized ACE cartridges are NJOY ACE cartridges 2.4% menthol and NJOY ACE cartridges 5% menthol.
The decision is significant because it is the first time that the FDA has authorized mint-flavored e-cigarette products to pass the PMTA. However, the FDA pointed out that applications are reviewed on a case-by-case basis and that authorization for this menthol product does not apply to any other mint-flavored e-cigarette products.
The FDA previously approved NJOY Ace and its three tobacco-flavored cigarettes on April 27, 2022. In March 2023, Altria acquired NJOY for US$2.75 billion in cash. The acquisition will be completed on June 1, 2023. However, the terms of the deal include an additional cash payment of $500 million, subject to product approvals obtained today, which would bring Altria’s total expenses to $3.25 billion.