FDA Rescinds JUUL Marketing Denial Orders


The FDA announced it is rescinding the Marketing Denial Orders (MDO) that were issued in June 2022 for JUUL device and JUUL pods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%. As a result, these products’ PMTA application status is now pending, and they remain available on the U.S. market during this review (note: this is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied). Click here for the announcement.