The U.S. Food and Drug Administration (FDA) has denied premarket tobacco product applications (PMTAs) for four Blu electronic cigarette products and one menthol-flavored myblu pod. This comes after the agency rejected applications for Blu’s entire blu PLUS+ product line in January.
The latest products to receive marketing denial orders (MDOs) are:
- blu Disposable Menthol 2.4%
- blu Disposable Vanilla 2.4%
- blu Disposable Polar Mint 2.4%
- blu Disposable Cherry 2.4%
- myblu Menthol 1.2% pod
According to the FDA, Blu did not provide enough evidence showing the potential public health impact of these products. Specifically, there was insufficient data on harmful ingredients in the aerosol for one product and battery safety issues for several products. Blu also failed to demonstrate that the benefits of adults completely switching or substantially reducing cigarette use would outweigh potential youth initiation risks.
With this latest decision, Blu’s entire disposable e-cigarette line has now been denied except for the Classic Tobacco flavor. The disposable products are small, cigarette-shaped vaping devices. Additionally, the myblu menthol pod was the last myblu product awaiting FDA review.
Since July 2022 when FDA Center for Tobacco Products Director Dr. Brian King took office, no vaping products have been authorized for marketing by the agency. Blu will likely appeal the new MDOs. Overall, the stringent FDA review process has resulted in only seven authorized vaping products to date – all made by major tobacco companies.
