FDA Rejects PMTAs: 5 More Blu Products Banned

Applications for Blu's PLUS+ range of cartridge-based e-cigarettes were also turned down by the government in January.

The following items were issued marketing denial orders (MDOs):
• 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%

The premarket tobacco applications (PMTAs) submitted by Blu for the menthol myblu pod and the four blu Disposables "lacked sufficient evidence regarding harmful as well as potentially harmful chemicals in the aerosol for a single item and battery safety for several products," according to a news statement from the FDA. Furthermore, the applicant failed to provide enough evidence to support the claim that the new products' ability to help adult smokers completely quit or significantly reduce their cigarette usage would exceed the danger to children.

With the exception of the Classic Tobacco-flavored device, which is still under FDA approval, the FDA's decision removes the entire blu Disposable range. The blu Disposables are vapes that resemble cigarettes and are compact, low-powered devices.

"No electronic cigarettes have been authorized after current FDA Center for Tobacco Products Director Brian King took over in July 2022."

The latest Myblu product to be examined by the FDA and earn an MDO is the menthol Myblu pod that was refused yesterday. But after the District of Columbia Circuit Court of Appeals rejected the FDA's appeal, the agency is carrying out a second round of court-ordered evaluations on the myblu device plus tobacco-flavored refill pods (which obtained MDOs in 2022 ).

Fontem US, LLC, the owner of Blu, is probably going to contest the new MDOs in court as well. MDOs have been challenged by a number of vape producers in federal courts throughout the US.

The FDA has only approved seven vaping devices and tobacco-flavored refills since granting itself regulatory control over vaping items in 2016. Since Brian King, the current director of the FDA Center for Tobacco Products, took office in July 2022, no vaping products have been approved.

Big Tobacco subsidiaries manufacture all items approved by the FDA; no bottled e-liquid, no open-system (refillable) devices, and no vaping products in flavors other than tobacco are permitted.