FDA Declines PMTA Applications for Five Additional Blu Products

The FDA rejected marketing applications for four Blu e-cigarettes and a menthol-flavored refill pod for the company's myblu gadget. In January, the government denied applications for Blu's complete blu PLUS+ brand of cartridge-based e-cigarettes.

Yesterday, the following products received marketing denial orders (MDOs):

• bluDisposable Menthol 2.4%
• blu Disposable Vanilla 2.4%
• blu Disposable Polar Mint 2.4%
• Blu Disposable Cherry 2.4%
• Myblu Menthol: 1.2%

The FDA's ruling eliminates the entire blu Disposable line, with the exception of the Classic Tobacco-flavored device, which is still being reviewed. The blu Disposables are "cigalikes"—small, low-powered vapes designed like cigarettes.

No vaping products have been approved since Brian King, the current FDA Center for Tobacco Products Director, was appointed in July 2022.

The menthol myblu pod refused yesterday is the final myblu product to be assessed by the FDA and issued an MDO. However, the FDA is undertaking a second round of court-ordered reviews on the myblu device and tobacco-flavored refill pods (which obtained MDOs in 2022) after the District of Columbia Circuit Court of Appeals decided against the agency on appeal.

Fontem US, LLC, the owner of Blu, is also likely to fight the new MDOs in court. Several dozen vape manufacturers have challenged MDOs in federal courts across the US.

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

All FDA-approved goods are manufactured by Big Tobacco companies, and the agency has approved no vaping products in non-tobacco flavors (including menthol), open-system (refillable) items, or bottled e-liquid.