FDA Rejects PMTAs for Five More Blu Products

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The FDA has denied marketing applications for four Blu e-cigarettes and a menthol-flavored refill pod for the company’s myblu device. In January, the agency also rejected applications for Blu’s entire blu PLUS+ line of cartridge-based e-cigarettes.

The products receiving marketing denial orders (MDOs) yesterday were:

• 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 FDA said in a press release that Blu’s premarket tobacco applications (PMTAs) for the four blu Disposables and the menthol myblu pod “lacked sufficient evidence regarding harmful and potentially harmful ingredients in the aerosol for one product and battery safety for several products. Additionally, the applicant did not present sufficient data demonstrating that the new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth.”

The FDA decision eliminates the entire blu Disposable line except the Classic Tobacco-flavored device, which remains under FDA review. The blu Disposables are “cigalikes”—small, low-powered, cigarette-shaped vapes.

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

The menthol myblu pod denied yesterday is the last myblu product to be reviewed by the FDA and receive an MDO. However, the agency is conducting a second round of court-ordered reviews on the myblu device and tobacco-flavored refill pods (which received MDOs in 2022), after the the District of Columbia Circuit Court of Appeals ruled against the FDA on appeal.

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

Since the FDA granted itself regulatory authority over vaping products in 2016, the agency has authorized just seven vaping devices, along with tobacco-flavored refills. No vaping products have been authorized since current FDA Center for Tobacco Products Director Brian King was appointed to the job in July 2022.

All FDA-authorized products are made by Big Tobacco subsidiaries, and the agency has authorized no vaping products in non-tobacco flavors (including menthol), no open-system (refillable) products, and no bottled e-liquid.

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