FDA issued five marketing denial orders to Fontem US LLC for four blu disposable and one myblu brand e-cigarette products. Due to the MDOs, the company must not market or distribute these products in the United States.
The currently marketed products that received an MDO 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%
In its statement, the agency said that the applications lacked sufficient evidence for the protection of public health, specifically “evidence regarding harmful and potentially harmful ingredients in the aerosol for one product and battery safety for several products.”
According to the 2023 National Youth Tobacco Survey, among youth who currently used e-cigarettes, 6% reported using blu brand e-cigarettes.
At the end of January, FDA issued an MDO to Bidi Vapor LLC for its Bidi Stick—classic e-cigarette, a closed-system, disposable, tobacco-flavored e-cigarette device. Following the decision, Bidi Vapor LLC and its partner Kaival Brands Innovations Group Inc. announced that the companies will appeal the FDA’s decision to deny Bidi Vapor’s premarket tobacco product application (PMTA) for Bidi Vapor’s classic tobacco-flavored Bidi Stick ENDS device.
Additionally, the FDA announced that it issued complaints for civil money penalties (CMPs) against 21 brick-and-mortar stores for the sale of unauthorized Esco Bar e-cigarettes. The FDA stated that it previously issued each retailer a warning letter for their sale of unauthorized tobacco products, and that follow-up inspections showed that the retailers had failed to comply.
The FDA is now seeking the maximum penalty amount of $20,678 from each retailer.