The Food and Drug Administration (FDA) issued marketing denial orders (MDOs) for four blu disposable and one myblu brand e-cigarette products from Fontem U.S., which sells blu e-cigarettes.
The company must not sell or distribute these products in the United States or it risks FDA enforcement action, but the company can submit new applications for these products, the agency said Monday.
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%
After reviewing the premarket tobacco product applications (PMTAs) for the menthol products, the FDA determined they lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, the standard used to judge applications required by the 2009 Family Smoking Prevention and Tobacco Control Act.
The application from Fontem U.S. failed to include sufficient evidence regarding “harmful and potentially harmful ingredients in the aerosol for one product and battery safety for several products,” the FDA said.
According to data from the 2023 National Youth Tobacco Survey, 6% of youth who use e-cigarettes reported using blu brand e-cigarettes.
Last month the FDA announced it has extended its review of PMTAs to the end of June. According to a recent status report, provided by the National Association of Tobacco Outlets (NATO), the FDA expects to have acted on 94% of covered applications by March 31.
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