FDA Denies Marketing for Blu Tobacco-Flavored Disposable Vape
The U.S. Food and Drug Administration (FDA) has denied marketing rights for the Blu disposable classic tobacco-flavored 2.4% nicotine e-cigarette, according to a recent agency announcement. The product, produced by Fontem US, cannot be legally marketed in the United States.
The FDA stated that the company’s application did not provide sufficient evidence to demonstrate that allowing the product on the market would be appropriate for the protection of public health. Specifically, the agency was not convinced that adult smokers would completely switch from combustible cigarettes to the Blu device. Instead, the FDA concluded that smokers were more likely to use both products (dual use), which could lead to additional health problems beyond those associated with smoking alone.
Bret Koplow, acting director of the FDA’s Center for Tobacco Products, emphasized that while authorized e-cigarettes can be a lower-risk alternative for adult smokers, “not all e-cigarettes are equal.” This decision adds to the very limited number of vaping products – only 39 – that have successfully received marketing authorization in the U.S.
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