FDA Rejects Marketing Application for Blu Tobacco-Flavored Disposable Vape
The U.S. Food and Drug Administration (FDA) has denied authorization for the sale of Blu’s disposable classic tobacco-flavored e-cigarette containing 2.4% nicotine, produced by Fontem US. As a result, the device can no longer be legally marketed in the United States.
In its decision, the FDA explained that the company failed to demonstrate the product would benefit public health. The agency determined that adult smokers were unlikely to fully transition from combustible cigarettes to the Blu device and instead were more prone to dual use — a pattern that could compound health risks rather than reduce them.
Bret Koplow, acting director of the FDA’s Center for Tobacco Products, noted that although certain authorized e-cigarettes may offer adult smokers a less harmful option, “not all e-cigarettes are equal.” This latest ruling underscores how few vaping products have cleared the FDA’s rigorous review process: only 39 e-cigarettes currently hold marketing authorization in the U.S.
