• On August 19, 2025, the FDA issued a Marketing Denial Order (MDO) for blu Disposable Classic Tobacco 2.4% by Fontem US, LLC—prohibiting its marketing or sale in the U.S. unless a new PMTA is approved.
• FDA found insufficient evidence that adults who smoke would completely switch or significantly reduce cigarette use; instead, the product risked promoting dual use, which can increase toxicant exposure.
• FDA emphasized that only 39 e‑cigarette products have been authorized to date—those demonstrating clear public health benefits—and stressed that not all e‑cigarettes are equal.

The U.S. Food and Drug Administration has issued a marketing denial order (MDO) for blu Disposable Classic Tobacco 2.4%, manufactured by Fontem US, LLC. The MDO prevents the company from selling or distributing the product in the United States.

The decision, announced on August 19, follows the agency’s review of Fontem’s premarket tobacco product application (PMTA), which the FDA determined did not provide sufficient evidence to show that the product would be appropriate for the protection of public health.

“While FDA-authorized e-cigarettes are a lower-risk alternative for adults who smoke cigarettes – especially if they completely switch – not all e-cigarettes are equal,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products. “FDA’s rigorous scientific review ensures authorized e-cigarettes provide a net benefit to public health.

“In this case, the company did not provide sufficient evidence of a benefit that outweighs the risk, particularly given evidence that adults who smoke generally do not stop or significantly curtail consumption of cigarettes when using this product.”

The agency noted that Fontem, a subsidiary of Imperial Brands, failed to demonstrate that smokers would completely switch to blu or substantially cut back on cigarettes. Instead, the evidence suggested that consumers were likely to use the product in addition to cigarettes.

Such dual use, according to the FDA, can lead to similar or even greater health risks than smoking alone due to prolonged exposure to toxicants.

Under federal law, products receiving an MDO may not be introduced into interstate commerce and must be removed from the market. Manufacturers, distributors, and retailers selling the denied product face potential enforcement action.

Fontem can submit a new application with additional evidence if it seeks reconsideration.

The FDA emphasized that this denial is part of its broader mandate to ensure all new tobacco products undergo rigorous, science-based review before being sold. To date, the agency has authorized just 39 e-cigarette products and devices, which remain the only vapor products legally allowed for sale in the United States.