On Tuesday, the Food and Drug Administration (FDA) said it issued a marketing denial order for blu Disposable Classic Tobacco 2.4%, an e-cigarette manufactured by Fontem US LLC.
This follows the agency’s decision in February 2024 to issue MDOs for four blu disposable and one myblue brand e-cigarette products.
This means the company cannot sell the product in the United States, or they risk enforcement action by the FDA, the agency said.
After reviewing Fontem US’s premarket tobacco product application (PMTA) for its blu Disposable Classic Tobacco 2.4% device, the FDA determined the application lacked sufficient evidence to demonstrate that permitting marketing of the product would be appropriate for the protection of the public health. This is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
Fontem US did not provide sufficient evidence that adults who smoke will completely switch to the new product or significantly reduce their cigarette consumption, the FDA said. The applicant’s evidence suggested that people will likely use the product in addition to cigarettes, the agency said.
“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,” the FDA’s Center for Tobacco Products Acting Director Bret Koplow said. “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.”
Manufacturers, distributors and retailers, like convenience stores, who sell or distribute this product are at risk of enforcement action, the FDA said.
To date, the FDA has authorized 39 e-cigarette products and devices—and these are the only e-cigarette products that can be legally marketed and sold in the United States, the agency said. To find a list of these products, visit the FDA’s searchable tobacco products database.
CSP could not immediately reach a representative of Fontem US for comment.
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