FDA Denies Marketing for blu Disposable E-Cigarette

August 19, 2025

Today, the U.S. Food and Drug Administration (FDA) issued a marketing denial order (MDO) for blu® Disposable Classic Tobacco 2.4%, an e-cigarette product manufactured by Fontem US, LLC. This means the company still must not market or distribute this product in the United States, or they risk enforcement action by FDA. The company may submit a new application for the product subject to this MDO.

FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product to the population as a whole. After reviewing the company’s PMTA, FDA determined that the application lacked sufficient evidence to demonstrate that permitting marketing of the product would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

The company did not provide sufficient evidence that adults who smoke will completely switch to the new product or significantly reduce their cigarette consumption. Instead, the application’s evidence suggests that people will likely use this product in addition to cigarettes, potentially exposing them to higher levels of toxicants than exclusive cigarette use. In general, long periods of using both e-cigarettes and cigarettes – often referred to as “dual use” – can result in harms to health similar to, or in addition to, the harms from exclusive use of cigarettes.

Additionally, FDA has authorized e-cigarettes currently on the market that had evidence that adults who smoke will completely switch to those products or significantly reduce their cigarette consumption and are potentially less harmful.

“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. FDA’s rigorous scientific review ensures authorized e-cigarettes provide a net benefit to public health,” said Bret Koplow, Ph.D., J.D., Acting Director of the FDA’s Center for Tobacco Products. “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.”

Tobacco products that receive an MDO from the FDA may not be introduced or delivered for introduction into interstate commerce and must be removed from the market. Manufacturers, distributors, and retailers who sell or distribute this product in interstate commerce are violating the law and are at risk of enforcement action. FDA posts information about MDOs on the Tobacco Products Marketing Orders webpage.

Today’s actions are part of FDA’s ongoing efforts to ensure all new tobacco products marketed in the United States undergo science-based review and receive marketing authorization from the agency. To date, FDA has authorized 39 e-cigarette products and devices; these are the only e-cigarette products that can be legally marketed and sold in the United States. To find a list of tobacco products that may be legally marketed and sold in the United States, visit the FDA’s Searchable Tobacco Products Database.