The U.S. Food and Drug Administration (FDA) this week issued a marketing denial order (MDO) for blu Disposable Classic Tobacco 2.4%, an e-cigarette product manufactured by Fontem US, LLC., per a press release.

The company must not market or distribute the product in the United States, but may submit a new application for the product subject to this MDO, the FDA said.

FDA said it has previously approved e-cigarettes that show evidence that adults who smoke will completely switch to those products or significantly reduce their cigarette consumption, and said the blu application did not meet this standard for approval. 

“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 Acting Director of the FDA’s Center for Tobacco Products Bret Koplow, Ph.D., J.D. “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. FDA posts information about MDOs on the Tobacco Products Marketing Orders webpage.