Today (August 19), the U.S. Food and Drug Administration (FDA) issued a Marketing Denial Order (MDO) for Fontem US, LLC’s blu Disposable Classic Tobacco 2.4% e-cigarette, prohibiting its marketing or sale in the United States. The decision bars the product due to insufficient evidence that it would help adult smokers quit cigarettes—and raises concerns about dual use increasing overall toxicant exposure. FDA emphasized that only e-cigarettes supported by robust evidence showing reduced harm or smoking cessation benefits have been granted market authorization.
“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.”
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. The company may submit a new application for the product subject to this MDO.
Industry observers interpret today’s decision as part of an increasingly stringent FDA posture, where even incumbent market players face rejection unless they clearly demonstrate both consumer and public health benefits. FDA-authorized products to date are limited to those with compelling evidence, and remain largely within tobacco-flavored, closed-system formats
Fontem joins smaller U.S.-based e-cigarette companies ECS Global, Texas Select Vapor, Fumizer, and American Vapor Inc. that received MDOs in the last month.
