The Food and Drug Administration has issued a marketing denial order (MDO) for Fontem US's Blu disposable classic tobacco-flavored 2.4% nicotine e-cigarette, marking another setback in the agency's rigorous review process for tobacco harm reduction products.
Insufficient Evidence for Complete Switching
The FDA's decision, announced on August 19, centered on the company's failure to demonstrate that adult smokers would completely transition to the Blu product or significantly reduce their cigarette consumption. According to the agency's analysis, the application's evidence suggested users would likely employ the device alongside traditional cigarettes rather than as a replacement.
"The company did not provide sufficient evidence that adults who smoke will completely switch to the new product or significantly reduce their cigarette consumption," the FDA stated. "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."
Regulatory Standards for E-Cigarette Authorization
The FDA has established stringent criteria for e-cigarette marketing authorization, requiring clear evidence of public health benefits. To date, the agency has authorized products only when manufacturers demonstrate that adult smokers will completely switch to the e-cigarette or significantly reduce their cigarette consumption while showing the products are potentially less harmful.
Bret Koplow, acting director of the FDA's Center for Tobacco Products, emphasized the agency's scientific approach: "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."
Limited Market Approvals
The rejection of Blu's application reflects the challenging regulatory landscape for e-cigarette manufacturers. Fewer than 30 vaping products have successfully obtained FDA marketing approval in the United States. Currently, only four brands have received authorization: Juul, Altria's Njoy, Reynolds American's Vuse, and Japan Tobacco's Logic.
Enforcement Implications
Under the MDO, the Blu disposable e-cigarette cannot be introduced into interstate commerce and must be removed from the market. The FDA warned that manufacturers, distributors, and retailers who continue to sell or distribute the product in interstate commerce are violating federal law and face potential enforcement action.
Koplow reinforced the agency's position on the specific denial: "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 FDA maintains information about marketing denial orders on its Tobacco Products Marketing Orders webpage, providing transparency in its regulatory decisions for tobacco harm reduction products.
