US FDA Rejects Imperial Tobacco’s blu 2.4% E-Cigarette Application, Citing Failure to Prove Health Benefits Outweigh Risks

Key Points:

• Ban Decision: FDA issued an MDO against Imperial Tobacco’s blu Disposable 2.4% Classic Tobacco e-cigarette, prohibiting sales and distribution in the US.
• Core Reason: FDA concluded that the application lacked sufficient scientific evidence to demonstrate that the product’s public health benefits outweigh its risks.
• Health Concerns: Evidence showed users may continue smoking while using the product (“dual use”), leading to exposure to harmful substances at levels comparable to or greater than smoking alone.
• Regulatory Context: Under the Family Smoking Prevention and Tobacco Control Act, all e-cigarette products must undergo FDA review and receive authorization before legal sale. To date, 39 e-cigarette products and devices have been authorized, excluding blu.
• Next Steps: blu may submit a new application for marketing authorization. Until approval is granted, the product cannot be sold in the US, and manufacturers, distributors, and retailers risk enforcement actions for violations.

According to an FDA announcement on August 19, the agency has issued an MDO for the blu® Disposable Classic Tobacco 2.4%, produced by Imperial Tobacco subsidiary Fontem US, LLC. This means the company is still prohibited from selling or distributing the product in the US market unless a new application is submitted and authorized.

The FDA evaluates Premarket Tobacco Product Applications (PMTAs) based on a public health standard, which considers the risks and benefits of a product to the entire population. After reviewing the company’s PMTA, the FDA determined that the application lacked sufficient evidence to demonstrate that authorizing this product would meet the requirement of protecting public health — the statutory standard set by the 2009 Family Smoking Prevention and Tobacco Control Act.

The company failed to provide adequate evidence showing that smokers would completely switch to this new product or significantly reduce their cigarette consumption. On the contrary, the evidence in the application suggested that people were more likely to use the product while continuing to smoke cigarettes. This could potentially expose them to higher levels of toxic substances than smoking cigarettes alone. In general, long-term concurrent use of e-cigarettes and cigarettes — commonly referred to as “dual use” — may pose health risks comparable to, or even greater than, smoking cigarettes alone.

In contrast, the FDA has authorized certain e-cigarettes currently available on the market because evidence shows that smokers either completely switch to these products or significantly reduce their cigarette use, with the potential for lower overall harm.

Dr. Bret Koplow, Acting Director of the FDA’s Center for Tobacco Products, stated:

“While FDA-authorized e-cigarettes are a less harmful alternative for smokers — especially when they completely switch — not all e-cigarettes are the same. FDA’s rigorous scientific review ensures that authorized e-cigarettes provide a net benefit to public health. In this case, the company did not provide sufficient evidence to show that the benefits of its product outweigh the risks, particularly since the evidence indicates that smokers typically do not quit or significantly reduce cigarette use while using this product.”

The FDA emphasized that tobacco products subject to a Marketing Denial Order (MDO) 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 such products in interstate commerce are in violation of the law and will face enforcement actions. Information about MDOs is published on FDA’s Tobacco Product Marketing Orders webpage.

According to the FDA, the August 19 action is part of the agency’s ongoing effort to ensure that all new tobacco products sold in the U.S. undergo scientific review and receive marketing authorization. To date, the FDA has authorized 39 e-cigarette products and devices; these are the only e-cigarettes legally permitted to be sold and distributed in the United States. For a searchable list of tobacco products that can be legally sold and distributed in the U.S., please visit the FDA’s “Searchable Tobacco Products Database.”