[2Firsts, August 22, 2025] — On August 20, 2025, the U.S. Food and Drug Administration (FDA) issued a Marketing Denial Order (MDO) for blu® Disposable Classic Tobacco 2.4%. The FDA stated that the application did not provide sufficient evidence to demonstrate that the product enables adult smokers to fully switch from or significantly reduce cigarette consumption. Imperial Brands later responded to 2Firsts through its U.S. subsidiary ITG Brands.
This denial stands in contrast to research results previously presented by Imperial Brands to the media. The company had stated that blu use helped some adult smokers—who initially had no intention to quit—reduce or even stop smoking altogether.
When contacted by 2Firsts for further comment, Lucas Seiler, Director of Communications for ITG Brands, provided the following written statement:
“We are disappointed that the FDA has issued a denial for our blu tobacco disposable product, despite our continued engagement and scientific investment. We believe our application demonstrates that our product is appropriate for the protection of public health, and we are evaluating all available options to ensure our products receive a fair and science-based review. As always, we remain committed to complying with all applicable regulations.”
The MDO has once again brought attention to the role of “behavioral science evidence” in the U.S. premarket tobacco application (PMTA) process. According to the FDA, blu’s application did not sufficiently demonstrate complete switching or meaningful reduction in cigarette use. The agency also raised concerns that long-term dual use may increase toxicant exposure.
2Firsts will continue to monitor developments in this case.
