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Marketing Denial Order issued for Vuse Solo Menthol 4.8%

PRESS RELEASE

17 MARCH 2023

Marketing Denial Order issued for Vuse Solo Menthol 4.8%

Today, U.S. Food and Drug Administration (“FDA”) has issued a Marketing Denial Order (“MDO”) for Vuse Solo’s 4.8% Menthol product.

FDA determined that the application lacked sufficient evidence to demonstrate that permitting the marketing of the product would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

A BAT spokesperson said:

“We are disappointed in FDA’s decision to issue an MDO for Vuse Solo’s 4.8% Menthol product. Reynolds intends to seek a stay of enforcement immediately and will pursue other appropriate avenues to allow Vuse to continue offering its innovative products to adult nicotine consumers age 21+ without interruption.

“We believe that menthol vapour products are critical to helping adult smokers migrate away from combustible cigarettes. FDA’s decision, if allowed to go into effect, will harm, not benefit, public health. Reynolds will challenge the denials.

“We remain confident in the quality of all of Reynolds’ applications, and we believe that there is ample evidence for FDA to determine that the marketing of these products is appropriate for the protection of public health.”

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