01/24/2024

News from FDA

Court decision and FDA MDOs

Court grants permanent stay of enforcement on marketing denial order for Vuse products
Vuse Alto, Vibe and Solo Menthol Pods continue to remain available for sale

The U.S. Court of Appeals (5th Circuit) granted R.J. Reynolds Vapor Company (RJRV) a permanent stay of enforcement on the FDA’s PMTA Marketing Denial Order (MDO) on Vuse Alto, Vibe and Solo Menthol Pods. As a result of this court action, these products will continue to be allowed on the market for sale.

The permanent stay follows the Court’s most recent October 2023 emergency stay ruling in immediate response to the FDA’s announcement issuing an MDO for VUSE Alto menthol pods in varying nicotine strengths.

The Court also denied FDA’s motion to transfer the case to another circuit. This means the 5th Circuit will decide on the merits of the case, which will likely take a significant amount of time.

FDA denies marketing applications for flavored blu e-cigarette products

On Feb. 5, FDA issued marketing denial orders (MDOs) to Fontem US LLC., for four blu Disposable and one myblu brand e-cigarette products. The denied products include a closed menthol e-liquid and several flavored disposable e-cigarettes. As a result, the company must not market or distribute these products in the United States or they risk FDA enforcement action. However, the company may submit new applications for the products that are subject to these MDOs. 

Read more here.

FDA denies marketing of Bidi e-cigarette product

On Jan. 22, FDA issued a marketing denial order (MDO) to Bidi Vapor LLC for its Bidi Stick – Classic e-cigarette. This product is a closed-system, disposable, tobacco-flavored e-cigarette device. The company must not market or distribute this product in the United States or they risk FDA enforcement action. The company may submit a new application to the agency for review that addresses these deficiencies.  Read more here. 

FDA denies marketing of Suorin and blu PLUS+ e-cigarette products

On Jan. 19, FDA issued marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products and to Fontem US, LLC for their blu PLUS+ brand e-cigarette products. The companies must not market or distribute these products in the United States or they risk FDA enforcement action. The companies may submit new applications for the products that are subject to these MDOs.  Read more here.