The U.S. Food and Drug Administration (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 company must not market or distribute these products in the United States or it risks FDA enforcement action, the agency said. Included in the MDOs is a requirement for retailers to remove the products that are subject to the MDOs from store shelves.
According to a statement from the agency, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.
The two denied Sourin products are an e-cigarette device, Suorin Air-Refillable E-Cigarette (various colors), and an empty refillable cartridge, Suorin Air-Empty Cartridge, that would allow a consumer to fill the cartridge with an e-liquid purchased separately. The agency said applications submitted by Shenzhen Youme Information Technology Co. Ltd. lacked sufficient evidence regarding abuse liability, which is the ability of a tobacco product to promote continued use and the development of addiction and dependence.
The FDA announced MDOs on eight blu Plus+ products, stating that Fontem US LLC failed to include sufficient ingredient information, harmful and potentially harmful constituent (HPHC) yield quantities and abuse liability information.
The denied blu Plus+ products include a battery and several prefilled e-liquids:
- blu Plus+ Battery
- blu Plus+ Carolina Bold 2.0%
- blu Plus+ Classic Tobacco 1.2%
- blu Plus+ Classic Tobacco 2.4%
- blu Plus+ Gold Leaf 1.2%
- blu Plus+ Gold Leaf 2.4%
- blu Plus+ Menthol 1.2%
- blu Plus+ Menthol 2.4%
The agency stated that it is also issuing MDOs for additional blu PLUS+ products not listed above. However, FDA has only publicly named products that FDA or the manufacturer have confirmed to be currently marketed to avoid the release of confidential commercial information.