FDA Denies PMTAs for Suorin, Blu Plus E-Cigarette Products

Agency says products must not be marketed, distributed in U.S.
Photograph: Shutterstock

Retailers must remove certain Suorin and blu Plus e-cigarette products from shelves following an announcement from the Food and Drug Administration.

The FDA on Friday issued marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products and to Fontem U.S. LLC for its blu Plus+ brand of e-cigarette products. The companies must not market or distribute these products in the United States or they risk FDA enforcement action, the agency said.

“Thorough scientific review of tobacco products applications is a key pillar of FDA’s comprehensive regulatory approach,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “It is the applicant’s responsibility to ensure that sufficient scientific evidence is included in an application to meet the necessary public health standard required by law. In these cases, such evidence was lacking.”

The denied Suorin products are an e-cigarette device, Suorin Air – Refillable E-Cigarette (in various colors) and Suorin Air – Empty Cartridge, which would allow a consumer to fill the cartridge with an e-liquid purchased separately, the FDA said. The premarket tobacco product applications (PMTAs) submitted for these products 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 said.

The denied blu Plus products include a batter 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%

Fontem U.S. failed to include sufficient ingredient information, harmful and potentially harmful constituent yield quantities and abuse liability information, among other deficiencies in their applications, the FDA said. The FDA also issued MDOs for additional blu Plus products not listed above. The FDA only publicly names products that the FDA or the manufacturer have confirmed to be currently marketed.

ITG Brands is the U.S. affiliate of Fontem U.S., which sells blu e-cigarettes. ITG Brands and Suorin could not immediately be reached by CSPDaily News for comment.

Since 2020, the FDA has received applications for more than 26 million deemed tobacco products and has made determinations on 99% of those applications. To date, the agency has authorized 23 e-cigarette devices and tobacco-flavored e-cigarette products.

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