U.S. FDA issues marketing denial orders to Suorin and blu PLUS+, restricting sales of some vape prod

  The U.S. FDA has issued marketing denial orders (MDO) to two Suorin electronic cigarette products and several blu PLUS+ electronic cigarette products.

On January 19, the U.S. Food and Drug Administration (FDA) issued MDOs to two Suorin electronic cigarette products from Shenzhen YouMe Information Technology Co. Ltd and multiple blu PLUS+ electronic cigarette products from Imperial Brands' subsidiary Fontem US, LLC. These two companies are prohibited from selling or distributing these products in the U.S. market, or they will face enforcement actions from the FDA. The companies may submit new applications for the products restricted by these MDOs.

Brian King, M.D., Director of the FDA's Center for Tobacco Products (CTP), stated:

"A thorough scientific review of tobacco product applications is a key pillar of the FDA's comprehensive regulatory approach. Applicants are responsible for ensuring that sufficient scientific evidence is included in their applications to meet the necessary public health standards mandated by law. In these cases, such evidence was lacking."

The FDA evaluates premarket tobacco product applications (PMTAs) based on public health standards, which consider the risks and benefits of the products to the entire population. After reviewing these companies' PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that allowing these products to be marketed would benefit public health.

The rejected Suorin products include a refillable electronic cigarette device, the Suorin Air, and a refillable empty pod, which consumers can fill with separately purchased electronic liquid.

The FDA stated that the application submitted by Shenzhen YouMe Information Technology Co. Ltd lacked sufficient evidence regarding the issue of abuse liability, which refers to the potential of tobacco products to promote sustained use and develop addiction and dependence.

According to the 2023 National Youth Tobacco Survey (NYTS), among high school and middle school students who used e-cigarettes in the past 30 days, 3.8% reported using Suorin brand products during that time.

The rejected blu PLUS+ products include a battery and several pre-filled 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%

In addition to other deficiencies in the application, Fontem US, LLC failed to provide sufficient ingredient information, harmful and potentially harmful constituents (HPHC) yield, and abuse liability information.

?Additionally, the applicants did not provide sufficient evidence to demonstrate that the potential benefits of this flavored new product for adult smokers, in terms of completely quitting smoking or significantly reducing cigarette consumption, outweigh the risks to youth.? According to the 2023 New York State survey, among high school and middle school students who used e-cigarettes in the past 30 days, 6.0% reported using blu brand products during that time.

The FDA also issued MDOs for other blu PLUS+ products not listed above. The FDA only publicly discloses the names of products that the FDA or manufacturers confirm are currently on the market to avoid disclosing confidential business information.