The Food and Drug Administration (FDA) has issued marketing denial orders (MDOs) for two Suorin brand e-cigarette products, manufactured by Shenzhen Youme Information Technology Co., and PLUS+ brand e-cigarette products, manufactured by Fontem U.S.
The FDA noted that the companies may submit new applications for the products that are subject to these MDOs.
“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. “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 FDA evaluates PMTAs based on a “public health standard that considers the risks and benefits of the product to the population as a whole,” the company noted in a statement.
After reviewing the companies’ PMTAs, the FDA reported 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, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
The denied Suorin products are an e-cigarette device, Suorin Air – Refillable E-Cigarette, 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 applications submitted by Shenzhen Youme Information Technology Co. 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 statement continued.
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 FDA determined that Fontem U.S. allegedly failed to include sufficient ingredient information, harmful and potentially harmful constituent (HPHC) yield quantities and abuse liability information.
“The applicant did not provide sufficient evidence demonstrating that the flavored new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth,” the administration stated.
The FDA is also issuing MDOs for additional blu PLUS+ products not listed above. However, the administration has only publicly named products that the FDA or the manufacturer have confirmed to be currently marketed to avoid the release of confidential commercial information.