FDA Issues Marketing Decisions on Several Vapor Products
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) issued several marketing denial orders (MDOs) covering multiple products by various companies, including Bidi Vapor, Shenzhen Youme Information Technology Co., Fontem US and Shenzhen IVPS Technology Co.
The rejected products include:
- The Bidi Stick Classic E-Cigarette
- Suorin Air Refillable E-Cigarette
- Suorin Air Empty Cartridge
- The blu PLUS+ Battery
- Seven blu PLUS+ prefilled e-liquids
- Twenty-two SMOK brand e-cigarette products
The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product to the population as a whole. After reviewing the companies' PMTAs, 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 public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
[Read more: Juul Labs Seeks FDA Approval for Age-Verified Menthol Vapor Product]
"Thorough scientific review of tobacco products applications is a key pillar of FDA's comprehensive regulatory approach," Brian King, director of the FDA's Center for Tobacco Products stated in regard to several of the denied 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."
In response to the decision, Bidi Vapors expressed the company's disappointment with the finding but wanted to clarify that this would only affect a single product.
"Bidi Vapor is … currently reviewing the opinion based on its merits," said Niraj Patel, Bidi CEO. "In the meantime, the decision only affects our 'Classic' or tobacco-flavored product. Our remaining 10 flavors are still under scientific review and available for sale. At this time, we are investigating legal remedies and expect to have updates in the coming days. For now, we ask that our wholesale and retail partners direct their questions to our sales representatives."
As a result of the MDOs, neither Bidi nor any of the other companies will be allowed to market or distribute the above list of products in the United States without risking an FDA enforcement action. The FDA may also enforce compliance by distributors or retailers, a duty it has taken seriously as it has ramped up its enforcement on illegal tobacco products in the last few years.