The FDA issued Marketing Denial Orders (Mdos) to 10 companies that together manufacture and sell about 6,500 flavored vape and e-cigarette products, according to a notice on the FDA’s website. The companies are not allowed to sell or distribute these products in the United States, and retailers that sell these illegal products may be at risk of FDA enforcement action.
The pre-market Tobacco product Application (PMTA) for various flavored e-cigarette products did not provide sufficient evidence that allowing the sale of these products was appropriate to protect public health. Some of the flavors rejected included citrus, strawberry cheesecake, Cool mint and menthol.
Since the spring of 2020, FDA has received more than 26 million applications for new tobacco products, mostly e-cigarette products, and today’s action further the agency’s continued progress in reviewing and issuing decisions.
To date, FDA has completed reviews and taken action on more than 99 percent of the applications.
“Science is the cornerstone of FDA’s tobacco product review process.” Dr. MATthew Farrelly, director of the Office of Science at the FDA’s Center for Tobacco Products. “Today’s decision to reject approximately 6,500 products was based on insufficient scientific evidence presented in the application. We will continue to ensure that all new tobacco products undergo robust, scientific premarket assessment to determine whether they meet appropriate public health standards for legal sale.”
The FDA evaluates PMTA based on public health standards that consider the risks and benefits of the product to the population as a whole. As part of its review of these companies’ PMtas, the FDA considered whether the products in the application showed additional benefits for adult smokers compared to tobacco-flavored e-liquids and e-cigarette products, which may outweigh the significant risks known to the flavoring agents for youths-oriented e-liquids and e-cigarette products. The evidence submitted by the applicant was insufficient to demonstrate such benefit, leading to today’s order of denial.
“The onus is on the applicant to provide sufficient scientific evidence to prove that marketing a new tobacco product is appropriate to protect public health.” Brian King, director of the Center for Tobacco Products. “To date, no flavored e-cigarette product has met the standard for scientific adequacy, including in this case. But if an applicant is to meet that standard, FDA will approve the product.”
Companies that have received Mdos include:
Imperial Vapors LLC
Big Time Vapes
SWT Global Supply Inc.
Great Lakes Vapor
DNA Enterprise LLC dba Mech Sauce
Absolute Vapor Inc.
The FDA did not disclose the names of the other two companies that received Mdos to protect potentially confidential business information (CCIs).
FDA remains committed to ensuring that all members of the industry – manufacturers, importers, distributors, and retailers – comply with the law. Tobacco products subject to a negative decision, including tobacco products subject to Mdos, may not be sold, distributed or marketed in the United States. Such products shall not be introduced or delivered for the purpose of introducing interstate commerce. If the product is already on the market, the product must be removed from the market or subject to enforcement risk.
Today’s action takes FDA one step further by ensuring that all identified new tobacco products undergo scientific review and receive FDA marketing authorization before they are legally sold. To learn more about tobacco products that the FDA has authorized to be manufactured, sold, and/or distributed in the United States, visit the Tobacco Product Marketing Order page.