FDA issues marketing denial orders for about 6,500 flavored vaping products

According to an announcement on the FDA's official website, the FDA has issued marketing denial orders (MDO) to 10 companies that collectively produce and sell about 6,500 flavored e-cigarette oils and e-cigarette products. These companies are prohibited from selling or distributing these products in the United States, and retailers selling these illegal products may face enforcement actions from the FDA.

The premarket tobacco product applications (PMTA) for various flavored e-cigarette products did not provide sufficient evidence to demonstrate that allowing the sale of these products is appropriate for the protection of public health. Some of the rejected product flavors include citrus, strawberry cheesecake, cool mint, and menthol. 

Since spring 2020, the FDA has received over 26 million applications for new tobacco products, most of which are e-cigarette products, and today's action further advances the FDA's ongoing progress in reviewing and issuing decisions.

To date, the FDA has completed reviews and taken action on over 99% of applications. 

"Science is the cornerstone of the FDA's tobacco product review process," said Dr. Matthew Farrelly, director of the FDA's Center for Tobacco Products Science Office. "Today's decision to deny approximately 6,500 products is based on insufficient scientific evidence provided in the applications. We will continue to ensure that all new tobacco products undergo robust, scientific premarket evaluations to determine whether they meet appropriate public health standards for legal sales."

The FDA evaluates PMTAs based on public health standards that consider the risks and benefits of the products to the entire population. As part of the review of these companies' PMTAs, the FDA considered whether the products in the applications demonstrated additional benefits to adult smokers compared to tobacco-flavored e-liquids and e-cigarette products, which may outweigh the known significant risks posed to youth by flavored e-liquids and e-cigarette products. The evidence submitted by the applicants was insufficient to demonstrate such benefits, leading to today's denial orders. 

"Applicants have the responsibility to provide sufficient scientific evidence to demonstrate that marketing a new tobacco product is appropriate for the protection of public health," said Brian King, director of the Center for Tobacco Products. "So far, no flavored e-cigarette products have met the standard of scientific sufficiency, including in this case. But if applicants meet that standard, the FDA will approve the product."

The companies receiving MDOs include:

Imperial Vapors LLC

Savage Enterprises

Big Time Vapes

SWT Global Supply Inc.

Great Lakes Vapor

DNA Enterprise LLC dba Mech Sauce

Absolute Vapor Inc.

ECBlend LLC

The FDA did not disclose the names of the other two companies that received MDOs to protect potential confidential commercial information (CCI).

The FDA remains committed to ensuring that all members of the industry—manufacturers, importers, distributors, and retailers—comply with the law. Tobacco products subject to denial orders, including those subject to MDOs, may not be sold, distributed, or marketed in the United States. Such products may not be introduced or delivered for introduction into interstate commerce. If products are already on the market, they must be removed or face enforcement risks.

Today's action further ensures that all newly identified tobacco products undergo scientific review and receive FDA marketing authorization before legal sales. For more information about tobacco products authorized by the FDA for manufacture, sale, and/or distribution in the United States, please visit the tobacco product marketing orders webpage.