The Food and Drug Administration on Friday issued marketing denial orders to 10 companies, which collectively manufacture and market about 6,500 flavored e-liquid and e-cigarette products. The premarket tobacco product applications (PMTAs) for the products did not provide sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health, the FDA said.
Flavors of denied products include Citrus, Strawberry Cheesecake, Cool Mint and Menthol. The companies may not market or distribute their products in the United States, and retailers who sell the illegal products risk FDA enforcement action, the agency said.
The companies that received MDOs include Imperial Vapors LLC, Big Time Vapes, SWT Global Supply Inc., Great Lakes Vapor, DNA Enterprise LLC doing business as Mech Sauce, Absolute Vapor Inc., ECBlend LLC and Savage Enterprises, according to FDA records. The FDA is not disclosing the names of the other two companies that received MDOs to protect potential confidential commercial information, it said.
“Science is a cornerstone of FDA’s tobacco product review process,” said Matthew Farrelly, director of the Office of Science within FDA’s Center for Tobacco Products. “Today’s decision to deny approximately 6,500 products was based on the lack of scientific evidence provided in the applications. We will continue to ensure all new tobacco products undergo robust, scientific premarket evaluation to determine whether they meet the appropriate public health standard to be legally marketed.”
The FDA has received PMTAs for more than 26 million new tobacco products since spring 2020, and has taken action on more than 99% of those applications, the agency said. It expects to finish reviewing some of the most prevalent e-cigarette brands’ applications by the end of the year.
As part of the FDA’s review of PMTAs, it considers the risks and benefits of the product on the population as a whole. The agency said it considered whether the products in the applications denied Friday showed an added benefit to adult smokers, as compared to tobacco-flavored e-liquid and e-cigarette products, that could outweigh the risk of flavored tobacco products to youth.
The evidence submitted by the applications was not sufficient to demonstrate such a benefit, the FDA said.
“It is the applicant’s responsibility to provide sufficient scientific evidence to demonstrate that marketing a new tobacco product is appropriate for the protection of the public health,” said Brian King, director of the CTP. “That bar of scientific sufficiency has not been met to date for any flavored e-cigarette product, including in this instance. But if an applicant were to meet that bar, FDA would authorize the product.”
Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.