FDA Denies Marketing Approval for 6,500 Flavored E-cigarettes
On May 12, the Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to 10 e-cigarette companies that manufacture and market an estimated 6,500 flavored e-liquid and e-cigarette products. The FDA's decision means these products can no longer be marketed or distributed in the U.S, with retailers risking enforcement action if they continue to sell these items.
The stated reason was that the companies' premarket tobacco product applications (PMTAs) did not provide sufficient evidence to demonstrate that the marketing of these flavored e-cigarette products would benefit public health. The FDA denied applications for various products with flavors including Citrus, Strawberry Cheesecake, Cool Mint, and Menthol.
The move is part of the FDA's ongoing review of over 26 million new tobacco product applications received since Spring 2020, most of which are for e-cigarette products. The FDA has now taken action on over 99% of these applications.
Matthew Farrelly, Ph.D., Director of the Office of Science within FDA’s Center for Tobacco Products, emphasized that today's denial was based on the lack of scientific evidence provided in the applications. He reiterated the FDA's commitment to ensure all new tobacco products undergo a rigorous, science-based premarket evaluation to assess their public health impact.
The FDA's public health standard requires an evaluation of the risks and benefits of a product on the population as a whole. The applicants failed to demonstrate an added benefit to adult smokers from these flavored products that could outweigh the known and substantial risk to youth, leading to denial orders.
Companies that received 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 names of the other two companies were not disclosed to protect potential confidential commercial information.
Thumbnail source: tobacco reporter
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