The U.S. Food and Drug Administration (FDA) has filed civil money penalty (CMP) complaints against four tobacco product manufacturers. The complaints were for manufacturing and selling e-liquids without marketing authorization. This is the first time the FDA has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.
As of Feb. 21, the FDA has filed CMP complaints against the following four manufacturers:
- BAM Group LLC dba VapEscape
- Great American Vapes LLC
- The Vapor Corner Inc.
- 13 Vapor Co. LLC
The FDA previously warned each of the companies that, by making and selling their e-liquids without marketing authorization from the FDA, they were in violation of the FDA’s premarket requirements for tobacco products and that failure to correct these violations could lead to an enforcement action, such as a CMP.
“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “We are prepared to use the full scope of our authorities to enforce the law — especially against those who have continued to violate the law after being warned by the agency.”
Currently, under the FD&C Act, the maximum CMP amount is $19,192 for a single violation relating to tobacco products. The FDA typically seeks the statutory maximum allowed by law and is doing so in these four cases. The companies the FDA has filed CMP complaints against can pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. Companies that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.
“These latest enforcement activities are part of a comprehensive approach to actively identify violations and to deter illegal conduct,” said King. “These actions should be a wakeup call that all tobacco product manufacturers — big or small — are required to obey the law.”
All new tobacco products, including all e-cigarettes, on the market without the statutorily required premarket authorization are marketed illegally and are subject to FDA enforcement action. Between January 2021 through Feb. 17, 2023, the FDA has issued more than 550 warning letters to firms — both large and small — for manufacturing, selling and/or distributing new tobacco products without marketing authorization from the FDA.
