February 22, 2023: “The U.S. FDA announced it has filed civil money penalty (CMP) complaints against four tobacco product manufacturers 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.
It is illegal to manufacture, sell, or distribute e-liquids that the FDA has not authorized.
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.
Despite the agency’s warning, these companies continue to make and sell their unauthorized e-liquids to consumers.
“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.”
As of Feb. 21, the FDA has filed CMP complaints against the following four manufacturers:
- BAM Group LLC doing business as VapEscape
- Great American Vapes LLC doing business as Great American Vapes
- The Vapor Corner Inc. doing business as Vapor Corner Inc., The Vapor Corner, and Vapor Corner
- 13 Vapor Co. LLC doing business as 13 Vapor
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 Dr. 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.
The FDA closely monitors manufacturer compliance with the law and may take action when violations occur. Between Jan. 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.
After receiving warning letters, a majority of these companies have complied and removed their products from the market. Manufacturers that continue to violate the law risk subsequent enforcement.
In addition to CMPs, the agency also has authority to take other enforcement action, as appropriate, including seizures, injunctions, and criminal prosecutions.
Manufacturers must submit a marketing application to the FDA and receive authorization to legally sell a new tobacco product in the United States.
The FDA encourages manufacturers to learn more about the three pathways to submit an application for new tobacco products.”