WASHINGTON, D.C.—The U.S. Food and Drug Administration on Feb. 22 announced it has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization. This marks the first time that the FDA has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic Act’s premarket review requirements for new tobacco products.
The agency had previously warned each of the four 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,” the FDA said in a news release.
As of Feb. 21, the FDA indicated it 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
Under the FD&C Act, the maximum CMP amount is $19,192 for a single violation relating to tobacco products, the FDA notes. The agency said it is seeking the statutory maximum allowed by law 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,” the agency states.
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 January 2021 and Feb. 17, 2023, the FDA has issued more than 550 warning letters to firms 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,” the FDA states. 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.
Federal Judge Rules in Elfbar Case
Separately, VPR Brands LP, maker of Elf brand vapes, won a favorable ruling in its trademark and patent-infringement case against a Chinese-based vape maker that sells Elfbar brand vapes.
Judge Aileen M. Cannon of the U.S. District Court for the Southern District of Florida “found that VPR has shown there is a likelihood of confusion and the company stands to suffer harm if Shenzhen Weiboli Technology Co. Ltd. is allowed to keep selling the Elfbar vapes, given the similarities between the products and how they are marketed,” according to Law360.com. Shenzhen Weiboli plans to appeal the order.