The Food and Drug Administration has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for making 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 Act’s premarket review requirements for new tobacco products.
The FDA previously warned each of the following companies that by making and selling their e-liquids without marketing authorization from the FDA, they were in violation of the agency’s premarket requirements for tobacco products:
- 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
Despite the FDA’s warnings, these companies continue to make and sell unauthorized e-liquids to consumers, the agency said.
“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” said Brian King, the FDA’s Center for Tobacco Products director. “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.”
Under the Food, Drug and Cosmetic Act, the maximum CMP amount is $19,192 for a single violation relating to tobacco products. The FDA is seeking the maximum fee allowed in these four cases.
“These latest enforcement activities are part of a comprehensive approach to actively identify violations and to deter illegal conduct,” King said. “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 e-cigarettes, on the market without the statutorily required premarket authorization are marketed illegally and subject to FDA enforcement action, the agency said. Between January 2021 and Feb. 17, 2023, the agency has issued more than 550 warning letters to firms for manufacturing, selling and/or distributing new tobacco products without marketing authorization.
Most companies comply and remove their products from the market after receiving warning letters, the FDA said. In addition to CMPs, the agency can also take other enforcement action, including seizures, injunctions and criminal prosecutions, for those who don’t comply.
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