Four e-cigarette manufacturers hit with FDA fines over unauthorized products

The Food and Drug Administration (FDA) has fined four electronic cigarette manufacturers over their alleged sales of unauthorized products. 

The FDA said in a release on Wednesday that the agency filed a complaint against BAM Group LLC, Great American Vapes LLC, the Vape Corner Inc. and 13 Vapor Co. LLC for allegedly producing and selling certain e-liquids for its products without receiving authorization to do so. 

The release states that the FDA previously warned the companies that they were violating its premarket requirements for tobacco products and that they could face fines. The agency is seeking the maximum financial penalty of $19,192 in each of the cases against the four firms. 

The manufacturers will be able to pay the fine, enter into an agreement to settle the complaint, request an extension of time to answer the complaint or file an answer and ask for a hearing. They need to respond within 30 days after they receive the complaint to avoid the possibility of being forced to pay the entire penalty by default. 

“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” Brian King, the director of the FDA’s Center for Tobacco Products, said in the release. “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.” 

The Hill has reached out to the four manufacturers for comment. 

The fines mark the first time the FDA has issued civil money penalty complaints against tobacco product manufacturers for violating the Federal Food, Drug and Cosmetic Act’s requirement that new tobacco products are reviewed before going to market, according to the release. 

The law grants the FDA the authority to oversee the safety of food, drugs and certain other products. 

The release states the agency has sent more than 550 warning letters since January 2021 to companies that manufacture, sell or distribute new tobacco products without being allowed. Most of the companies that receive these warnings have taken their products off the market and followed FDA regulations, the agency said.