FDA Files Civil Money Penalty Complaints Against E-Cigarette Manufacturers

FDA Files Civil Money Penalty Complaints Against E-Cigarette Manufacturers
FDA filed lawsuits against 4 tobacco product manufacturers for unauthorized production and sale of e-cigarette oil.

The US Food and Drug Administration (FDA) has announced that it is suing four tobacco product manufacturers for producing and selling e-cigarette liquid without authorization. These companies must submit marketing applications to the FDA, such as a pre-market tobacco product application (PMTA), and obtain authorization before introducing new e-cigarette products to the US market.

So far, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are currently the only e-cigarette products that may be legally sold in the United States.

On February 21, the Tobacco Products Center (CTP), a division of the FDA, imposed civil penalties against four tobacco product manufacturers for manufacturing and selling products without the required marketing authorization. This marks the first time that the CTP has imposed civil penalties against tobacco product manufacturers for failing to comply with pre-market review requirements. The CTP will continue to consider civil penalties against manufacturers who do not comply with the FD&C Act and applicable regulations.

Currently, according to this law, the maximum civil penalty for tobacco products is $19,192.

The FDA has imposed civil fines on four manufacturers as follows:

BAM Group LLC is a company that needs further context to be properly reported on. Without additional information, it is unclear what the company does and what newsworthy events it may be involved in.

Great American Vapes LLC is a company that produces vaping products.

The Vapor Corner Inc. cannot be translated to journalistic English as it appears to be a company name.

13 Vapor Co. Limited Liability Company

The FDA has stated that manufacturers who violate the law will face more enforcement actions, including seizures, injunctions, and criminal prosecutions.


The Food and Drug Administration (FDA) has initiated legal action against four manufacturers of e-cigarette products by filing civil money penalty complaints.

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