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FDA Files First Civil Money Penalty Complaints Against Vapor Companies

February 27, 2023 || Originally posted on csnews.com

The four companies had previously been notified they were making and selling e-liquids without the agency's marketing authorization.

The Food and Drug Administration (FDA) filed civil money penalty (CMP) complaints against four tobacco product manufacturers on Feb. 21 for manufacturing and selling e-liquids without marketing authorization.

This marks the agency's first CMP complaints to enforce the Federal Food, Drug and Cosmetic (FD&C) Act's requirements for premarket review for new tobacco products.

It is illegal to manufacture, sell or distribute e-liquids not authorized by the FDA. According to the agency, it had previously warned each of the companies about making and selling their e-liquids without marketing authorization and that failure to correct these violations could lead to an enforcement action, such as a CMP.

Despite this, the companies reportedly continue to make and sell unauthorized e-liquids to consumers, the FDA said.

The CMP complaints were filed against:

• BAM Group LLC dba VapEscape
• Great American Vapes LLC dba Great American Vapes
• The Vapor Corner Inc. dba Vapor Corner Inc., The Vapor Corner and Vapor Corner
• 13 Vapor Co. LLC dba 13 Vapor

"Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA," said Brian King, 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."

The current maximum CMP amount under the FD&C Act is $19,192 for a single violation relating to tobacco products. The FDA is seeking the maximum penalty in these four cases as it typically does. The companies 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 fail to take actions within 30 days of 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," King said. "These actions should be a wakeup call that all tobacco product manufacturers — big or small — are required to obey the law."

The FDA previously filed complaints for permanent injunctions in federal district courts against six companies that continued to market vapor products that failed to submit premarket tobacco product applications and continued to illegally manufacture, sell and distribute their products after receiving warnings, as Convenience Store News previously reported.

Between January 2021 through Feb. 17, 2023, the FDA issued more than 550 warning letters to both large and small firms for manufacturing, selling and/or distributing new tobacco products without marketing authorization. A majority of these companies subsequently complied and removed their products from the market, the agency added.