By Jen Christensen, CNN
The US Food and Drug Administration announced Wednesday that it has filed complaints against four makers of e-cigarette products, as the companies did not get authorization from the FDA to sell their products in the US market. This is the first time that the agency has filed what it calls a civil money penalty, or CMP, against e-cigarette makers who have not complied with the federal process.
From 2021 through last Friday, the FDA said it sent out 550 warning letters to tobacco firms, large and small, for making and selling products that are not authorized. A majority of the companies, the FDA said, have removed their products from the market.
The four companies that did not heed the FDA’s warning and are facing fines are 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; and 13 Vapor Co. LLC, doing business as 13 Vapor. All four had previously been warned by the FDA that sales of their products were illegal. The companies apparently ignored the warning, and they are still making and selling e-cigarette liquids.
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A ‘top priority’
BAM Group LLC, Great American Vapes LLC, The Vapor Corner Inc, and 13 Vapor Co LLC did not immediately respond to CNN’s request for comment.
“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” said Dr. 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 FDA said that the maximum fine is $19,192 for a single violation of the law, and that the agency is seeking the maximum fine allowed by law. Companies are allowed to pay the fine, enter into a settlement, request an extension to address the fine, or request a hearing. The companies are given 30 days or to respond, or will have to pay the full penalty as a default.
“These actions should be a wakeup call that all tobacco product manufacturers – big or small – are required to obey the law,” King said.
If the companies continue to violate the law, the FDA has the authority to take additional action. The agency can seize products, file injunctions to not sell the products, and the companies can face criminal prosecutions.
Erika Sward, the assistant vice president of national advocacy for the American Lung Association, said the move against these manufacturers is a good one.
“With these fines, FDA is finally speaking a language these manufacturers understand,” Sward told CNN.
Sward added that these fines are probably just the tip of the iceberg when it comes to the number of fines that should be levied against not just manufacturers, but also against importers and distributors.
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~ CNN’s Jennifer Korn contributed to this report. The-CNN-Wire™ & © 2023 Cable News Network, Inc., a Warner Bros. Discovery Company. All rights reserved.
