FDA Submits Complaints on E-Cigarette Manufacturers

According to the FDA’s report on February 22, a civil money penalty (CMP) complaint was filed against four tobacco manufacturers for selling unauthorized e-cigarettes. It is FDA’s first time filing a CMP against e-cigarette products for not complying with their procedures.

From 2021 through February 17, 2023, the FDA allegedly distributed 550 warnings to tobacco manufacturers for creating and selling unauthorized products. They reported that most companies have pulled their products off the market.

These four companies, however, failed to comply with the warning and continued to distribute and sell unauthorized e-cigarettes.

• 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

"Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA," said the director of the FDA’s Center for Tobacco Products, Brian King, Ph.D., M.P.H. "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 FD&C Act, the maximum fine is $19,192 for one law violation. In most cases, the FDA aims for the statutory maximum permitted by law. Companies that have been the subject of CMP complaints have the options of paying the fine, participating in a settlement agreement, asking for an extension to respond to the complaint, or responding to the complaint and requesting a hearing.

Companies risk a default order resulting in the entire penalty amount if they do not respond within 30 days. In order to legally sell any new products, manufacturers need to submit a marketing application to the FDA and get officially authorized to sell new tobacco products.

King concluded: "These latest enforcement activities are part of a comprehensive approach to actively identify violations and to deter illegal conduct. These actions should be a wakeup call that all tobacco product manufacturers—big or small—are required to obey the law."