FDA fines e-cigarette manufacturers for illegally selling products

The FDA has filed civil money penalty complaints against four e-cigarette manufacturers for producing and selling products without marketing authorization.

It is the first time that the FDA has filed civil money penalty complaints (CMPs) against manufacturers to enforce premarket review requirements for tobacco products under the Federal Food, Drug and Cosmetic Act, according to a press release from the agency.

The FDA filed CMP complaints against BAM Group LLC doing business as VapEscape, Great American Vapes LLC, The Vapor Corner Inc. and 13 Vapor Co. LLC.

“These latest enforcement activities are part of a comprehensive approach to actively identify violations and to deter illegal conduct,” Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products, said in the release. “These actions should be a wake-up call that all tobacco product manufacturers — big or small — are required to obey the law."

The FDA has issued more than 550 warning letters for manufacturing or distributing new tobacco products without marketing authorization between January 2021 and Feb. 17, 2023. It has also recently denied marketing to a few companies that manufactured e-cigarettes that are popular among children and adolescents. However, recent research has suggested that the bans on some flavored e-cigarettes seem ineffective.

Most companies that received the warning letters have been compliant and removed their products from the market, according to the release. The manufacturers that continue manufacturing or distributing the unauthorized products risk additional enforcement; the FDA said it could take other action, like injunctions, seizures and even criminal prosecutions.

The FDA said it had warned the companies that they were violating the premarket requirements for tobacco products and that “failure to correct these violations could lead to an enforcement action, such as a CMP.” However, the companies continued to manufacture and sell their unauthorized products.

“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” King 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 maximum CMP amount for a single violation relating to tobacco products is $19,192, and the FDA is seeking that amount from each of the four companies, according to the release. The companies have three choices: pay the penalty, request an extension to file a response to the complaint or enter into a settlement agreement. If the companies do not take action within a month, they “risk a default order” that would require the full amount, according to the release.