U.S. FDA Files First Civil Money Penalties for Illicit Sales

Credit: VetKit

Some manufacturers of e-liquids could soon be paying nearly $20,000 per violation for selling vaping products without approval. Today, the U.S. Food and Drug Administration announced it has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization.

This marks the first time the regulatory agency has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket tobacco product application (PMTA) process.

The FDA previously warned each of the companies that, by making and selling their e-liquids without marketing authorization from the FDA, they were in violation of the FDA’s PMTA requirements and that failure to correct these violations could lead to enforcement action, such as a CMP, according to a press release.

Despite the agency’s warning, the companies continue to make and sell their unauthorized e-liquids to consumers.

“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” said Brian King, Ph.D., M.P.H., 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.”

As of Feb. 21, the FDA has filed CMP complaints against the following four manufacturers:

  • 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

Currently, under the FD&C Act, the maximum CMP amount is $19,192 for a single violation relating to tobacco products. The FDA typically seeks the statutory maximum allowed by law and is doing so in these four cases.

The companies the FDA has filed CMP complaints against 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 do not take action within 30 days after 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,” said King. “These actions should be a wakeup call that all tobacco product manufacturers—big or small—are required to obey the law.”    

Manufacturers that continue to violate the law risk subsequent enforcement, according to the FDA. In addition to CMPs, the agency also has the authority to take other enforcement action, as appropriate, including seizures, injunctions, and criminal prosecutions.