The civil money complaints, which carry a maximum penalty of $19,192 for a single violation, are intended to hold tobacco companies accountable for selling e-liquids—or vape juice—without FDA approval.
The FDA said Wednesday that for the first time, it has filed civil money penalty (CMP) complaints against 4 tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization.
The CMP complaints, which carry a maximum penalty of $19,192 for a single violation, are aimed at enforcing the federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products. The FDA said it is seeking the statutory maximum allowed by law.
The FDA said it previously warned each of the companies that, by making and selling their products without marketing authorization, they were in violation of premarket requirements for tobacco products and that failure to correct the violations could lead to an enforcement action. It is illegal to manufacture, sell, or distribute e-liquids that the FDA has not authorized.
The companies continue to make and sell their unauthorized e-liquids despite the agency’s warnings, the FDA said.
“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products, said in a statement. “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 4 firms are:
The companies may 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.