The U.S. Department of Justice, acting on behalf of the FDA, asked a federal court yesterday to issue an injunction that would shut down a small Florida vape manufacturer. The company, Vape Junkie Ejuice, manufactures e-liquid, which the FDA Center for Tobacco Products (CTP) says has not been authorized by the agency.
The DOJ is asking the U.S. District Court for the Middle District of Florida to issue a permanent injunction preventing Vape Junkie Ejuice from manufacturing, selling, and distributing e-cigarette products. Violating a court injunction could lead to serious penalties, including ruinous fines,
The company previously received at least one warning letter from the FDA that cited sales of unauthorized products. It does not appear the company submitted premarket tobacco applications (PMTAs) that were accepted by the FDA for review.
The FDA has not authorized the sale of a single bottled e-liquid, or any vaping products in non-tobacco flavors.
The action marks the second time the FDA has partnered with the DOJ to enforce its authority under the Tobacco Control Act. In October 2022, the DOJ sought injunctions against six tiny vape businesses the FDA accused of selling unauthorized products. The CTP says partnering with the Justice Department is “part of FDA’s comprehensive approach to enforcing the law.”
“FDA has been abundantly clear that we will not stand by as bad actors choose to blatantly disregard the law, especially after being duly warned,” said CTP Director Brian King in a press release. “This manufacturer continued to break the law, and that behavior has consequences.”
The owners of Vape Junkie Ejuice, named in the complaint and FDA press release as Jessica M. Fitzgerald and Michelle L. Allen, appear to have opened the business in 2011, after one of them successfully quit smoking with e-cigarettes and decided—like so many did at that time—to help other smokers quit. According to the company’s website, Vape Junkie operates two vape shops in Florida, in addition to the manufacturing business.
The FDA has not authorized the sale of a single bottled e-liquid, or any vaping products in non-tobacco flavors. Since the agency granted itself authority over vaping products in 2016, it has authorized just seven vaping devices and a handful of tobacco-flavored refills—all manufactured by businesses owned by major tobacco companies.