The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and retailers. The agency has been criticized for not doing enough to fight the sale of unauthorized vapor products, but these actions should at least remind manufacturers and retailers that the agency’s warning letters are not empty threats.
FDA announced on December 4 that the Department of Justice (DOJ) filed a complaint on FDA’s behalf against two individuals doing business as “Vape Junkie Ejuice,” an online e-liquid manufacturer, wholesaler, and retailer. This is not Vape Junkie Ejuice’s first run-in with the agency: the company was issued a warning letter on April 22, 2022, notifying it of being in violation of the Family Smoking Prevention and Tobacco Control Act’s premarket review requirements. The warning letter specifically indicated that continued violations could lead to further action, including an injunction. The filing of this injunction proceeding indicates that FDA is conducting follow-up investigations on recipients of warning letters to ensure that they have indeed ceased the allegedly violative conduct. We wrote about previous injunction actions filed against ENDS retailers here.
Companies in this position can potentially settle with FDA by agreeing not to manufacture, sell, or distribute any new tobacco products until the products receive FDA marketing authorization, FDA inspects the facilities to determine compliance with the law, and FDA notifies the companies in writing that they appear to be in compliance with the law.
On December 5, FDA announced the issuance of 25 new civil money complaints against brick-and-mortar and online retailers of Elfbar, Lost Mary, Puff Xtra, Flum, and Pod King disposable ENDS. The brick-and-mortar retailers are spread across the country in 14 states from Washington to Virginia. They appear to be both standalone vape shops and franchised convenience stores.
Each of these retailers also previously received warning letters, and FDA indicated in its press release that it observed that the retailers had not corrected the violations during follow-up inspections. The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. The retailers can pay the penalty, enter into a settlement agreement based on mitigation factors, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. We wrote about previous CMP actions by FDA here and here.
Manufacturers and retailers can likely expect more of these enforcement actions as pressure on the agency continues to mount. As of November 2023, FDA had issued approximately 640 warning letters to firms for manufacturing and/or distributing illegal ENDS products and issued more than 400 warning letters to retailers for the sale of unauthorized ENDS. Recipients of these warning letters who have not ceased the allegedly unlawful conduct are likely to be the first targets for enforcement action.