On May 25, the FDA issued warning letters to e-cigarette manufacturer Shenzen Innokin Technology Co. Ltd. and e-cigarette distributor Breeze Smoke, LLC, the companies responsible for two popular disposable flavored e-cigarette products. stating that these companies have been manufacturing, distributing and/or importing unauthorized tobacco products in the United States.
According to the 2022 National Youth Tobacco Survey, more than 55 percent of current youth e-cigarette users most often use disposable e-cigarette products. Esco Bars and Breeze are currently the best-selling brands of disposable products in the United States.
On May 12, the FDA also issued an import alert for Esco Bars products. The Import Alert places these tobacco products on the Red List, allowing FDA to deny or detain products upon entry and prevent the sale of unauthorized e-cigarette products.
said Brian King, director of the FDA’s Center for Tobacco Products. Because e-cigarettes are so appealing to young people, it is important to have the FDA ensure legal compliance for these products.
The e-cigarette companies receiving warning letters today manufacture, distribute or import tobacco products that are not authorized by the FDA, a prohibited practice under the Federal Food, Drug and Cosmetic (FD&C) Act. the FDA typically issues warning letters when an investigation or inspection first finds a violation. Most recipients of warning letters will correct the stated violation. However, failure to correct violations in a timely manner may result in other FDA actions, such as injunctions, forfeitures, and/or civil fines.
DFA gives companies that receive a warning 15 days to respond and outline how they will address the violation. If the violation is not adequately addressed, a series of enforcement actions will be taken against them. The 23 tobacco-flavored e-cigarettes currently authorized by the FDA are the only e-cigarette products that are currently legal and safe to sell in the United States.
By one count, from January 2021 through May 19 of this year, more than 560 warning letters have been issued by the DFA, and ten civil fines and six injunctions have been proposed. The FDA will continue to take action against any unauthorized e-cigarette manufacturers, e-cigarette distributors, and especially those e-cigarette products most commonly used by youth.