On May 25th, the FDA issued warning letters to Shenzen Innokin Technology Co. Ltd., which produces Esco Bars products, and Breeze Smoke, LLC, which imports and distributes Breeze products, for companies responsible for two popular disposable flavored e-cigarette products. These companies have been manufacturing, distributing, and/or importing unauthorized tobacco products in the United States.

According to the 2022 National Youth Tobacco Survey, over 55% of current youth e-cigarette users use disposable e-cigarette products the most frequently. Esco Bars and Breeze are currently the best-selling disposable product brands in the United States.

Today's action emphasizes the FDA's commitment to protecting teenagers from illegal flavored disposable e-cigarette products. On May 12th, the FDA also issued an import alert for Esco Bars products. Import alerts include these tobacco products on a red list, allowing the FDA to refuse or detain products upon entry, and preventing illegal products from being distributed in the United States

Science clearly indicates that the majority of young people who use e-cigarettes report that the products they use are disposable and flavored, "said Brian King, director of the FDA Tobacco Products Center and PhD in Public Health. Given their appeal to young people, these products are a priority for FDA compliance and enforcement actions


The electronic cigarette company that received the warning letter today produces, distributes, or imports tobacco products without FDA authorization, which is prohibited under the Federal Food, Drug, and Cosmetics (FD&C) Act. The FDA usually issues a warning letter when an investigation or inspection reveals a violation for the first time. Most recipients of warning letters will correct the stated violations. However, failure to promptly correct violations may result in FDA taking other actions, such as injunctions, seizures, and/or civil fines.

We will continue to use all the tools in our regulatory toolbox to ensure that those who manufacture, distribute, or sell illegal e-cigarette products are held accountable, "Dr. Jin said. Companies that receive warning letters have 15 days to respond to the FDA, outlining how they will address the violation issue. If a company does not fully address the violation issue, we may take a series of enforcement actions waiting for them

So far, the FDA has authorized 23 tobacco flavored e-cigarette products and devices. These are currently the only electronic cigarette products that can be legally sold in the United States. The distribution or sale of illegally marketed products will be subject to enforcement actions.

The FDA has always been firmly committed to protecting young people from the hazards of tobacco products by ensuring that illegal products are not marketed, distributed, or sold. These efforts include continuous monitoring of the market to identify non compliant products, including e-cigarettes.

From January 2021 to May 19, 2023, the FDA has issued over 560 warning letters, imposed ten civil fines, and imposed six bans on companies selling illegal e-cigarettes. All of these actions are part of the FDA's permanent compliance and enforcement portfolio, and the latest count of these actions will continue to be regularly reported. The FDA will continue to take action against anyone who manufactures, distributes, imports, or sells unauthorized e-cigarette products, especially those most commonly used by teenagers.