U.S. FDA Warns E-cigarette Manufacturers Esco Bars and Breeze Smoke

Today’s news, on May 26, according to foreign reports, on May 25, the FDA issued warning letters to Shenzen Innokin Technology Co. Ltd., the manufacturer of Esco Bars products, and Breeze Smoke, LLC, responsible for importing and distributing Breeze products, regarding two popular disposable flavored e-cigarette products.

The FDA stated 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, over 55% of current youth e-cigarette users most commonly use disposable e-cigarette products. Esco Bars and Breeze are currently the best-selling disposable product brands in the U.S.

Today’s action emphasizes the FDA’s commitment to protecting youth from illegal flavored disposable e-cigarette products.

On May 12, the FDA also issued an import alert for Esco Bars products. The import alert places these tobacco products on a red list, allowing the FDA to refuse or detain products upon entry and prevent illegal products from being distributed in the U.S.

"Science clearly shows that most young people who use e-cigarettes report that the products they use are disposable and flavored," said Dr. Brian King, director of the FDA’s Center for Tobacco Products and a public health expert. "Given their appeal to youth, these products are a priority for FDA compliance and enforcement actions."

Companies receiving warning letters for producing, distributing, or importing unauthorized tobacco products are prohibited under the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA typically issues warning letters when violations are first discovered during investigations or inspections. Most recipients of warning letters will correct the stated violations. However, failure to promptly correct violations may lead to further actions by the FDA, such as injunctions, seizures, and/or civil fines.

"We will continue to use all tools in our regulatory toolbox to ensure that those who manufacture, distribute, or sell illegal e-cigarette products are held accountable," Dr. King said. "Companies that receive warning letters have 15 days to respond to the FDA, outlining how they will address the violations. If a company fails to adequately resolve the violations, we may take a range of enforcement actions against them."

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

The FDA remains firmly committed to protecting youth from the harms of tobacco products by ensuring that illegal products are not marketed, distributed, or sold. These efforts include ongoing market monitoring to identify non-compliant products, including e-cigarettes.

From January 2021 to May 19, 2023, the FDA has issued over 560 warning letters, proposed ten civil fines, and issued six injunctions against companies selling illegal e-cigarettes. All these actions are part of the FDA’s ongoing compliance and enforcement efforts, and the latest counts will continue to be reported regularly. 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 youth.