On May 25, the FDA issued warning letters to Shenzhen Innokin Technology Co. Ltd., which manufactures Esco Bars products, and Breeze Smoke, LLC, which imports and distributes Breeze products, for two popular disposable flavored e-cigarette products.
On May 25, the FDA issued warning letters to Shenzhen Innokin Technology Co. Ltd., which manufactures Esco Bars products, and Breeze Smoke, LLC, which imports and distributes Breeze products, for two popular disposable flavored e-cigarette products.
The FDA alleges 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% of current youth vaping users use disposable vaping products most often. Esco Bars and Breeze are currently the best-selling disposable product brands in the United States.
Today's action underscores FDA's commitment to protecting youth from illegal flavored, single-use e-cigarette products.
On May 12, the FDA also issued an import alert for Esco Bars products. Import Alert redlists these tobacco products, allowing FDA to deny or detain products upon entry and prevent distribution of illicit products in the U.S.
"The science is clear that the majority of young people who use e-cigarettes report that the products they use are disposable and flavored," said Brian King, PhD, public health, director of the FDA's Center for Tobacco Products. "Given their appeal to youth, these products are a priority for FDA compliance and enforcement actions."
The vaping companies that received warning letters today manufacture, distribute or import tobacco products that are not authorized by the FDA, which is prohibited under the federal Food, Drug and Cosmetic (FD&C) Act. FDA typically issues a warning letter when an investigation or inspection first discovers a violation. Recipients of most warning letters will correct the stated violations. However, failure to correct violations in a timely manner may result in additional FDA action, such as an injunction, forfeiture, and/or civil monetary penalties.
"We will continue to use all the tools in our regulatory toolbox to ensure that those who manufacture, distribute or sell illegal vaping products are held accountable," Dr. King said. “Companies that receive a warning letter have 15 days to respond to the FDA outlining how they will address the violation. If a company does not adequately address the violation, we may have a series of enforcement actions awaiting them.”
To date, the FDA has authorized 23 tobacco-flavored vaping products and devices. These are currently the only vaping products that can be legally sold in the United States. Distribution or sale of illegally marketed products will be subject to enforcement action.
FDA remains deeply 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 monitoring of the market to identify offending products, including e-cigarettes.
From January 2021 through May 19, 2023, the FDA has issued more than 560 warning letters, proposed ten civil fines, and proposed six injunctions against companies selling illegal e-cigarettes. All of these actions are part of FDA's standing compliance and enforcement portfolio, and updated counts of these actions will continue to be reported regularly. FDA will continue to take action against anyone who manufactures, distributes, imports or sells unauthorized vaping products, especially those most commonly used by youth.
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Tel：+86 13871529372
Add：6 / F, block B, building 2, Fuyong Tongtai times center, Bao'an District, Shenzhen Website
