FDA Warns Against Unauthorized Tobacco Products in US

On May 25th, the US Food and Drug Administration (FDA) issued warning letters to Shenzhen Xinyikang Technology Co., Ltd., the manufacturer of Esco Bars products, and Breeze Smoke, LLC, the importer and distributor of Breeze products.

The FDA has stated that these companies have been manufacturing, distributing, or importing unauthorized tobacco products in the United States, which is prohibited under the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA typically issues warning letters when investigating or inspecting initial violations. Most recipients of warning letters will correct the stated violations. However, failure to promptly correct violations may result in the FDA taking other actions, such as injunctions, seizures, and/or civil penalties.

On May 12, the FDA 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 the products upon entry and prevent illegal distribution within the United States.

Brian King, the director of the FDA's Center for Tobacco Products and a public health doctor, stated that companies that received warning letters have 15 days to respond to the FDA and outline how they plan to address their violations. If a company fails to adequately address their violations, the FDA may take a range of enforcement actions against them.

The following is the full text of the FDA announcement on their official website:

On May 25th, the US Food and Drug Administration (FDA) issued warning letters to two companies responsible for producing the popular disposable flavored electronic cigarette products Esco Bars and Breeze, which are manufactured by Shenzhen New Yikang Technology Co., Ltd. and imported and distributed by Breeze Smoke, LLC. The companies have been accused of 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 United States.

Today's actions underscored the FDA's commitment to protecting young people from the harms of illicit flavored disposable electronic cigarette products. On May 12th, 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 the products upon entry and prevent illegal products from being distributed in the United States.

Dr. Brian King, director of the Tobacco Product Center at the FDA, stated that scientific evidence clearly shows that most young individuals who use e-cigarettes claim that they use disposable and flavored products. He further added that due to the appeal of such products to young individuals, they are the top priority for FDA compliance and enforcement actions.

Today, an e-cigarette company that produced, distributed or imported tobacco products without authorization from the FDA received a warning letter. This is a prohibited action under the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA typically issues warning letters when irregularities are first discovered during investigation or inspection. Most of the recipients of warning letters will correct the stated non-compliance. However, failure to timely correct non-compliant behavior may result in the FDA taking other actions, such as injunctions, seizure, and/or civil penalties.

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," said Dr. Jin. "Companies who receive warning letters have 15 days to respond to the FDA, outlining how they will address the violations. If a company fails to adequately address 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 United States. Distribution or sales of illegally marketed products will be subject to law enforcement action.

The FDA is dedicated 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 non-compliant products, including e-cigarettes.

From January 2021 to May 19, 2023, the US Food and Drug Administration (FDA) has issued over 560 warning letters, proposed ten civil monetary penalties, and issued six injunctions to companies selling illegal electronic cigarettes. All of these actions are part of the FDA's ongoing efforts to enforce compliance and regulations, with updates on these actions being regularly reported. The FDA will continue to take action against anyone manufacturing, distributing, importing, or selling unauthorized electronic cigarette products, especially those most commonly used by youth.