FDA Sends Warning Letters to Makers of Esco Bars and Breeze

The firms have been distributing unauthorized products, says the FDA.

May 26, 2023

WASHINGTON—The Food and Drug Administration has issued warning letters to firms responsible for two popular flavored, disposable e-cigarette products—Shenzen Innokin Technology Co. Ltd., which makes Esco Bars products, and Breeze Smoke LLC, which imports and distributes Breeze products. These firms have been manufacturing, distributing and/or importing unauthorized tobacco products, and Esco Bars and Breeze are among the most commonly sold brands of disposable products in the United States, according to the FDA.

The FDA also recently issued an import alert for Esco Bars products. The import alert places these tobacco products on the red list, which allows FDA to refuse or detain the product at the time of entry and to prevent illegal products from being distributed in the U.S.

“The science clearly shows that a majority of youth who use e-cigarettes report that the products they are using are disposable and flavored” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “Given their appeal to youth, these products are a priority for FDA compliance and enforcement action.”

The e-cigarette firms that received warning letters today make, distribute or import tobacco products that lack authorization from FDA, which is a prohibited act under the Federal Food, Drug, and Cosmetic (FD&C) Act. FDA generally sends warning letters the first time an investigation or inspection reveals a violation. A majority of recipients of warning letters correct the stated violation. However, failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties.

“Firms receiving a warning letter have 15 days to respond to FDA outlining how they will address the violation. If a firm doesn’t adequately address the violation, we have a bevy of enforcement actions at our disposal that potentially await them,” said Dr. King.

To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully sold in the U.S. The distribution or sale of unlawfully marketed products is subject to enforcement action.

From January 2021 through May 19, 2023, the FDA issued more than 560 warning letters, filed 10 civil money penalties and filed six injunctions to firms marketing illegal e-cigarettes.