FDA Issues Warning to Esco Bar and Breeze

On May 25, the U.S. Food and Drug Administration (FDA) issued warning letters to Shenzhen Innokin Technology Co., Ltd. manufacturer of Esco Bars, and Breeze Smoke, LLC, manufacturer of Breeze products.

The FDA said these companies have been manufacturing and distributing/importing unauthorized tobacco products in the U.S., which is prohibited under the Federal Food, Drug, and Cosmetic (FD&C) Act. the FDA typically issues warning letters when violations are first discovered during an investigation or inspection. Most recipients of warning letters will correct the stated violation. However, failure to correct violations in a timely manner may result in other FDA actions, such as injunctions, seizures, and/or civil fines.

On May 12, FDA also issued an import alert for Esco Bars products, FDA said. The Import Alert places these tobacco products on the Red List, which allows FDA to deny or detain products upon entry and prevents distribution of the products in the United States.

Companies that receive a warning letter have 15 days to respond to FDA outlining how they will address the violation," said Brian King, P.H., Ph.D., director of FDA's Center for Tobacco Products. If a company does not adequately address the violation, we may have a series of enforcement actions waiting for them."