FDA Issues Import Alert on Unauthorized Vapes

The alert identified more than 20 companies located in China, South Korea and the U.S.

May 19, 2023

ALEXANDRIA, Va.—The Food and Drug Administration (FDA) has issued an import alert, allowing the Customs and Border Protection (CBP) to detain at the border any new tobacco products that have not received marketing authorization, reports Tobacco Reporter.

“Divisions may detain, without physical examination, the tobacco products identified on the Red List of this Import Alert. If the division is not sure whether a tobacco product is the same product as one identified on the Red List, the division should consult with the Center for Tobacco Products (CTP)” the alert states. “CTP concurrence is required to add a product to the Red List.”

Companies on the red list include the importers, manufacturers and transporters of vaping product brands ELFBAR, EBDESIGN, Eonsmoke, Esco Bar and Stik, along with other companies. The alert identified more than 20 companies located in China, South Korea and the United States.

Being on the Red List means the CBP can detain shipments of these products without inspecting them. Companies can be removed from the Red List by providing information to the FDA that adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation.

“The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, ‘Detention without Physical Examination (DWPE),'” the alert states.