FDA Issues Warnings to Esco Bars, Breeze Smoke
New move parallels separate action to enlist Customs and Border Patrol to help with enforcement
WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) issued warning letters on Esco Bars and another popular vaping brand, Breeze Smoke. On May 25, 2023, the FDA sent the letters to Shenzen Innokin Technology Co. Ltd. who make Esco Bars products and Breeze Smoke, LLC, who import and distribute Breeze products. These firms have been manufacturing, distributing, and/or importing unauthorized tobacco products in the United States, according to the FDA.
Earlier in the month, the FDA announced additional steps to enforce its regulatory authority, using the U.S. Customs and Border Protection agency to stop entry of electronic nicotine delivery systems (ENDS) devices that the agency said are not compliant with its regulations. Among the brands facing such action are Elf Bar and Esco Bars.
For the border patrol notice, in the case of Elf Bar and Esco Bars, the FDA said those products are “misbranded” because they do not have a marketing order and its manufacturer failed to provide the FDA with required product information.
The FDA also served similar import-detention orders to several U.S. distributors for failing to pay user fees.
The action the FDA took is known as “detention without physical examination” and places the products on what the agency calls a “Red List.” Customs officials at the border can keep these products from entering the United States until the responsible parties produce the necessary records, documentation, or payment to satisfy the FDA.
Calling the devices “new tobacco products,” the FDA said these products “do not have the required FDA marketing authorization [and] are adulterated under section 902(6)(A) of the Food, Drug & Cosmetics Act.”
For a full list of recent FDA detention-order actions, click here.
