FDA WARNING_LETTER - Vape Hoop - December 13, 2023

On December 12, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Vapehoop.com after reviewing their website and determining they offer unauthorized electronic nicotine delivery system (ENDS) products for sale in the U.S. These products are considered tobacco products under the FD&C Act, as amended on March 15, 2022, to include products with nicotine from any source.

The FDA identified specific "new tobacco products" lacking required premarket authorization: Elf Bar BC5000 Vape – Sakura Grape, Kangvape Onee MAX Vape – Pear Cotton Candy, and Cali Bars V2 6000 Disposable Vape – Gummy. These products were not commercially marketed in the U.S. before February 15, 2007, and lack FDA marketing authorization orders or exemptions. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Vapehoop.com must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction. The letter also notes that imported products appearing adulterated or misbranded may be detained or refused admission.