# FDA WARNING_LETTER - Huff Vape LLC d/b/a Huff Vape - December 13, 2023

Source: https://www.keypedia.com/records/warning_letter/huff-vape-llc-dba-huff-vape/5ce45a63-f25b-4ec0-9c8e-75c159771c1f

> FDA WARNING_LETTER for Huff Vape LLC d/b/a Huff Vape on December 13, 2023. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Huff Vape LLC d/b/a Huff Vape
- Inspection Date: 2023-12-13
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On December 12, 2023, the FDA issued a Warning Letter to Antonios Hanna regarding the sale and distribution of unauthorized electronic nicotine delivery system (ENDS) products on the website https://www.huffvape.com. The FDA's Center for Tobacco Products determined that products offered for sale, including Elf Bar BC5000 Miami Mint, Elf Bar EBDesign TE6000 Hawaii Punch, and Funky Republic TI7000 Passion Fruit Kiwi Lime, are "new tobacco products" as defined by section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)). These products were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because no notice or information was provided as required by section 905(j). The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The recipient is required to submit a

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- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)

Company: https://www.keypedia.com/companies/huff-vape-llc-dba-huff-vape/4477ffea-4ac9-4917-8e15-7cf26a6c7ba8

Office: https://www.keypedia.com/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374