FDA WARNING_LETTER - Half Empty, LLC d/b/a Vape Street - September 14, 2023

On September 14, 2023, the FDA issued a Warning Letter to Daniel Nguyen, operating vape-street.com, for offering unauthorized electronic nicotine delivery system (ENDS) products for sale in the United States. The FDA's review of the website found ENDS products, specifically "Elf Bar EBDesign BC5000 Disposable – Strazz" and "Elf Bar EBDesign BC5000 Disposable – Tropical Rainbow Blast," which are considered tobacco products under section 201(rr) of the FD&C Act, as amended to include nicotine from any source.

These products are deemed "new tobacco products" because they 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 adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires a written response within 15 working days detailing actions taken to address these 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 non-compliant products may be detained or refused admission.