FDA WARNING_LETTER - M N T LLC d/b/a ZMARKSTHESPOT - December 13, 2023

The FDA issued a Warning Letter to Mayur Patel regarding the website https://zmarksthespot.com, which offers electronic nicotine delivery system (ENDS) products for sale in the United States. These products are considered tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Specifically, the products Elf Bar BC5000 Vape – Gumi, KangVape TC8000 – Apple Grape, and Cali Bars Disposable 4500 Puffs – Frozen Grape were identified as new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. Consequently, these products are deemed 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 the violations, including discontinuing the sale/distribution of the non-compliant products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.