FDA WARNING_LETTER - 7 Daze, LLC - April 03, 2025

On April 3, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to 7 DAZE LLC, identifying violations related to the marketing of e-liquid products. The FDA determined that 7 DAZE LLC manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine from any source and are intended for human consumption.

The primary violation cited is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the product "DAZE Salt Series FUSION RASPBERRY GREEN APPLE WATERMELON 30mL 30mg/mL" was identified as a new tobacco product not commercially marketed in the U.S. before February 15, 2007, and lacking FDA marketing authorization. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the absence of required premarket notification under section 905(j).

The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement. 7 DAZE LLC is required to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing the sale/