FDA WARNING_LETTER - MVRB2, LLC, d/b/a Kure CBD & Vape - May 16, 2025

On May 15, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Kure CBD & Vape, identifying violations related to the manufacturing, sale, and distribution of e-liquid products. The FDA determined that Kure CBD & Vape's "Berry Berry Confusing" e-liquid product is a "new tobacco product" under section 201(rr) of the FD&C Act, as it contains nicotine from any source and is intended for human consumption.

The product is considered a "new tobacco product" because it was not commercially marketed in the United States as of February 15, 2007, and lacks the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

Kure CBD & Vape is required to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative product and outlining a plan for maintaining compliance with the FD&C Act. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/