FDA WARNING_LETTER - Alohma, LLC d/b/a Kure CBD & Vape - July 11, 2025

On July 10, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Alohma, LLC, d/b/a Kure CBD & Vape, based on a review of inspection records. The letter states that Alohma, LLC 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 identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the product "Skwezed Sweet Summer Watermelon Strawberry 3MG 100ML" was cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. 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 notice or information under section 905(j).

Alohma, LLC is required to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuation dates for the violative products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure