FDA WARNING_LETTER - blackeditionliquidz.com - August 19, 2025

The FDA issued a warning letter to Black Edition LLC, located at 1019 Waimanu St STE 206, Honolulu, HI, concerning their e-liquid products listed on the website https://blackeditionliquidz.com. The inspection revealed that these products, including Blue Razz TFN, All Pink TFN, and Candy Cane TFN, are being manufactured and sold in the U.S. without the required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Under the FD&C Act, any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or modified after this date, is considered a "new tobacco product" and requires a marketing authorization order. The products in question lack such authorization, rendering them adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively.

The FDA mandates Black Edition LLC to cease the unlawful marketing of these products and to ensure compliance with all applicable regulations. The company must submit a written response within 15 working days detailing corrective actions, including the cessation of violative sales and a compliance plan. Failure to comply may result in enforcement actions, including penalties, seizure, or injunction.

This warning serves as an opportunity for Black Edition LLC to address the violations and align with regulatory requirements. The company is advised to refer to the FDA"s searchable tobacco products database for authorized products and to maintain compliance with the FD&C Act and its implementing regulations.