FDA WARNING_LETTER - divineliquors.com - August 26, 2025

The FDA issued a Warning Letter to Divine Liquors, located at 6585 Osler St, Unit 100, San Diego, CA, on August 22, 2025, following an inspection of their website. The inspection revealed that the company was offering electronic nicotine delivery system (ENDS) products for sale in the U.S. without the necessary premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). The products in question, including EB TE6000 – Lemon Drop and EB TE6000 – Key West, are considered "new tobacco products" as they were not commercially marketed in the U.S. before February 15, 2007, and lack the required FDA marketing authorization.

Under the FD&C Act, all new tobacco products must have a premarket authorization order to be legally marketed. The absence of such authorization renders these products adulterated and misbranded. The FDA has extended its jurisdiction to include products containing nicotine from any source, as per the Consolidated Appropriations Act, 2022.

Divine Liquors is required to submit a written response within 15 working days, detailing actions taken to address the violations and ensure compliance with the FD&C Act. Failure to comply may result in regulatory actions, including penalties, seizure, or injunction. The company must also ensure that all marketing and advertising comply with FDA regulations. The letter serves as a notification and an opportunity for the company to rectify the issues.