FDA WARNING_LETTER - relevantvapes.com - December 01, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to relevantvapes.com on December 5, 2025, following a review of their website, which identified the online sale of unauthorized electronic nicotine delivery system (ENDS) products. The FDA determined that products such as Funky Republic TI7000 – Pink Bomb and Funky Republic TI7000 – Pomelo Pearl Grape are considered "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These products require premarket authorization, which relevantvapes.com has not obtained. Consequently, the sale of these ENDS products is a violation of the FD&C Act, rendering them both adulterated and misbranded due to the absence of the necessary regulatory clearance. The regulatory framework, established under sections like 201(rr) and 910(a) of the FD&C Act, mandates that all new tobacco products undergo specific authorization processes before being marketed in the United States. To address these violations, relevantvapes.com is required to submit a written response within 15 working days from receipt of the letter. This response must describe the specific actions taken to discontinue the sale and distribution of the violative products and include a detailed plan for maintaining full compliance with all applicable FDA regulations to prevent future unauthorized marketing.