FDA WARNING_LETTER - Vape.com - October 01, 2025

The FDA Center for Tobacco Products issued a Warning Letter to Hellosynixvape.com on October 9, 2025, after reviewing its website. The agency determined the company is offering electronic nicotine delivery system (ENDS) products, specifically "Hello Synix 30000 – Raspberry Peach Lime" and "Hello Synix 30000 – Mexican Mango," for sale in the United States without the necessary premarket authorization.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these products are considered "new tobacco products" and, lacking FDA marketing authorization, are deemed adulterated and misbranded. The FDA expressed significant concern regarding the products" design and advertising, which feature functionalities imitating smartphones, including a touch screen, Bluetooth for AI chat, photo-taking, music player, games, and a "Find Your Device" function. These characteristics are believed to appeal to youth and could help conceal the products" nature as tobacco products.

Hellosynixvape.com is required to promptly address these violations, ensure all products comply with the FD&C Act, and submit a written response within 15 working days. This response must detail the corrective actions taken, including the dates when violative sales and distribution ceased. Failure to comply may lead to further regulatory actions, such as civil money penalties, product seizure, or injunction.