FDA WARNING_LETTER - happyones.us - July 22, 2025

The FDA issued a warning letter to Happy Ones Vape, operated by QH Tech Corp, located in Miami, FL, following an inspection of their website, https://happyones.us. The inspection revealed that the company is marketing electronic nicotine delivery system (ENDS) products, specifically Fume Eternity 20000 Puffs – Watermelon Berry and Fume Eternity 20000 Puffs – Tropicanna, without the necessary premarket authorization. These products are classified as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not marketed in the U.S. before February 15, 2007, and lack FDA marketing authorization.

The FDA"s jurisdiction over these products is established under sections 201(rr) and 901(b) of the FD&C Act, following amendments that extend regulation to all nicotine-containing products, regardless of the source. The products in question are deemed adulterated and misbranded due to the absence of required marketing authorization and necessary notifications.

The FDA requires Happy Ones Vape to cease the sale and distribution of these products immediately and to submit a written response within 15 working days detailing corrective actions, including discontinuation dates and compliance plans. Failure to comply may result in enforcement actions such as civil penalties, seizure, or injunction. The company is advised to ensure all products and marketing comply with the FD&C Act and FDA regulations. The response should be directed to the FDA"s Center for Tobacco Products, with reference number RW2502310.