FDA WARNING_LETTER - KTX Warehousing & Logistics Ltd. Co. d/b/a VapePuffer - June 13, 2024

On June 12, 2024, the FDA issued a Warning Letter to Daryl Kosoris regarding electronic nicotine delivery system (ENDS) and e-liquid products sold on vapepuffer.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act, including those with nicotine from any source, and are subject to FDA jurisdiction.

The letter states that "new tobacco products" require premarket authorization. The FDA identified three specific products lacking this authorization: Bad Drip Vape Juice E-Liquid- 60ml - Cereal Trip, Bad Drip Vape Juice E-Liquid- 60ml - Don’t Care Bear, and HQD Glaze Disposable Vape 12000 Puffs - Sky Mint. These products are considered new tobacco products as they were not commercially marketed before February 15, 2007, and lack the required marketing orders. Consequently, they are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA expressed particular concern that the Bad Drip Labs e-liquid products' design imitates prescription pill bottles, potentially appealing to youth and encouraging ingestion or concealment. The letter emphasizes that unauthorized sales are prohibited and contribute to public health concerns.

The firm must submit a written response within 15 working days detailing actions taken