Quad Life USA Inc. – FDA Warning Letter, Sep 13, 2024

The FDA issued a Warning Letter to Anand Swaroop and Om Prakash Sharma of Quadlifeusa.com on September 12, 2024, after reviewing their website and identifying the sale of e-liquid products, specifically "Nicotine 10% Diluted with Vegetable Glycerin" and "Nicotine 10% Diluted with Propylene Glycol." These products are classified as tobacco products under section 201(rr) of the FD&C Act, especially following the 2022 amendment extending FDA's jurisdiction to products containing nicotine from any source. The FDA determined that these are "new tobacco products" that were not commercially marketed before February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the absence of required information under section 905(j). The firm must submit a written response within 15 working days detailing actions to discontinue violative sales and ensure compliance, or face potential regulatory actions including civil money penalties, seizure, and injunction.