FDA WARNING_LETTER - LJ's E-Smokes LLC - April 13, 2021

The FDA issued a Warning Letter to Ginger Williams after reviewing the website ljesmokes.com, identifying e-liquid products, specifically LJ’s Signature - Caramel Cappuccino and LJ’s Signature - Banana Shake, being manufactured and sold in the U.S. These products are classified as "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed before February 15, 2007. The firm is offering these products without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the failure to provide required information under section 905(j). The FDA emphasized the firm's responsibility to ensure all its tobacco products and marketing comply with the FD&C Act and FDA regulations. A written response is required within 15 working days, detailing corrective actions, including discontinuing violative activities and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, product seizure, or injunction.