FDA WARNING_LETTER - King Distribution LLC d/b/a Lava Vape USA - September 14, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Fadi Salim on September 14, 2023, following a review of the website lavapods.com. The review determined that Electronic Nicotine Delivery System (ENDS) products were offered for sale or distribution in the United States.

The identified violations stem from the marketing of "new tobacco products" without required premarket authorization, as mandated by section 910(a) of the FD&C Act. Specifically, the products Lava 2 Pink Pod System, Lava 2 Pink Lemonade Pods, and Lava 2 Watermelon with Mint Pods were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes that the definition of "tobacco product" now includes products containing nicotine from any source, not just tobacco-derived nicotine, due to the Consolidated Appropriations Act, 2022.

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale/distribution of the non-compliant products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.