LA VAPOR INC. – FDA Warning Letter, Jul 10, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to LA VAPOR INC. after reviewing inspection records, determining the company sells and distributes Electronic Nicotine Delivery System (ENDS) products in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act, especially following the March 15, 2022, amendment expanding jurisdiction to products containing nicotine from any source. Generally, new tobacco products require premarket authorization under section 910(a) of the FD&C Act to be legally marketed. LA VAPOR INC. was found to be marketing specific ENDS products, namely Suorin Air Mod Pod Kit – Clear Red (40W) and Suorin Air Mod Pod Kit – Gunmetal (40W), which are new tobacco products lacking the required FDA marketing authorization. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice under section 905(j). The FDA mandates a written response within 15 working days detailing actions taken to cease violative sales/distribution and ensure future compliance, warning that failure to address these violations may result in regulatory actions such as civil money penalties, seizure, or injunction.