LA Vape Co – FDA Warning Letter, Sep 14, 2023

The FDA issued a Warning Letter to Peter Nesh on September 14, 2023, after reviewing the website https://shop.lavapeco.com, which offers Electronic Nicotine Delivery System (ENDS) products for sale in the U.S. These products are considered tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Specifically, the product "ElfBar 5000 Lemon Mint" was found to be a new tobacco product not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. This renders the product 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 or information under section 905(j).

The FDA requires a written response within 15 working days detailing actions taken to address these violations, including discontinuation of violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The letter also notes that imported products appearing