FDA EIR - American Vape Company LLC - September 08, 2022

An FDA inspection of American Vape Company LLC, also operating as American Vapor Company and its subsidiary KoKo Distribution LLC, was conducted from August 31 to September 8, 2022. The inspection focused on compliance with the Family Smoking Prevention and Tobacco Control Act and amendments to the Federal Food, Drug, and Cosmetic Act, particularly concerning non-tobacco derived nicotine (NTN) products, which fell under FDA regulation effective April 14, 2022. The primary issue identified was the company's continued marketing and distribution of Pastel Cartel Esco Bars NTN e-liquid products without the required FDA marketing authorization. Additionally, advertisements lacked mandatory nicotine warning statements, and the use of the term "natural" in promotions was flagged as a potential unapproved modified risk claim. Minor production errors, such as inconsistent batch labeling and mispackaging, were also observed. The FDA advised the company to rectify these issues, update all advertising with proper warnings, remove unapproved claims, and cease marketing unauthorized NTN products. The agency warned that non-compliance could lead to severe regulatory actions, including product seizures, injunctions, and civil penalties.