FDA WARNING_LETTER - Lucky's Vape Lounge LLC - April 16, 2021

The FDA issued a Warning Letter to Lucky’s Vape Lounge, LLC, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that Lucky’s Vape Lounge, LLC manufactures and distributes e-liquid products, which are deemed tobacco products under section 201(rr) of the FD&C Act.

The primary violation is the marketing of a "new tobacco product," specifically "Lucky’s VapeWaterpop 6 e-liquid product," without the required premarket authorization. This product was not commercially marketed in the United States as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) of the FD&C Act is also cited as a prohibited act under section 301(p).

Lucky’s Vape Lounge, LLC is a registered manufacturer with over 16,000 products listed with the FDA. The letter emphasizes the firm's responsibility to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction.

The firm is required to submit a written response within 1