American Legends Eliquid – FDA Warning Letter, Sep 29, 2022

The FDA issued a Warning Letter to American Legends Eliquid on September 29, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, due to containing nicotine and being intended for human consumption. Recent legislation expanded this definition to include nicotine from any source.

The primary violation identified is the marketing of American Legends E Liquid Loki 18MG e-liquid without the required premarket authorization. This product is considered a "new tobacco product" as it was not commercially marketed in the U.S. 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, as no required notice or information was provided.

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA requires American Legends Eliquid to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing sales and distribution of the non-compliant products, and outlining a plan for maintaining future compliance. Failure to comply may result in regulatory actions such as civil money penalties