FDA WARNING_LETTER - Jams Vaporium - November 02, 2023

The FDA issued a Warning Letter to Jamz Vaporium on November 2, 2023, following a review of inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act due to containing nicotine from any source.

The primary violation identified is the marketing of a "new tobacco product," specifically "JV Tropic Thunda 3mg" e-liquid, without the required premarket authorization. This product is considered "new" because 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 under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Jamz Vaporium must submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales/distribution of the non-compliant products and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.