FDA WARNING_LETTER - Vital Vapers LLC - October 06, 2022

The FDA issued a Warning Letter to Vital Vapers LLC on October 6, 2022, following a review of submissions and inspection records. The FDA determined that Vital Vapers LLC manufactures and distributes e-liquid products, specifically "Vital Vapers Angle e-liquid products," which are considered tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include products containing nicotine from any source.

The primary violation identified is that these e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j). The manufacture, sale, or distribution of such products constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Vital Vapers LLC is required to submit a written response within 15 working days detailing actions taken to address these violations, including dates of discontinued sales/distribution and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money