FDA WARNING_LETTER - Vital Vapers LLC - October 13, 2022

The FDA issued a Warning Letter to Vital Vapers LLC on October 13, 2022, following a review of submissions and inspection records. The FDA determined that Vital Vapers LLC manufactures and distributes "Angle e-liquid products" which are considered tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine from any source and are intended for human consumption.

The primary violation 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. Specifically, Vital Vapers LLC has not obtained a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt from this requirement.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under 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 must submit a written response within 15 working days detailing actions taken to address these violations, including discontinuation