FDA WARNING_LETTER - Southbound Vapes - January 19, 2023

On January 19, 2023, the FDA issued a Warning Letter to Southbound Vapes, identifying that the company manufactures and distributes e-liquid products, specifically "Berry Blast e-liquid products," which are deemed tobacco products under the FD&C Act.

The FDA determined these 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. This renders them adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) due to the absence of required notice or information under section 905(j).

The letter states that marketing these products without authorization is unlawful and a prohibited act under sections 301(k) and 301(p) of the FD&C Act. Southbound Vapes is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.