FDA WARNING_LETTER - 9 South Vapes - October 07, 2021

The FDA issued a Warning Letter to 9 South Vapes, LLC, identifying violations related to the manufacturing and distribution of e-liquid products. The FDA determined that 9 South Vapes, LLC manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation cited is the marketing of a "new tobacco product" without the required premarket authorization. Specifically, the "9 6mg 60 ML nicotine e-liquid product" was found to be 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. This renders the product 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 information under section 905(j).

The letter states that the firm is a registered manufacturer with over 400 products listed with FDA. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement action, including civil money penalties, seizure, and/or injunction.

9 South Vapes, LLC is required to submit a written response within 15 working days detailing actions taken to address the violations, including