FDA WARNING_LETTER - Van Howling Enterprise LLC d/b/a Driftwood Vapor - April 05, 2021

The FDA issued a Warning Letter to Van Howling Enterprise LLC d/b/a Driftwood Vapor, identifying that their DRIFTWOOD VAPOR Watermelon 3MG e-liquid product is a "new tobacco product" lacking the required marketing authorization. This product was not commercially marketed in the U.S. as of February 15, 2007, and does not have an FDA marketing authorization order or exemption.

Consequently, the product is deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) because required notice or information under section 905(j) was not provided. The manufacture, sale, and/or distribution of such a product constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The FDA requires Van Howling Enterprise LLC to submit a written response within 15 working days detailing corrective actions, including the discontinuation dates of violative sales and distribution, and a plan for maintaining compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The firm is a registered manufacturer with over 3,600 products listed with FDA, and it is their responsibility to ensure compliance with all applicable provisions of the FD&C Act and FDA regulations.