FDA WARNING_LETTER - Vanity Vapor - April 28, 2025

On April 24, 2025, the FDA issued a Warning Letter to Vanity Vapor, identifying violations related to the manufacturing, sale, and distribution of e-liquid products in the United States. The FDA determined that Vanity Vapor's e-liquid products, specifically "Milk Chocolate," are "new tobacco products" under section 201(rr) of the FD&C Act because they contain nicotine and are intended for human consumption.

These products are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, the "Milk Chocolate" e-liquid product is 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).

Vanity Vapor is required to submit a written response within 15 working days from receipt of the letter, detailing actions taken to address the violations, including dates of discontinued sale/distribution and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.