FDA WARNING_LETTER - Custom Vapors LLC - October 07, 2021

The FDA issued a Warning Letter to Custom Vapors LLC, identifying two e-liquid products, "Custom Vapors Cantaloupe 3mg 120ml" and "Custom Vapors Naked 3mg 120ml," as new tobacco products marketed without required premarket authorization. These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because they were not commercially marketed before February 15, 2007, and lack FDA marketing authorization orders or exemptions.

The company's Premarket Tobacco Product Application (PMTA), STN PM0003470, submitted on September 8, 2020, received a Marketing Denial Order on August 31, 2021, covering 276 products. The FDA states that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement action, with products lacking pending applications or having received Marketing Denial Orders being high enforcement priorities.

Custom Vapors LLC is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale and distribution of non-compliant products, and outlining a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.