Distinctive USA LLC – FDA Warning Letter, Feb 1, 2024

On January 31, 2024, the FDA issued a Warning Letter to Gloria E Duque Revelo and Alex Revelo regarding the sale of unauthorized electronic nicotine delivery system (ENDS) products on their website, distinctivevapes.com. The FDA's Center for Tobacco Products determined that products listed on the website, specifically "Elf Bar 5000BC Disposable Vape 5000 Puffs - Sakura Grape" and "Elf Bar Lost Mary OS 5000 Puffs Disposable Vape - Energy," are tobacco products under section 201(rr) of the FD&C Act.

These products are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.