FDA WARNING_LETTER - Sunset Wholesale Tobacco, Inc. - June 13, 2025

On June 12, 2025, the FDA issued a Warning Letter to Sunset Wholesale Tobacco, Inc. following a review of inspection records, determining the company sells and distributes Electronic Nicotine Delivery System (ENDS) products in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction and compliance requirements.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, the product "Pod Juice OXBAR MAGIC MAZE 2.0 ZODIAC EDITION LIBRA II CLEAR PINK 5% Nicotine" was found to be a new tobacco product, not commercially marketed before February 15, 2007, and lacking an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires Sunset Wholesale Tobacco, Inc. to submit a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales/distribution of the violative products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.