FDA WARNING_LETTER - Day 2 Day LLC d/b/a Day 2 Day Tobacco - September 14, 2023

The FDA Center for Tobacco Products issued a Warning Letter on September 14, 2023, to Akberet Kelete Daniel and Amanuel Bahlibi, regarding the sale of Electronic Nicotine Delivery System (ENDS) products on their website, https://day2daytobacco.com.

The FDA determined that the ENDS products, specifically Bang XXL – Honeydew Melon Ice, Cali Bar - Peach Ice, and Elf Bar – Tropical Rainbow Blast, are "new tobacco products" under section 201(rr) of the FD&C Act. These products 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 because the necessary notice or information was not provided as required by section 905(j). The letter emphasizes that all new tobacco products marketed without statutory premarket authorization are unlawful and subject to enforcement action, including civil money penalties, seizure, and/or injunction.

The firm is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales and a plan