FDA WARNING_LETTER - Etomic LLC d/b/a Rogue Liquids - January 11, 2022

The FDA issued a Warning Letter to Matt Schwarmann of Rogue Liquids on January 7, 2022, after reviewing their website, rogueliquids.com. The FDA determined that Rogue Liquids manufactures and offers for sale e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, without the required premarket authorization. Products such as Rogue Sucka Punch, Rogue Tricks Mix, and Rogue Wildberry Rainbow are considered "new tobacco products" as they were not commercially marketed before February 15, 2007, and lack an FDA marketing authorization order. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, specifically for failing to provide required information under section 905(j). Although a Premarket Tobacco Product Application (PMTA) was submitted, it received a "Refuse to Accept" determination. The letter states that all new tobacco products marketed without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. Rogue Liquids must submit a written response within 15 working days detailing actions to address these violations, discontinue violative activities, and outline a plan for maintaining compliance with the FD&C Act.