FDA WARNING_LETTER - Smooth Vapes Hawaii - July 27, 2023

On July 27, 2023, the FDA issued a Warning Letter to Brash LLC d/b/a Smooth Vapes Hawaii, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that Smooth Vapes Hawaii manufactures and distributes e-liquid products, which are deemed tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation cited is the marketing of a "new tobacco product," Smooth Vapes Hawaii Guava Whip 3mg, without the required premarket authorization. This product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order, a substantial equivalence order, or an exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j).

The letter states that marketing new tobacco products without premarket authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. Brash LLC is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuation dates for violative sales and distribution, and a plan for maintaining compliance.