Modfathers Vapor – FDA Warning Letter, Jan 19, 2023

The FDA issued a Warning Letter to Modfathers Vapor on January 19, 2023, based on a review of submissions and inspection records. The letter states that Modfathers Vapor manufactures and distributes e-liquid products, specifically "ACAI DOUGHNUT 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 identified is the marketing of "new tobacco products" without the required premarket authorization. The FDA determined that the "ACAI DOUGHNUT e-liquid products" were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required information under section 905(j).

The letter emphasizes that marketing new tobacco products without premarket authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. Modfathers Vapor is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the