Unlit Vapor Shoppe LLC – FDA Warning Letter, Feb 9, 2023

The FDA issued a Warning Letter to Unlit Vapor Shoppe LLC on February 9, 2023, following a review of submissions and inspection records. The FDA determined that Unlit Vapor Shoppe LLC manufactures and distributes e-liquid products, specifically "Unlit Vapor Shoppe Papa Smurf 3 mg 50/50 e-liquid," which are considered tobacco products under the FD&C Act.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The "Papa Smurf" e-liquid 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. This renders the product 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 FDA considers the sale of such products a prohibited act under sections 301(k) and 301(p) of the FD&C Act. The letter emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction.

Unlit Vapor Shoppe LLC is required to submit a written response within 15 working