FDA WARNING_LETTER - Loveli Design LLC d/b/a Alice in Vapeland - February 25, 2025

The FDA issued a Warning Letter to John Flynn of Alice Extracts on February 21, 2025, following a review of their website, aliceextracts.com. The FDA determined that e-liquid products manufactured and offered for sale, specifically "Unflavored Alice 60ml 6mg," "Unflavored Alice 60ml 11mg," and "Unflavored Alice 15ml 18mg," are tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The primary violation is the lack of required premarket authorization orders 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 due to the absence of required notices or information under Section 905(j).

The letter mandates prompt action to address these violations and bring products into compliance. A written response is required within 15 working days, detailing corrective actions, including discontinuation of violative sales and a plan for maintaining