FDA WARNING_LETTER - Mister-E-Liquid LLC - March 25, 2025

The FDA issued a Warning Letter to Mister-E-Liquid LLC on March 21, 2025, following a review of inspection records. The FDA determined that Mister-E-Liquid LLC manufactures, sells, and/or distributes e-liquid products, which are classified as 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.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the product "MEL MISTER-E-LIQUID MENTHOL" was found to be a new tobacco product, not commercially marketed in the U.S. as of February 15, 2007, and lacking an FDA marketing authorization order or 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 absence of required notice or information under section 905(j).

Mister-E-Liquid LLC 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 violative products, and outlining a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure