FDA WARNING_LETTER - KCs Vapors LLC - March 20, 2025

The FDA issued a Warning Letter to KC’s Vapors LLC on March 20, 2025, following a review of inspection records. The FDA determined that KC’s Vapors LLC manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, including those containing nicotine from any source as per the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the product "Sweet Guava" e-liquid was cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information under section 905(j) was not provided.

KC’s Vapors LLC is required to submit a written response within 15 working days from receipt of the letter. The response must detail actions taken to address the violations, including dates of discontinued sale/distribution of the violative products, and a plan for maintaining compliance with the FD&C Act. Failure to comply may result in regulatory actions such as