FDA WARNING_LETTER - Daddy’s Vapor Distro Inc. - November 08, 2024

This FDA Warning Letter, dated November 6, 2024, informs Daddy’s Vapor Distro Inc. that it sells and/or distributes e-liquid products, which are regulated as tobacco products under the FD&C Act. The letter highlights that the definition of "tobacco product" was expanded on March 15, 2022, to include products with nicotine from any source.

The primary violation identified is the marketing of a "new tobacco product" without required premarket authorization. Specifically, the product "MRKT PLCE ELIQUID Blood Orange Tangoberry 100ML 3MG" was found to be a new tobacco product, as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires the company to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and/or distribution of the violative products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.