Favorite Daughter, LLC d/b/a Phoenix Vapor Shop – FDA Warning Letter, Aug 29, 2024

On August 29, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to Favorite Daughter, LLC d/b/a Phoenix Vapor Shop, based on a review of inspection records. The company 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 amended on March 15, 2022.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the e-liquid product "Hopscotch" was cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks 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).

The FDA requires the company to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuation dates for 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.