FDA WARNING_LETTER - my vapor den - April 28, 2025

On April 24, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to My Vapor Den Inc, d/b/a Nu Age Smoke & Vape, following a review of inspection records. The letter states that the company sells and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine from any source and are intended for human consumption.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization order. Specifically, the product "Twin Pack Candy King Tropic Bubblegum Collection 3MG 2x60 ML" was found to be a new tobacco product because it was not commercially marketed in the United States 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 the discontinuation of the violative sale and distribution of these products, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.