Alohma, LLC d/b/a Kure CBD & Vape – FDA Warning Letter, Apr 28, 2025

The FDA's Center for Tobacco Products issued a Warning Letter to My Vapor Den Inc, d/b/a Nu Age Smoke & Vape, on April 24, 2025, following a review of inspection records. The company sells e-liquid products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source, effective March 15, 2022.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Twin Pack Candy King Tropic Bubblegum Collection 3MG 2x60 ML" 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 from receipt of the letter. This response must detail actions taken to address the violations, including dates of discontinued sales and distribution of the violative products, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The letter emphasizes the company's responsibility to ensure all tobacco