The Vapor Club LLC – FDA Warning Letter, Feb 28, 2025

On February 27, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to The Vapor Club LLC, based on a review of inspection records. The letter states that The Vapor Club LLC sells and/or distributes e-liquid products in the United States, which are considered tobacco products under section 201(rr) of the FD&C Act, as they are made or derived from tobacco or contain nicotine from any source and are intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the product "Beard Vape Co. No. 24 Salted Caramel Malt 6MG 120 ML" was cited. This product is deemed a new tobacco product because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, this product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j).

The FDA requires The Vapor Club LLC 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 sales/distribution of the violative products