WTech Enterprises LLC d/b/a Good Vibes Vapor – FDA Warning Letter, Aug 24, 2023

On August 24, 2023, the FDA issued a Warning Letter to WTech Enterprises LLC d/b/a Good Vibes Vapor, following a review of inspection records. The FDA determined that the company manufactures and distributes e-liquid products, including "Energy Demon," which are considered tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine and are intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. The "Energy Demon" e-liquid product 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, as no required notice or information was provided under section 905(j).

The FDA cited sections 301(k) and 301(p) of the FD&C Act for prohibited acts related to the sale of adulterated/misbranded products and failure to provide required reports. The company is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as