FDA WARNING_LETTER - The Vapor Master LLC - March 09, 2023

On March 9, 2023, the FDA issued a Warning Letter to The Vapor Master LLC, following a review of submissions and inspection records. The FDA determined that The Vapor Master LLC manufactures and distributes e-liquid products, specifically "Vanilla e-liquid products," which are considered tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include products containing nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. These Vanilla e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the absence of required notices or information under section 905(j).

The FDA states that manufacturing, selling, or distributing such adulterated or misbranded products is a prohibited act under section 301(k), and failure to provide required reports under section 905(j) is a prohibited act under section 301(p). The company is required to submit a written response within 15 working days, detailing actions taken to address violations, including