FDA WARNING_LETTER - Majestic Vapors, LLC - July 20, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Lance Aaron Harrison of Majestic Vapor (majesticvapor.com) after determining that the company offers Electronic Nicotine Delivery System (ENDS) products for sale in the U.S. without the required marketing authorization. The FDA identified specific products, including "The FITT by Envii – Starter Kit – Fruit," "The FITT by Envii – Starter Kit – Cream," and "Steep Vapors – Pop Deez," as "new tobacco products" under section 910(a) of the FD&C Act. These products were not commercially marketed before February 15, 2007, and lack the necessary FDA marketing authorization orders (section 910(c)(1)(A)(i)). Consequently, they 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 premarket notification (section 905(j)). The FDA also expressed particular concern regarding the "Steep Vapors – Pop Deez" product, whose packaging imitates food products appealing to children, contributing to the rising youth appeal and use of ENDS. Majestic Vapor is required to submit a written response within 15 working days detailing corrective actions, including discontinuing sales and a plan for maintaining compliance with the FD&C Act. Failure to comply may result in further regulatory action, including detention and refusal of admission for imported products.