FDA WARNING_LETTER - Mighty Vapors, LLC, d/b/a Ovo Manufacturing & Distribution - August 08, 2019

The FDA issued a Warning Letter to Mighty Vapors, LLC, d/b/a Ovo Manufacturing & Distribution, on August 8, 2019, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act.

The FDA determined that six specific e-liquid products—Hulk Tears NicSalts, Frozen Hulk Tears NicSalts, Majestic Mango NicSalts, Frozen Majestic Mango NicSalts, Mystery Pop NicSalts, and Frozen Mystery Pop NicSalts—are adulterated and/or misbranded. These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. Consequently, they require premarket review and a marketing authorization order from the FDA under section 910(c)(1)(A)(i) of the FD&C Act.

The company is in violation because these products lack the required FDA marketing authorization orders, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the absence of required notices or information under section 905(j). The introduction of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a), and failure to provide required reports is prohibited under section