Yogi's Vape – FDA Warning Letter, Aug 2, 2022

The FDA issued a Warning Letter to Yogi's Vape - Hays on August 1, 2022, following a review of submissions and inspection records. The letter states that Yogi's Vape - Hays manufactures and distributes e-liquid products, specifically "Yogi's Key Lime Pie" and "Yogi's Pinky and the Brain," which are considered tobacco products under section 201(rr) of the FD&C Act due to containing nicotine.

The primary violation is that these e-liquid products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided.

The FDA considers the manufacturing, sale, and/or distribution of these unauthorized products to be prohibited acts under sections 301(k) and 301(p) of the FD&C Act. Yogi's Vape - Hays is required to submit a written response within 15 working days, detailing actions taken to address the violations