FDA WARNING_LETTER - Yogi’s Vape Lounge - August 02, 2022

On August 1, 2022, the FDA issued a Warning Letter to Yogi’s Vape Lounge for manufacturing and distributing unapproved new tobacco products. The FDA determined that Yogi’s Vape Lounge manufactures and distributes e-liquid products, specifically "Yogi’s Pinky & The Brain" and "Yogi’s Squirter," which are considered tobacco products under section 201(rr) of the FD&C Act. These products are "new tobacco products" because 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 adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided per section 905(j). The failure to provide such reports and the sale of adulterated/misbranded products are prohibited acts under sections 301(k) and 301(p).

Yogi’s Vape Lounge must submit a written response within 15 working days detailing actions to address violations, including discontinuing violative sales and a plan for compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure,