FDA WARNING_LETTER - Yogi’s Vape Lounge - December 01, 2021

The FDA issued a Warning Letter to Yogi’s Vape Lounge on December 1, 2021, for manufacturing and distributing unapproved new tobacco products. The FDA determined that e-liquid products, including "Yogi’s Squirter 3mg 60ml" and "Yogi’s Pinky & The Brain 6mg 60ml," are tobacco products under the FD&C Act and require premarket authorization. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack the required FDA marketing authorization order, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Yogi’s Vape Lounge is a registered manufacturer with over 31,300 listed products. Their Premarket Tobacco Product Application (PMTA), STN PM0003759, submitted on September 2, 2020, received a Marketing Denial Order on September 9, 2021, covering 24,760 products. The FDA considers products without pending applications or with Marketing Denial Orders as high enforcement priorities.

The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution of violative products, and a plan for maintaining compliance