FDA WARNING_LETTER - Yogi's Vape Hays - March 15, 2022

The FDA issued a Warning Letter to Yogi's Vape on March 15, 2022, following a review of submissions and inspection records. The FDA determined Yogi's Vape manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, Yogi’s Key Lime Pie 3mg 120ml and Yogi’s Pinky & the Brain 6mg 60ml e-liquid products were found to be commercially marketed after February 15, 2007, without an FDA marketing authorization order, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act.

Yogi's Vape is a registered manufacturer with over 31,300 products listed. A 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. Products with Marketing Denial Orders or