FDA WARNING_LETTER - SV3, LLC d/b/a Mi-One Brands - December 13, 2022

The FDA issued a Warning Letter to Geoff Habicht and Amir Hakak on December 2, 2022, after reviewing the website mipod.com. The review determined that Electronic Nicotine Delivery System (ENDS) products, specifically Smoking Vapor Blueberry Cartridges 50pk, Smoking Vapor Vanilla Cartridges 50pk, and Smoking Vapor Grape Blend E-Cigar, are manufactured and offered for sale or distribution in the U.S. These products are deemed "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

The FDA found these ENDS products are being marketed without the required premarket authorization order, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. While the firm submitted Premarket Tobacco Product Applications (PMTAs) for 14 other products, the products listed in this Warning Letter are not included in those applications and lack the necessary authorization.

The letter requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.