FDA WARNING_LETTER - Kuni Vapes, LLC

The FDA Center for Tobacco Products reviewed kunivapes.com and determined that e-liquid products, specifically Vape Tree Unicorn Milk e-liquid, are offered for sale or distribution in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The FDA found that Vape Tree Unicorn Milk e-liquid is misbranded under section 903(a)(7)(B) of the FD&C Act because it was sold to a person younger than 18 years of age. This violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products, including e-liquids, to individuals under 18. The product is a "covered tobacco product" as defined by 21 C.F.R. § 1140.3.

The letter requires immediate correction of this violation and similar issues to ensure compliance with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates of violative sales and a plan for maintaining compliance, is required within 15 working days. The reference number for the response is RW1700777.