FDA WARNING_LETTER - Mixology Ltd d.b.a. Mixology Vape - September 07, 2022

On August 19, 2022, the FDA issued a Warning Letter to Mixology Vape (https://www.mixologyvape.co.nz) for selling electronic nicotine delivery systems (ENDS) to customers in the United States. The FDA determined that the Pacha Mama Disposable Vape Device – Pink Lemonade ENDS product was sold to an individual under 21 years of age, which constitutes a violation.

Under section 201(rr) of the FD&C Act, ENDS products are classified as tobacco products. Effective April 14, 2022, the definition of "tobacco product" expanded to include products containing nicotine from any source. As of December 20, 2019, it is illegal for retailers to sell tobacco products to anyone under 21, as per section 906(d)(5) of the FD&C Act. The sale to an underage individual renders the product misbranded under section 903(a)(7)(B) of the FD&C Act.

Mixology Vape must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, injunction, or refusal of import. The letter also reminds the company about premarket authorization requirements for "new tobacco products."