FDA WARNING_LETTER - Massive Vapor

The FDA Center for Tobacco Products issued a Warning Letter to Christa Lee regarding the sale of e-liquid products on the website https://squareup.com/store/massive-vapor. The FDA determined that the "Massive Vapor Mama Mia e-liquid" is a tobacco product under section 201(rr) of the FD&C Act and is misbranded under section 903(a)(7)(B) of the FD&C Act.

The primary violation identified was the sale of this e-liquid product to a person younger than 18 years of age, which violates 21 C.F.R. § 1140.14(b). This regulation prohibits retailers from selling covered tobacco products, including e-liquids, to minors. The FDA's investigation confirmed a minor purchased the "Massive Vapor Mama Mia e-liquid" from the website.

The letter requires immediate corrective action for this violation and any similar issues across all sales platforms. Failure to comply may result in further FDA actions, including 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 RW1700798.