Fallout Vapor Inc. – FDA Warning Letter

The FDA issued a Warning Letter to Joseph Hunter Knight regarding the sale of e-liquid products on the website https://squareup.com/market/fallout-vapor. The FDA determined that "Project Trinity Broken Arrow 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 because it was sold to a person younger than 18 years of age.

This sale violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including e-liquids, to individuals under 18. The product is deemed a "covered tobacco product" under 21 C.F.R. § 1140.3 and § 1100.2.

The FDA requires immediate correction of this violation and similar issues, ensuring compliance with the FD&C Act for all tobacco products, labeling, and advertising across all sales channels. 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 and a compliance plan, is required within 15 working days.