FDA WARNING_LETTER - Vapor Stix Inc

The FDA Center for Tobacco Products issued a Warning Letter to Jim Sanders regarding e-liquids sold on vapor-stix.net. The FDA determined that Space Jam Andromeda e-liquid is a tobacco product under section 201(rr) of the FD&C Act and is misbranded under section 903(a)(7)(B) because it was sold to a person younger than 18 years of age.

The investigation revealed a specific instance where a minor purchased Space Jam Andromeda e-liquid from the website. 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 deemed a "covered tobacco product" under 21 C.F.R. § 1140.3 and § 1100.2.

The letter requires immediate correction of this violation and similar issues to ensure compliance with the FD&C Act and FDA's regulations. 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 dates of discontinued sales and a plan for maintaining compliance, is required within 15 working days.