FDA WARNING_LETTER - The Vape Shack 808 LLC - May 07, 2019

On April 26, 2019, the FDA issued a Warning Letter to Jason and Justin Inouye, owners of The Vape Shack 808, regarding their e-liquid products sold on http://www.thevapeshack808.com. The FDA determined that their Cherry Cheesecake 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 to a minor violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including e-liquids, to individuals under 18. The FDA's investigation confirmed a minor purchased the Cherry Cheesecake e-liquid from their website. The letter emphasizes that this violation is not exhaustive and requires immediate correction of this and similar issues to ensure compliance with the FD&C Act and FDA regulations. Failure to comply may result in further FDA action, including 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.