FDA WARNING_LETTER - Vaping Studio Inc - March 17, 2020

On January 14, 2020, the FDA issued a Warning Letter to Paula Williams regarding e-liquid products sold on vapingstudio.com. The FDA determined that the 10ml BOGO e-liquid product is a tobacco product under section 201(rr) of the FD&C Act and is misbranded.

The primary violation is that the website advertising for the 10ml BOGO e-liquid product fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(b), which mandates this warning for covered tobacco products in advertising. Consequently, the product is misbranded under section 903(a)(7)(B) of the FD&C Act. Additionally, the product is misbranded under section 903(a)(7)(A) of the FD&C Act because the omission of the warning makes the advertising misleading by failing to reveal material facts about the product's consequences.

The letter requires immediate correction of these violations and similar issues across all advertising platforms. 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 dates of discontinuation of violative activities and a plan for compliance, is required within 15 working days