FDA WARNING_LETTER - V2 Cigs

The FDA's Center for Tobacco Products issued a Warning Letter to V2.com after determining that their e-liquid products, specifically V2 Vanilla Platinum e-liquid, are offered for sale or distribution in the U.S. and are considered tobacco products under the FD&C Act.

The primary violation identified was the sale of a misbranded tobacco product to a minor. An FDA investigation revealed that a person under 18 years of age purchased Zig-Zag Dragonberry e-liquid and received V2 Vanilla Platinum e-liquid from the website. This violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products to individuals under 18. Consequently, the product is misbranded under section 903(a)(7)(B) of the FD&C Act.

V2.com is required to immediately correct this violation and any similar issues to ensure compliance with the FD&C Act and FDA's implementing regulations across all sales and advertising platforms. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative sales and a plan for maintaining compliance.