FDA WARNING_LETTER - VitaCig Canada - December 10, 2019

The FDA's Center for Tobacco Products reviewed vitacig-canada.com and determined that e-liquid products, specifically STLTH Frost Pod Pack, are offered for sale to U.S. customers. These products are classified as tobacco products under section 201(rr) of the FD&C Act. The FDA found that the STLTH Frost Pod Pack e-liquid product 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 violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products to minors. The company is required to immediately correct this violation and any similar ones, ensuring all tobacco products and related advertising comply with the FD&C Act and FDA regulations. 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 of violative sales and a compliance plan, must be submitted within 15 working days.