FDA WARNING_LETTER - Prodigy Vapor

The FDA Center for Tobacco Products reviewed the website https://www.prodigyvapor.com and found that e-liquid products, specifically Apple Cereal e-liquid, are offered for sale or distribution in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the sale of Apple Cereal e-liquid to a person younger than 18 years of age, which misbrands the product under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products to individuals under 18.

The company is required to immediately correct this violation and any similar ones, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations across all sales channels. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded products imported into the U.S. are subject to detention.

A written response detailing corrective actions, including dates of discontinued violative sales and a plan for maintaining compliance, must be submitted within 15 working days. The