FDA WARNING_LETTER - EcigWEcig

The FDA issued a Warning Letter to EcigWecig following a review of their website, http://www.ecigwecig.com, which revealed that their e-liquid products, specifically Honey Bear e-liquid, are tobacco products subject to FDA jurisdiction. The primary violation identified was the sale of Honey Bear e-liquid to a person younger than 18 years of age. This action violates 21 C.F.R. ? 1140.14(b), which prohibits retailers from selling covered tobacco products to minors, and consequently renders the product misbranded under section 903(a)(7)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). EcigWecig is required to immediately correct this violation and any similar deficiencies, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. A written response detailing corrective actions, including dates of discontinuing violative sales and a plan for sustained compliance, must be submitted within 15 working days. Failure to comply may result in severe enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction.