Delaware Vapor – FDA Warning Letter, Oct 8, 2019

On September 30, 2019, the FDA issued a Warning Letter to Andrew Wolford of Delaware Vapor, LLC, following a review of their website, http://www.delawarevapor.com. The FDA determined that e-liquid products, specifically Perfected Vapes Crunchberry e-liquid, are manufactured and sold in the U.S. and are considered tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified was the sale of Perfected Vapes Crunchberry e-liquid to a person younger than 18 years of age, which constitutes misbranding 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 the sale of covered tobacco products, including e-liquids, to minors.

Delaware Vapor is required to immediately correct this violation and any similar issues to ensure compliance with the FD&C Act and FDA regulations. 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