FDA WARNING_LETTER - Holy Cow Ejuice - April 02, 2019

The FDA issued a Warning Letter to Holy Cow eJuice after reviewing their websites, https://www.holy-cow-ejuice.myshopify.com and https://www.holycowejuice.com, which offer e-liquid products. The FDA determined that the company's New Cloud E-juice Blue e-liquid is a tobacco product subject to FDA jurisdiction. The letter identifies two primary violations: first, the sale of New Cloud E-juice Blue 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 and violates 21 C.F.R. § 1140.14(b). Second, the failure of the company's website to include the required nicotine warning statement for the New Cloud E-juice Blue e-liquid product, leading to misbranding under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act, and violating 21 C.F.R. § 1143.3(a) and/or (b). Holy Cow eJuice must immediately correct these violations and submit a written response within 15 working days detailing corrective actions and a plan for maintaining compliance. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.