FDA WARNING_LETTER - Ron's Vapor Station - July 07, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Ronald A. Crouse concerning e-liquid products offered for sale on ronsvaporstation.com. The FDA determined that these e-liquid products, including Lucid Air 5,000 Puff – Strawberry Ice and Glas BSX Series Banana Cream Pie with Just Nic Pods, are tobacco products under the FD&C Act, with jurisdiction extended to products containing nicotine from any source as of April 14, 2022. The primary violation identified was the sale of these products to an individual under 21 years of age. This sale violates section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)), rendering the products misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). The letter stresses the firm's responsibility to ensure compliance with all applicable FD&C Act provisions and FDA regulations, including 21 C.F.R. Parts 1140, 1141, and 1143. Ron's Vapor Station must submit a written response within 15 working days, detailing corrective actions taken, including discontinuing violative sales and a plan for maintaining compliance. Failure to address these violations may lead to regulatory actions such as civil money penalties, seizure, or injunction.