Vaping Delights LLC – FDA Warning Letter, Jul 7, 2022

On June 30, 2022, the FDA issued a Warning Letter to Michael Andrew Hurley regarding e-liquid products sold on vaping-delights.com. The FDA determined that e-liquid products, including those containing nicotine from any source, are tobacco products subject to FDA jurisdiction.

The primary violation identified was the sale of a tobacco product, specifically "Glas BSX Series – PBLS" e-liquid, to an individual under 21 years of age. This constitutes misbranding under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), as it violates section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)), which prohibits the sale of tobacco products to persons under 21.

The letter emphasizes the retailer's responsibility to ensure compliance with the FD&C Act and FDA regulations, including 21 C.F.R. Parts 1140, 1141, and 1143. Failure to correct violations may result in regulatory actions such as civil money penalties, seizure, or injunction. The FDA also noted that "new tobacco products" require premarket authorization.

A written response detailing corrective actions, including discontinuation of violative sales and a