Vape On LLC d/b/a Imperial Vapor Co. – FDA Warning Letter, Aug 29, 2024

On August 29, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to Vape On LLC d/b/a Imperial Vapor Co. following a review of inspection records. The FDA determined that Imperial Vapor Co. manufactures, sells, and/or distributes e-liquid products, specifically "White Peach Ice," which are considered tobacco products under section 201(rr) of the FD&C Act due to containing nicotine from any source and being intended for human consumption.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. The "White Peach Ice" e-liquid product was not commercially marketed in the U.S. as of February 15, 2007, and lacks the necessary FDA marketing authorization or exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because no notice or information was provided as required by section 905(j).

The FDA requires Imperial Vapor Co. to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative products and a plan for maintaining compliance. Failure to comply may result in regulatory actions