FDA WARNING_LETTER - Vapor Candy Inc d/b/a The Vape Stop - December 01, 2022

On December 1, 2022, the FDA issued a Warning Letter to Vapor Candy Inc d/b/a The Vape Stop, following a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation identified is the marketing of a "new tobacco product," specifically Vapor Candy Xtra Sweet VS Reserve 6MG e-liquid, without the required premarket authorization. This product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order, a substantial equivalence order, or an exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j).

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA requires the company to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant