FDA WARNING_LETTER - Vapor Mix - May 09, 2025

On May 8, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Vapor Mix, identifying that the company manufactures, sells, and/or distributes e-liquid products, including "Grape Bubble Gum," to U.S. customers. These products 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 is that Vapor Mix's e-liquid products are "new tobacco products" that lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and do not have FDA marketing authorization or an exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j).

Vapor Mix is required to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing the sale/distribution of the non-compliant products and outlining a plan for maintaining compliance. Failure to comply may result in regulatory actions