FDA WARNING_LETTER - Madvapes Vape Shop - May 16, 2025

On May 15, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Madvapes Vape Shop for manufacturing, selling, and/or distributing e-liquid products without required marketing authorization. The FDA determined that Madvapes Vape Shop's "Higgy’s Nilla Nutz 6mg" e-liquid product is a "new tobacco product" as defined by section 910(a) of the FD&C Act, because it was not commercially marketed in the United States as of February 15, 2007.

The product lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act and is not exempt from this requirement. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The FDA emphasized that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. Madvapes Vape Shop must submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing the sale/distribution of the violative product and a plan for future compliance.