FDA WARNING_LETTER - JSMT LLC d/b/a VaporFI - March 20, 2025

On March 20, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to JSMT LLC, d/b/a VaporFi, based on a review of inspection records. The FDA determined that VaporFi manufactures, sells, and/or distributes e-liquid products, specifically "LMN BLEND," 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 "new tobacco products" without the required premarket authorization order. The "LMN BLEND" e-liquid product was not commercially marketed in the United States as of February 15, 2007, and lacks FDA marketing authorization under section 910(c)(1)(A)(i) of the FD&C Act, nor is it exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notices or information were not provided under section 905(j).

VaporFi is required to submit a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales/distribution and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties