FDA WARNING_LETTER - Vapor Plus OK LLC - November 29, 2022

On November 10, 2022, the FDA issued a Warning Letter to Nadeem Khan of Vapor Plus OK after reviewing their website, vaporplusok.com. The FDA determined that e-liquid products, specifically "B-Razz," were being manufactured and offered for sale or distribution in the United States. 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 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. "B-Razz" was deemed a new tobacco product because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j).

Vapor Plus OK is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuation of violative activities and a plan for future compliance. Failure to comply may result in regulatory actions