FDA WARNING_LETTER - JP Ventures LLC dba iVape - October 12, 2023

On October 12, 2023, the FDA issued a Warning Letter to JP Ventures LLC d/b/a iVape, following a review of inspection records. The FDA determined that iVape manufactures and distributes e-liquid products, including "Carolina Crush," which are considered tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. 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 failure to provide required notices or information under section 905(j).

The letter states that manufacturing, selling, or distributing such adulterated or misbranded products is a prohibited act under section 301(k) and 301(p) of the FD&C Act. iVape is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution of non-compliant products, and outlining a plan for maintaining