FDA WARNING_LETTER - Chevaline Investments, LLC d/b/a VaporCore - January 05, 2023

On January 5, 2023, the FDA issued a Warning Letter to Chevaline Investments, LLC d/b/a VaporCore, based on a review of submissions and inspection records. The FDA determined that VaporCore manufactures and distributes "Watermelon Machine Gun e-liquid products" for commercial distribution in the United States. These e-liquid products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. The "Watermelon Machine Gun e-liquid 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. The failure to provide a required report under section 905(j) is also cited as a prohibited act.

The FDA requires prompt action to address these violations, including discontinuing the sale and distribution of the non-compliant products. VaporCore must submit a written response within 15 working days detailing actions taken to achieve compliance, including discontinuation dates and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and