FDA WARNING_LETTER - Dragon Vapors LLC - September 06, 2022

The FDA issued a Warning Letter to Dragon Vapors LLC on August 31, 2022, following a review of submissions and inspection records. The FDA determined that Dragon Vapors LLC manufactures and distributes e-liquid products, specifically "Mango e-liquid products," which are deemed tobacco products under the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. The "Mango e-liquid products" were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption. This renders the products 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 a prohibited act.

Dragon Vapors LLC's Premarket Tobacco Product Application (PMTA), STN PM0001232, submitted on September 8, 2020, received a "Refuse To Accept" determination on February 2, 2021, covering 50,778 products.

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuation dates for violative sales/distribution and a plan for future compliance. Failure to