FDA WARNING_LETTER - K&D Vapors Inc - July 22, 2021

The FDA issued a Warning Letter to K&D Vapors, identifying that the company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act. The letter states that K&D Vapors' "Texas Juice 3mg 33ml e-liquid product" is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the distribution of this new tobacco product without the required premarket authorization from the FDA, specifically a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The letter emphasizes that manufacturing or selling adulterated/misbranded tobacco products, or failing to provide required reports, are prohibited acts under sections 301(k) and 301(p) of the FD&C Act. K&D Vapors, a registered manufacturer with over 2,100 listed products, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/