FDA WARNING_LETTER - Big D Vapor LLC - April 07, 2020

The FDA's Center for Tobacco Products reviewed the website bigdvapor.net and determined that Electronic Nicotine Delivery System (ENDS) products were offered for sale or distribution in the U.S. These products are regulated as tobacco products under the FD&C Act, effective August 8, 2016.

The FDA identified violations for offering "new tobacco products" without required premarket authorization. Specifically, SKOL/JUUL Compatible Pods - Mango, SMPO Replacement Pods - Mango, and Fit Universal Pods - Red Apple were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lacked 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 absence of required premarket notification under section 905(j).

The letter requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance. Failure to comply may result in civil money penalties, seizure, and/or injunction. Adulterated and misbranded products are also subject to import detention and refusal.