FDA WARNING_LETTER - ADP Marketing LLC d/b/a Vaporistic - August 23, 2022

On August 23, 2022, the FDA issued a Warning Letter to ADP Marketing LLC d/b/a Vaporistic for manufacturing and distributing e-liquid products, specifically "Captain Crunch e-liquid products," without required marketing authorization. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include products containing nicotine from any source.

The FDA determined that these e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt. Consequently, the 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 notice or information under section 905(j).

The letter states that the failure to provide the required report under section 905(j) is a prohibited act under section 301(p) of the FD&C Act, and any act resulting in adulterated or misbranded products held for sale after interstate commerce shipment is prohibited under section 301(