Nice Guys Distributing – FDA Warning Letter, Apr 15, 2021

The FDA issued a Warning Letter to Nice Guys Distributing, identifying that their e-liquid product, "Mr. Nice Guy’s E-Juice Etc. 2 Pussy Cat," is a "new tobacco product" lacking the required premarket authorization. This determination stems from the product not being commercially marketed in the U.S. as of February 15, 2007, and not having an FDA marketing authorization order or exemption.

Consequently, the product is deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for failing to provide required notice or information under section 905(j). The manufacture, sale, or distribution of such a product is a prohibited act under sections 301(k) and 301(p) of the FD&C Act.

Nice Guys Distributing, a registered manufacturer with over 600 listed products, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation dates for the violative product, and a plan for ongoing compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction.