VAPORIZIT LLC – FDA Warning Letter, Jun 28, 2022

This FDA Warning Letter, dated June 28, 2022, addresses Vaporizit LLC for manufacturing and distributing e-liquid products, specifically "Vaporizit Cosmic Cow e-liquid products," without required premarket authorization. The FDA determined these products are "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack 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 authorization or notice under section 905(j). The letter states that marketing such products unlawfully is a prohibited act under sections 301(k) and 301(p) of the FD&C Act.

Vaporizit LLC is a registered manufacturer with over 12,800 listed products. The FDA prioritizes enforcement against products without pending applications or those with Marketing Denial Orders. The company is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction