Rev Products LLC – FDA Warning Letter, Aug 16, 2022

The FDA issued a Warning Letter to the company operating revecig.com for violations related to the manufacture and sale of Electronic Nicotine Delivery Systems (ENDS) products. The FDA determined that ENDS products, including "Banana Ice," "Cola Ice," and "Ice Grape," were offered for sale in the U.S. without the required premarket authorization. These products are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Additionally, the company failed to register its manufacturing establishment at 1309 Coffeen Avenue Suite 2579 Sheridan, WY 82801, as required by section 905(c) of the FD&C Act, resulting in the misbranding of all tobacco products manufactured there under section 903(a)(6). The introduction or delivery of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a) and 301(k) of the FD&C Act.

The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation of violative activities and a plan for future compliance.