Nicotine River LLC – FDA Warning Letter, Oct 25, 2022

The FDA issued a Warning Letter to Grant Boatman of Nicotine River, LLC on October 19, 2022, following a review of their website, nicotineriver.com. The FDA determined that e-liquid products, including SyNic Nicotine, SyNic Smooth Nicotine Salt, SyNic Pure Nicotine, and PurNic Pure Nicotine, were manufactured and offered for sale or distribution in the U.S. These products are classified as tobacco products under the FD&C Act, as amended on March 15, 2022, to include products containing nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. These e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because no notice or information was provided as required by section 905(j).

The FDA has not received an application for marketing authorization for these products. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The company is required to submit a written response within 15 working days detailing actions taken to address the violations