FDA WARNING_LETTER - Smart Smoke, Inc. - May 24, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Joshua Jamerson and Melanie Jamerson of Smart Smoke, Inc. following a review of their website, smartsmoke.com. The FDA determined that the company manufactures and offers for sale or distribution e-liquid products, specifically SmartNic Hazelnut and SmartNic Blackberry, which are considered tobacco products under section 201(rr) of the FD&C Act.

These e-liquid products are deemed "new tobacco products" because they were not commercially marketed in the United States as of February 15, 2007. The primary violation is that these products are being marketed without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and a plan for maintaining future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The letter also notes that imported products appearing adulterated or misbranded may be detained or refused admission.