HiggyCigs, LLC d/b/a Viral Vapes – FDA Warning Letter, Nov 30, 2023

The FDA issued a Warning Letter to HiggyCigs, LLC d/b/a Viral Vapes on November 30, 2023, following a review of inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, including those containing nicotine from any source as per the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the e-liquid product "Orange" was found to be a new tobacco product, not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. This renders the product 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). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

HiggyCigs, LLC is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing the sale and distribution of non-compliant products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure