FDA WARNING_LETTER - Northland Vapor Company, LLC - December 07, 2022

The FDA conducted an inspection of Wonky Confections, LLC, a manufacturer of ready-to-eat human food products containing Delta-8 THC, from November to December 2022. The inspection revealed significant violations, resulting in a Warning Letter. The firm's "Death by Gummy Bears" and "Wonky Weeds" gummy products were found to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act because Delta-8 THC is an unapproved and unsafe food additive, lacking Generally Recognized As Safe (GRAS) status. Additionally, these products were adulterated under section 402(a)(4) due to preparation, packing, or holding under insanitary conditions. Specific Current Good Manufacturing Practice (CGMP) violations included failure to ensure proper employee handwashing (21 CFR 117.10(b)(3)), inadequate handwashing facilities (21 CFR 117.37(e)), and improper cleaning and sanitizing of food-contact surfaces (21 CFR 117.35(a)). The products were also misbranded under section 403(w) for failing to declare soy, a major food allergen, on their labels. Finally, the facility failed to register with FDA as required by section 415 of the FD&C Act, which is a prohibited act under section 301(dd). The FDA requires a written response within 15 working days detailing corrective actions and a timeline, and facility registration within 30 working days, warning of potential legal action if non-compliance persists.