Northland Vapor Company, LLC

Warning LetterOpen

Brett T. Erpelding Chief Executive Officer Northland Vapor Company, LLC 201 Fifth Street North, 16th Floor Fargo , ND 58102 United StatesIssued Jul 7, 2023Division of Human and Animal Food Operations West I

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations6

Issue DateJul 7, 2023

Product TypeFood & Beverages

StatusOpen

Letter Details

Firm: Northland Vapor Company, LLC
Location: Brett T. Erpelding Chief Executive Officer Northland Vapor Company, LLC 201 Fifth Street North, 16th Floor Fargo , ND 58102 United States
FEI Number: N/A
Country: United States
Issue Date: July 07, 2023
Issuing Office: Division of Human and Animal Food Operations West I
Product Type: Food & Beverages
Status: Open

Summary

Northland Vapor Company, LLC manufactured ready-to-eat gummy products containing Delta-8 THC that were determined to be adulterated due to containing unsafe food additives and being prepared, packed, or held under insanitary conditions where they may have become contaminated with filth or rendered injurious to health. The FDA inspection of the Wonky Confections facility in Moorhead, Minnesota (conducted November-December 2022) identified multiple CGMP and sanitation deviations documented on Form FDA-483, which the company's December 2022 response failed to adequately address. The specific products cited—"Death by Gummy Bears" and "Wonky Weeds" gummy bear products—violated section 402(a)(2)(C)(i) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, making their introduction into interstate commerce illegal.

Northland Vapor Company, LLC FDA Warning Letter, July 7, 2023