What happened
Original notice title
Northland Vapor Company, LLC MARCS-CMS 648568, July 07, 2023
From the archived source record
Based on the inspection, a review of the product labels collected during the inspection, and laboratory analysis of your products, FDA has determined that your “Death by Gummy Bears” and “Wonky Weeds” gummy bear products you manufactured in your facility are adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. § 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Additionally, we have determined that the RTE food products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. Based on our review of the inspectional findings and the response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. This letter informs you that your firm markets Delta-8 THC-containing products that may pose a serious health risk to consumers. Adulterated Human Foods (section 402(a)(2)(C)(i) of the FD&C Act) According to your product labeling, your “Death by Gummy Bears” and “Wonky Weeds” gummy bear products are foods to which Delta-8 THC has been added. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the FD&C Act, 21 U.S.C. § 348(a), and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(i). Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a). Some of the available data raise serious concerns about potential harm from Delta-8 THC.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- deaad6bb1adb
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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