What happened
Original notice title
North Carolina Hemp Exchange, LLC dba NC Hemp Shoppe MARCS-CMS 649018, June 29, 2023
From the archived source record
FDA has determined that your Stoner Patch Delta-8 Gummies Watermelon 500mg, Stoneo Oreo Cookies Delta-8 THC, Delta-8 THC Flamin Hot Cheetos, and Stoney Patch 500mg products 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. Furthermore, it is a prohibited act to introduce adulterated food into interstate commerce under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). This letter is to inform you that your firm markets Delta-8 THC-containing products, and Delta-8 THC may pose a serious health risk to consumers. FDA is particularly concerned that your products are in forms (e.g., candy, cookies, and chips) that are appealing to children, that mimic well-known snack food brands by using similar brand names, logos, or pictures on packaging, and that consumers may confuse with traditional foods. Therefore, with these products there is a risk of unintended consumption of the Delta-8 THC ingredient by consumers. In June 2022, FDA warned consumers about the accidental ingestion by children of food products containing THC. 1 As noted in the warning, the agency received over 125 adverse event reports from January 1, 2021, through May 31, 2022, related to children and adults who consumed edible products containing THC. Adulterated Human Foods According to your product labeling, your Stoner Patch Delta-8 Gummies Watermelon 500 mg, Stoneo Oreo Cookies Delta-8 THC, Delta-8 THC Flamin Hot Cheetos, and Stoney Patch 500mg 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).
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
- 4414f0efcf6c
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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