What happened
Original notice title
Koi CBD, LLC MARCS-CMS 651252, July 18, 2023
From the archived source record
FDA has determined that your products, Koi brand “Delta 8 Gummies” and Hemp Living brand “Pot Rocks,” are adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (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 that may pose a serious health risk to consumers. Adulterated Human Foods According to your product labeling, your Koi brand “Delta 8 Gummies” and Hemp Living brand “Pot Rocks” 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. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Therefore, your Koi brand “Delta 8 Gummies” and Hemp Living brand “Pot Rocks” are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act because they bear or contain an unsafe food additive. Introduction of these adulterated foods into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). * * * This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products.
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
- adcb36c34b45
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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