What happened
Original notice title
11-11-11 Brands MARCS-CMS 627690, November 16, 2022
From the archived source record
FDA has determined that your Mood33 Hemp Infused Herbal Tea 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. FDA is particularly concerned that your products are in a form (herbal tea or beverage) that consumers may confuse with traditional foods. Therefore, with these products there is a risk of unintended consumption of the CBD ingredient by consumers, which is exacerbated due to the failure of the label to list CBD as an ingredient. Adulterated Human Foods and 301(ll) Your Mood33 Hemp Infused Herbal Tea products are foods to which CBD 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). The available data raises serious concerns about potential harm from CBD added to conventional food. Our review of publicly available data associated with the one FDA-approved CBD drug, as well as our review of published scientific literature, identified potential for liver injury from CBD and potentially harmful interactions with certain drugs. 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 Mood33 Hemp Infused Herbal Tea products 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.
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
- 6a5a1209f57a
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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