What happened
Original notice title
Infusionz, LLC MARCS-CMS 629248, November 16, 2022
From the archived source record
FDA has determined that all strengths, varieties, and various flavors of your CBD gummies, CBD fruit snacks, CBD gum, CBD candy, CBD oil/tinctures, and CBD lollipops products are adulterated under section 402(a)(2)(C)(i) of 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 some of your products are in forms that are appealing to children. For example, children may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites. You also market other products that consumers may confuse with traditional foods for humans, including your CBD gummies, CBD fruit snacks, CBD gum, CBD candy, and CBD lollipops products; therefore, with these products there is a risk of unintended consumption of the CBD ingredient by consumers. Adulterated Human Foods and 301(ll) According to your product labeling, your CBD gummies, CBD fruit snacks, CBD gum, CBD candy, CBD oil/tinctures, and CBD lollipops 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). Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. 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.
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
- 49ca544b97c1
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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