What happened
Original notice title
Naturally Infused LLC MARCS-CMS 628036, November 16, 2022
From the archived source record
FDA has determined that your CBD Lollipops, CBD Infused Sugar, CBD Gummies, CBD Infused coffees, D8 THC Infused coffees, and Delta-8 THC Gummies 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. Further, the claims on your website and social media websites establish that all strengths and varieties of CBD Lollipops, CBD Infused Sugar, CBD Gummies, CBD Infused coffees, CBD Isolate in MCT Oil, CBD Plus CBG in MCT Oil, CBD/CBG/CBN Isolates in MCT Oil, CBD/CBG/CBN/Delta 8 THC, Full Spectrum Oil CBD, Roll & Rub CBD Oil, and Spray & Rub CBD (hereinafter referred to as “your CBD-containing products for humans”) are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your CBD-containing products for humans are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). Over the past several years, FDA has warned the public on various illegally marketed CBD-containing products. This letter is to inform you that your firm markets Delta-8 THC-containing products that may pose a serious health risk to consumers. As stated above, the Agency is particularly concerned that some of your products are in forms that are appealing to children. Therefore, there is a risk that consumers of these products, including children, will unintentionally consume CBD or Delta-8 THC ingredients. 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. We have particular safety concerns with the CBD Lollipops product, which was purchased from your website and did not have a label on the packaging indicating that the lollipops contain CBD.
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
- ba952127b219
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.
Sources, dates, and coverage →