What happened
Original notice title
CBD American Shaman, LLC MARCS-CMS 628753, November 16, 2022
From the archived source record
FDA has determined that your CBD Suckers, CBD Hard Candies, Cookies [with] 10mg CBD per Serving, CBD Sparkling Tea, CBD Sparkling Water, CBD Coffee, CBD Honey Sticks, CBD Honey, Doggy Chews (all flavors), Soft & Tender Doggy Chews, Horsey Chews, Doggy Nugs, and Kitty Nugs 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 CBD Sparkling Tea, CBD Sparkling Water, CBD Coffee, CBD Honey Sticks, and CBD Honey; therefore, with these products there is a risk of unintended consumption of the CBD ingredient by consumers. In addition, “CBD + ZINC OXIDE Sunscreen” is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act [21 U.S.C. 355(a)], and is misbranded under section 502(ee) of the FD&C Act [21 U.S.C. 352(ee)]. These violations are described in more detail below. Further, the claims on your website and social media websites establish that your Canine 300 Tincture, Doggy Chews (all flavors), Soft & Tender Doggy Chews, Canine 300 CBD and Terpene Rich Hemp Oil Water Soluble, Feline 300 Tincture, Horsey Chews, Doggy Nugs, and Kitty Nugs products, which you promote as products containing CBD for use in pets, are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act [21 U.S.C. 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. 351(a)(5)].
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
- d2170961f52b
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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