What happened
Original notice title
KOI CBD LLC MARCS-CMS 593391, November 22, 2019
From the archived source record
The claims on your website establish that your “CBD HEALING BALM,” “CBD VAPE OIL,” “FULL SPECTRUM CBD TINCTURE,” “KOI LOTION,” “KOI CBD Gummies,” and “KOI CBD Infused Shot” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). FDA has also determined that your “KOI Naturals CBD Spray for Pets” and “KOI CBD Soft Chews” products 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). Unapproved New Drugs Based on our review of your website, your “CBD HEALING BALM,” “CBD VAPE OIL,” “FULL SPECTRUM CBD TINCTURE,” “KOI LOTION,” “KOI CBD Gummies,” and “KOI CBD Infused Shot” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Misbranded Drugs Your “CBD HEALING BALM,” “CBD VAPE OIL,” “FULL SPECTRUM CBD TINCTURE,” “KOI LOTION,” “KOI CBD Gummies,” and “KOI CBD Infused Shot” products are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Prohibited Act under 301(ll) and Adulterated Human Foods We note that your “KOI CBD Gummies” product appears to be promoted as a conventional human food.
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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 87ae4ea0c53d
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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