What happened
Original notice title
Whole Leaf Organics, LLC MARCS-CMS 593176, November 22, 2019
From the archived source record
The claims on your website establish that your “CBD-EX,” “CBD MAX 1000 mg,” “CBD-RX,” “CBD Defend,” and “CBD Enflame” 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, these 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 “CBD-EX,” “CBD-MAX 1000 mg,” “CBD-RX,” “CBD Defend,” and “CBD Enflame” 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). FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue. [2] Unapproved New Drugs Based on our review of your website, your “CBD-EX,” “CBD MAX 1000 mg,” “CBD-RX,” “CBD Defend,” and “CBD Enflame” 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. Examples of claims observed on your website that establish the intended uses of your products as drugs include, but may not be limited to, the following: On your product page for “CBD Defend”: “CBD Defend contains CBD…associated with decreasing the risk for cancer development…fighting DNA damage and reversing manipulation at the cellular level.” On your product page for “CBD-EX”: “[W]hole Leaf Organics CBD-EX…CBD isolate and Curcumin.
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
- d43b73ff2b3c
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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