What happened
Original notice title
Cali Botanicals, LLC MARCS-CMS 575320, June 11, 2019
From the archived source record
FDA has determined that these products 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, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health. Unapproved New Drugs and Misbranded Drugs Claims on your website establish that the above-mentioned products are drugs as defined by 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, including opiate withdrawal and addiction, and/or because they are intended to affect the structure or function of the body. Other uses include the treatment of diabetes, diarrhea, and fever.” “[Kratom] aid[s] in leveling the often deadly risks of opiate withdrawal as well as its use an antidiabetic by lowering blood sugar levels. In addition, your kratom products are misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). According to section 502(f)(1) of the FD&C Act, a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). Thus, your kratom products’ labeling fail to bear adequate directions for their intended uses, which causes the products to be misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). 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). The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products.
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
- 11983a180b28
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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