What happened
Original notice title
Mitra Distributing Inc. MARCS-CMS 562402, September 04, 2018
From the archived source record
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. Learn more about kratom and how it can be the solution to promoting an opiate free lifestyle by visiting our About Kratom page” On the webpage with the Blog dated July 17, titled “Tragic Death of (b)(6) ”: “[I]s there a better way? In addition, your kratom products are misbranded under 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), because they lack adequate directions for use. Your above-mentioned kratom products are prescription drugs as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), because in light of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs. A drug is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), if the drug 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).
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
- 4b33924db4bc
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 →