What happened
Original notice title
KratomNC MARCS-CMS 576964, May 16, 2019
From the archived source record
Food and Drug Administration (FDA) reviewed your website at the internet address [see original source] in May 2019 and has determined that your website provides a telephone number that customers can call to order various kratom products, including but not limited to, “Green Bali Powder,” “Red Indo Powder,” “Gold Bali Powder,” “White Indo Powder” and “ Super White Powder.” 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 your kratom products, including “Green Bali Powder,” “Red Indo Powder,” “Gold Bali Powder,” “White Indo Powder” and “ Super White Powder,” 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 addiction, and/or because they are intended to affect the structure or function of the body. In addition, your kratom products, “Green Bali Powder,” “Red Indo Powder,” “Gold Bali Powder,” “White Indo Powder” and “ Super White Powder,” are misbranded under 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, 21 U.S.C. 352(f)(1), a drug is misbranded if, among other things, it fails to bear adequate directions for use. 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).
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
- 59518bbb0077
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 →