Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The claims on your website establish that your kratom 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).
Passage 2You market kratom products for the treatment or cure of opioid addiction and withdrawal symptoms.
Passage 3However, these products have not been determined by FDA to be safe and effective for these (or any other) uses.
Passage 4Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal.
Passage 5The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health.
Passage 6Your kratom 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.
Passage 7Your kratom products are not generally recognized as safe and effective for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).
Passage 8There are no FDA-approved applications in effect for any of the above mentioned products.