What happened
Original notice title
Revibe, Inc. MARCS-CMS 553137, May 18, 2018
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 (the 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 The claims on your website establish that the above-listed products are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. 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 undersection 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). The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your 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
- efe92a3cb2ec
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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