What happened
Original notice title
King Bio Inc. MARCS-CMS 542987, January 11, 2018
From the archived source record
Your product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 355(a), and a misbranded drug under sections 503(b) and 502(f)(1) of the Act, 21 U.S.C. 353(b) and 352(f)(1). In addition, FTC has reviewed your marketing claims for AddictaPlex for potential violations of Sections 5 and 12 of the FTC Act, 15 U.S.C. 45(a) and 52. AddictaPlex is a prescription drug as defined in section 503(b)(1)(A) of the Act, 21 U.S.C. 353(b)(1)(A), because in light of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer such drug. Therefore, this product is misbranded under section 503(b)(4) of the Act, 21 U.S.C. 353(b)(4), in that its label fails to bear the symbol, “Rx only.” AddictaPlex is intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Thus, your product’s labeling fails to bear adequate directions for use, which causes the product to also be misbranded under section 502(f)(1) of the Act, 21 U.S.C. 352(f)(1). Section 301(a) of the Act, 21 U.S.C. 331(a), prohibits the introduction or delivery for introduction into interstate commerce of a misbranded drug. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health. The definition of “drug” in section 201(g)(1) of the Act, 21 U.S.C. 321(g)(1), includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same regulatory requirements as other drug products; nothing in the Act exempts homeopathic drug products from any of the requirements related to adulteration, labeling, misbranding, or approval.
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
- 634ac066f3c2
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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