FDA WARNING_LETTER - King Bio Inc.

On January 11, 2018, the FDA and FTC issued a Warning Letter to King Bio, Inc. regarding their AddictaPlex product, marketed on www.drkings.com and www.facebook.com/kingbionaturalmedicine/.

The FDA determined AddictaPlex 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). The product is intended to diagnose, mitigate, prevent, treat, or cure opioid addiction, as evidenced by claims like "Homeopathy to Beat Addiction" and "A natural aid to help provide recovery, restoration or relief from the symptoms of overconsumption of alchols [sic] and other drugs." The FDA explicitly states that despite being labeled as homeopathic, AddictaPlex is not exempt from drug regulations, especially given the nationwide public health emergency regarding opioid addiction, which overrides the enforcement policies of CPG 400.400.

The FTC also reviewed marketing claims for potential violations of Sections 5 and 12 of the FTC Act, 1