King Bio Tops List Of Homeopathic Firms FDA Warns In Show Of Enforcement
FDA warns King Bio, three other homeopathic product marketers. In addition to GMP deficiencies, "we continue to see products labeled as homeopathic that are being marketed without approval for a wide array of diseases and conditions, from chronic pain to cancer,” says FDA Commissioner Gottlieb.
You may also be interested in...
In addition proposing $28.4m in monograph user fees, agency’s FY 2021 budget justification includes among its legislative initiatives proposing to require "Field Alert Reports" for drug products not marketed under an approved application, such as monograph OTCs.
Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.
FDA says Newton Laboratories sells unapproved Rx homeopathics because its products are labeled to treat diseases and conditions including allergies, chicken pox and “suicidal tendency.” Warning letter says firm also has repeatedly violated same GMPs across more than a decade of inspections.