title: Federal regulation of unapproved chelation products.
abstract: Chelation products can be helpful in the treatment of metal poisoning. However, many unapproved products with unproven effectiveness and safety are marketed to consumers, frequently via the internet. This paper describes the primary responsibility of the Health Fraud and Consumer Outreach Branch of the United States Food and Drug Administration to identify and address health fraud products. Efforts to prevent direct and indirect hazards to the population's health through regulatory actions are described.
authors.affiliation: Office of Unapproved Drugs and Labeling Compliance, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA, charles.lee@fda.hhs.gov.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Lee
mesh_terms: D002614:Chelating Agents / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*; D015913:Chelation Therapy / Q000009:adverse effects / Q000592:standards; D003257:Consumer Product Safety; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D005607:Fraud / Q000517:prevention & control; D033161:Government Regulation; D006801:Humans; D020407:Internet; D004366:Nonprescription Drugs / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*; D011786:Quality Control; D018570:Risk Assessment; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D002614:Chelating Agents; D004366:Nonprescription Drugs