Saturday, January 4, 2014

From the FDA: Federal regulation of unapproved chelation products

 2013 Dec;9(4):313-7. doi: 10.1007/s13181-013-0342-7.

Federal regulation of unapproved chelation products.

Author information

  • 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.

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.

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