Dietary Supplements Postmarketing Safety

Under the Dietary Supplement Health And Education Act of 1994 (DSHEA), the U.S. Food and Drug Administration (FDA) was given several post-marketing responsibilities to ensure the safety of dietary supplements. If a dietary supplement presents “a significant or unreasonable risk of illness or injury” or contains “a poisonous or deleterious substance which may render it injurious to health,” FDA has the authority to remove the product from the market. Effective December 22, 2007, the Dietary Supplement and Nonprescription Drug Consumer Protection Act mandates that manufacturers, packers, and distributors of dietary supplements in the U.S. report information about serious adverse events associated with the use of these supplements to FDA.

A “serious” adverse event is defined as one that results in:

  • Death;
  • A life-threatening experience;
  • Inpatient hospitalization;
  • Persistent or significant disability of incapacity;
  • A congenital anomaly or birth defect; or
  • Requires, based on a reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.