1.5.1: Food and Drug Administration
- Page ID
- 88573
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The Food, Drug, and Cosmetics Act of 1938 created the Food and Drug Administration (FDA) under the Department of Health and Human Services. The FDA is responsible for the safety, effectiveness, security, and quality of drugs, cosmetics, and food. To ensure public safety, the FDA approves and monitors the safety of products released to the public (U. S. Food and Drug Administration, 2018a). The FDA has created the Federal Adverse Event Reporting System (FAERS), a public database that dispenses information related to adverse events caused by drugs and biologic products. Healthcare professionals, consumers, and manufacturers may submit voluntary reports to FAERS related to drug safety concerns. These concerns are collected in a database that is available to the public (U.S. Food and Drug Administration, 2021a).