What does FDA approval mean?

You’ve heard it many times before: A product is advertised as “FDA-approved.” But what does that really mean?

In the United States, prescription drugs and biologics are required to undergo rigorous laboratory, animal, and human clinical testing before they can be put on the market. The Food and Drug Administration (FDA) reviews the results of these studies to:

• verify the identity, potency, purity, and stability of the “ingredients,” and
• demonstrate that the drug is safe and effective for its intended use.