What FDA does (and doesn't) do: DSHEA explained
Under DSHEA, FDA does not have authority to approve dietary supplements before they are marketed. [1]
Who is responsible
A firm is responsible for making sure its supplements aren't adulterated or misbranded. [1]
Generally, a firm doesn't have to give FDA the evidence it relies on for safety, except for some products with a new dietary ingredient. [1]
FDA generally does not approve supplement claims or other labeling before use. [1]
What FDA does
FDA's rules require manufacturers to follow current good manufacturing practices that help ensure identity, purity, quality, strength and composition. [1]
FDA investigates adverse event reports and complaints from consumers, health professionals and industry. [1]
FDA periodically inspects supplement manufacturing facilities. [2]
Sources
- U.S. FDA — Questions and Answers on Dietary Supplements retrieved 2026-10-27
- NIH Office of Dietary Supplements — Dietary Supplements: What You Need to Know retrieved 2026-10-27