How Dietary Supplements Are Regulated in the United States

Dietary supplements are regulated differently from prescription and over-the-counter drugs. FDA generally does not approve supplements for safety and effectiveness before they are marketed.

Health note: This page is educational, not medical advice. New, worsening, sudden, or functionally significant cognitive symptoms deserve appropriate professional evaluation.

No routine premarket approval for effectiveness

FDA states that it is not authorized to approve dietary supplements for safety and effectiveness before they are marketed.

Company responsibility

Manufacturers and marketers are responsible for ensuring products are safe and that claims and labeling comply with the law.

FDA still has enforcement authority

FDA can inspect facilities, monitor adverse-event and safety issues, and take action against products that violate applicable law.

What consumers should do

Use clear labels, reputable sellers, realistic claims, and professional advice when medications or medical conditions create additional risk.

Memory Measure standard: We distinguish merchant claims from ingredient research and from evidence on a finished formula. An ingredient study does not automatically prove that a multi-ingredient product works.