By · Last updated: October 15, 2026
Short answer: No. In the United States, dietary supplements do not need FDA approval before they are sold. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the manufacturer is responsible for making sure a supplement is safe and correctly labeled. The FDA oversees supplement manufacturing and labeling and can act against products that are unsafe, contaminated or mislabeled. The FTC oversees supplement advertising.
Are supplements regulated by the FDA?
Yes. Dietary supplements are regulated by the FDA even though the agency does not approve them for safety and effectiveness before sale. Manufacturers have legal responsibilities for product safety, manufacturing and labeling. The FDA can inspect facilities and act against products that violate the law. Regulation and premarket product approval are different things; the FDA’s consumer guide explains the distinction.
- Manufacturing: companies must follow the FDA’s current Good Manufacturing Practice rules for supplements (21 CFR Part 111), covering how products are made, tested and recorded.
- Labeling: labels must include a Supplement Facts panel, serving size, ingredient amounts and the manufacturer or distributor’s name and address.
- New ingredients: a “new dietary ingredient” not sold before 1994 generally requires a safety notification to the FDA before it is marketed.
- After sale: companies must report serious adverse events, and the FDA can issue warnings, recalls or seizures for unsafe or misbranded products.
What claims can supplements make?
Supplements may describe how a nutrient or ingredient supports the body’s normal structure or function, for example “supports healthy energy levels.” These statements must carry the disclaimer: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” Supplements may not claim to treat or cure a disease.
Are multivitamins FDA approved?
Multivitamins sold as dietary supplements do not receive FDA approval for safety and effectiveness before sale. The same distinction applies to vitamin supplements sold as tablets, capsules or gummies. A facility registration, a required label disclaimer or an independent testing mark does not turn a dietary supplement into an FDA-approved product. Check the actual product label and ask a qualified health professional about suitability for you.
What does “FDA-registered facility” mean?
Food and supplement manufacturing facilities must register with the FDA. Registration means the FDA knows the facility exists; it is not an approval of the facility or its products. Be wary of any supplement that claims to be “FDA approved.”
How to protect yourself
- Choose products with complete Supplement Facts labels and clear ingredient amounts.
- Look for independent verification; see what third-party tested means.
- Avoid products promising to cure diseases or deliver dramatic, fast results.
- Tell your doctor and pharmacist about every supplement you take, since some interact with medications.
Read more in our supplement guides or browse Valdivia Life supplements.
Further reading from official health agencies
For independent, evidence-based information on the nutrients and herbs mentioned in this guide:
This article is general information, not legal or medical advice.
This article is for general information only and is not medical advice. Supplements are not a substitute for diagnosis or treatment by a qualified healthcare provider. Statements about dietary supplements have not been evaluated by the Food and Drug Administration, and supplements are not intended to diagnose, treat, cure, or prevent any disease.