Skip to main content
Supplement ScienceSupplementScience

How the FDA Regulates Dietary Supplements

This content is for informational purposes only and does not constitute medical advice. Statements about dietary supplements have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease. Individual results may vary — consult your healthcare provider before starting any supplement. Full disclaimer

Unlike medicines, dietary supplements are not approved by the FDA before they are sold.

Unlike medicines, dietary supplements are not approved by the FDA before they are sold. Under a 1994 law (DSHEA), manufacturers are responsible for their own products' safety and honest labeling, and supplements may not be marketed as treatments for specific illnesses. The FDA mostly acts after a problem appears.

Key Takeaways

  • The FDA does not approve dietary supplements for safety or effectiveness before they are sold.
  • Under DSHEA (1994), the manufacturer is responsible for product safety and truthful labeling.
  • Supplements may make structure/function claims with a disclaimer, but not disease claims.
  • Oversight is mostly after the fact: the FDA acts on adulteration, contamination, or illegal claims.
  • 'FDA-registered facility' does not mean 'FDA-approved' — no supplement is FDA-approved.

Get the free evidence-based How the FDA Regulates Dietary Supplements guide — delivered in 60 seconds.

No spam. Unsubscribe anytime.

A different system from medicines

Medicines must be proven safe and effective and approved by the U.S. Food and Drug Administration (FDA) before they can be sold. Dietary supplements are not: the FDA does not approve them for safety or effectiveness before they reach shelves [1].

The 1994 law that set the rules

The framework comes from the Dietary Supplement Health and Education Act of 1994 (DSHEA) [2]. Under DSHEA:

  • A manufacturer — not the FDA — is responsible for making sure its products are safe and that label claims are truthful and not misleading.
  • Companies must follow current Good Manufacturing Practices (cGMPs) for identity, purity, strength, and composition (see [what cGMP means](/learn/what-cgmp-means-supplements)).
  • New dietary ingredients can require a safety notification to the FDA before marketing.

What companies can and cannot say

Supplements may carry structure/function claims ('supports immune health') but not disease claims ('treats, cures, or prevents' a named condition). Structure/function claims must be accompanied by the familiar FDA disclaimer. The line between the two is explained in structure/function vs. disease claims.

How enforcement actually works

Because there is no pre-market approval, oversight is mostly post-market: the FDA can act against products that are adulterated, contaminated, or making illegal claims, and it collects adverse-event reports. The Federal Trade Commission (FTC) separately requires that advertising be truthful and backed by competent and reliable scientific evidence; its 2022 Health Products Compliance Guidance spells out that standard [3].

What this means for you

'FDA-registered facility' is not the same as 'FDA-approved product' — no supplement is FDA-approved. Independent quality verification and honest, evidence-based claims matter more than regulatory-sounding label language. Report problems to your clinician and the FDA (see how to report a supplement problem).

Frequently Asked Questions

Does the FDA approve dietary supplements?

No. The FDA does not review or approve supplements for safety or effectiveness before they go on sale. Manufacturers are responsible for that themselves under the 1994 DSHEA law, and the FDA generally steps in only after a product is already on the market.

What is the difference between a structure/function claim and a disease claim?

A structure/function claim describes an effect on normal body function, such as 'supports bone health,' and must carry the FDA disclaimer. A disease claim says a product acts on a named illness, which is not allowed for supplements. The wording, not just the intent, determines which category a statement falls into.

Does 'FDA-registered' on a label mean the product is approved?

No. Facilities that make supplements register with the FDA, but registration is not approval of any product. No dietary supplement is 'FDA-approved,' so treat that phrasing on labels or ads as marketing rather than a safety guarantee.

Who regulates supplement advertising?

The Federal Trade Commission oversees advertising and requires claims to be truthful and supported by competent and reliable scientific evidence. The FDA focuses on labeling, manufacturing quality, and safety, while the FTC focuses on the marketing claims themselves.

References

  1. National Institutes of Health, Office of Dietary Supplements (2023). Dietary Supplements: What You Need to Know. NIH Office of Dietary Supplements.
  2. U.S. Congress (1994). Dietary Supplement Health and Education Act of 1994 (DSHEA). Public Law 103-417.
  3. U.S. Federal Trade Commission (2022). Health Products Compliance Guidance. U.S. Federal Trade Commission.