How Supplements Are Regulated
What the U.S. FDA does and does not review for dietary supplements: no approval before sale, company responsibility, new ingredient notices, adverse event reports and label claims.
Content last updated . This page has not been medically reviewed.
This page describes the United States only, as FDA and NIH describe it on their own pages. Rules in other countries differ; see UK, Canada and Australia and the EU. For the fuller legal picture, read US regulation: DSHEA and FDA oversight.
Who is responsible for safety
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers and distributors are responsible for evaluating the safety and labeling of their products before marketing. [3] FDA says they have "initial responsibility" for making sure supplements meet the safety standards. [2]What FDA does and does not review
| Question | What the source says | Source type |
|---|---|---|
| Does FDA approve a supplement before sale? | No. | FDA [1] |
| Does a firm have to send FDA its safety evidence? | Generally not, before or after marketing. | FDA [2] |
| Is there any exception? | A supplement with a "new dietary ingredient" generally needs a notification to FDA at least 75 days before marketing, with the basis for the firm's conclusion that it is reasonably expected to be safe. There is an exception when the ingredient is already in the food supply in an unaltered form. | FDA [2] |
| Can FDA act against an unsafe product? | Yes, after it reaches the market. | FDA [3]; NIH [4] |
| Are there manufacturing rules? | Yes. FDA's regulations require current good manufacturing practices for those who manufacture, package or hold supplements. | FDA [2] |
| Does FDA approve label claims? | Generally not before use. | FDA [2] |
Reporting problems
Manufacturers and distributors must record, investigate and forward to FDA any reports they receive of serious adverse events linked to their products. [2] FDA also reviews reports from health care providers and consumers to look for early safety signals. [2] Labels must carry a domestic address or phone number for reporting serious adverse events to the company. [2] If you think a supplement harmed you, FDA says the first step is to contact or see your health care provider immediately. [2] Our reporting guide is How to report a side effect in the US.Label claims
When a label makes a structure/function claim (a claim about an effect on a structure or function of the body), the firm must have substantiation that the claim is truthful and not misleading. [2] Such a claim must be accompanied by a disclaimer that FDA has not evaluated it. [2] NIH adds that the Federal Trade Commission requires advertising to be truthful and not misleading. [4] See Reading supplement labels.Limits of what we read
- We did not find, in the pages we read, how often FDA tests products on shelves. This is not described in the sources we read, so we make no claim either way.
- "Regulated" does not mean "tested before sale." Quality can still vary; see Product quality and contamination.
- A third-party seal is not an FDA approval; see Third-party testing and certifications.
What this means for you
A product on a shelf has not been approved by FDA for safety. Ask a pharmacist or clinician before adding one, particularly alongside medicines. See Talking with a health professional.Frequently asked questions
Does FDA approve supplements?
No. FDA is not authorized to approve dietary supplements for safety and effectiveness before they are marketed. [1]
Who is responsible for a supplement's safety?
Manufacturers and distributors have initial responsibility for making sure their supplements meet the safety standards. [2]
Can FDA remove an unsafe supplement?
FDA has authority to take action against an adulterated or misbranded supplement after it reaches the market. [3]
Do companies have to report side effects?
They must record, investigate and forward to FDA any reports of serious adverse events they receive. [2]
Does "not evaluated by FDA" mean the claim is false?
Not by itself. The disclaimer tells readers that FDA has not evaluated the claim. [2] It does not tell you whether the claim is true.
References
- U.S. Food and Drug Administration. Information for Consumers on Using Dietary Supplements. Read 2026-10-22.
- U.S. Food and Drug Administration. Questions and Answers on Dietary Supplements. Read 2026-10-22.
- U.S. Food and Drug Administration. Dietary Supplements. Read 2026-10-22.
- National Center for Complementary and Integrative Health (NIH). Using Dietary Supplements Wisely. Read 2026-10-22.