United States · Supplements
FDA Supplement Labeling in the United States
A practical guide to FDA Supplement Labeling for supplements sold in the United States: who it applies to, what to prepare, and the mistakes that cause rejection.
Who needs this
- Dietary supplements sold in the United States
- Imported and private-label supplements
Documents you need
- Supplement Facts panel
- Structure/function claim substantiation
- GMP records
Compliance checklist
Tick each item as you collect it. Saved in this browser only.
How to comply
- Draft the Supplement Facts panel
- Review claims for compliance
- Verify ingredient and serving information
- Finalize the label
Brief for your lab or agent
Copy this into an email, then edit the product and channel.
Request: FDA Supplement Labeling — United States Product category: Supplements Authority: U.S. Food and Drug Administration (FDA) and FTC Legal basis: Dietary Supplement Health and Education Act (DSHEA); 21 CFR 101 Documents we already have: 1. Supplement Facts panel 2. Structure/function claim substantiation 3. GMP records Questions: 1. Does our product fall under FDA Supplement Labeling in the United States? 2. Which test standards or evidence do you accept? 3. What is the current fee and lead time? 4. Is a local representative required, and can you act as one?
Cost and timeline
Before the product is sold.
Label review and testing costs vary.
Common rejection reasons
- Supplement Facts panel incorrectly formatted
- Claims that imply disease treatment
- Missing disclaimer for structure/function claims
Official sources
FAQ
Is a supplement the same as a drug?
No. Supplements are regulated as a category of food and cannot claim to treat or cure disease.
What claims are allowed?
Structure/function claims are allowed with the required disclaimer; disease claims are not.
Is GMP required?
Yes. Dietary supplements must be manufactured under the applicable GMP rules.
How long does FDA Supplement Labeling take?
Before the product is sold.
How much does FDA Supplement Labeling cost?
Label review and testing costs vary.
What happens if I sell without it?
Misbranding findings and enforcement action.
Who regulates FDA Supplement Labeling in the United States?
U.S. Food and Drug Administration (FDA) and FTC.
Related requirements
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