United States · Cosmetics
U.S. Cosmetic Claims Compliance in the United States
A practical guide to U.S. Cosmetic Claims Compliance for cosmetics sold in the United States: who it applies to, what to prepare, and the mistakes that cause rejection.
Who needs this
- Cosmetic labels and advertising in the U.S.
- Online product pages and influencer content
Documents you need
- Claim substantiation file
- Label and advertising review
- Clinical or consumer study data
Compliance checklist
Tick each item as you collect it. Saved in this browser only.
How to comply
- Classify each claim
- Substantiate before publishing
- Remove drug-type claims
Brief for your lab or agent
Copy this into an email, then edit the product and channel.
Request: U.S. Cosmetic Claims Compliance — United States Product category: Cosmetics Authority: FDA and Federal Trade Commission (FTC) Legal basis: FD&C Act; FTC Act Documents we already have: 1. Claim substantiation file 2. Label and advertising review 3. Clinical or consumer study data Questions: 1. Does our product fall under U.S. Cosmetic Claims Compliance 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 claim is published.
Testing and claim review costs vary.
Common rejection reasons
- Claims that imply disease treatment
- Unsubstantiated efficacy claims
- Advertising inconsistent with the label
Official sources
FAQ
What is a drug claim?
A claim that the product treats, cures, mitigates, or prevents a disease, which moves it outside the cosmetic category.
Is puffery allowed?
Vague, non-material opinion statements are generally tolerated, but objective claims need substantiation.
Who enforces advertising claims?
The FTC enforces advertising substantiation, while the FDA enforces labeling and product classification.
How long does U.S. Cosmetic Claims Compliance take?
Before the claim is published.
How much does U.S. Cosmetic Claims Compliance cost?
Testing and claim review costs vary.
What happens if I sell without it?
Warning letters, enforcement, and false advertising liability.
Who regulates U.S. Cosmetic Claims Compliance in the United States?
FDA and Federal Trade Commission (FTC).
Related requirements
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