United States · Cosmetics
FDA Cosmetics Registration in the United States
A practical guide to FDA Cosmetics Registration for cosmetics sold in the United States: who it applies to, what to prepare, and the mistakes that cause rejection.
Who needs this
- Cosmetic products marketed in the United States
- Facilities that manufacture or process cosmetics for the U.S. market
Documents you need
- Facility name, address, and contact details
- Product categories and brand names
- U.S. agent information for foreign facilities
Compliance checklist
Tick each item as you collect it. Saved in this browser only.
How to comply
- Confirm the product is a cosmetic and not a drug
- Create an FDA account and register the facility
- Submit a product listing for each marketed product
Brief for your lab or agent
Copy this into an email, then edit the product and channel.
Request: FDA Cosmetics Registration — United States Product category: Cosmetics Authority: U.S. Food and Drug Administration (FDA) Legal basis: FD&C Act, as amended by MoCRA (2022) Documents we already have: 1. Facility name, address, and contact details 2. Product categories and brand names 3. U.S. agent information for foreign facilities Questions: 1. Does our product fall under FDA Cosmetics Registration 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
Complete before marketing; FDA processing time varies.
FDA does not publish a flat registration fee; confirm current portal requirements.
Common rejection reasons
- Product claims reclassify the item as a drug
- Wrong facility type selected in the portal
- Missing U.S. agent for a foreign facility
Official sources
FAQ
Is FDA registration the same as FDA approval?
No. Registration and listing are administrative filings; they are not an approval or certification of safety.
Do small businesses have to register?
MoCRA includes limited exemptions for certain small businesses. Check current FDA guidance before relying on an exemption.
How often must registration be renewed?
Facility registration is subject to biennial renewal, and product listings must be kept current.
How long does FDA Cosmetics Registration take?
Complete before marketing; FDA processing time varies.
How much does FDA Cosmetics Registration cost?
FDA does not publish a flat registration fee; confirm current portal requirements.
What happens if I sell without it?
Marketplace removal, customs detention, and FDA enforcement action.
Who regulates FDA Cosmetics Registration in the United States?
U.S. Food and Drug Administration (FDA).
Related requirements
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