Cosmetic Facility Registration
$349
Facility registration support for foreign cosmetic manufacturers and processors when FD&C Act section 607 applies. We check activity and exemptions before preparing a filing.
This filing-only offer requires an existing FEI and, for a foreign facility, an appointed U.S. agent. If either record is missing or uncertain, ask us to check the right scope before payment.
What's included
- ✓ Cosmetic facility registration under FD&C Act section 607, when required
- ✓ Submission record and status follow-up; FDA does not issue a compliance certificate
- ✓ Direct FDA filing — no government fees required
How It Works
Check the facility and collect details
We check the actual manufacturing or processing activity and applicable exemptions. The owner or operator supplies its facility details, FEI if already assigned, product categories and foreign-facility U.S. agent contact. The label-named responsible person has a separate product-listing role.
Prepare and submit the filing
If registration is required, we prepare Form FDA 5066 information and submit through an available FDA route such as Cosmetics Direct. Preparation time depends on complete information and FEI availability; FDA processing is separate.
Review the submission record
We share the available submission/status record. A registration number or submission is not FDA approval, certification or a promise of market admission. Renewal is due every two years from the initial registration date; required registration changes generally must be amended within 60 days.
Common questions
What is MoCRA and why does it require registration?+
FD&C Act section 607, added by MoCRA, provides for cosmetic facility registration by the owner or operator and product listing by the label-named responsible person. The duties are separate and depend on the activity, product and exemptions. Certain small businesses are exempt from registration/listing, but not when handling specified products that regularly contact the eye mucous membrane, are injected, are intended for internal use, or alter appearance for more than 24 hours without customary consumer removal.
Do foreign cosmetic manufacturers need to register?+
A foreign facility that manufactures or processes cosmetics for U.S. distribution may need to register unless an exemption applies. Solely labeling, relabeling, packaging, repackaging, holding or distributing a product is not by itself covered manufacturing or processing; filling a product container is not treated as mere packaging for this exception. A newly covered facility generally registers within 60 days of first manufacturing or processing cosmetics for U.S. distribution, subject to the statutory transition dates. For a required registration, renewal is biennial from that facility's initial registration date; required information changes generally must be amended within 60 days.
Is an FEI number required before registration?+
FDA uses the FEI as the facility registration number. The $349 filing service requires a usable FEI; FEI acquisition is separate and is included in the $449 Cosmetics Starter. DUNS may be supplied as optional information; it is not a substitute for FEI and is not universally required for this cosmetic filing.
What about product listing — is that separate?+
Yes. Facility registration and product listing are two separate filings under MoCRA. This $349 service covers facility-registration filing only. A covered foreign facility must supply its appointed U.S. agent information, but first-year agent coverage is not included in this offer. For product listing, see our Cosmetic Product Listing service ($75/product). The Cosmetics Brand Launch Bundle ($1,249) includes both filings.
Related Articles
MoCRA Cosmetic Facility Registration: Who Registers and What Changed
Apr 7, 2026
A practical guide to facility owner/operator registration, the label-named responsible person, FEI, exemptions, renewal and product listing under FD&C Act section 607.
Cosmetic Product Listing Under MoCRA: Responsible Person, Grouping and Updates
Jul 10, 2026
Who lists cosmetics with FDA, what Form 5067 requires, when certain variants may share a listing, and how initial and annual updates work.
What foreign cosmetic facilities should prepare before registration
Mar 9, 2026
The main facility details and product information you should organize before starting your MoCRA-related filing work.
Need registration + listings + label reviews?
The Cosmetics Brand Launch Bundle ($1,249) includes facility-registration assistance, agreed first-year U.S. agent coverage, five product-listing service units and five label reviews. FDA filing groups may differ from our commercial billing units.