Cosmetic Facility Registration
MoCRA: This information is applicable to: All Cosmetic Manufacturers
Under the new MoCRA requirements, if your business is not exempt as a small business, you must register your facility with the FDA.1
Failure to register your facility is a prohibited act.2
What qualifies as a "facility"?
A "facility" is a place that manufactures or processes cosmetic products for sale in the United States.
It does not include a place that only labels, relabels, packages, repackages, holds, or distributes cosmetic products. If you purchase packaged cosmetics and only apply a label to them, you don’t need to register your facility.
However, "packaging" and "repackaging" do not include filling a container with a cosmetic product. If you buy bulk product and fill containers, that does make your business a cosmetic facility and you would need to register it (if you aren’t otherwise exempt).
Who is responsible for facility registration?
As owner or operator of the facility, you would typically be responsible for facility registration.
However, if you make cosmetic products for someone else as a contract manufacturer and their name is listed on the product label as the responsible person, they could submit the facility registration. Only one registration is required, no matter how many customers you make products for.
Is there a fee to register?
No.
What information is required in the facility registration?
First, before registering the facility, you need to get an FDA Establishment Identifier (FEI). Information on how to request an FEI can be found in the FEI Portal FAQ.
Once you have the FEI, you can submit your facility registration. You’ll need the following info:3
- Name of the owner and/or operator of the facility (your name);
- Facility’s name, physical address, email address, and telephone number;
- FEI
- All brand names under which cosmetic products manufactured or processed in the facility are sold;
- Cosmetic category or categories (see FDA Cosmetic Product Categories) and responsible person for each cosmetic product manufactured or processed at the facility. If the product is contract manufactured for a different company, the responsible person is the entity identified on the product label.; and
- Type of submission (initial, amended, biennial renewal, or abbreviated renewal).
- Optional:
- Parent company name (if applicable)
- Facility DUNS number4 (if any)
- Additional contact information
How do I submit a registration?
Facility Registrations are submitted through the Cosmetics Direct portal on the FDA website. The process is pretty straightforward. You will need the information listed above.
There is a User Guide for the Cosmetics Direct portal and a pretty good tutorial for the process of registering your facility. Both are available on the home page of the portal.
When does it go into effect?
All cosmetic facilities operating as of July 1, 2024 must complete their registration by July 1, 2024.
Any new facility that starts operation after July 1, 2024, must register within 60 days after starting operations.5,6
What if my information changes?
If any of your information changes, you must update your registration within 60 days of the change.7
Does the registration have to be renewed?
Once registered, your registration must be renewed biennially (every two years).8 If you haven’t had to make any updates since your last registration or renewal, there will be a short form for renewing.
Can my registration be suspended?
Yes. Your facility registration could be suspended by the FDA if they found that a product manufactured or processed there and distributed in the United States had a reasonable probability of causing serious adverse health consequences or death and it was possible that other products in the facility could be affected.
Before suspending your registration, the FDA would have to give you notice and an opportunity to address the situation. There is also a provision for an informal hearing if you feel the suspension is unreal or unfair.
If your registration is suspended, then any products made in the facility are prohibited.
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1 21 USC 364c(a) and 21 USC 364h(a)
2 21 USC 331(hhh)
3 21 USC 364c(b)(2)
4 Data Universal Numbering System (DUNS) number is a unique non-digit identification number provided by Dun & Bradstreet. See What is a DUNS Number?
521 CFR 364c(a)(1)
6Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing
721 USC 364c(a)(4)
821 USC 364c(a)(2)
