If your facility manufactures or processes cosmetics for the U.S. market, one of the first things you’ll need under the Modernization of Cosmetics Regulation Act (MoCRA) is an FEI number. It stands for FDA Establishment Identifier, and without one, your facility registration can’t be filed. Here’s what it is, how to get one, and how long to expect.
What an FEI is
The FEI is FDA’s unique identifier for your physical facility. It ties your establishment to its registration, its product listings, and any correspondence FDA sends about it. Think of it as your facility’s permanent record number in FDA’s systems — once issued, you keep using the same one.
Why you need it BEFORE registration
FDA’s facility registration form (Form FDA 5066) requires the FEI number. That means the FEI request comes first in the sequence: request the FEI, wait for it to be issued, then file the registration through FDA Cosmetics Direct. If you already have an FEI from prior FDA business (for example, a drug or device registration at the same site), check the FEI Search Portal first and reuse it — requesting a duplicate slows everything down.
How to request an FEI
FEI requests are handled by email. Send your request to feiportal@fda.hhs.gov with the following information:
- Your facility’s legal firm name (plus any DBAs — “doing business as” names)
- The facility’s physical address and mailing address
- A contact person: name, phone number, and email
- A description of the activities conducted at the site
- Any existing FDA numbers associated with the facility, if you have them
- Former names or addresses of the facility, if applicable
Include everything in one complete request. Incomplete submissions are the most common reason for delays.
How long it takes
According to FDA’s finalized guidance (Registration and Listing of Cosmetic Product Facilities and Products, December 2024, footnote 5), FEI requests are typically processed in 7–10 business days. Note the word “typically” — that’s FDA’s own nonbinding language, not a guaranteed turnaround. In practice, plan for two full weeks so an FEI delay doesn’t hold up your registration timeline.
Because the FEI is the longest-lead item in the process, request it as early as possible — ideally in parallel with gathering the rest of your registration details (brand names, responsible persons, product categories). Don’t wait until everything else is ready.
Is there a fee?
When checked in September 2026, FDA charged no fee for issuing an FEI, and no fee for facility registration or product listings. Government fee policies can change, so treat this as current information rather than a permanent promise.
What happens after you get your FEI
Once your FEI is issued, your facility registration can be filed through Cosmetics Direct at direct.fda.gov. For foreign facilities, the registration must name a U.S. agent — a person or business physically present in the United States who serves as FDA’s contact for the facility.
This article is for educational purposes only and is not legal advice. US MoCRA Agent is a private service provider and is not affiliated with or endorsed by the FDA. Regulatory details are based on FDA’s published guidance and are current as of September 2026; always verify requirements against FDA’s official sources before acting.