FDA Cosmetic Facility Registration in Cosmetics Direct: 2026 Step-by-Step Guide
Updated: Oct 5
Published by US Compliance Agent LLC · Updated October 2026
If you make or process cosmetics that are sold in the United States, FDA requires two separate things under the Modernization of Cosmetics Regulation Act (MoCRA):
Facility registration, filed for each facility by its owner or operator
Product listing, filed for each product by the Responsible Person, the company named on the label
Both are filed in FDA's Cosmetics Direct portal. This guide explains who has to file, what you need before you start, how to complete the facility registration step by step, and how to keep it current, including the two-year renewal that many facilities now face.
Do you have to register?
Under section 607 of the Federal Food, Drug, and Cosmetic Act, every facility that manufactures or processes cosmetic products for distribution in the United States must register with FDA. That includes foreign factories and contract manufacturers (OEM/ODM) making products sold under someone else's brand.
A contract manufacturer that makes products for several brands needs only one registration for the facility. The facility can file it itself, or any one of the brands it makes products for can file it.
Small business exemption. Businesses whose average U.S. sales of cosmetic products over the previous three years are under $1,000,000 (adjusted for inflation) are exempt from registration and listing. The exemption does not apply if you make or process products that:
regularly come into contact with the mucous membrane of the eye (such as mascara or eyeliner)
are injected
are intended for internal use
are intended to change appearance for more than 24 hours, where the consumer does not normally remove them
Facility registration vs. product listing
These are two different filings with different owners and deadlines.
Requirement | Facility registration | Product listing |
Who files | Facility owner or operator | Responsible Person (brand on the label) |
What it covers | One facility | One product, or a group of near-identical products |
Deadline for new | Within 60 days of starting to make or process cosmetics | Within 120 days of first marketing the product |
Keeping it current | Renew every 2 years; report changes within 60 days | Update annually |
What you need before you start
Have these ready before you log in:
FEI number. FDA uses the FDA Establishment Identifier as the facility registration number, so you need one before you register. If you don't have one, request it through FDA's FEI portal or by emailing feiportal@fda.hhs.gov.
An FDA Direct account. Create it at direct.fda.gov. You can choose a Cosmetics Direct account or a combined account.
Your U.S. Agent's details (foreign facilities only). The law requires the registration to include a contact for the facility's U.S. Agent: name, U.S. street address, phone number, and email.
Facility details. Legal name, physical address of the site where cosmetics are made, phone, and email.
Every brand name under which products from the facility are sold in the U.S.
The product category for each product, from FDA's list of cosmetic product categories and codes.
The Responsible Person for each product, meaning the manufacturer, packer, or distributor whose name appears on the label.
How to register your facility in Cosmetics Direct
Step 1: Log in. Go to direct.fda.gov and sign in to your Cosmetics Direct account.
Step 2: Open the facility registration form. Choose the cosmetic product facility registration option and start a new registration.
Step 3: Enter the facility information. Enter the facility's legal name (not a brand name), full physical address, phone, email, and FEI number. Make sure the country is correct for a foreign facility.
Step 4: Enter your U.S. Agent. Foreign facilities must enter the U.S. Agent's name, U.S. street address, phone number, and email. Use the exact details your agent gave you.
Step 5: Enter brands, categories, and Responsible Persons. List every brand name sold from the facility. For each product made there, add its product category and its Responsible Person.
Step 6: Check and submit. Run the portal's validation check, fix any flagged fields, and submit.
Step 7: Save your confirmation. Keep a copy of the confirmation for your records. Cosmetics Direct now shows each facility's registration status and renewal date.
Other ways to file. Cosmetics Direct is FDA's free tool for creating Structured Product Labeling (SPL) files. You can also build SPL files with other software or with SPL Xforms and submit them through FDA's ESG NextGen gateway; setting up an ESG NextGen account can take one to three weeks. Paper forms exist too (Form FDA 5066 for registration, Form FDA 5067 for listing), but FDA strongly encourages electronic filing.
Product listing: what the Responsible Person files
Product listing is not part of the facility registration. The Responsible Person files it, separately or together with a registration. Each listing must include:
the registration number of every facility where the product is made or processed
the Responsible Person's name and contact number
the product name as it appears on the label
the product category or categories
a full ingredient list, including any fragrances, flavors, or colors
One listing can cover several products when their formulas are identical, or differ only in colors, fragrances or flavors, or package size.
If you are a factory making products for a U.S. brand, the brand normally files the product listings, but it needs your facility registration number to do so.
Keeping your registration current
Renew every two years from your first registration date. The renewal date is not a fixed calendar window. FDA's own example: a facility first registered on February 20, 2024 must renew by February 20, 2026. Because FDA expected existing facilities to register by July 1, 2024, many renewals fall due during 2026, and some have already passed. Check the renewal date shown in Cosmetics Direct.
Use the abbreviated renewal if nothing has changed. If your information is the same as in your last submission, you can file the shorter abbreviated renewal. You can also renew early.
Report changes within 60 days. If anything required in the registration changes, such as the address, brands, product categories, Responsible Persons, or your U.S. Agent, notify FDA within 60 days.
Update product listings every year. The Responsible Person must update each listing annually.
FDA does not issue registration certificates
FDA states that it does not provide certificates or other documents to verify compliance with facility registration. If a provider offers you an "FDA certificate" for your cosmetics registration, it is not an FDA document.
Why accurate registration matters
FDA can suspend a facility's registration if a product made there has a reasonable probability of causing serious adverse health consequences or death. While a registration is suspended, no products from that facility can be sold into the U.S.
Wrong or outdated U.S. Agent details create a quieter problem: if FDA cannot reach you through your agent, you may miss an inspection notice or an adverse event inquiry.
Common problems and how to fix them
FEI not recognized. Email feiportal@fda.hhs.gov to confirm your number or request a new one.
U.S. Agent address rejected. Use a physical U.S. street address, not a P.O. box.
Product category unclear. Check FDA's list of cosmetic product categories and codes and choose the closest match.
Validation errors. Fix every flagged field before submitting. Missing required fields and address formatting are the most common causes.
Need a U.S. Agent for your registration?
Our MoCRA U.S. Agent service is $249 per year. You get the U.S. Agent name, address, phone, and email to enter in Cosmetics Direct, usually within one business day, plus same-business-day forwarding of FDA correspondence.
We don't file your registration or product listings, and we don't act as your Responsible Person. If you're unsure which role is which, read MoCRA U.S. Agent vs. Responsible Person, or see what a MoCRA U.S. Agent does.
Ready to designate your agent? Visit our MoCRA U.S. Agent service page.
US Compliance Agent LLC is a private company. We are not affiliated with, endorsed by, or connected to the FDA or any U.S. government agency. We do not provide legal advice, regulatory consulting, product testing, or certification services.
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