MoCRA registration is two separate filings. According to FDA, the owner or operator of each facility that makes or processes cosmetics for the US registers that facility, and the responsible person (the company named on the label) lists each product, with its ingredients and the facility's registration number. FDA charges no fee, and neither filing is an approval.
This is general information based on FDA's published guidance, not legal advice. Confirm your own obligations with FDA or a regulatory adviser.
The problem: "my factory is FDA registered, so I'm covered"
Founders launching a US skincare line made overseas often say this. It mixes up the two filings. A manufacturer's facility registration covers the building. It does not list your serum or your gift set. According to FDA, that listing is the responsible person's job, which usually means the brand.
The reverse problem is just as common. A brand starts its product listing and hits a required field it cannot fill: the facility registration number of the plant that makes the product. If nobody asked an overseas manufacturer for that number during the project, the listing stalls. The fix: know who files what, collect the fields early, and file in order.
What is MoCRA registration?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed on December 29, 2022. FDA calls it the most significant expansion of its cosmetics authority since the Federal Food, Drug, and Cosmetic Act of 1938. For the wider picture, read what MoCRA is; this post covers only registration and listing.
Is FDA registration required for cosmetics?
For most companies, yes. According to FDA, every owner or operator of a facility that manufactures or processes cosmetics for US distribution must register each facility, and the responsible person must list each marketed product, unless an exemption applies. This cosmetic registration is mandatory, unlike the old Voluntary Cosmetic Registration Program (VCRP), which FDA says stopped accepting submissions on March 27, 2023.
Facility registration: who registers and what goes in it
MoCRA facility registration belongs to the facility, not the product. FDA's guidance says a registration must include:
The owner and/or operator name
The facility name, physical address, email and phone number
For a foreign facility, the US agent's name and phone number (and email if available)
Any registration number previously assigned
All brand names under which cosmetics made there are sold
The product categories, and the responsible person, for each cosmetic product made there
The submission type: initial, amended, biennial renewal or abbreviated renewal
The FEI number comes first. According to FDA, the facility registration number is the FDA Establishment Identifier (FEI), and the owner or operator must obtain one before registering. FDA says FEI requests for cosmetic facilities are typically processed in 7 to 10 business days, and a facility that already has an FEI from other FDA business uses the same one.
Note that the facility registration carries your brand name, categories and you as responsible person.
Product listing: what the responsible person files
FDA defines the responsible person as the manufacturer, packer or distributor whose name appears on the label. According to FDA's guidance, a company outside the US can be the responsible person, but each label must then carry a domestic address, domestic phone number or electronic contact information (which may be a website) for adverse event reports. Our guide to cosmetic labeling requirements covers the rest of the label.
According to FDA, a cosmetic product listing must include:
The facility registration number of each 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
The ingredient list, including fragrances, flavors and colors, by the names required under 21 CFR 701.3 or the common or usual name
Any listing number previously assigned, and the submission type
FDA's guidance also says one listing can cover formulations that differ only in colors, fragrances or flavors, or in quantity of contents, so five shades of one balm can share a listing.
Who files what when your manufacturer is overseas
Here is the handoff map we walk brands through.
Fields your manufacturer supplies
Facility registration number (FEI). FDA's guidance requires it on your listing for every facility that makes or processes the product. If a facility is exempt and has no number, FDA says its name and address can be given instead.
Facility name and physical address, exactly as in its FDA records, so your listing matches its registration.
Confirmation that your brand name and product categories are on its registration.
The US agent's name and contact, since it is the foreign facility that needs one.
Fields you supply as the brand
Product name from your final label artwork.
Ingredient list from the released formula, matching the label.
Product category, agreed with your manufacturer so it matches the registration.
Responsible person name and contact number, the company named on your label.
The contract manufacturer rule
According to FDA's guidance, a facility that makes products for one or more responsible persons needs only a single registration. Either the contract manufacturer or a responsible person whose products are made there may submit it, not both. For how these relationships usually split work, see how contract manufacturing works.
FDA's guidance also says a contract manufacturer outside the US must be registered, and there is no exemption for following ISO 22716. Good GMP and registration are separate questions.
What is a US agent under MoCRA?
FDA requires a US agent on a foreign facility's registration. FDA's guidance describes the agent as a person or business that resides in or keeps a place of business in the US and is physically present there, not a mailbox or answering service. In questions issued for comment in its December 2024 revision, FDA's guidance describes the duties as limited: helping FDA communicate with the facility, answering questions about its imported products, helping schedule inspections, and receiving FDA documents when FDA cannot reach the facility directly. FDA says it does not endorse any US agent.
The order of operations and the deadlines
According to FDA's guidance, this is the sequence and the clocks:
FEI number. The facility owner or operator obtains an FEI.
Facility registration. A facility that starts making cosmetics for the US after December 29, 2022 registers within 60 days of starting (or by February 27, 2024, whichever is later). FDA did not enforce registration and listing until July 1, 2024.
Number to the brand. The manufacturer passes the facility registration number to the responsible person.
Product listing. A product first marketed after December 29, 2022 is listed within 120 days of marketing it in interstate commerce.
Amendments. Registration changes, including cancellation, are filed within 60 days.
Biennial renewal. Registration renews every two years from the initial date. FDA's example: registered February 20, 2024, renew by February 20, 2026. An abbreviated renewal exists when nothing changed.
Annual listing updates, including telling FDA a product was discontinued.
FDA announced on February 11, 2026 that Cosmetics Direct now shows registration status and renewal date fields and emails reminders to the facility contact, account contact and US agent before renewal.
How to file: Cosmetics Direct, ESG NextGen or paper forms
According to FDA, there are three routes:
Cosmetics Direct, FDA's Structured Product Labeling (SPL) portal for registration and listing, launched December 18, 2023.
SPL software plus ESG NextGen, FDA's Electronic Submissions Gateway; FDA notes the free account can take one to three weeks to set up.
Paper: Form FDA 5066 for facilities and Form FDA 5067 for products.
FDA strongly encourages electronic submission and offers a Decision Tool for facilities unsure whether they must register. See FDA's registration and listing page and the full FDA guidance document.
Exemptions: small businesses and the products that never qualify
According to FDA, the MoCRA small business exemption covers companies whose average gross annual US cosmetic sales over the previous 3 years are under $1,000,000, adjusted for inflation. FDA says it never applies to products that regularly contact the mucus membrane of the eye, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours where consumer removal is not customary.
Other points from FDA's guidance:
FDA issues no small business exemption certificates. Exempt companies may register and list voluntarily.
A drug-cosmetic goes in the drug listing, not the cosmetic product listing.
A storage-only building does not register. A batch release testing lab does.
Samples are the one founders miss. FDA's guidance (also in the questions issued for comment) says the responsible person generally must still list consumer samples and gifts, while industry R&D samples not meant for consumers need no listing. If your launch includes sachets or a gift set, put them in your listing plan.
Fees, registration numbers and the "FDA registered" claim
According to FDA, there is no fee to register or list. FDA does not issue certificates, confirmation letters or verification documents, and reiterated this on September 9, 2026. A registration or listing number does not mean FDA approval; FDA describes registration and listing as neither an approval program nor a promotional tool.
FDA can also suspend a facility's registration if a product made there has a reasonable probability of causing serious adverse health consequences or death, and distributing products from a suspended facility in the US is a prohibited act. For scale, FDA reported 16,398 active facility registrations and 1,298,361 active product listings as of June 30, 2026.
How Hong Shin fits into your US filings
Hong Shin is a Canadian-owned contract manufacturer headquartered in Taipei, making products in Taiwan and South Korea since 2012 for brands in 16 countries. Our certifications include ISO 22716, ISO 9001, SEDEX and BSCI, and we hold US FDA facility registration.
As our page on manufacturing for US skincare brands explains, we map your formula, claims and target states to the right MoCRA and OTC pathways before sampling, and build facility registration, product listing and safety records into the project. As the name on the label, your brand is still the responsible person who lists the products. The benefit: facility fields in hand before the 120-day listing clock starts, a listing that matches your label, and renewals on a calendar.
Working details that affect your filings:
Samples. We run sachet sampling and kit assembly in 1 to 10 mL formats. If they go to consumers, plan their listings with the full sizes.
First-run MOQ. 1,500 units per SKU on Taiwan lines, 3,000 on South Korea lines (where SPF serums and cream serums are made).
Sampling fees. $120 private label, $300 to build on an existing formula, $500 full custom.
Planning a US launch? Send us your brief with your SKUs, markets and timeline.
FAQ
Does FDA charge a fee for MoCRA registration?
No. According to FDA, there is no fee to submit a facility registration or a product listing.
Where do I find a MoCRA registration number?
According to FDA, it is the facility's FEI; FDA's FEI Search Portal shows whether an entity has one. Listing numbers are not public, and FDA issues no certificate.
Do I need to register if my manufacturer is already FDA registered?
Usually you still list your products as responsible person. FDA's guidance says the facility needs only one registration, filed by either party.
Do free samples need a MoCRA product listing?
FDA's guidance says consumer samples and gifts generally need a listing; industry R&D samples not meant for consumers do not.
How often do MoCRA registrations and listings renew?
According to FDA, facility registration renews every two years from the initial date, and product listings are updated annually.
Written by Tanya Lee, Hong Shin Cosmetics. Sources: FDA, Registration and Listing of Cosmetic Product Facilities and Products (content current as of September 9, 2026); FDA Guidance for Industry, Registration and Listing of Cosmetic Product Facilities and Products (December 2024 revision).