MoCRA Cosmetic Facility Registration: Who Must Register, What to File and When to Renew

FDA COMPLIANCE · COSMETICS · MoCRA

Updated November 2026. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) made facility registration and product listing mandatory. Many beauty brands selling on Amazon, Shopify, Walmart or TikTok Shop have listed products but are less sure who registers the factory and when renewal is due. FDA counted 16,398 active facility registrations as of June 30, 2026, and facilities that registered in 2024 reach their first two-year renewal in 2026. This guide is general information, not legal advice.

Who must register a cosmetic facility under MoCRA?

Section 607 of the FD&C Act requires every owner or operator of a facility that manufactures or processes cosmetics for U.S. distribution to register it. FDA reads “manufacturing or processing” broadly, including testing and control steps. Foreign facilities are covered and must name a U.S. agent.

FDA’s definition of a facility leaves out:

• Beauty shops and salons, unless they manufacture or process products on site.
• Cosmetic retailers, direct sellers, retail distribution facilities and pharmacies, unless they make products that are not sold directly to consumers at that location.
• Sites that only label, relabel, package, repackage, hold or distribute cosmetics. Filling a container with product does count as manufacturing, so a filler is not exempt.

For most private label brands, the factory registers and the brand, as the responsible person named on the label, handles product listing.

Who files when a contract manufacturer makes your product?

MoCRA requires only one registration per facility, even if a contract manufacturer makes products for many brands plus its own line. The law lets either the contract manufacturer or any responsible person whose products are made there submit the registration. If a brand registers the factory, the factory does not file a second registration for the same site.

In practice, ask your manufacturer three questions before you launch:

1. Is the facility registered, and what is its FEI number?
2. Does the registration include your brand names and the right product categories?
3. When is the next renewal date, and who will file it?

Keep the answers on file, because product listing asks which facilities make each product. Our guide to MoCRA product listing in Cosmetics Direct covers the listing side.

Which small businesses are exempt from facility registration?

MoCRA exempts small businesses whose average gross annual U.S. sales of cosmetic products over the previous three years are less than $1,000,000, adjusted for inflation. The exemption does not apply, regardless of sales, if the business manufactures or processes:

• Products that regularly contact the mucous membrane of the eye. FDA gives eye shadow, eye makeup remover, eyeliner and false eyelash adhesive as examples.
• Products that are injected.
• Products intended for internal use.
• Products meant to alter appearance for more than 24 hours where removal by the consumer is not part of normal use. FDA’s examples include certain nail polishes, some hair dyes and eyebrow dyes, and tattoo inks.

FDA does not issue exemption certificates, so keep your own sales records. Drug and device establishments are also outside cosmetic facility registration unless they make cosmetics that are not drugs or devices. Exempt businesses may register voluntarily.

What information goes into a cosmetic facility registration?

Under section 607 and FDA’s December 2024 guidance, a registration must include:

• The name of the facility owner or operator.
• The facility name, physical address, email address and phone number.
• For a foreign facility, the name and phone number of its U.S. agent, plus email if available.
• The facility registration number previously assigned, if any. This is the FEI.
• All brand names under which cosmetics made or processed at the facility are sold.
• The product category or categories, and the responsible person, for each cosmetic made or processed there.
• The type of submission: initial, amended, biennial renewal or abbreviated renewal.

The FEI step most often stalls a first filing: get the FEI first, and make sure the registration address matches the address in FDA’s FEI Search Portal. Our explainer on FEI numbers vs FDA registration numbers walks through how to look one up or request one.

How do you submit a MoCRA facility registration?

FDA accepts three routes:

1. Cosmetics Direct, FDA’s free online portal, which builds and submits the filing in Structured Product Labeling (SPL) format.
2. SPL authoring software and the Electronic Submissions Gateway Next Generation. FDA warns that a gateway account can take one to three weeks to set up.
3. Paper Form FDA 5066, Registration of Cosmetic Product Facility. FDA strongly encourages electronic submission instead.

FDA charges no fee for facility registration or product listing under section 607.

When is MoCRA facility registration due, and how does renewal work?

• New facilities: register within 60 days of first manufacturing or processing cosmetics for U.S. distribution.
• Changes: file an amended registration within 60 days of any change to the required information, including a cancellation.
• Renewal: every two years, counted from the date of initial registration. FDA’s example: a registration received February 20, 2024 must be renewed by February 20, 2026.

FDA offers two renewal types in Cosmetics Direct: a biennial renewal when something changed, and an abbreviated renewal when nothing changed since the last submission. Since February 2026, Cosmetics Direct shows Registration Status and Renewal Date fields, and FDA emails reminders to the facility contact, account contact and U.S. agent. You can renew early.

Failing to register is a prohibited act under the FD&C Act, and FDA can suspend the registration of a facility whose products pose a serious risk, which stops U.S. sales from that site.

What should you send when a marketplace asks for proof of registration?

On September 9, 2026, FDA reminded facilities, retailers and responsible persons that it does not provide certificates or other documents to verify cosmetic facility registration or product listing. So when a marketplace asks for an “FDA certificate,” send accurate records instead: the facility FEI, your product listing numbers, and your own submission confirmations. Our article on what to send when a marketplace asks for an FDA certificate has a checklist, and our answer on registration vs approval explains how to describe a filing without overstating it.

Registration is one part of MoCRA. Brands also need product listing, serious adverse event reporting within 15 business days, safety substantiation records and compliant labels. See our FDA cosmetic labeling guide and our answer on U.S. agents and responsible persons under MoCRA.

How Eva Commerce helps

Eva Commerce files MoCRA facility registration and biennial renewal ($440 every two years), MoCRA product listing ($100 per product, one-time, with updates free while it is the same product) and U.S. Agent service for foreign facilities ($250 a year). We confirm the FEI, map your brands and categories, and track the renewal date. Full details and other FDA services are on our FDA compliance services page.

Because Eva also grows brands on Amazon, Walmart, TikTok Shop and Shopify, the same team can answer a marketplace document request and keep your listings live. Book a call or call 858-315-2020 to check your MoCRA status.

Frequently asked questions

Who has to register a cosmetic facility under MoCRA?

Every owner or operator of a facility that manufactures or processes cosmetics for distribution in the United States, including foreign facilities, unless an exemption applies. Salons, retailers and sites that only label, package, hold or distribute are generally excluded.

How often does a MoCRA facility registration need to be renewed?

Every two years, counted from the date of the initial registration. Changes to the registration must be filed within 60 days, and new facilities must register within 60 days of starting production.

Does FDA charge a fee for cosmetic facility registration?

No. FDA does not charge a fee to submit a cosmetic facility registration or product listing. Any fee you pay goes to the service provider that prepares and files it.

Does a brand that uses a contract manufacturer need to register?

Only one registration is needed per facility. Either the contract manufacturer or a responsible person whose products are made there may submit it. Most brands confirm the factory’s FEI and registration rather than filing their own.

Is my small cosmetic business exempt from MoCRA registration?

Possibly. Businesses with average U.S. cosmetic sales under $1,000,000 a year over three years, adjusted for inflation, are exempt, unless they make eye-area, injected, internal-use or long-wear products. FDA does not issue exemption certificates.

Can Eva Commerce file my MoCRA facility registration?

Yes. Eva files MoCRA facility registration and renewal, product listing and U.S. Agent service, and tracks your renewal date. Book a call or call 858-315-2020.

Sources: FDA, Registration and Listing of Cosmetic Product Facilities and Products; FDA, Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (December 2024); FDA, Modernization of Cosmetics Regulation Act of 2022 (MoCRA); FDA, Cosmetic Product Categories and Codes; FDA, Form FDA 5066: Registration of Cosmetic Product Facility; FD&C Act sections 604, 607 and 612. General information, not legal advice.

Related Eva guides: FDA compliance services, MoCRA product listing guide, FEI number vs FDA registration number, FDA registration and U.S. Agent guide, private label cosmetics.