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MoCRA renewal briefing

MoCRA facility-registration renewal: dates, status, and what to do.

An evergreen briefing on the biennial renewal cycle under MoCRA: how your facility's date is set, how to verify it, and how to catch up if renewal is overdue.

Renewals Every two years
Wall calendar marking a facility's biennial renewal date

Reviewed by Cassandra Maddocks, chemist & biochemist · last reviewed 26 July 2026

If you sell cosmetics in the United States, your MoCRA facility registration renews every two years, on a date set by your facility's own initial registration (see FDA's registration and listing guidance). The law behind this is MoCRA, the Modernization of Cosmetics Regulation Act. This page sets out what MoCRA requires, what the renewal covers, who it applies to, how the renewal date actually works, and the steps to be ready in good time.

The deadline at a glance
  • Cosmetic manufacturing facilities must renew their FDA registration every two years.
  • Each facility's renewal is due two years from its initial registration date, and every two years after that.
  • Each facility's own renewal date is two years from its initial registration date, so deadlines are staggered through 2026, not all on 1 July.
  • Foreign facilities are included, and a foreign facility that must register also needs a US Agent physically present in the United States.
  • There is no FDA fee to register a facility or list a product.
  • Renewal is a recurring two-year obligation, so a tracking system prevents the next one from slipping.

What MoCRA is, in plain terms

MoCRA is the Modernization of Cosmetics Regulation Act, the law that gave the FDA direct oversight of cosmetics for the first time. It introduced two duties that most brands meet through the FDA. A facility that manufactures or processes cosmetics for the US market has to register with the FDA. Separately, the Responsible Person, meaning the manufacturer, packer, or distributor whose name appears on the product label under FD&C Act section 609(a) and FPLA section 4(a), has to list each marketed cosmetic product with the FDA, including its ingredients, and update that listing every year.

The FDA registration and listing page with the biennial facility registration requirement highlighted
The FDA's Registration and Listing page for cosmetic product facilities, with the registration and biennial renewal requirement highlighted. Captured 26 July 2026. View the official text.

Facility registration and product listing are two different obligations, and they often sit with two different parties. This is where brands trip up. A brand that uses a contract manufacturer will usually find that the manufacturer registers the facility, while the brand named on the label still has to file the product listing and handle adverse-event reporting itself. Assuming the manufacturer "handles all the FDA stuff" is one of the most common gaps we see.

What the biennial renewal covers

MoCRA requires registered facilities to renew that registration every two years. The renewal is not a re-application from scratch. It confirms that the facility's registration details are current. There are two forms of renewal. A facility whose details changed files a full biennial renewal. A facility with no changes files an abbreviated renewal. Separately, and on a shorter clock, a facility must notify the FDA within 60 days of any change to its registration information rather than waiting for the two-year point.

Renewal timing is set per facility, not by a shared calendar date. It is not a single fixed date that applies to everyone. Each facility's actual renewal falls two years from its own initial registration date, which produces staggered deadlines running through 2026. A facility registered early in the compliance window is due earlier than one registered later. The only way to know your true date is to check when your facility first registered, and to verify it in FDA's Cosmetics Direct.

How the dates came about
  • The statutory compliance date for facility registration and product listing was 29 December 2023.
  • The FDA delayed enforcement by six months, moving the effective date to 1 July 2024.
  • Two years on from that window, the first biennial renewals fell due through 2026, each on its facility's own anniversary, and they recur every two years.
  • The US-contact-on-label requirement for adverse-event reporting applied from 29 December 2024.

Who this affects

The renewal applies to any company whose cosmetics are marketed in the United States and whose facilities are subject to MoCRA registration. That covers domestic manufacturers and foreign facilities that supply the US market. If you are an international brand selling into the US, this almost certainly applies to you, and a foreign facility that must register also has to designate a US Agent. The US Agent has to reside in the United States or maintain a place of business there and be physically present, because the role is the FDA's communication liaison for the foreign facility. A mailbox or an answering service does not meet that test.

The US Agent is a separate thing from the Responsible Person, and mixing them up is common among foreign sellers. The Responsible Person can sit outside the US. The US Agent has to be inside it. There is also a third requirement that people fold into the same confusion: the product label must carry a US contact for adverse-event reporting, a requirement that applied from 29 December 2024, and that label contact is distinct again from the foreign-facility US Agent role.

Brands that registered when MoCRA first came into force, then did not think about it again, are the ones most likely to be caught out. There is no single reminder that reaches every brand, the rules are unfamiliar to teams used to the old US regime, and international brands may not be watching FDA calendars closely.

The small-business exemption, and where it stops

MoCRA defines a small business as one whose average gross annual US cosmetic sales for the previous three-year period are under $1,000,000, a figure that is inflation-adjusted. A qualifying small business is exempt from Good Manufacturing Practice requirements, facility registration, and product listing. That is real relief, and it means a genuinely small brand may have no facility-registration renewal to make at all.

Two points catch people out. First, the exemption does not apply across the board. It does not cover products that regularly contact the mucous membrane of the eye, products that are injected, products for internal use, or products that alter appearance for more than 24 hours where removal is not part of ordinary use. The exemption is all-or-nothing at the firm level, so a single eyeliner or eye cream in your range can knock the whole exemption out and pull your facilities back into the registration and renewal rules. Second, being exempt from registration and listing does not exempt you from everything. Adverse-event reporting, labeling requirements, and safety substantiation still apply to every firm, exempt or not. Keeping a safety substantiation record on file for each product is the obligation that remains even for the smallest brand. The exemption’s full boundaries are mapped in our small-business exemption guide.

The wider set of MoCRA duties

Renewal is one date inside a larger set of ongoing obligations. It helps to see the whole picture, because the renewal is easier to keep on top of when it sits inside a system rather than being a one-off task.

  • Facility registration and its biennial renewal. Register the facility, renew every two years, and notify the FDA within 60 days of any change to the registration details.
  • Annual product listing. The Responsible Person lists each marketed product with its ingredients and updates the listing every year. A product already on the market by the compliance date had to be listed by that date. A new product must be listed within 120 days of being marketed in the US.
  • Adverse-event reporting. The Responsible Person reports serious adverse events to the FDA within 15 business days and files any follow-up within a further 15 business days. Adverse-event records are kept for six years, or three years for smaller businesses.
  • Safety substantiation. Every product needs adequate substantiation of safety on file, and this applies even to firms that are exempt from registration and listing.
  • Labeling. The label has to carry a US contact for adverse-event reporting, in place since 29 December 2024.
  • US Agent. A foreign facility that must register designates a US Agent physically present in the United States as its FDA liaison.

A point worth stating plainly, because it causes real confusion: listing a product with the FDA does not mean the product is "FDA approved." The FDA does not approve cosmetic products before they go on the market. Listing records that the product exists and what is in it. It is not a mark of approval, and describing it that way on a label or a store page is a mistake.

Equally worth knowing what is not on this list yet. Three MoCRA rulemakings are still pending as of our last review and impose no obligations today: fragrance allergen labelling (the FDA's proposed rule has been repeatedly delayed past its June 2024 statutory deadline), cosmetic GMP regulations (no finalisation date), and standardised talc asbestos testing: the FDA's proposed rule was formally withdrawn on 28 November 2025 with intent to reissue. The biennial renewal obligation is among the duties already in force, not these.

How the filing actually works

Facility registration and product listing are filed through the FDA's own systems, and there is no FDA fee for either. Before you can submit, the facility needs an FDA Establishment Identifier, the FEI number. The FDA's free authoring tool for these submissions is Cosmetics Direct, which produces the filing in Structured Product Labeling (SPL) format, an XML-based format. Brands new to FDA systems tend to find the SPL and XML side of Cosmetics Direct intimidating and easy to get wrong. There are paper alternatives for those who prefer them: Form FDA 5066 for facility registration and Form FDA 5067 for product listing.

One more layer sits underneath the federal rules. MoCRA explicitly lets individual states keep making their own cosmetics rules, so the federal requirements sit on top of a state patchwork, with California among the more active states. A product can meet MoCRA in full and still face separate state-level obligations.

How to check your status and renew

Being ready comes down to a short set of concrete checks. Working through them now, rather than in late June 2026, leaves room to fix anything that is out of date.

  • Confirm which of your facilities are registered and find the initial registration date for each, since that date sets the true renewal deadline.
  • Work out your real renewal date. Your renewal date is the two-year anniversary of your facility's initial registration. If it has already passed, review your registration status and complete the renewal submission without delay.
  • Check that your product listing is current, reflects the products you actually sell, and has had its annual update.
  • Confirm your US Agent is in place if any of your facilities are outside the United States, and that the agent is a real US presence, not a mailbox.
  • Check your labels carry a US contact for adverse-event reporting.
  • File the biennial renewal before your date, using the abbreviated form if nothing changed or the full form if it did, and keep a record of the filing.
  • Put a tracking system in place so the next two-year renewal, and the annual listing update, do not catch you out.

What can go wrong if the renewal lapses

A facility registration that is not renewed can lapse, and a lapsed registration puts the products that depend on that facility out of step with MoCRA. That is the direct risk of missing the date. The more common problems we see are upstream of that: a brand that never realised the manufacturer's facility registration did not cover its own product listing, a firm that assumed its small-business status was permanent after adding an eye product, or a foreign facility relying on a mailbox as a US Agent. Each of these is straightforward to fix once it is spotted, and much harder to unpick after an FDA query has landed.

How CIG helps

CIG manages MoCRA facility registration, maintains your annual product listing, acts as your US Agent for foreign facilities, and tracks your renewal and listing dates so no deadline is missed. MoCRA facility registration and product listing setup is a fixed $900. Every submission is confirmed with you before it is filed. Your renewals can be folded into ongoing Compliance Care so the calendar is watched for you. If you are unsure of your current status, the fastest way to find out is to ask us. For the wider picture, read the full MoCRA guide or the US market overview.

Put this into practice

Renewals recur. Stay covered.

Common questions

MoCRA renewal and deadline: frequently asked questions.

The questions brands ask most often about biennial renewals, the small-business exemption, the US Agent, and what MoCRA actually requires.

Both, in a sense. Facilities renew every two years, and each facility's own renewal falls two years from its initial registration date. That produces staggered deadlines through 2026. Renewal dates recur on each facility's own two-year anniversary. Verify your facility's exact date in FDA's Cosmetics Direct. Check your facility's initial registration date to know your true deadline.

The statutory compliance date for facility registration and product listing was 29 December 2023. The FDA delayed enforcement by six months, moving the effective date to 1 July 2024. A product already on the market by the compliance date had to be listed by that date. A new product must be listed within 120 days of being marketed in the United States. The renewal now coming up is the first two-year renewal of those facility registrations.

Every two years. A facility whose registration details changed files a full biennial renewal, and a facility with no changes files an abbreviated renewal. Separately, you have to notify the FDA within 60 days of any change to your registration information, rather than waiting for the two-year point.

No. There is no FDA fee to register a facility or list a product under section 607 of the FD&C Act. The facility needs an FDA Establishment Identifier (FEI) before submitting. The FDA's free authoring tool is Cosmetics Direct, which files in Structured Product Labeling (SPL) format. Paper alternatives are Form FDA 5066 for registration and Form FDA 5067 for listing. What you may pay for is help preparing and filing the submissions correctly, not the filing itself.

Possibly. MoCRA defines a small business as one whose average gross annual US cosmetic sales for the previous three-year period are under $1,000,000, inflation-adjusted. A qualifying small business is exempt from Good Manufacturing Practice requirements, facility registration, and product listing. So a genuinely small brand may have no facility-registration renewal to make. The exemption is not automatic across your whole range, though. See the next question.

The exemption does not apply to products that regularly contact the mucous membrane of the eye, products that are injected, products for internal use, or products that alter appearance for more than 24 hours where removal is not part of ordinary use. The exemption is all-or-nothing at the firm level, so a single eyeliner, eye cream, or similar product in your range can void the exemption and bring your facilities back into the registration and renewal rules.

Yes. Being exempt from registration and listing does not remove the other duties. Adverse-event reporting, labeling requirements, and safety substantiation apply to every firm. You have to keep adequate substantiation of safety on file for each product, and this is the obligation that remains even for the smallest brand.

Yes. Facility registration and product listing are two separate obligations, and they often sit with two different parties. The manufacturer registers the facility. The Responsible Person, meaning the manufacturer, packer, or distributor whose name appears on the label, files the product listing and handles adverse-event reporting. Assuming the manufacturer handles all of it is one of the most common gaps, and it leaves the brand's own listing unfiled.

They are different roles. A foreign facility that must register has to designate a US Agent who resides in or maintains a place of business in the United States and is physically present there. The US Agent is the FDA's communication liaison for the foreign facility. The Responsible Person can be located outside the US. So a foreign brand can be its own Responsible Person while still needing a separate US Agent inside the United States. A mailbox or answering service does not qualify as a US Agent.

If your foreign facility is one that must register under MoCRA, then yes, it has to designate a US Agent physically present in the United States. This is separate from the requirement that your product label carry a US contact for adverse-event reporting, which applied from 29 December 2024. The label contact and the foreign-facility US Agent are two distinct things.

The requirement most brands need to act on is the US contact for adverse-event reporting, which has to appear on the product label and has been in effect since 29 December 2024. This lets a consumer or the FDA reach a US point of contact if a serious adverse event occurs. State-level labeling rules can also apply on top of the federal requirement, since MoCRA leaves states free to set their own cosmetics rules.

MoCRA requires adequate substantiation of safety for each product, kept on file. It does not prescribe a single method, and clinical trials are not automatically required. What matters is that the evidence you hold is adequate to support the safety of the product as it is used. This requirement applies to every firm, including those exempt from registration and listing.

The Responsible Person reports serious adverse events to the FDA within 15 business days, and submits any follow-up information within a further 15 business days. Adverse-event records are kept for six years, or three years for smaller businesses.

No. The FDA does not approve cosmetic products before they go on the market. Listing records that the product exists and what is in it. It is not an approval, and describing a listed product as "FDA approved" on a label or a store page is a mistake.

MoCRA is the Modernization of Cosmetics Regulation Act, the law that gave the FDA direct oversight of cosmetics. Its main duties for most brands are facility registration for the sites that manufacture or process cosmetics for the US market, and annual product listing by the Responsible Person, along with adverse-event reporting, safety substantiation, and labeling requirements.

A facility registration that is not renewed can lapse, and a lapsed registration puts the products that depend on that facility out of step with MoCRA. Renewing before your date, and keeping a record of the filing, avoids that. If you are unsure whether your registration is current, the quickest route is to check your facility's initial registration date and its renewal history, or ask us to check for you.

Don't let your registration lapse.

Tell us your facilities and products and we will confirm your MoCRA status and quote your coverage at a fixed price, before your next renewal falls due.

In practice

Compliance, in the real world.

Wall calendar marking a biennial renewal date
A renewal reminder on a laptopFacility registration being renewed