The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was enacted on December 29, 2022. It came as part of the Consolidated Appropriations Act, 2023. It represents the most significant expansion of the US Food and Drug Administration’s authority over cosmetics since the Federal Food, Drug, and Cosmetic Act (FD&C Act) was enacted in 1938.
MoCRA introduced Section 607 into the Federal Food, Drug, and Cosmetic Act (FD&C Act). The section made cosmetic facility registration and cosmetic product listing, among several other requirements, mandatory for businesses covered under the law.
This article explains the main regulatory changes introduced under MoCRA and the obligations applicable to cosmetic manufacturers and responsible persons.
Who is the Responsible Person under MoCRA?
MoCRA applies to the “responsible person,” including the manufacturer, packer, or distributor whose name appears on the product label under Section 609(a) of the FD&C Act and Section 4(a) of the Fair Packaging and Labeling Act. Such a person has several obligations to perform under this framework. It includes cosmetic product listing, maintaining safety substantiation records, and reporting serious adverse events associated with the use of the cosmetic product.
Compliance Requirements for Cosmetics Under MoCRA
MoCRA introduced several requirements that cosmetic businesses need to consider when manufacturing, processing, marketing, or distributing cosmetics in the United States.
The principal requirements include:
- Cosmetic facility registration
- Cosmetic product listing
- Serious adverse event reporting
- Safety substantiation
- Additional labelling requirements
- Good manufacturing practice requirements to be established by FDA
- FDA records-access authority
- FDA mandatory recall authority
Let’s read about the important ones in detail here:
1. MoCRA Cosmetic Facility Registration Requirements
The changes introduced under MoCRA apply to facilities manufacturing or processing cosmetic products for distribution in the United States. Section 607(a) requires facility owners and operators to register their facilities with the FDA within one year from the date of enactment.
It further states that every person who owns or operates a facility that engages in the “manufacturing or processing of a cosmetic product for distribution in the United States” is required to register each facility with the FDA and renew the same every two years. Cosmetic product facility registration renewal instructions can be referred from the following links:
- User’s Guide to Cosmetics Direct (2026)
- Cosmetics Direct – Facility Registration Tutorial (2026)
FDA’s Facility Registration System
The FDA’s current registration system is Cosmetics Direct. It is its electronic submission portal for cosmetic product facility registrations and cosmetic product listings. They updated Cosmetics Direct in February 2026 to support biennial facility registration renewal, including registration status and renewal date fields and automated renewal reminders.
Further, the authorities intend to use the FDA Establishment Identifier (FEI) as the required facility registration number. Facilities should obtain or confirm their FEI before submitting the facility registration.
Important Note:
Facility registration is not FDA approval of a cosmetic product. The FDA expressly states that cosmetic facility registration and product listing are neither a cosmetic approval program nor a promotional tool, and the FDA does not issue certificates for these submissions.
2. MoCRA Cosmetic Product Listing Cosmetic Product Listing
As per Section 607(c) of the FD&C Act, the responsible person is required to submit to the FDA “a cosmetic product listing” for each cosmetic product, including ingredients, within 120 days after that product is marketed in US interstate commerce and provide updates annually.
Cosmetics Direct can be used to submit both facility-registration and product-listing information electronically. FDA also provides paper submission options through the applicable FDA forms.
3. Exemptions for Certain Small Businesses
MoCRA provides exemptions from certain facility-registration, product-listing, and GMP requirements for qualifying small businesses. However, these exemptions do not apply to certain categories of cosmetic products.
The small-business exemptions do not apply to facilities or responsible persons associated with the following:
- Cosmetic products that regularly come in contact with the eye’s mucous membrane when used, such as eyeliner, eye serums, and creams.
- Products that are injected into the skin, like dermal fillers.
- Products intended for internal use.
- Cosmetics intended to alter appearance for more than 24 hours under customary or usual conditions of use, and removal by the consumer is not part of such conditions, such as permanent hair dye.
Some exemptions also apply to products and facilities subject to requirements for drugs and devices.
4. Adverse Event Reporting
MoCRA added Sections 605 (Adverse Event Reports), 610 (Serious Adverse Health Consequences or Death To Humans, SAHCOD), and 704 (Inspections) of the FD&C Act, authorizing the FDA to access and copy records related to adverse events associated with the use of cosmetic products.
If the responsible person receives new medical or other information concerning the adverse event within one year after the initial report, that information must also be submitted to FDA within 15 business days of receipt.
The adverse events submitted to FDA can be accessed from the FDA Adverse Event Monitoring System (AEMS) Public Dashboard for Cosmetic Products.
What Is a Serious Adverse Event?
FDA defines a serious adverse event to include an event resulting in outcomes such as the following:
- Death
- A life-threatening experience
- Inpatient hospitalisation
- Persistent or significant disability or incapacity
- Congenital anomaly or birth defect
- Infection
- Significant disfigurement, including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent/significant alteration of appearance, other than as intended under customary or usual conditions of use
It can also be an event requiring medical or surgical intervention, based on reasonable medical judgment, to prevent one of these outcomes.
5. FDA Enforcement & Mandatory Recall Authority
MoCRA added Section 611 to the FD&C Act, granting the FDA the power to initiate the mandatory recall of cosmetics. In order to do so, the FDA must determine that there is a reasonable probability that the cosmetic is adulterated as per Section 601 or misbranded as per Section 602 of the Act.
Secondly, the use of or exposure to the cosmetic will cause serious adverse health consequences or death (SAHCOD). If the agency determines that, it will notify the responsible person to voluntarily cease distribution and recall such cosmetics.
If the responsible person refuses to do so voluntarily within the timeline as prescribed by the FDA, the agency is authorized to order the responsible person to immediately cease distribution of such cosmetics with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order.
The FDA published draft guidance in December 2025 explaining its approach to the mandatory cosmetics recall authority. That document is draft guidance, not a final regulation.
6. MoCRA Labeling Requirements
As per MoCRA, cosmetic labels must clearly mention the responsible person’s (manufacturer, packer, or distributor) domestic address and contact information. The ingredients list should be in descending order. The instructions should be clear about product usage and warnings, since improper labeling can potentially result in unsafe use.
Another update is the disclosure of fragrance allergens on the label of cosmetic products, instead of grouping them under the term “fragrance.” However, it is in the proposed stage. The FDA has recently updated its timelines with a proposed rule to be published in May 2026. It establishes an official list of reportable allergens that will impact labeling for a broad range of products, with potential phased implementation expected between 2026 and 2028.
Further to this, cosmetics intended for licensed professionals must now be clearly labeled “for professional use only.” This will help a consumer identify a product easily before purchase.
7. Safety Substantiation Record-Keeping
In accordance with Section 608 of FDCA, the responsible person (manufacturer or marketer) is required to ensure and maintain records supporting “adequate safety substantiation,” with a responsibility that the cosmetic product to be marketed in the US by 29 December 2023 is safe.
The FDA does not require a specific testing protocol for showing the individual cosmetic product or ingredient’s safety. Companies can use relevant safety data that are already available, provided the evidence used to support it is scientifically robust. The authorities also state that animal testing is not a requirement for marketing a cosmetic product.
Adequate safety substantiation may be supported by relevant tests, studies, research, analyses, or other evidence or information evaluated by qualified experts with appropriate scientific training and experience.
Adverse Event Record Retention
Section 605(e)(1) mandates maintaining records related to an adverse event for a period of six years after the date of creating such a record. However, for a responsible person operating a small business (as mentioned in Section 612 (b)), who is not engaged in the manufacturing or processing of the cosmetic products, the records must be maintained for a minimum of three years.
MoCRA Good Manufacturing Practices Regulations
MoCRA requires the FDA to establish Good Manufacturing Practice (GMP) regulations for cosmetic product facilities. The law directs the Food & Drug Administration to consider factors including public health risks and the size and scope of the businesses subject to the requirements. The authorities have published a Draft Guidance for Industry: Cosmetic Good Manufacturing Practices as part of its implementation work.
FDA Records Access Authority Under MoCRA
MoCRA gives FDA authority, under specified conditions, to access and copy certain records relating to cosmetic products, including safety records. The FDA issued draft guidance in January 2026 describing this records-access authority. This authority is an important expansion of the FDA’s ability to review information relevant to cosmetic-product safety and compliance.
MoCRA vs. Previous FDA Cosmetics Regulation
Before MoCRA, FDA operated the Voluntary Cosmetic Registration Program (VCRP), under which cosmetic establishments and products could be voluntarily reported to FDA. FDA states that establishment registration and product filings under the VCRP were not mandatory.
MoCRA changed this framework by creating mandatory facility-registration and cosmetic-product-listing requirements for covered businesses, subject to statutory exemptions. It also introduced or expanded FDA authorities and industry requirements as discussed in this article.
Managing MoCRA Compliance Through FDA’s Electronic Systems
FDA’s Cosmetics Direct is the agency’s electronic submission portal for cosmetic facility registration and cosmetic product listing. It supports the creation, validation, and submission of the applicable Structured Product Labeling (SPL) submissions.
The FDA also provides the FEI Search Portal to help businesses determine whether a facility already has an FDA Establishment Identifier.
For adverse-event reporting, responsible persons can submit serious adverse-event reports to FDA using the applicable electronic or paper reporting process.
Current FDA Registration Portal
FDA’s current Cosmetics Direct materials were updated in February 2026 to support biennial facility-registration renewals. Registered facilities can now see their registration status and renewal date and receive automated renewal reminders.
Also Read: Cosmetics Compliance Check Software
Does MoCRA Apply to Foreign Cosmetic Manufacturers?
Yes. Imported cosmetics must comply with the same US laws and regulations applicable to cosmetics produced domestically. A foreign business that manufactures or processes cosmetics distributed in the United States may therefore have MoCRA obligations depending on its role and whether a statutory exemption applies.
For facility-registration purposes, FDA’s definition of a facility includes an establishment, including an establishment of an importer, that manufactures or processes cosmetic products distributed in the United States. Foreign companies should also carefully determine who qualifies as the responsible person for each cosmetic product because product-listing and serious-adverse-event obligations attach to the responsible person.
Conclusion
MoCRA is groundbreaking legislation that strengthens the FDA’s oversight of the cosmetics industry and ensures the safety of cosmetic products for consumers. Although MoCRA imposes new obligations on cosmetic manufacturers and distributors, the benefits to consumers are evident, as it guarantees the safety and effectiveness of the cosmetics they use daily. Cosmetic manufacturers and importers now have the responsibility to comply with these new regulations.
Artixio can assist you with:
- US Agent Services for non-US cosmetic manufacturers
- Cosmetic Products Facility Registration
- Cosmetic Product Listing
- Responsible Person for Cosmetics
- MoCRA Labeling Compliance
- Safety Substantiation
- SPL for cosmetic submissions
- Cosmetic GMP compliance
- Adverse Event Reporting and Management
Need support with MoCRA compliance in the United States? Explore Artixio’s USA regulatory services for assistance with cosmetic facility registration, product listing, labeling compliance, safety substantiation, and other FDA requirements. Connect today at info@artixio.com.
FAQs
What are the steps to MoCRA compliance?the steps to MoCRA compliance?
Businesses should first determine whether they and their products are subject to MoCRA and whether any statutory exemption applies. Covered facility owners or operators must register applicable facilities with FDA, while the responsible person must list covered cosmetic products and maintain the required safety and adverse-event records. Responsible persons must also report serious adverse events within 15 business days.
Is FDA registration for cosmetics the same as product approval?
No. The FDA states that cosmetic facility registration and product listing are not a cosmetic approval program, and the FDA does not issue certificates for these submissions. Companies remain responsible for ensuring that their cosmetics comply with applicable US requirements.
How long does the FDA cosmetic product registration process take?
Timelines vary depending on your product complexity and documentation. However, with complete information, we help you finalize FDA cosmetic product registration and facility submissions more quickly.
Does MoCRA require animal testing for cosmetics?
No. FDA states that animal testing is not a requirement for marketing a cosmetic product. Companies must nevertheless ensure that they have adequate safety substantiation supported by scientifically robust evidence.
