On 29 December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) became part of the Consolidated Appropriations Act, 2023 (Pub. L. 117–328).
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 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.
Mandatory Requirements for Cosmetics Under MoCRA
The mandatory requirements of MoCRA include the following:
MoCRA Mandatory 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.
As per Section 607(a) of the FD&C Act, every person that 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 FDA and renew the same every two years. Cosmetic product facility registration renewal instructions can be referred from the following links:
Also Read: US FDA Cosmetic Registration Process Steps
MoCRA Product Listing
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. As per Section 607(c) of the FD&C Act, the responsible person requires to submit to FDA “a cosmetic product listing” for each cosmetic product, including ingredients within 120 days after that product is marketed in U.S. interstate commerce and providing their updates annually.
Exemptions
Certain small businesses are exempted from GMP, register facilities and list cosmetic product(s) as well as certain products and facilities subject to drug and device requirements are also exempted.
However, small businesses exemptions do not apply to manufacture or process certain high-risk products, including:
- Cosmetic products that are regularly come in contact with the eye’s mucus membrane when used, such as, eyeliner, eye serums and creams.
- Products which are injected into the skin like dermal fillers.
- Products intended for internal use.
- Products 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.
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 FDA to access and copy records related to adverse event associated with the use of a cosmetic product.
- In this regard, it is mandatory for a responsible person to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days and must submit a copy of the label on or within the retail packaging of such cosmetic product. FDA can also access the adverse event report during an inspection.
- The adverse events submitted to FDA can be accessed from FDA Adverse Event Monitoring System (AEMS). This web-based tool improves transparency and provides a chance to public to query the FDA AEMS.
FDA Enforcement & Mandatory Recall Authority
MoCRA added Section 611 to the FD&C Act, granting FDA the power to initiate the mandatory recall over cosmetics. In order to do so, 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; and 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.
MoCRA Labeling Requirements
As per MoCRA, cosmetic labels must clearly mention the responsible person (manufacture, packer or distributor); ingredients list in descending order; domestic contact information and include the mechanisms for reporting adverse events with clear instructions about product usage and warnings, since the improper labelling potentially result in unsafe use.
- Another update is the mandatory disclosure of fragrance allergens on the label of cosmetic product, instead of grouping them under the term “fragrance”. However, it is under proposed stage. The FDA has recently updated its timelines with a proposed rule to be published in May, 2026 which establishes an official list of reportable allergens, which will impact labelling 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 labelled “for professional use only.” This will help a consumer to easily identifying a product before purchase.
Safety Substantiation Record-Keeping
In accordance with Section 608 of FDCA, the responsible person (manufacture or marketer) requires to ensure and maintain records supporting “adequate safety substantiation”, with a responsibility that the cosmetic product to be marketed in U.S. by 29 December 2023 is safe.
The “adequate substantiation of safety”, as referred above, is defined in Section 608(c) as the tests of studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.
Section 605(e)(1) mandates maintaining records related to an adverse event for a period of six years after the date of creating such record. However, for responsible person operating a small business (as mentioned in Section 612 (b)), who does 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
FDA is authorized to establish GMP regulations cosmetic products manufacturing facilities which will help ensure that products are consistently produced in a safe and clean environment, reducing the risk of contamination or other safety issues. FDA has published the Draft Guidance for Industry: Cosmetic Good Manufacturing Practices that revises the “Cosmetic Good Manufacturing (GMP) Guidelines/Inspection Checklist” by updating it to set forth current practice, and clarify certain topic areas based on recent experience.
MoCRA Compliance Checklist
This addresses key FDA requirements regarding cosmetic safety, ingredient verification, and finished product testing, including how to approach claim substantiation for marketing materials. It also provides guidance on implementing good manufacturing practices (GMPs), navigating cosmetic labeling rules, and conducting quality assurance testing. The detailed steps can be referred from Section II provided here Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products.
MoCRA and State Law Pre-emption
21 U.S. Code § 379s (Section 752 of the FD&C Act) has established “Preemption for labeling or packaging of cosmetics”. This prohibits States from enforcing any requirement for labelling or packaging of a cosmetic that is different from or identical to existing legislation under that chapter, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.) to ensure the national uniformity with Laws.
However, the FDA Secretary may grant exemptions upon application by a State and notify the requirements for labelling or packaging by regulations which protects an important public interest that is otherwise unprotected and would not cause a cosmetic violated from any requirement under Federal Law.
MoCRA vs Previous FDA Cosmetics Regulation
Previously registration of cosmetic products and manufacturing facilities was optional. However, registration has now become mandatory for cosmetics, and the US FDA has discontinued accepting both electronic and paper submissions since March 2023. Cosmetic manufacturers and importers are now required to comply with the new regulations. Certain exemptions also exist for products and facilities that are subject to requirements for drugs and devices.
FDA had fewer tools to protect public health and ensuing safe cosmetic products. After the enactment of MoCRA that applies to all manufacturers, packers, or distributors of cosmetics distributed in the U.S., require compliance with its updated, and mandatory requirements. The major updates include mandatory facility registration, cosmetic product listing, serious adverse event reporting, safety substantiation, GMP, allergen disclosure and mandatory recall authority which were in the previous cosmetics regulations either voluntary or limited enforced structure.
Managing MoCRA Compliance Using Software
The output for the MoCRA compliance is best achieved through the following important software facilities:
- Cosmetic Direct: FDA Direct is U.S. Food and Drug Administration’s web-based and free structured product labeling (SPL) authoring tool. Registration of Cosmetic Product Facility and Cosmetic Product Listing. This free software system will provide Registration of Cosmetic Product Facility and Cosmetic Product Listing, information to FDA/Office of Cosmetics and Colors (OCAC) about cosmetic product manufacturers/processors and cosmetic products on the market.
- FEI Search Portal: This tool helps determine the operator or facility already has an FDA Establishment Identifier (FEI) number which is required to facilitate the registration process.
- FDA Adverse Event Monitoring System (AEMS) Public Dashboard for Cosmetic Products: This updates the number of adverse reports received by FDA for cosmetic products. Serious Adverse Event Reports (SAERs) are mandatory to submit by industry’s responsible person starting 29 December 2023.
Also Read: Cosmetics Compliance Check Software
MoCRA Compliance Transition Timelines
US FDA has given different transition timelines for different regulatory obligations. By 29th December 2023, professional use cosmetics should bear specific labelling information; RP must submit serious adverse events along with a copy of the label to FDA within 15 business days after a report is received; existing facilities manufacturing or processing cosmetics in the US must register with the FDA; the Responsible Person must submit to FDA a cosmetic product listing.
By 29 December 2024, a domestic address, domestic phone number, or electronic contact information through which the RP can receive adverse event reports is required on product’s label before.
The facilities manufacturing or processing cosmetics in the US for the first time after 29 December 2022 have an additional 60 days to register and must register by February 28 2024.
If the products are first marketed after 29 December 2023, RP must submit a product listing within 120 days of marketing such products in interstate commerce followed by annual updates to such listing.
Implementation of Modernization of Cosmetics Regulation Act (MoCRA)
In the past, registration of cosmetic products and manufacturing facilities for cosmetics was optional. However, it is now mandatory to register cosmetics, and as a result, the US FDA has stopped accepting electronic or paper submissions since March 2023.
To prepare for the implementation of new regulations under MOCRA, the US FDA has been issuing drafts of guidelines that cover the registration of cosmetic product facilities and products. The Agency has also released technical specifications for the implementation of Structured Product Labeling (SPL) and the validation procedures. The draft guideline for Good Manufacturing Practices in the cosmetic market in the USA is also to be finalized and released by US FDA.
Conclusion
MoCRA is a 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 has the ability to assist you with”
- US Agent Services for non-US Cosmetics manufacturers
- Cosmetic Products Facility Registration
- Cosmetic Product Listing
- Responsible Person for Cosmetics
- MoCRA Labeling Compliance
- Safety Substantiation
- SPL for the cosmetic submissions
- Cosmetic GMP compliance
- Adverse Event Reporting and Management
FAQs – Modernization of Cosmetics Regulation Act of 2022
What are steps to MoCRA compliance?
Manufacturers or marketers should:
- Get a US agent if your facility is based outside the US
- Register your facility with the FDA
- Identify the responsible person(s) for your products
- The responsible person(s) must complete the required tasks for product listing, safety substantiation and adverse events
Is FDA registration for cosmetics the same as product approval?
No. The FDA does not “approve” cosmetic product before they are placed into the market. However, companies must complete FDA registration for cosmetic products, ensure accurate labeling, and meet all safety requirements under MoCRA.
What is the deadline for FDA cosmetic facility registration?
The initial deadline provided by the FDA was 1st July 2024, for both domestic and foreign cosmetic products facilities. Current updates and annual renewals are required to comply.
Can I hire only one service, like facility registration or U.S. Agent?
Yes. All of the services — including cosmetic facility registration, MoCRA compliance consulting, and U.S. Agent services — are available separately or as part of a complete support package.
How long does the FDA cosmetic product registration process take?
Timelines vary depending on your product complexity and documentation. However, with complete information, we typically finalize FDA cosmetic product registration and facility submissions within a few business days.
Do companies that manufacture both OTCs drugs and cosmetic products have to comply with the mandated requirements for both?
Products which are classified as drugs and cosmetics under the FDCA, the drug requirements take precedence over the cosmetic requirements.
Does MoCRA address animal testing?
MoCRA does not include any specific provisions related to animal testing, however, Cruelty-Free International (CFI) and the Humane Society of the United States (HSUS) are some of the key stakeholders to advocate for the passage of the Humane Cosmetics Act.
Why Is This New MoCRA Law So Significant?
It’s not just that it’s been more than 80 years since the passing of the FDCA, but also the fact that it only provided general guidance outside of one requirement, that being that finished products be safe when used in accordance with labeling. Modernization Cosmetics Regulation Act 2022 MoCRA aims to achieve that.
How Do I Know if Modernization of Cosmetics Regulation Act 2022 Applies to My Business?
The criteria for exemption from MoCRA is fairly straightforward. Generally, the requirements apply to all cosmetics manufacturers, packers, importers and distributors in the U.S., as well as those outside the country that market their products in the U.S.
