The United States remains one of the world's largest and most influential beauty markets, attracting cosmetic brands from across the globe. While the U.S. regulatory framework has historically been perceived as less complex than some international markets, the introduction of the Modernization of Cosmetics Regulation Act (MoCRA) has significantly transformed the regulatory landscape for cosmetic products. MoCRA introduced mandatory requirements for facility registration, product listing, safety substantiation, and adverse event reporting, placing greater responsibility on companies to demonstrate product safety and regulatory compliance.
Your products may already be on the market, but if the FDA requests evidence supporting their safety, businesses must be prepared with scientifically defensible documentation. In today's regulatory environment, MoCRA compliance is no longer optional, it is a fundamental requirement for sustainable market access and consumer confidence.
What is MoCRA?
The Modernization of Cosmetics Regulation Act (MoCRA), enacted in 2022, represents the most significant expansion of FDA authority over cosmetic products in decades. It introduced a more structured regulatory framework for cosmetics marketed in the United States, strengthening oversight across the product lifecycle. MoCRA has transformed regulatory compliance from a voluntary practice into a business-critical requirement for market access and consumer safety.
MoCRA established mandatory requirements for facility registration, product listing, safety substantiation, serious adverse event reporting, and compliance with Good Manufacturing Practices (GMPs). The legislation also expanded FDA authority, including access to certain records and the ability to order mandatory recalls when products may pose a serious risk to public health.
Key Requirements of MoCRA Compliance
Facility Registration
Any facility that manufactures or processes cosmetic products for distribution in the United States is generally required to register with the FDA. This requirement applies to both domestic and foreign facilities, with foreign facilities required to designate a U.S. Agent.
Companies are required to update facility registration information within 60 days of any changes to the submitted information and renew their registration biennially. Facility registration may be submitted electronically through Cosmetics Direct or by using Form FDA 5066.
Exemption: Certain small businesses may qualify for exemptions from facility registration and product listing requirements based on their average gross annual sales of cosmetic products in the United States. However, these exemptions generally do not apply to products that are injected, intended for internal use, intended to alter appearance for more than 24 hours under customary conditions of use, or regularly come into contact with the eye's mucous membrane.
Product Listing
MoCRA requires cosmetic products marketed in the United States to be listed with the FDA, including product ingredients. The Responsible Person is responsible for maintaining product listings and ensuring compliance with key regulatory obligations. The Responsible Person is also responsible for updating product listings annually, as applicable. Product listing must be done through Cosmetics Direct or by using Form FDA 5067.
Flexible Listing: A single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.
Safety Substantiation
Safety Substantiation is one of the most significant requirements introduced under MoCRA. It requires the Responsible Person to maintain adequate records demonstrating that each cosmetic product is safe under its intended or reasonably foreseeable conditions of use.
Safety substantiation is a scientifically justified body of evidence supporting the safety of the finished product. This may include ingredient safety data, published scientific literature, toxicological risk assessments, exposure evaluations, product testing, microbiological and stability testing, and other relevant scientific evidence. A scientifically robust Toxicological Risk Assessment forms the foundation of an effective safety substantiation program, helping demonstrate that the finished cosmetic product is safe under its intended or reasonably foreseeable conditions of use.
Serious Adverse Event Reporting
MoCRA requires the Responsible Person to report any Serious Adverse Event (SAE) associated with a cosmetic product to the FDA within 15 business days. The initial report must include a copy of the product label, and any relevant follow-up information should be submitted as required.
Companies should maintain complete records of adverse events, including investigations, supporting documentation, and communications related to each reported case. These records may be reviewed by the FDA during inspections to verify compliance with post-market surveillance requirements.
Labeling Compliance
Accurate labeling is a fundamental requirement for cosmetic products marketed in the United States. Misbranding risks may arise from false or misleading claims, missing required information, and legibility violations.
Product labels must comply with applicable FDA requirements and include, where applicable:
· Domestic address, domestic phone number, or electronic contact information of the Responsible Person
· Product identity
· Net quantity of contents
· Ingredient declaration (INCI names)
· Fragrance allergen disclosure (once FDA requirements become applicable)
· Required warning statements (where applicable)
Companies should also ensure that cosmetic claims are truthful, scientifically substantiated, and do not imply drug-like benefits.
Good Manufacturing Practices (GMP)
MoCRA requires the FDA to establish Good Manufacturing Practices (GMP) regulations for cosmetic products, reinforcing the importance of consistent manufacturing and quality management.
Cosmetic manufacturers should proactively implement robust quality systems aligned with recognized industry standards, such as ISO 22716.
Effective GMP practices help minimize contamination risks, ensure batch-to-batch consistency, strengthen product traceability, and support overall product quality and regulatory compliance.
Recordkeeping and Inspection Readiness
Effective recordkeeping is the foundation of MoCRA compliance. Cosmetic brands should maintain organized and readily accessible documentation supporting facility registration, product listings, safety substantiation, adverse event reports, labeling, manufacturing controls, and consumer complaints.
Maintaining inspection-ready records not only facilitates regulatory inspections but also demonstrates a company's commitment to regulatory compliance, product quality, and consumer safety.
Common MoCRA Compliance Gaps to Avoid
Failing to maintain facility registration and product listing updates. MoCRA requires ongoing regulatory maintenance, including biennial facility registration renewal.
Incomplete Safety Substantiation: Relying solely on supplier documents without a comprehensive scientific safety assessment for the finished product.
Inadequate Documentation: Failing to maintain inspection-ready records supporting product safety, labeling, manufacturing controls, and regulatory compliance.
Insufficient Adverse Event Management: Not having a structured process to capture, investigate, document, and report Serious Adverse Events within the required timelines.
Non-compliant Labels and Claims: Using cosmetic claims that are misleading, inadequately substantiated, or unintentionally position the product as a drug.
Conclusion
MoCRA has redefined the regulatory expectations for cosmetic products marketed in the United States. Compliance extends far beyond facility registration and product listing. It requires a systematic approach to Safety Substantiation, labeling, quality, Serious Adverse Event reporting, and regulatory documentation throughout the product lifecycle.
By establishing robust compliance systems and maintaining scientifically defensible records, cosmetic brands can strengthen consumer confidence, reduce regulatory risk, and maintain long-term regulatory compliance.
At SciQra, we support cosmetic brands with science-driven regulatory and toxicological solutions, including Toxicological Risk Assessments, Safety Substantiation, MoCRA compliance support, claims review, impurity assessment, and regulatory strategy.
MoCRA Compliance FAQs
Who needs to comply with MoCRA?
MoCRA applies to various entities involved in the cosmetic supply chain. Depending on the business model, compliance may involve cosmetic manufacturers, brand owners, private-label companies, contract manufacturers, importers, and foreign manufacturers exporting cosmetic products to the U.S.
2. Who is the Responsible Person under MoCRA?
Under MoCRA, the Responsible Person is the manufacturer, packer, or distributor whose name appears on the cosmetic product label. The Responsible Person is responsible for maintaining product listings, Safety Substantiation records, Serious Adverse Event reporting, and ensuring compliance with applicable FDA requirements.
3. What records may the FDA access under MoCRA?
The FDA may request records related to Serious Adverse Events, communications associated with reported events, safety substantiation, manufacturing and quality records, raw material and finished product testing, distribution records, inventory records, and recall documentation when necessary to determine compliance or investigate potential safety concerns.
4. Is a Cosmetic Product Safety Report (CPSR) prepared for the EU sufficient for MoCRA compliance?
While an EU Cosmetic Product Safety Report (CPSR) provides valuable scientific information and can support Safety Substantiation, it does not automatically satisfy all U.S. regulatory requirements. Cosmetic brands should conduct a U.S.-specific regulatory assessment to address MoCRA requirements, product classification, labeling, and other FDA expectations.
5. Is FDA registration mandatory for cosmetics under MoCRA?
Yes. Cosmetic facilities that manufacture or process products for distribution in the United States are generally required to register with the FDA, unless a specific exemption applies. Registration must be renewed biennially, and the Responsible Person must also ensure that applicable cosmetic products are listed with the FDA.