At a Glance
• MoCRA (FDA Cosmetics Act) facility registration and product listing requirements are now enforced
• New adverse event reporting requirements mandate 15-day FDA notifications for serious events
• Good Manufacturing Practices (cGMP) final rule deadline approaches December 29, 2025
• Contact information must appear on all cosmetic product labels as of December 29, 2024
• PFAS safety assessment requirements take effect with ongoing FDA evaluation
The cosmetic industry regulations landscape transformed dramatically with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Understanding cosmetic regulatory compliance becomes essential for business survival in 2025. The FDA cosmetics act creates unprecedented oversight requirements that impact every aspect of operations. Smart brands must navigate these changes strategically to maintain market access and avoid costly penalties.
MoCRA Overview and Current Status
The Regulatory Revolution
With many provisions of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) already in effect and others still waiting in the wings, 2025 marks a critical compliance year. This legislation represents the most significant cosmetic regulation overhaul in decades.
The FDA gained expanded authority over cosmetic products and facilities. Previously voluntary programs became mandatory requirements with enforcement consequences. Brands must adapt operations to meet these new standards immediately.
As of January 1, 2025, the number of unique, active facility registrations is 9,528 and the number of unique, active product listings is 589,762. These numbers demonstrate widespread industry compliance efforts.
Key Enforcement Dates and Milestones
The July 1, 2024 deadline for facility registration and product listing has passed. However, ongoing compliance requires annual updates and maintenance. New products and facilities must register within specified timeframes.
The December 29, 2024 deadline has recently passed for the requirement for Responsible Persons to update their product labels with contact information. Brands must ensure all products display required contact details.
Also Read: Why SDS for Hazardous Chemicals Is a Must-Have in Every Manufacturing Unit
Facility Registration Requirements
Who Must Register
A “Responsible Person,” like a manufacturer, packer or distributor, must list each marketed cosmetic product with the FDA. This designation covers both domestic and foreign facilities serving U.S. markets.
Contract manufacturers, private label producers, and importers fall under registration requirements. The definition extends beyond traditional manufacturers to include various supply chain participants.
Small businesses and artisan producers aren’t exempt from registration requirements. Revenue thresholds don’t apply to facility registration obligations under MoCRA.
Registration Process and Maintenance
Facilities must register using Form FDA 5066 through electronic or paper submission methods. Form FDA 5066: Registration of Cosmetic Product Facility captures essential facility information and operations details.
Annual renewal requirements ensure registration accuracy and currency. Facilities must update information within 60 days of significant changes. This includes ownership changes, location modifications, or operational updates.
Foreign facilities require U.S. agent designation for regulatory communications. Agents serve as primary contacts for FDA correspondence and inspections.
| Registration Element | Requirement | Timeline | Consequences of Non-Compliance |
| Initial Registration | All facilities manufacturing/packing cosmetics | Already required | FDA enforcement action |
| Annual Updates | Product listing refresh | Annually by December 31 | Registration suspension |
| Change Notifications | Material facility changes | Within 60 days | Compliance violations |
| U.S. Agent (Foreign) | Designated representative | At registration | Import refusal |
Product Listing Obligations
Comprehensive Product Information
A list of product ingredients must be provided and updated annually. This requirement covers all marketed products regardless of distribution size. Ingredient lists must reflect current formulations accurately.
Product categories, intended uses, and target demographics require disclosure. Marketing claims and product positioning influence listing requirements. Special-use products may trigger additional disclosure obligations.
Private label arrangements complicate listing responsibilities. Responsible persons must coordinate to avoid duplicate listings while ensuring complete coverage.
Annual Update Requirements
Product listings require annual maintenance to remain current. New products need listing within specific timeframes after market introduction. Discontinued products require removal from active listings.
Formulation changes trigger listing updates even for existing products. Ingredient modifications, concentration changes, or supplier substitutions may require notifications.
The FDA provides electronic systems for efficient listing management. Bulk upload capabilities accommodate large product portfolios effectively.
Adverse Event Reporting
Mandatory Reporting Timeline
A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days. This creates strict compliance timelines for event processing.
Serious adverse events include hospitalizations, permanent disability, or life-threatening conditions. Consumer complaints require evaluation to determine reporting obligations. Legal counsel often assists with determination processes.
The responsible person must include a copy of the label on or within the retail packaging of such cosmetic product when reporting events. Complete documentation supports FDA evaluation processes.
Documentation and Record-Keeping
Companies must maintain comprehensive adverse event records. Documentation includes consumer contact information, medical records, and product samples when available. Record retention requirements extend beyond initial reporting periods.
Investigation procedures ensure thorough event evaluation. Internal processes should capture all relevant details for FDA submission. Quality assurance teams typically manage these responsibilities.
Consumer privacy considerations affect information collection and sharing. HIPAA compliance may apply to medical information gathering and transmission.
Good Manufacturing Practices (cGMP) Requirements
Upcoming Deadline Pressure
MoCRA required FDA to issue a proposed rule to establish cosmetic good manufacturing regulations by December 29, 2024, and to establish the final rule on December 29, 2025. The final rule deadline approaches rapidly.
Companies should remain vigilant for updates from the FDA, while simultaneously working to prepare their operations for the December 2025 deadline. Proactive preparation prevents last-minute compliance scrambles.
Current FDA guidance suggests cGMP requirements will mirror existing food and drug manufacturing standards. Personnel training, facility cleanliness, and quality control systems require attention.
Manufacturing Standards Preparation
Quality management systems need documentation and procedure development. Standard operating procedures, batch records, and testing protocols require establishment. Third-party audits help identify compliance gaps.
Personnel training becomes critical for successful implementation. Current good manufacturing practices training ensures workforce readiness. Ongoing education maintains compliance standards over time.
Supply chain management must incorporate cGMP considerations. Vendor qualifications, raw material testing, and supplier audits support compliance objectives.
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Labeling and Safety Requirements
Contact Information Mandate
All cosmetic products must display responsible person contact information prominently. This requirement took effect December 29, 2024, affecting all marketed products. Non-compliant products face removal from commerce.
Contact information must include physical address and phone number or website. Email addresses alone don’t satisfy the requirement completely. International brands need U.S. contact designation.
Packaging redesigns may be necessary for compliance achievement. Label space limitations create design challenges for small products. Creative solutions maintain aesthetic appeal while meeting regulations.
Safety Substantiation Standards
Safety Substantiation Requirements: December 29, 2023 established safety documentation obligations. Companies must maintain adequate safety evidence for all marketed products.
Safety assessments consider ingredient safety, product formulation, and intended use patterns. Scientific literature, in-house testing, and supplier data support safety determinations. Documentation must withstand regulatory scrutiny.
PFAS (per- and polyfluoroalkyl substances) assessments require special attention. Must assess the use and safety of per- and polyfluoroalkyl substances (PFAS) in cosmetic products and, by December 29, 2025. This emerging requirement affects many formulations.
Compliance Strategy and Best Practices
Establishing Internal Systems
Cross-functional teams coordinate compliance efforts most effectively. Legal, regulatory, quality, and operations departments must collaborate closely. Clear responsibility assignments prevent oversight gaps.
Technology solutions streamline compliance management. Electronic systems track registration renewals, product updates, and adverse event reports. Automated reminders prevent missed deadlines.
Regular compliance audits identify potential issues before FDA inspections. Internal assessment programs maintain readiness for regulatory scrutiny. Corrective action procedures address identified deficiencies promptly.
Third-Party Support Resources
NSF’s certification and testing services help the industry align with FDA and MoCRA for cosmetic good manufacturing practices and product certification. Professional services providers offer specialized expertise.
Regulatory consultants provide guidance on complex compliance issues. Legal counsel assists with interpretation and enforcement matters. Testing laboratories support safety substantiation requirements.
Industry associations offer resources and training programs. Trade organizations provide regulatory updates and best practice sharing. Networking opportunities facilitate peer learning experiences.
Cost Management Considerations
Compliance costs impact budget planning significantly. Registration fees, system development, and personnel training require financial resources. Early planning prevents cost overruns and rushed implementations.
Technology investments pay dividends through efficiency gains. Automated systems reduce manual effort and error rates. Scalable solutions accommodate business growth effectively.
Risk management approaches balance compliance costs with enforcement consequences. Strategic investments focus on highest-risk areas first. Phased implementation spreads costs over manageable timeframes.
Enforcement and Penalties
FDA Inspection Authority
The FDA gained expanded inspection authority under MoCRA. Cosmetic facilities face potential inspections without advance notice. Preparation ensures readiness for regulatory visits.
Documentation availability becomes critical during inspections. Electronic systems provide rapid access to required records. Staff training prepares personnel for inspector interactions.
Corrective action responses must address identified deficiencies promptly. FDA expects comprehensive remediation plans with timelines. Follow-up inspections verify correction implementation.
Penalty Structure and Consequences
Non-compliance triggers various enforcement actions. Warning letters, product seizures, and injunctive relief represent escalating responses. Criminal charges apply to willful violations.
Import refusal affects international supply chains. Products failing compliance requirements face border detention. Correction procedures must address deficiencies before release.
Brand reputation damage from enforcement actions affects market position. Consumer confidence erosion impacts sales performance. Proactive compliance prevents negative publicity.
Future Regulatory Trends
Evolving FDA Guidance
FDA has requested that the public provide comments on the additional three questions of the Guidance by January 13, 2025. Ongoing guidance development clarifies implementation details.
Industry feedback shapes regulatory interpretation and enforcement approaches. Active participation in comment periods influences final requirements. Trade associations coordinate industry positions effectively.
Regulatory science advances inform future requirements. New testing methods and safety assessment approaches may be incorporated. Technology developments enable more efficient compliance solutions.
International Harmonization Efforts
Global regulatory alignment efforts continue advancing. International cooperation reduces compliance complexity for multinational brands. Harmonized standards streamline product development processes.
Mutual recognition agreements may reduce duplicate requirements. Shared databases and information systems improve efficiency. Cross-border enforcement cooperation increases effectiveness.
Conclusion
The cosmetic industry regulations environment in 2025 demands strategic compliance planning and execution. Cosmetic regulatory compliance affects every aspect of operations from product development to market distribution. The FDA cosmetics act creates accountability standards that reshape industry practices fundamentally.
Successful brands treat compliance as competitive advantage rather than regulatory burden. Proactive approaches prevent enforcement actions while building consumer trust. Investment in robust compliance systems supports sustainable business growth.
The December 2025 cGMP deadline represents the next major compliance milestone. Early preparation ensures smooth implementation without operational disruption. Strategic planning positions brands for continued regulatory success.
Need expert guidance navigating these complex regulatory requirements? Elchemy’s regulatory affairs team helps brands achieve full MoCRA compliance while maintaining operational efficiency.
