The cosmetic industry has entered a new era of regulation with the introduction of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA is the largest revision of cosmetics rules in the United States after more than eight decades and gives rise to a lot of changes in regard to the FDA’s authority and new compliance requirements for cosmetic products manufacturers.
Regardless of whether you have already launched a cosmetic product on the market or only plan to do that, MoCRA compliance will be an integral part of your business. Be it a skincare company or a cosmetic product brand, understanding how to comply with MoCRA will give you an opportunity to preserve the accessibility of your product.
Here is how you can make it possible.
What Is MoCRA?
The Modernization of Cosmetics Regulation Act (MoCRA) was signed into law in December 2022 as part of the Consolidated Appropriations Act.
The law significantly expands FDA oversight of cosmetic products sold in the United States and introduces new requirements related to:
- Facility Registration
- Product Listing
- Safety Substantiation
- Adverse Event Reporting
- Record Keeping
- Labeling Compliance
- Mandatory Recall Authority
The primary goal of MoCRA is to improve consumer safety while increasing transparency throughout the cosmetic industry.
Why MoCRA Compliance Matters
Many cosmetic companies previously operated under limited FDA oversight compared to pharmaceutical or medical device manufacturers.
MoCRA changes that reality.
Failure to comply with MoCRA requirements may result in:
FDA Enforcement Actions
The FDA now has increased authority to inspect records and take action against non-compliant companies.
Product Recalls
Products lacking proper safety documentation may face market withdrawal.
Import Delays
Imported cosmetics may be detained if required registrations and listings are incomplete.
Brand Reputation Damage
Consumers increasingly expect transparency and safety from cosmetic brands.
Compliance helps demonstrate a commitment to product quality and consumer protection.
Facility Registration Requirements
One of the most significant changes under MoCRA is mandatory facility registration.
Who Must Register?
Facilities that manufacture or process cosmetics that are meant for distribution in the United States usually have to be registered with the FDA.
These are some examples:
- Cosmetic manufacturers
- Contract manufacturers
- Private label manufacturers
Manufacturers located outside of the United States but supply cosmetics to the U.S. market
Changes to Registration Information
Facilities that are registered need to keep their registration details current at all times.
Cosmetic Product Listing Requirements
In addition to facility registration, MoCRA requires cosmetic product listings.
What Information Must Be Submitted?
Product listings typically include:
- Product name
- Product category
- Ingredient information
- Responsible person details
- Facility information
The FDA uses this information to improve oversight and consumer protection efforts.
Maintaining Accurate Listings
Companies should implement procedures to ensure product listings remain current as formulations and products evolve.
Safety Substantiation Requirements
One of MoCRA’s most important provisions involves safety substantiation.
What Is Safety Substantiation?
Manufacturers must maintain adequate evidence demonstrating that cosmetic products are safe under their intended conditions of use.
Safety substantiation may include:
- Toxicological assessments
- Scientific literature reviews
- Ingredient safety evaluations
- Product testing data
- Expert safety opinions
Why It Matters
Products lacking sufficient safety documentation may be considered adulterated under FDA regulations.
Developing robust safety files helps protect both consumers and businesses.
Cosmetic Labeling Compliance
Accurate labeling remains a critical component of MoCRA compliance.
Key Labeling Requirements
Labels should clearly identify:
- Product identity
- Net quantity
- Ingredient declarations
- Responsible person contact information
- Warnings when required
Fragrance Allergens
Future FDA regulations may require additional disclosure of fragrance allergens to improve consumer awareness.
Companies should monitor evolving guidance related to labeling updates.
Adverse Event Reporting Requirements
MoCRA introduces mandatory adverse event reporting obligations for cosmetic companies.
What Is an Adverse Event?
An adverse event is an undesirable health-related outcome associated with the use of a cosmetic product.
Examples include:
- Severe allergic reactions
- Significant skin irritation
- Infections
- Hair loss
- Serious injuries
Reporting Responsibilities
Responsible persons must:
- Investigate reports
- Maintain records
- Submit serious adverse event reports to the FDA within required timeframes
Establishing an effective reporting system is critical for compliance.
Record Keeping Requirements
Documentation plays a major role in MoCRA compliance.
Companies should maintain records related to:
Product Safety
Documentation supporting safety substantiation.
Adverse Events
Reports, investigations, and corrective actions.
Manufacturing Activities
Production records and quality controls.
Regulatory Submissions
Facility registrations and product listings.
Well-organized documentation improves audit readiness and demonstrates compliance.
Common MoCRA Compliance Challenges
Many cosmetic companies face difficulties adapting to the new requirements.
Lack of Regulatory Expertise
Smaller brands often have limited experience with FDA compliance programs.
Incomplete Safety Documentation
Many companies must develop safety substantiation files from scratch.
Product Listing Complexity
Managing large product portfolios can make listings difficult to maintain.
Changing Regulatory Expectations
FDA guidance continues to evolve as MoCRA implementation progresses.
Working with regulatory experts can simplify these challenges.
Best Practices for MoCRA Compliance
Conduct a Compliance Gap Assessment
Evaluate existing operations against MoCRA requirements.
Develop Safety Substantiation Programs
Ensure every product has adequate safety support documentation.
Implement Documentation Controls
Maintain organized records for inspections and audits.
Train Employees
Personnel should understand reporting requirements and compliance responsibilities.
Monitor Regulatory Updates
FDA guidance and enforcement priorities may continue evolving.
Staying informed helps prevent future compliance issues.
How JJCC Group Supports MoCRA Compliance
JJCC Group provides comprehensive regulatory consulting services for cosmetic manufacturers navigating MoCRA requirements.
Their services include:
- FDA Facility Registration
- Cosmetic Product Listing
- Safety Substantiation Reviews
- Labeling Compliance Assessments
- Adverse Event Reporting Systems
- Regulatory Strategy Development
- Quality Management Support
- Audit Readiness Programs
By combining scientific expertise with regulatory knowledge, JJCC Group helps cosmetic brands achieve compliance while maintaining operational efficiency.
Conclusion
MoCRA is the most impactful regulatory reform ever undertaken in the cosmetics sector in decades. Cosmetic manufacturers who manage themselves in advance on issues such as registration of their facilities, product listings, substantiations of safety, adverse events reportings, and product labeling will have a competitive edge.
As opposed to seeing compliance as a challenge, cosmetic manufacturers must take this new regulation as an opportunity to enhance their products’ quality, reputation, and performance.
Regulatory consultants are available to make the whole compliance process easy for your company.
FAQs
What is MoCRA?
MoCRA stands for the Modernization of Cosmetics Regulation Act of 2022, which significantly expands FDA oversight of cosmetic products.
Who must comply with MoCRA?
Cosmetic manufacturers, processors, brand owners, and certain foreign facilities selling products in the U.S. may be subject to MoCRA requirements.
What is cosmetic facility registration?
Facility registration requires qualifying cosmetic manufacturing facilities to register with the FDA and maintain updated information.
What is a cosmetic product listing?
A product listing is a submission that provides the FDA with information about cosmetic products marketed in the United States.
What is safety substantiation?
Safety substantiation is evidence demonstrating that a cosmetic product is safe under its intended conditions of use.
Does MoCRA require adverse event reporting?
Yes. Serious adverse events associated with cosmetic products must be documented and reported according to FDA requirements.
How can JJCC Group help with MoCRA compliance?
JJCC Group assists with facility registration, product listing, safety substantiation, labeling reviews, adverse event reporting, and overall cosmetic regulatory compliance
