Cosmetic Products

Modernization of Cosmetics Regulation Act

Expert regulatory guidance to help cosmetic manufacturers comply with FDA MoCRA requirements, ensuring product safety, accurate labeling, facility registration, and smooth market access without compliance risks.

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MoCRA Compliance

Navigate MoCRA with Confidence

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant update to cosmetic law since 1938—expanding FDA oversight across product safety, labeling, recordkeeping, and adverse event reporting.

At [Your Company Name], we provide expert guidance and regulatory support to help your cosmetic business comply with MoCRA’s new requirements.

FDA Facility Registration & Product Listing
Safety Substantiation & Ingredient Review
Labeling Compliance (Including Fragrance Allergens)
Adverse Event Reporting Systems
Responsible Person Designation & Recordkeeping

MoCRA Requirements

Some of the new requirements of MoCRA include

Some of the key new MoCRA requirements include mandatory recalls, timely facility registration, complete product listing, and efficient adverse event reporting.

Mandatory recall authority

The FDA can order a mandatory recall if a cosmetic is adulterated or misbranded.

01/

Facility registration

Cosmetic facilities must register with the FDA by July 1, 2024 for full MoCRA compliance.

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Product listing

Cosmetic companies must list each marketed cosmetic product, including ingredients.

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Adverse event reporting

Companies must provide a way for consumers to report adverse effects on packaging.

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Over 30 Years Regulatory Expertise
Successfully Registered 500+ Cosmetic Products
Completed 100+ FDA Facility Compliance Projects
Developed 250+ Safety Substantiation Records
Conducted 200+ Product Labeling Reviews

Our Achievements

Proven regulatory compliance success

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Core Services

Our services include

We offer comprehensive support including GMP facility setup, SOP development, process validation, audits, training, and regulatory compliance for pharmaceutical and biologic manufacturers.

Safety substantiation records

Companies must develop, review, and maintain detailed safety substantiation records for all cosmetic products consistently.

Good manufacturing practice regulations

Companies must follow GMP regulations and maintain proper documentation and standardized manufacturing processes.

Adverse event reporting

Companies must implement reliable systems for documenting and reporting all adverse cosmetic product events.

Cosmetics Direct

An electronic submission portal for registering and listing cosmetic products and facilities

Xforms

An SPL authoring tool for registering and listing cosmetic products and facilities

Form FDA 5066 and Form FDA 5067

Paper forms for registering and listing cosmetic products and facilities

Safety substantiation records

Companies must maintain detailed safety substantiation records for full compliance.

MoCRA Compliance Guide: Ensure FDA Cosmetic Approval Efficiently

Get Expert Help

Ensure your mocra compliance today

Partner with JJCC Group’s regulatory experts to navigate MoCRA requirements, register facilities, list products, and maintain full FDA compliance efficiently and confidently.

Testimonial

What our clients say about JJCC

Our clients trust JJCC Group for expert MoCRA compliance guidance, efficient FDA registration, and accurate cosmetic regulatory support worldwide.

Professional, knowledgeable team guided us through FDA registration and complete product listing accurately and efficiently.

Sarah Bennett OWNER

The team helped our cosmetic brand navigate complex FDA regulations seamlessly, accurately, and very effectively.

Bts Ashik OWNER

JJCC Group’s expertise in cosmetic regulatory compliance is unmatched, providing exceptional service and continuous support.

Shadin De Manager

Faqs

Frequently asked questions

Get clear answers to your most common questions about the Modernization of Cosmetics Regulation Act (MoCRA). Learn how to ensure FDA compliance, manage facility registration, product listing, labeling, safety substantiation, adverse event reporting, and maintain Good Manufacturing Practices for your cosmetic products efficiently and confidently.

What is MoCRA compliance requirement?

MoCRA compliance ensures cosmetic products, labeling, and facilities meet updated FDA regulations, protecting consumers and avoiding enforcement actions.

When must facilities register FDA?

All cosmetic manufacturing facilities must complete FDA registration by July 1, 2024, to meet MoCRA requirements.

Do all products require listing?

Yes, each marketed cosmetic product must be listed with the FDA, including full ingredient disclosure.

What is adverse event reporting?

Companies must provide a system for consumers to report any negative reactions or adverse events related to cosmetic products.

What is mandatory recall authority?

The FDA can mandate recalls if a cosmetic product is found adulterated or misbranded under MoCRA regulations.