J&J Consulting Group- FDA Regulatory Compliance
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- Info@jjccgroup.org
- (800) 999-7781
FDA MoCRA Compliance Services for Cosmetic Manufacturers
Modernization of Cosmetics Regulation Act for Cosmetic Manufacturers
FDA MoCRA Compliance Consulting for Cosmetic Manufacturers | Expert regulatory guidance for cosmetic product safety substantiation, FDA facility registration, product listing, adverse event reporting, and label compliance under the Modernization of Cosmetics Regulation Act. Avoid penalties and ensure smooth U.S. market access.
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1 (800) 999-7781
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
Mandatory recall authority
The FDA can order a mandatory recall if a cosmetic is adulterated or misbranded.
Facility registration
Cosmetic facilities must register with the FDA by July 1, 2024 for full MoCRA compliance.
Product listing
Cosmetic companies must list each marketed cosmetic product, including ingredients.
Adverse event reporting
Companies must provide a way for consumers to report adverse effects on packaging.
- 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
Delivering Regulatory Compliance with a Proven Track Record
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
Our experts handle end-to-end SPL Xforms submissions for cosmetic manufacturers, ensuring accurate FDA facility registration and product listing in full compliance with MoCRA requirements.
Form FDA 5066 and Form FDA 5067
We streamline Form FDA 5066 and 5067 filings for cosmetic manufacturers, delivering accurate facility and products registrations that keep your operations MoCRA-compliant and audit-ready.
Safety substantiation records
Expert safety substantiation services for cosmetic products — we compile and maintain MoCRA-compliant records, including ingredient assessments, toxicological reviews, and exposure data, to demonstrate product safety and protect your brand from regulatory risk.
MoCRA Compliance Guide: Ensure FDA Cosmetic Approval Efficiently
From Formula to Shelf — MoCRA Compliance Made Simple
Navigating FDA’s Modernization of Cosmetics Regulation Act (MoCRA) can be overwhelming — from cosmetic facility registration and product listing to safety substantiation, label compliance, and adverse event reporting. Each requirement carries real risk: missed deadlines, border holds, recalls, or even suspended registrations.
We simplify the entire MoCRA compliance process for cosmetic manufacturers and responsible persons. Our regulatory team manages Form FDA 5066 and 5067 submissions, SPL Xforms filings, safety documentation, and ongoing FDA reporting — giving your brand a clear, compliant path from formula to shelf.
Testimonial
What our clients say about JJCC
Professional, knowledgeable team guided us through FDA registration and complete product listing accurately and efficiently.
Faqs
Frequently asked questions
What is MoCRA, and why does it matter for my cosmetic business?
MoCRA (the Modernization of Cosmetics Regulation Act of 2022) is the most significant expansion of FDA’s authority over cosmetics since 1938. It introduces mandatory requirements for facility registration, product listing, safety substantiation, adverse event reporting, and label compliance. Non-compliance can result in border holds, recalls, suspended registrations, or products being deemed misbranded or adulterated.
Who needs to comply with MoCRA?
Any manufacturer, packer, or distributor whose name appears on a cosmetic product label sold in the U.S. — known as the “Responsible Person” — must comply. This includes domestic and foreign cosmetic facilities, contract manufacturers, and brand owners. Certain small businesses are exempt, but exemptions do not apply to products involving the eye mucus membrane, injectables, internal-use products, or long-wear products.
What services does JJCC Group offer under MoCRA?
JJCC Group provides end-to-end MoCRA compliance support, including:
- FDA facility registration (Form FDA 5066)
- Cosmetic product listing (Form FDA 5067)
- SPL Xforms submissions
- Safety substantiation record preparation
- Cosmetic label review and compliance
- Adverse event reporting setup
- U.S. Agent services for foreign manufacturers
- Ongoing regulatory monitoring and renewals
What is the difference between Form FDA 5066 and Form FDA 5067?
Form FDA 5066 is used for cosmetic facility registration — every manufacturer or processor must register their facility and renew every two years. Form FDA 5067 is used for cosmetic product listing — the Responsible Person must list each marketed product, including its full ingredient list, and update the listing annually.
What is SPL Xforms, and do I need it?
SPL Xforms is an FDA-provided tool for creating Structured Product Labeling (SPL) files used in cosmetic registration and product listing submissions. It’s ideal for manufacturers handling bulk submissions or building SPL files offline. JJCC Group manages SPL Xforms submissions on your behalf, ensuring accurate formatting and successful FDA acceptance.
What is safety substantiation, and why is it required?
Under MoCRA, every cosmetic product must have adequate substantiation of safety before being marketed. This means maintaining records — including ingredient assessments, toxicological data, and exposure evaluations — that demonstrate the product is safe under intended use. JJCC Group helps build and maintain audit-ready safety substantiation files that meet FDA's standard.
Do foreign cosmetic manufacturers need a U.S. Agent?
Yes. Any foreign facility registering with the FDA under MoCRA must designate a U.S. Agent who serves as the official point of contact with the FDA. JJCC Group offers U.S. Agent services, ensuring your business stays connected and responsive to FDA communications.
