J&J Consulting Group- FDA Regulatory Compliance
- 1101 California Ave Suite 100 Corona CA 92881
- 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
MoCRA changed the rules for every cosmetic company
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the largest expansion of FDA’s cosmetics authority since 1938. Facility registration, product listing, adverse event reporting and safety substantiation are now required and enforced. FDA can also order mandatory recalls. JJCC Group gets you compliant and keeps you there as the remaining MoCRA rules arrive.
FDA does not approve cosmetics before sale, except for color additives. Compliance rests with the company.
- 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
Facility registration (Form FDA 5066)
Required; renew every 2 years
Product listing (Form FDA 5067)
Required; update every year
Serious adverse event reports
Required within 15 business days
Safety substantiation records
Required for every product
- 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.
Facility registration and product listing
through Cosmetics Direct or SPL files.
Responsible Person
support and U.S. Agent service for foreign facilities.
Safety substantiation files
prepared with our toxicologists.
Adverse event reporting systems
and records.
Label and claims review
including drug-claim risks and professional-use labeling.
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
- Confirm the product is a cosmetic, not a drug.
- Build the safety substantiation file.
- Register the facility and list the product.
- Finalize a compliant label.
- Set up adverse event intake and reporting.
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 business?
MoCRA is the Modernization of Cosmetics Regulation Act of 2022. It added registration, listing, adverse event reporting, safety substantiation and recall authority, so every cosmetic company now has federal compliance duties.
Does FDA approve cosmetics?
No. FDA does not approve cosmetics or their labels before sale. Only color additives need FDA approval.
Who is the Responsible Person?
The manufacturer, packer or distributor whose name appears on the label. That company is responsible for listing, adverse event reporting and safety substantiation.
Who needs to comply with MoCRA?
Responsible Persons and facilities that manufacture or process cosmetics for U.S. distribution, domestic or foreign, including contract manufacturers.
Is there a small business exemption?
Yes, for companies under the sales threshold. It does not cover products that contact the eye’s mucous membrane, are injected, are used internally, or alter appearance for more than 24 hours.
What is the difference between Form FDA 5066 and 5067?
Form 5066 registers a facility, renewed every 2 years. Form 5067 lists a product, updated every year.
What is SPL, and do I need it?
Structured Product Labeling is an electronic format FDA accepts for registration and listing. Most small companies use the Cosmetics Direct portal instead; SPL suits bulk submissions.
What is safety substantiation?
It is evidence that your product is safe under its labeled or customary use. You must have it on file before marketing.
How fast must serious adverse events be reported?
Within 15 business days of receiving the report. Keep adverse event records for 6 years, or 3 years for qualifying small businesses.
Does my label need new information under MoCRA?
Yes. Labels must include domestic contact information for adverse event reports. Professional-use products need extra labeling.
Is there a cosmetic GMP rule yet?
Not yet. MoCRA requires FDA to issue one, and FDA has not finalized it. ISO 22716 is the best benchmark until then.
Do I have to label fragrance allergens?
Not yet. MoCRA requires FDA to issue a fragrance allergen rule, which is still pending. We track it for our clients.
Do foreign cosmetic manufacturers need a U.S. Agent?
Yes. Foreign facilities must name a U.S. Agent when they register. We can serve in that role.
Can FDA recall my cosmetic?
Yes. MoCRA gave FDA mandatory recall authority when a cosmetic is likely adulterated or misbranded and could cause serious harm.
When is a cosmetic considered a drug?
When it claims to treat or prevent disease or change body structure or function. Sunscreens, anti-dandruff shampoos and antiperspirants are drugs as well as cosmetics.
Can FDA see our records?
Yes. MoCRA lets FDA access safety and adverse event records in certain situations, such as a serious health risk.
What services does JJCC Group offer under MoCRA?
Registration, listing, U.S. Agent service, safety substantiation, adverse event systems, labeling review and GMP gap assessments.
How long does MoCRA compliance take?
Registration and listing can be done in days once data is ready. Safety substantiation and label fixes usually take 4 to 8 weeks per product line.
