MoCRA Compliance Services
FDA Regulatory Support for Cosmetic Brands, Manufacturers & Distributors
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most sweeping overhaul of U.S. cosmetic regulations in over 80 years. Signed into law in December 2022 and enforced by the FDA, MoCRA introduces mandatory compliance requirements for virtually all cosmetic products sold in the United States.
At Gegahelix, we offer end-to-end MoCRA compliance consulting—helping brands, manufacturers, and contract fillers meet the full scope of regulatory obligations under this new law. Whether you're a global skincare brand or an indie cosmetics startup, we ensure your products are legally marketable and regulator-ready.
What is MoCRA?
MoCRA (Modernization of Cosmetics Regulation Act) significantly expands the FDA's authority over cosmetic products and ingredients. For the first time in U.S. history, cosmetics are subject to:
- Mandatory facility registration
- Product listings with ingredient declarations
- Safety substantiation requirements
- Adverse event reporting
- Fragrance allergen disclosures
- Mandatory recordkeeping and GMP (Good Manufacturing Practices)
What Products Fall Under MoCRA?
MoCRA applies to any product intended for application to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance.
This includes (but is not limited to):
- Skincare products (serums, creams, moisturizers, exfoliants)
- Hair care (shampoos, conditioners, treatments, dyes)
- Color cosmetics (foundation, lipstick, mascara, eyeshadow)
- Nail products (polish, remover, strengtheners)
- Fragrances and perfumes
- Body washes, soaps, and lotions
- Deodorants and grooming products
- Tattoo inks and semi-permanent colorants
- CBD and hemp-infused cosmetics
Note: OTC drugs (e.g. acne creams, sunscreen) are not governed by MoCRA—they remain under FDA drug regulations.
MoCRA Compliance Deadlines
- Facility registration deadline: July 1, 2024
- Product listing deadline: July 1, 2024
- Adverse event recordkeeping and serious event reporting: In effect now
- Safety substantiation: Required for all marketed products
- Fragrance allergen labeling: Final rule expected 2025
- GMP Rulemaking: Draft rule issued; enforcement expected late 2025
Gegahelix MoCRA Compliance Services
We offer complete regulatory support to help cosmetic companies comply with all MoCRA requirements:
1. FDA Facility Registration
- Register all U.S. and foreign manufacturing or processing facilities
- Assign and track Facility Registration Numbers (FRN)
- Update registration annually and as needed
2. FDA Product Listings
- Submit product name, brand name, intended use, and ingredient list
- Assign unique product codes (UPCs/SKUs)
- Ensure updates are filed within 120 days of changes
3. Ingredient Reviews & Safety Substantiation
- Conduct toxicological assessments for each ingredient
- Perform safety assessments on finished formulations
- Justify safe use under normal or expected exposure conditions
- Provide documentation suitable for FDA audits and import reviews
4. Fragrance Allergen Disclosure Consulting
- Identify regulated fragrance allergens
- Prepare compliant labels and customer communications
- Monitor FDA final rulemaking and future EU alignment
5. Adverse Event Monitoring & Reporting
- Design adverse event intake and tracking systems
- File Serious Adverse Event Reports (SAERs) to FDA within 15 days
- Maintain FDA-accessible records for 6 years
6. GMP (Good Manufacturing Practices) Readiness
- Evaluate GMP systems and documentation
- Align SOPs, sanitation, training, and traceability to draft FDA rule
- Conduct pre-inspection audits
MoCRA Documentation Gegahelix Prepares
- FDA Facility Registration records
- FDA Product Listing XML or SPL files
- Safety Substantiation Reports (toxicology, exposure, NOAEL/TTC)
- Fragrance allergen declarations
- Adverse Event Reporting protocols
- GMP audit reports and checklists
- Master ingredient database with regulatory status
- EU/Canada cross-compliance alignment (for global brands)
Who Needs to Comply?
- Brand Owners selling cosmetics in the U.S. (domestic or foreign)
- Manufacturers and Contract Fillers
- Distributors and private-label product developers
- Retailers sourcing from overseas or unregistered brands
Why MoCRA Compliance Matters
- FDA now has recall authority for non-compliant cosmetics
- Retailers and platforms may delist unregistered products
- Distributors are demanding MoCRA registration proof
- Customs holds and import detentions are rising for undeclared facilities
- Non-compliance risks include warning letters, product seizures, and class actions
Why Gegahelix?
Deep Regulatory Expertise
We're not just consultants—we're regulatory scientists who understand the nuance behind toxicology, labeling, and submission structure.
Global & U.S. Focus
We support MoCRA compliance as well as EU Cosmetic Regulation (EC 1223/2009), Canada's Cosmetic Hotlist, and global harmonization.
Fast, Reliable, Audit-Ready Documentation
Whether you need registration, safety assessments, or full documentation kits, we deliver FDA-grade outputs—on time.
Trusted by Over 100 Brands
We work with emerging startups, enterprise brands, and manufacturers with complex SKU portfolios.
Ready to Get Compliant?
Contact Gegahelix today for a free MoCRA compliance review or to request an ingredient safety evaluation sample.
Gegahelix: Where Regulatory Expertise Meets Cosmetic Innovation.
Talk to a MoCRA Expert
Our dedicated FDA regulatory experts partner closely with your cosmetic brand, guiding you step-by-step through MoCRA compliance requirements. Receive tailored support in facility registration, product listings, safety substantiation, and adverse event reporting, ensuring your cosmetic products meet all FDA regulatory standards.
Navigate cosmetic regulations with confidence—partner with Gegahelix to streamline your path to MoCRA compliance and sustained market success.