MoCRA — FDA Cosmetics Registration & Compliance
Facility Registration
Product Listing
Safety Records
Adverse Events
What is MoCRA?
The Modernization of Cosmetics Regulation Act (MoCRA), signed into law December 29, 2022, is the most significant update to US cosmetics regulation in over 85 years. For the first time, FDA has mandatory authority over cosmetic facility registration, product listing, safety records, and adverse event reporting.
If your company manufactures, processes, or markets cosmetics in the United States — including foreign companies exporting to the US — MoCRA compliance is now a legal requirement, not optional.
- Mandatory facility registration with biennial renewal
- Every cosmetic product must be listed with FDA
- Safety substantiation records required and available on demand
- Serious adverse events must be reported within 15 business days
Key MoCRA Deadlines
MoCRA Requirements Explained
Facility Registration
- All domestic & foreign cosmetic manufacturers must register
- Applies to facilities that manufacture or process cosmetics for US sale
- Biennial renewal required (odd-numbered years)
- Small businesses with under $1M in average annual sales may qualify for exemption
Product Listing
- Each cosmetic product marketed in the US must be listed with FDA
- Listing includes product name, ingredients, and facility information
- Updates required when formulation or label changes
- Must be submitted through FDA's Cosmetics Direct portal
Safety Substantiation
- Adequate safety records must be maintained for each product
- Records must support safety for intended use and reasonably foreseeable misuse
- FDA can request records within 120 days
- No pre-market approval — but records must be ready on demand
Adverse Event Reporting
- Serious adverse events must be reported to FDA within 15 business days
- Must maintain records of all adverse events for 6 years
- Applies to responsible persons (brand owners / distributors)
- FDA can mandate recalls for safety concerns
Who Needs MoCRA Compliance Support?
- Foreign cosmetics manufacturers selling into the US market
- Domestic cosmetic manufacturers and packers
- Brands relabelling or repackaging cosmetics for US sale
- Contract manufacturers producing cosmetics for US-brand clients
- Companies updating formulas or launching new cosmetic lines
What We Do For You
- FDA Cosmetics Direct account setup
- Facility registration form completion
- Product listing for your full cosmetic portfolio
- Safety substantiation file review & gap analysis
- Adverse event reporting procedure setup
- Biennial renewal management
- Fragrance allergen label compliance (Dec 2025)
Are Your Cosmetics MoCRA Compliant?
MoCRA FAQ
Is MoCRA registration the same as food facility registration?
No — MoCRA created a separate cosmetic facility registration system. Cosmetics-only facilities register specifically as cosmetic manufacturers under MoCRA, not under the food facility registration system.
My company is outside the US. Do we need to register?
Yes. Foreign facilities that manufacture or process cosmetics for US sale must register with FDA. You will also need to designate a US Agent or responsible person for FDA communications.
What counts as a 'serious adverse event'?
Serious adverse events include those that result in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability, congenital anomaly, or require medical or surgical intervention.
What is safety substantiation?
Safety substantiation means maintaining adequate data and information to support the safety of your cosmetic product under its intended and reasonably foreseeable conditions of use. FDA does not pre-approve this — but can request your records at any time.
Do small businesses have to register?
Small businesses with average annual gross sales of cosmetics under $1 million (using the 3-year average) are exempt from facility registration and product listing, with some exceptions (e.g., products that come into contact with mucous membranes or eyes).