MoCRA compliance, operationalized for growth teams
MoCRA transformed cosmetics compliance into an active operating requirement. From facility registration to product listing and adverse event workflows, we help your team execute with speed and consistency without a sales-call-first process. Read our complete MoCRA compliance guide for a detailed walkthrough of every requirement.
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Quick answer: what MoCRA requires in 2026
In 2026, the most urgent MoCRA milestone is the first biennial cosmetics facility registration renewal (July 2026), while product listing, safety substantiation, labeling, and serious adverse event reporting remain ongoing obligations. Companies should keep facility and product data current and maintain a response workflow for 15-business-day adverse event filings.
Filing forms to know
- Form FDA 5066: Cosmetic facility registration submission.
- Form FDA 5067: Cosmetic product listing submission.
Key MoCRA Deadlines Are Approaching
Missing a MoCRA deadline can result in product detention, FDA warning letters, and loss of your registration status. Know where you stand.
Product Listing
All cosmetic products distributed in the US must be listed with FDA. Required since December 2024.
Facility Registration Renewal
First biennial renewal for cosmetics facilities registered under MoCRA. Missing this means your facility registration lapses.
July 1, 2026
Adverse Event Reporting
Serious adverse events must be reported to FDA within 15 business days. Required since March 2025.
GMP Final Rule
Good Manufacturing Practice final rule pending. FDA has not yet published an NPRM. Date TBD.
What MoCRA Requires
Six core obligations every cosmetics company must meet to stay compliant with FDA regulations. See the cosmetics industry page for services and pricing.
Facility Registration
All facilities manufacturing or processing cosmetics for the US market must register with FDA through Cosmetics Direct.
Product Listing
Every cosmetic product marketed in the US must be listed with FDA, including ingredients, categories, and responsible person info.
Adverse Event Reporting
Serious adverse events must be reported to FDA within 15 business days. Records must be kept for 6 years.
Safety Substantiation
Responsible persons must ensure adequate substantiation of product safety before marketing.
Labeling Compliance
Labels must include INCI ingredient names, responsible person contact, and adverse event reporting info.
Responsible Person Designation
Every cosmetic product must have a designated Responsible Person in the US who is accountable for compliance.
How Assurentry runs MoCRA workflows
A repeatable process designed for cosmetics teams that need clean handoffs across regulatory, quality, and operations.
Map products and facilities
Capture accountable entities, products, and ownership so submissions are consistent.
Prepare filing inputs
Standardize core data for registration, listing, and record retention before submission.
Execute submissions
Run filing workflows and keep status visibility in one place for your internal team.
Monitor and update
Track changes, adverse event triggers, and renewal milestones so compliance stays current.
MoCRA Complete Package
Everything you need for full MoCRA compliance in one transparent package. No hidden fees.
MoCRA Complete
per facility, billed annually
- FDA facility registration via Cosmetics Direct
- Product listing for up to 25 products
- Biennial renewal management
- Compliance monitoring and alerts
- Adverse event reporting guidance
- Renewal reminders and deadline tracking
- Dedicated compliance specialist
- Document storage and audit trail
No long-term contracts. Cancel anytime.
Start your MoCRA registration
Complete this form and our team will begin your MoCRA compliance setup within 1 business day.
Not sure if MoCRA applies to you?
Our MoCRA readiness review helps identify filing scope, data requirements, and next actions before you start submissions.
Start MoCRA WorkflowWhat Assurentry automates for MoCRA
After initial setup, most MoCRA tasks run without manual intervention from your team.
Facility registration via Cosmetics Direct — filed for you
Product listing with ingredient disclosure — automated submission
Responsible Person designation — set up once, maintained automatically
Adverse event reporting workflow — 15-business-day tracking and alerts
Biennial renewal processing — one-click renewal before July 2026 deadline
Safety substantiation record keeping — document vault with audit trail
Labeling compliance checks — automated pre-submission review
Deadline monitoring — proactive alerts for every MoCRA milestone
MoCRA Compliance FAQs
Answers to the most common questions about MoCRA and cosmetics FDA compliance.
What is MoCRA and who does it affect?
The Modernization of Cosmetics Regulation Act (MoCRA) is the most significant update to US cosmetics regulation in over 80 years. It affects every company that manufactures, processes, or distributes cosmetics in the US -- including foreign manufacturers exporting to the US market.
When is the next MoCRA deadline?
The most critical upcoming deadline is the first biennial facility registration renewal in July 2026. Facilities that registered in 2023 or 2024 must renew during this window or lose their active registration status with FDA.
Do small businesses need to comply with MoCRA?
Yes. Small business exemptions (under $1M annual cosmetics sales) expired in December 2025. All companies must now fully comply with facility registration, product listing, adverse event reporting, safety substantiation, and labeling requirements regardless of size.
What happens if I miss a MoCRA deadline?
Missing MoCRA deadlines can result in your facility registration lapsing, products being deemed adulterated or misbranded, import detention of your shipments, FDA warning letters, product seizure, and even mandatory recalls. FDA now has significant enforcement authority over cosmetics.
Does MoCRA apply to foreign manufacturers?
Yes. Any foreign facility that manufactures cosmetics for distribution in the US must register with FDA, list their products, and designate a US Agent. Foreign companies must also comply with adverse event reporting and safety substantiation requirements.
What is included in Assurentry's MoCRA package?
Our $249/year MoCRA Complete Package includes facility registration via Cosmetics Direct, product listing for up to 25 products, biennial renewal management, compliance monitoring, adverse event reporting guidance, deadline tracking, and a dedicated compliance specialist.
How long does MoCRA registration take?
With Assurentry, facility registration typically takes 3-5 business days once all required information is provided. Product listing can be completed concurrently. We handle the submission through FDA's Cosmetics Direct portal on your behalf.
What is safety substantiation under MoCRA?
Safety substantiation means the responsible person must have adequate evidence demonstrating that a cosmetic product is safe under its intended conditions of use. This can include ingredient safety data, clinical testing, toxicological assessments, and historical safety data.
Prepare Early for the July 2026 Renewal Window
The first biennial renewal cycle is approaching. Join 2,800+ companies that use Assurentry to keep MoCRA filings current.
No credit card required. Setup takes under 10 minutes.