MoCRA Compliance Check
Modernization of Cosmetics Regulation Act of 2022
Check if your product requires FDA facility registration and product listing
MoCRA Status (Q1 2026)
10,820 facilities registered (7,728 foreign + 1,800 domestic) and 681,831 products listed. Top foreign: China (4,260), Korea (617), India (309), Italy (273), France (245). GMP final rule expected. All other requirements actively enforced. 46,000+ adverse events reported since Dec 2023. Biennial facility renewals now due for facilities registered July 2024.
Business Size
What is your annual gross cosmetic sales in the US?
Product Type
Distribution Channel
Facility Location
Where is your manufacturing facility located?
📋 Your MoCRA Requirements
📅 Key MoCRA Dates
⚠️ Recent FDA Enforcement
FDA has issued warning letters citing MoCRA violations (2024-2025). Actual enforcement cases:
Common Violation Categories
🔄 Renewal Calendar
Facility Registration — Biennial
- Every 2 years from your original registration date
- Anniversary-based — NOT calendar year
- Window: Oct 1 – Dec 31 of the year due, or within 60 days of anniversary
- Late = registration expires, products may be refused at import
Product Listing — Annual
- Update window: Oct 1 – Dec 31 each year
- Confirm or update: ingredients, labeling, categories, RP, facilities
- Even if nothing changed, submit abbreviated renewal
- Inactive listings increase enforcement risk
60-Day Amendment Rule: Any change to facility or product info must be filed within 60 days — name, address, U.S. Agent, ingredients, category, responsible person, or manufacturing facility changes.
🌍 Foreign Facility Registration by Country
7,728 foreign facilities registered (71% of all registrations). Top 10 countries:
🚫 Common Submission Errors
Top mistakes when registering facilities or listing products via Cosmetics Direct:
📦 FDA Product Categories (17 Codes)
Required when listing products. Select the most specific category that applies:
📋 Ingredient Ordering Rules (21 CFR 701.3)
List in descending order by weight
May be listed in any order after Tier 1 ingredients
Always listed last, in any order, using CI numbers or FDA names
Tips: Use INCI nomenclature. Fragrance/flavor may be listed as "Fragrance" or "Flavor" (until allergen rule finalized). Trade names are NOT acceptable. UNII codes are optional but recommended for SPL submissions.
🖥️ Cosmetics Direct — Submission Status Guide
After submitting via Cosmetics Direct, your submission moves through these statuses:
Stuck? Day 1-2: wait. Day 3: email cosmeticsdirect@fda.hhs.gov. Day 4: call 1-888-INFO-FDA. Day 5+: request override via spl@fda.hhs.gov.
📝 Submission Format Requirements
Phone Numbers
Must include + country code
Dates
YYYYMMDD format only
Label Images
.JPG only (not PNG/PDF/HEIC)
✅ Pre-Submission Checklist
All Facilities
- ☐ FEI number obtained and verified
- ☐ All required fields completed
- ☐ Phone numbers include + country code
- ☐ Contact emails valid and monitored
- ☐ Product name matches label exactly
- ☐ Ingredient list includes ALL ingredients (INCI)
- ☐ Product category selected (01-17)
- ☐ Images are .JPG, under 1MB, no special chars
- ☐ Confirmation statement agreed to
Foreign Facilities Only
- ☐ U.S. Agent designated with physical US address
- ☐ U.S. Agent confirmed within 30 days
- ⚠ If 30-day window passes: registration INVALIDATED — must file new initial registration
- ☐ FEI active in FDA database
- ☐ Responsible Person (US brand owner) info included
- ☐ Phone numbers use + prefix (not 00)
🏭 Contract Manufacturer (CMO) FEI Guide
Using a contract manufacturer? Here's how FEIs work:
Key rule: One FEI per physical facility. The CMO registers their facility; you (the brand) list your products under their FEI. The same CMO FEI is shared across all brands they manufacture for.
CMO FEI Verification
- Search FEI Portal by CMO name + address
- Request written confirmation: FEI, site address, MoCRA registration
- Cross-reference FEI Portal result with CMO data
- Red flag: no record or different address
Contract Clauses to Include
- CMO must maintain active FEI + MoCRA registration
- Notify brand of changes within 5-10 business days
- Brand has right to verify FEI and request proof
- Multiple facilities? List ALL FEIs in one product listing
🔧 FEI Troubleshooting
FEI rejected or not recognized? Follow this checklist:
Common FEI Failure Scenarios
📆 Renewal Countdown Strategy
Start preparing 4 months before your biennial renewal date:
📞 Key FDA Contacts & Portals
🧪 Talc & Asbestos Testing (MoCRA Section 3505)
Status (Feb 2026): No mandatory federal testing requirement. FDA proposed rule (Dec 2024) was withdrawn Nov 2025 citing MAHA/RFK Jr. priorities. New rule expected — no timeline announced. MoCRA Section 3505 mandate remains unfulfilled.
Contamination Evidence
J4-1 vs. IWGACP Gold Standard
| Parameter | CTFA J4-1 (1976) | IWGACP Gold Standard |
|---|---|---|
| Detection limit | 0.5% by weight | 0.0001% (1,000–5,000× better) |
| Chrysotile (95% of asbestos) | Excluded by design | Mandatory reporting |
| TEM requirement | None | Always required (parallel, not conditional) |
| Reporting unit | Weight percent (pass/fail) | Fibers per gram + dimensions |
| Magnification | PLM ~400× (conditional) | PLM 400× + TEM 20,000× |
| Threshold | 0.5% amphiboles only | Zero tolerance — any fiber = positive |
EU Context
ECHA has recommended classifying talc as Category 1B carcinogen. EU-wide restriction on talc in cosmetics expected by 2027. May eliminate talc from all EU-destined formulations entirely.
Formulator Guidance
- • Require dual PLM + TEM/EDS/SAED from talc suppliers — any future rule will mandate this
- • Reject CoAs based solely on J4-1 or USP methods — cannot detect trace contamination
- • Demand chrysotile reporting — suppliers omitting it use obsolete protocol
- • Require fibers/gram, NOT weight percent — correlates with inhalation risk
- • Annual industry cost: $3.54M across ~801 manufacturers, ~13,961 products
- • ISO standards: 22262-1:2012 (PLM) + 10312:2019 (TEM)
CBD/Cannabinoid MoCRA Requirements
FDA has NOT approved CBD in cosmetics. Enforcement discretion applied. ANY therapeutic claim = unapproved drug.
Correct INCI Naming
Prohibited Claims on CBD Cosmetics
- ✗ Pain relief / reduces pain
- ✗ Anti-inflammatory
- ✗ Anxiety reduction / calming (therapeutic)
- ✗ Sleep improvement
- ✗ Skin disease treatment
- ✗ "Soothing relief" (therapeutic context)
Prohibited INCI Forms
- ✗ "CBD Oil", "Hemp CBD"
- ✗ "Full-Spectrum Hemp Extract"
- ✗ "Anti-inflammatory CBD", "Healing Hemp"
Key Dates
MoCRA-Specific for CBD
- • AER (Adverse Event Reporting) — NO small business exemption
- • 15 business day deadline to respond to FDA warning letters
- • FDA records access authority (Jan 2026 draft guidance)
- • Trade secret: Form FDA 2512/2513, 180+ day review
- • Safety substantiation file: 10 components required (composition, IFRA, allergens, MoS, stability, CoA, toxicologist sign-off)
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