MoCRA 2024-2025: The Complete Compliance Guide for Cosmetic Brands

MoCRA by the Numbers (January 2025)

9,528

Facilities Registered

589,762

Products Listed

Warning Letters

10+

Months GMP Delayed

What Is MoCRA?

The Modernization of Cosmetics Regulation Act (MoCRA) was signed into law on December 29, 2022, as part of the Consolidated Appropriations Act of 2023. It represents the first major update to FDA's cosmetic regulatory authority since the Federal Food, Drug, and Cosmetic Act of 1938.

For 85 years, the U.S. cosmetics industry operated under a largely voluntary framework. Companies weren't required to register facilities, list products, or report adverse events to the FDA. MoCRA fundamentally changes this landscape.

MoCRA's Core Requirements

Facility Registration - All manufacturing and processing facilities must register with FDA
Product Listing - All cosmetic products must be listed with ingredient information
Adverse Event Reporting - Serious adverse events must be reported within 15 calendar days
Good Manufacturing Practice (GMP) - Facilities must follow GMP requirements
Safety Substantiation - Companies must have adequate evidence of product safety
Labeling Requirements - New labeling rules including fragrance allergen disclosure
Mandatory Recall Authority - FDA can now order mandatory recalls

Requirement #1: Facility Registration

Under Section 607 of the FD&C Act (as amended by MoCRA), every facility that manufactures or processes cosmetic products for distribution in the United States must register with FDA. This applies to both domestic and foreign facilities.

Deadline Passed

December 29, 2024

The facility registration deadline has passed. If your facility is not yet registered, you are currently non-compliant and should register immediately. Use our MoCRA Compliance Checker to verify your status.

What Triggers Registration?

Manufacturing - Making, fabricating, packaging, labeling, or holding cosmetic products
Processing - Any activity that changes the nature or composition of a cosmetic
Contract Manufacturing - Third-party manufacturers must register; brand owners list the products

Registration Process

Registration is submitted through FDA's Cosmetics Direct electronic portal. Required information includes:

Facility name, address, and contact information
Type of business operations conducted
Product categories manufactured
Parent company information (if applicable)
U.S. Agent information (for foreign facilities)

Registration must be renewed between October 1 and December 31 of each even-numbered year (next renewal: 2026).

Requirement #2: Product Listing

Section 607(c) requires "responsible persons" to submit a cosmetic product listing for each cosmetic product. The responsible person is typically the manufacturer, packer, or distributor whose name appears on the product label.

Required Information

Data Element	Details
Product Name	As it appears on the label
Product Category	FDA's standardized cosmetic categories
Responsible Person	Name, address, contact information
Facility Registration Number	Where product is manufactured
Ingredient List	Complete ingredient listing in descending order
Fragrance/Flavor	Can be listed as "fragrance" or "flavor" with some exceptions

Product listings must be updated within 60 days of any changes to the information previously submitted, and annually to confirm accuracy.

Requirement #3: Adverse Event Reporting

This is where MoCRA has immediate, serious teeth. Under Section 605, responsible persons must report serious adverse events to FDA within 15 calendar days of receiving the report.

What Qualifies as a "Serious Adverse Event"?

An adverse experience that results in:

Death
A life-threatening experience
Inpatient hospitalization
A persistent or significant disability or incapacity
A congenital anomaly or birth defect
An infection
Significant disfigurement (including serious and persistent rashes, burns, etc.)

Reporting Requirements

Initial Report - Within 15 calendar days of receiving information
Follow-up Information - Within 1 year of initial report
Record Retention - Records must be maintained for 6 years

Companies should establish internal procedures for collecting, evaluating, and reporting adverse events. Consumer-facing staff should be trained to recognize and escalate potential serious adverse events immediately.

Requirement #4: Labeling - Fragrance Allergen Disclosure

MoCRA requires disclosure of fragrance allergens on cosmetic product labels. However, implementation has been delayed.

Status: Delayed

The fragrance allergen disclosure rule, originally expected in June 2024, has been delayed. FDA has not yet finalized the list of allergens requiring disclosure or the labeling format. Monitor FDA announcements for updates.

When implemented, this requirement will likely align with or reference the EU's expanded list of 82 fragrance allergens. Brands selling internationally should already be preparing for allergen disclosure to meet EU requirements under Regulation (EC) No 1223/2009.

Small Business Exemption

MoCRA provides limited exemptions for small businesses, but they're narrower than many brands assume.

Small Business Threshold

Less than $1,000,000 in average annual gross sales

Calculated over the previous 3-year period, adjusted for inflation

What Small Businesses Are Exempt From:

Facility Registration - Exempt
Product Listing - Exempt
GMP Requirements - Exempt

What Small Businesses Are NOT Exempt From:

Adverse Event Reporting - Required for ALL companies
Safety Substantiation - Required for ALL companies
Labeling Requirements - Required for ALL companies
Prohibited Ingredients - Applies to ALL companies
Mandatory Recall Authority - FDA can recall ANY company's products

Common Misconception

"I'm a small business, so MoCRA doesn't apply to me."

Reality: Even exempt small businesses must report serious adverse events within 15 days, substantiate product safety, and comply with all labeling requirements. The exemption only covers registration, listing, and GMP - not the core safety obligations.

GMP Requirements: Delayed But Coming

MoCRA requires FDA to establish Good Manufacturing Practice (GMP) regulations for cosmetics -- assess your readiness with our GMP Advisor. These regulations will be largely based on ISO 22716:2007 (Cosmetics - Good Manufacturing Practices).

GMP Timeline Status

Milestone	Original Target	Status
Proposed Rule	December 2024	Delayed 10+ months
Final Rule	TBD	Pending proposed rule
Compliance Date	TBD	Likely 1-2 years after final rule

While GMP enforcement is delayed, smart brands are preparing now. ISO 22716 covers:

Personnel qualifications and training
Premises and equipment requirements
Raw materials and packaging controls
Production and in-process controls
Quality control laboratory operations
Documentation and record-keeping
Internal audits and corrective actions

Warning Letter Analysis: What's Being Cited

As of January 2025, FDA has issued 7 warning letters citing MoCRA violations. Analyzing these letters reveals FDA's enforcement priorities and common compliance failures.

Companies Cited (2024-2025)

Landy International
Violations related to product safety substantiation and adverse event reporting procedures
Choice All Natural
Cited for failure to maintain adequate safety evidence and labeling violations
Diora Kimya
Foreign facility compliance issues and product listing deficiencies

Common Violation Categories

Safety Substantiation Failures
Companies unable to demonstrate "adequate substantiation of safety" as required under Section 608. FDA expects documentation including ingredient safety assessments, stability testing, and microbiological testing.
Adverse Event Reporting Deficiencies
Failure to report serious adverse events within the 15-day window, or lacking procedures to collect and evaluate consumer complaints.
Labeling Non-Compliance
Missing or incorrect ingredient declarations, improper warning statements, or failure to include required contact information.
Registration/Listing Failures
Operating without facility registration or failing to list products in Cosmetics Direct.

Complete MoCRA Timeline

Date	Milestone	Status
Dec 29, 2022	MoCRA signed into law	Complete
Dec 29, 2023	Adverse event reporting begins	In Effect
July 1, 2024	Product listing portal opens	Complete
Dec 29, 2024	Facility registration deadline	Passed
Dec 29, 2024	Product listing deadline	Passed
June 2024	Fragrance allergen rule (original)	Delayed
2025	GMP proposed rule	Pending
Oct-Dec 2026	First facility registration renewal	Upcoming

MoCRA Compliance Checklist

Use this checklist to assess your current compliance status and identify gaps:

Immediate Actions (If Not Complete)

[ ] Register all manufacturing facilities in FDA Cosmetics Direct
[ ] Submit product listings for all cosmetic products
[ ] Establish adverse event reporting procedures with 15-day reporting capability
[ ] Train customer service staff on recognizing and escalating serious adverse events

Safety Substantiation

[ ] Document ingredient safety assessments for all formulations
[ ] Conduct stability testing and retain documentation
[ ] Perform microbiological testing and challenge testing where applicable
[ ] Maintain safety data files that can be provided to FDA upon request

GMP Preparation

[ ] Obtain ISO 22716:2007 and review requirements
[ ] Conduct gap assessment against ISO 22716 standards
[ ] Develop SOPs for production, quality control, and documentation
[ ] Implement batch records and traceability systems

Labeling Review

[ ] Verify ingredient declarations are complete and accurate
[ ] Confirm contact information for adverse event reporting is on labels
[ ] Prepare for fragrance allergen disclosure when rule is finalized
[ ] Review warning statements and ensure compliance with 21 CFR 740

The Bottom Line

MoCRA represents the most significant shift in U.S. cosmetics regulation since 1938. With nearly 10,000 facilities now registered and almost 600,000 products listed, the industry is adapting to a new compliance reality.

Key takeaways for brands:

Deadlines have passed - If you haven't registered and listed, you're already non-compliant
Adverse event reporting applies to everyone - No exemptions, 15-day window
Safety substantiation is mandatory - "We've been selling it for years" is not adequate evidence
GMP is coming - Use the delay to prepare, not to procrastinate
FDA is actively enforcing - 7 warning letters show this isn't theoretical

The brands that treat MoCRA as an opportunity to strengthen their compliance infrastructure will be positioned for long-term success. Those who view it as merely a bureaucratic hurdle may find themselves on the receiving end of FDA's expanded enforcement authority.

References

Modernization of Cosmetics Regulation Act of 2022, Public Law 117-328, Title III, Subtitle E
FDA Cosmetics Direct Portal: https://www.fda.gov/cosmetics/cosmetics-direct
21 U.S.C. 364 - Registration and Product Listing (Section 607)
21 U.S.C. 364d - Adverse Event Reporting (Section 605)
21 U.S.C. 364f - Good Manufacturing Practice (Section 606)
ISO 22716:2007 - Cosmetics: Good Manufacturing Practices (GMP)
FDA Warning Letters Database - Cosmetics, 2024-2025