What is MoCRA and when did it take effect?

MoCRA (Modernization of Cosmetics Regulation Act) is US legislation that significantly expanded FDA authority over cosmetics. It was signed into law on December 29, 2022, with various requirements phasing in through 2025.

Do I need to register my facility if I only sell online?

Yes. If you manufacture, process, or pack cosmetics for distribution in the US — regardless of sales channel — you must register your facility with the FDA, unless you qualify for the small business exemption.

What happens if I miss the registration deadline?

Facilities that fail to register may face FDA enforcement action including warning letters, import alerts (for foreign facilities), or other regulatory consequences. Late registration is still strongly recommended.

Are natural or organic cosmetics exempt from MoCRA?

No. MoCRA applies to all cosmetics regardless of how they are marketed. Natural, organic, clean, and conventional cosmetics are all subject to the same requirements.

Do I need FDA approval before selling cosmetics?

No. Unlike drugs, cosmetics do not require pre-market FDA approval. However, you must register your facility, list your products, and comply with all MoCRA requirements.

What's the difference between registration and listing?

Facility registration identifies WHERE cosmetics are made. Product listing identifies WHAT products are sold. Both are required under MoCRA, and both are done through FDA's Cosmetics Direct portal.

How do MoCRA requirements compare to EU regulations?

MoCRA brings US regulations closer to EU standards but key differences remain. The EU requires a formal CPSR (safety report) while MoCRA requires safety substantiation documentation. The EU has more extensive ingredient restrictions through its Annexes.

Can I use the same product listing for multiple sales channels?

Yes. A single product listing covers all sales channels (retail, online, professional). However, if you sell different formulations or sizes, each may need separate listing depending on how different they are.

MoCRA FDA Guidelines: Complete Compliance Guide for 2026

What is MoCRA?

The Modernization of Cosmetics Regulation Act (MoCRA) is landmark legislation signed into law on December 29, 2022, as part of the Consolidated Appropriations Act of 2023. According to FDA's official overview, MoCRA represents the most significant expansion of FDA's authority over cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.

Why MoCRA Matters

Before MoCRA, the FDA had limited authority over cosmetics. The agency couldn't require registration, mandate safety testing, or issue recalls. MoCRA changes all of this, bringing cosmetic regulation closer to the oversight seen in the EU.

MoCRA grants the FDA new authorities including:

Mandatory facility registration for cosmetic manufacturers and processors
Product listing requirements for all cosmetic products
Adverse event reporting obligations
Safety substantiation requirements
Recall authority for contaminated or unsafe products
Records access during inspections

Who Must Comply with MoCRA?

Under 21 U.S.C. § 364c, the following entities must comply with MoCRA requirements:

MoCRA Compliance by Entity Type
Entity Type	Registration Required	Product Listing Required
US Manufacturers	Yes	Yes
US Contract Manufacturers	Yes	Brand owner lists
Foreign Manufacturers (exporting to US)	Yes	Yes
Distributors Only	No	No
Retailers (private label)	Depends	Yes, for own brands

Responsible Person Requirement

Every cosmetic product sold in the US must have a designated responsible person. According to FDA guidance, the responsible person is typically:

The manufacturer if they market under their own name
The brand owner if a different company manufactures the product
The US agent for foreign companies without a US presence

Foreign Brands Take Note

If you're a non-US company selling cosmetics in the United States, you must designate a US-based responsible person or US agent for FDA communications.

MoCRA Requirements Overview

1. Facility Registration

All facilities that manufacture or process cosmetics for US distribution must register with the FDA. Based on FDA facility registration guidance:

Facility Registration Requirements

Register via FDA's Cosmetics Direct portal
Provide facility name, address, and contact information
List all cosmetic product categories manufactured
Renew registration biennially (every 2 years)
Update within 60 days of any material changes to facility information

Registration Deadline: Initial registration was required by December 29, 2023. New facilities must register within 60 days of beginning operations.

2. Product Listing

Every cosmetic product distributed in the US must be listed with the FDA. Per FDA product listing requirements:

Product Listing Process

Access Cosmetics Direct

Log into FDA's Cosmetics Direct portal using your facility registration credentials.

Enter Product Information

Provide product name, category, and responsible person details.

Submit Ingredient List

List all ingredients in descending order of predominance (by weight).

Upload Label Image

Provide an image of the product label showing all required information.

Submit and Maintain

Submit the listing and update within 60 days of any product changes.

Listing Deadline: Products on the market before December 29, 2023 must be listed by July 1, 2024. New products must be listed within 120 days of market entry.

3. Adverse Event Reporting

MoCRA establishes mandatory adverse event reporting for the first time. According to FDA adverse event guidance:

Adverse Event Reporting Timeframes
Event Type	Reporting Deadline	Method
Serious adverse event	15 business days	FDA MedWatch
Non-serious adverse event	Not required	N/A
Follow-up information	Within 1 year	FDA MedWatch

* Serious adverse events include death, life-threatening conditions, hospitalization, or significant disability

4. Safety Substantiation

Under 21 U.S.C. § 364d, responsible persons must ensure there is adequate substantiation of safety for each cosmetic product. This includes:

Toxicological data on ingredients
Product stability testing
Microbiological testing where appropriate
Documentation available for FDA inspection

New Requirement

Unlike the EU's mandatory CPSR, MoCRA does not require a specific safety report format. However, you must have documentation demonstrating safety substantiation available upon FDA request.

5. Labeling Requirements

MoCRA introduces new labeling requirements including contact information and fragrance allergen disclosure. Per FDA guidance:

Contact information for adverse event reporting must appear on labels
Professional-use products have specific labeling exemptions

Fragrance Allergen Labeling: PENDING

Status (January 2026): FDA missed its statutory deadline (December 29, 2025) for fragrance allergen labeling requirements. - FDA proposed rule expected: May 2026 - Final rule likely effective: 2027 or later - Current requirement: None — companies have no federal obligation to disclose specific fragrance allergens as of January 2026 Note: California has separate state-level fragrance allergen requirements.

6. Good Manufacturing Practices (GMP)

The FDA is authorized to establish GMP requirements for cosmetics. According to FDA GMP guidance, facilities should follow current industry standards while formal regulations are developed.

GMP Status: DELAYED

Current Status (January 2026): - Statutory deadline for proposed rule: December 29, 2024 — MISSED - FDA moved GMP to "Long-Term Actions" list (October 2025) - Proposed rule timeline: To Be Determined - Recommended: Follow ISO 22716 or equivalent industry standards while awaiting formal regulations

Small Business Exemptions

MoCRA provides exemptions for small businesses with less than $1 million in average annual gross sales over the preceding 3 years. Under FDA small business guidance and Section 612 of the FD&C Act:

Small Business Exemptions (< $1M Average Gross Sales)
Requirement	Small Business Status	Notes
Facility Registration	FULLY EXEMPT	Unless manufacturing high-risk products
Product Listing	FULLY EXEMPT	Unless manufacturing high-risk products
Adverse Event Reporting	NOT EXEMPT	All businesses must report within 15 business days
Adverse Event Records	REDUCED	3 years retention (vs. 6 years for non-exempt)
GMP Compliance	FULLY EXEMPT	When finalized; unless high-risk products
Safety Substantiation	NOT EXEMPT	All businesses must maintain records

CRITICAL: High-Risk Product Restriction

Small businesses lose ALL exemptions if they manufacture even ONE of these product types: - Products contacting mucous membrane of the eye (mascara, liquid eyeliner, eyelash adhesive) - Injectable cosmetic products - Products for internal use - Products altering appearance for more than 24 hours (permanent hair dye, gel/acrylic nails)

MoCRA Timeline & Deadlines

Key MoCRA Deadlines
Requirement	Deadline	Status
Law Enacted	December 29, 2022	Complete
Facility Registration Opens	December 29, 2023	Complete
Initial Facility Registration	December 29, 2023	Passed
Product Listing (existing products)	July 1, 2024	Passed
Fragrance Allergen Labeling	PENDING	FDA missed statutory deadline; proposed rule expected May 2026
Biennial Registration Renewal	Every 2 years	Ongoing
GMP Regulations	TBD	Moved to long-term actions (October 2025)

Compliance Costs

Based on industry surveys and PCPC guidance, typical compliance costs include:

Enforcement & Penalties

MoCRA grants the FDA new enforcement authorities:

Mandatory recall authority for contaminated or unsafe products
Facility inspection powers with records access
Import alerts for non-compliant foreign facilities
Warning letters and regulatory actions

Enforcement Status

As of 2026, FDA has begun active enforcement of MoCRA requirements. Facilities that fail to register or list products may face warning letters, import alerts, or other regulatory action.

MoCRA vs. EU Cosmetic Regulations

For brands operating in multiple markets, understanding the differences between US and EU requirements is essential:

MoCRA vs. EU Regulation 1223/2009
Requirement	US (MoCRA)	EU
Facility Registration	Required	Not required
Product Notification	Required (FDA)	Required (CPNP)
Safety Report	Substantiation required	CPSR mandatory
Responsible Person	Required	Required
Adverse Event Reporting	Serious events only	Serious events only
Pre-market Approval	No	No
Ingredient Restrictions	Limited	Extensive (Annexes)

Next Steps for Compliance

List all cosmetic products distributed in the US

Designate a responsible person for adverse event reporting

Ensure safety substantiation documentation is available

Monitor FDA progress on fragrance allergen labeling (proposed rule expected May 2026)

Establish adverse event monitoring and reporting procedures

Check Your MoCRA Readiness

Not sure if you're fully compliant? Take our free MoCRA readiness assessment to identify any gaps in your compliance status.

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