MoCRA Compliance Guide for Cosmetics

What Is MoCRA and Why Does It Matter?

The Modernization of Cosmetics Regulation Act (MoCRA), signed into law on December 29, 2022, is the most significant update to US cosmetics regulation since 1938. It requires cosmetics companies to register facilities, list products, report serious adverse events, substantiate product safety, and follow good manufacturing practices. For the latest official information, see the FDA Cosmetic Registration portal. For over 80 years before MoCRA, cosmetics were essentially self-regulated, with FDA having limited authority over the industry.

MoCRA grants FDA new mandatory authorities over cosmetics, aligning US requirements more closely with international standards, particularly those in the European Union. For the latest timeline details, see our MoCRA Deadlines 2026 guide. The law creates a comprehensive regulatory framework covering:

Who Must Comply with MoCRA?

MoCRA applies to a broad range of cosmetics businesses. If you manufacture, distribute, or market cosmetics in the United States, you likely have MoCRA obligations.

Responsible Persons

MoCRA introduces the concept of the "responsible person" - the entity accountable for compliance. The responsible person is typically:

• Domestic companies: The manufacturer, packer, or distributor whose name appears on the product label
• Foreign companies: The US importer, who becomes the responsible person for products manufactured abroad

Covered Entities

• Cosmetics manufacturers (domestic and foreign)
• Contract manufacturers making products for other brands
• Cosmetics importers
• Cosmetics distributors with their name on product labels
• Private label cosmetics brands

Small Business Exemptions (Expired)

MoCRA previously included limited exemptions for businesses with average gross annual sales of cosmetics under $1 million. These exemptions expired in December 2025. All cosmetics companies, regardless of size, must now fully comply with facility registration and product listing requirements.

How Do I Register a Cosmetics Facility Under MoCRA?

One of MoCRA's most significant requirements is mandatory facility registration. Previously voluntary, cosmetics facility registration with FDA is now required by law.

Who Must Register?

• Every facility that manufactures or processes cosmetics for distribution in the US
• Contract manufacturers making cosmetics for other companies
• Foreign facilities exporting cosmetics to the United States

Registration Information

Facility registration requires providing:

• Facility name, address, and contact information
• Name of owner/operator and contact person
• Types of cosmetics manufactured (product categories)
• Brand names of cosmetics manufactured at the facility

Registration Process

FDA has implemented an electronic registration system through the Cosmetics Direct portal. For a step-by-step walkthrough, see our how to register cosmetics under MoCRA guide, or check your readiness with the MoCRA Readiness Checker:

1. Create an FDA account (if you don't have one)
2. Access Cosmetics Direct through FDA Industry Systems
3. Complete facility registration form
4. Submit registration - no fee required
5. Receive FDA registration confirmation

Registration Renewal

Unlike food facility registration, cosmetics facility registration is biennial. Registrations must be renewed every two years during the period from October 1 through December 31.

What Products Must Be Listed Under MoCRA?

In addition to facility registration, MoCRA requires listing of all cosmetic products marketed in the United States. Product listing provides FDA with information about products in the marketplace.

What Must Be Listed?

Every cosmetic product intended for distribution in the United States must be listed, including:

• Products manufactured domestically
• Products manufactured abroad and imported to the US
• Private label products
• Products sold only through professional channels

Product Listing Information

For each product, you must provide:

• Product name: As it appears on the label
• Responsible person: Name and contact information
• Product category: Using FDA's cosmetics product categories
• Ingredient list: Complete listing of ingredients
• Manufacturing facility: Where the product is made

Updates and Maintenance

Product listings must be kept current. You should update listings within 60 days when:

• A product is discontinued
• Significant changes are made to a product
• A new product is introduced

What Is Adequate Safety Substantiation for Cosmetics?

MoCRA codifies the requirement that cosmetic products must have "adequate substantiation of safety." This means you must have reasonable data and documentation supporting the safety of your products.

What is Adequate Substantiation?

Adequate substantiation means you have sufficient evidence to conclude a product is safe under its intended and reasonably foreseeable conditions of use. This can include:

• Toxicological data: Safety assessments of ingredients
• Published literature: Scientific studies supporting ingredient safety
• Historical use data: Long history of safe use
• Stability testing: Product stability and shelf life data
• Microbiological testing: Challenge testing, preservative efficacy
• Clinical testing: Human safety testing (patch tests, etc.)

Record Keeping

Safety substantiation records must be maintained and available for FDA inspection. While you don't submit safety data with registration, FDA can request it during inspections or investigations.

What Are the MoCRA Labeling Requirements?

MoCRA maintains existing cosmetics labeling requirements while adding new ones. Proper labeling is essential for compliance and consumer protection.

Required Label Elements

• Product identity: Name identifying the product
• Net contents: Quantity of product
• Responsible person: Name and address of manufacturer, packer, or distributor
• Ingredient list: In descending order of predominance
• Warnings: As required for specific products or ingredients
• Directions for safe use: If not obvious from the product

MoCRA Label Additions

MoCRA adds new labeling requirements:

• Contact information: Phone number or electronic contact for adverse event reporting
• Fragrance allergen disclosure (proposed rule): FDA NPRM anticipated ~May 2026. Once finalized, specific allergens in fragrance must be individually listed on labels. This is not yet a compliance requirement.

How Do I Report Adverse Events Under MoCRA?

MoCRA establishes mandatory serious adverse event (SAE) reporting for cosmetics - a requirement that previously applied only to dietary supplements and drugs.

What is a Serious Adverse Event?

A serious adverse event is an adverse event that results in:

• Death
• Life-threatening experience
• Inpatient hospitalization
• Persistent or significant disability or incapacity
• Congenital anomaly or birth defect
• Medical or surgical intervention to prevent one of the above
• Significant disfigurement (including serious and persistent rash, second/third-degree burns, hair loss, or persistent skin discoloration)

Reporting Requirements

• Timeline: Report within 15 business days of receiving the report
• To FDA: Submit via FDA's CFSAN Adverse Event Reporting System (CAERS)
• Required information: Contact info, product identification, description of adverse event
• Follow-up: Submit new safety information within one year

Record Keeping

You must maintain records of all adverse event reports (including non-serious events) for 6 years. Records must be available for FDA inspection.

What Are the Fragrance Allergen Disclosure Requirements?

MoCRA requires disclosure of certain fragrance allergens on product labels. This aligns US requirements more closely with EU regulations that have required allergen disclosure for years.

Covered Allergens

FDA is developing the list of fragrance allergens that must be disclosed. The EU currently requires disclosure of 26 specific fragrance allergens, and FDA's list is expected to be similar.

Implementation Timeline

FDA's NPRM on fragrance allergen disclosure is anticipated around May 2026. This is a proposed rule, not a compliance deadline. After public comment and finalization, companies will have a compliance period to update labels.

What Good Manufacturing Practices Apply to Cosmetics?

MoCRA requires cosmetics to be manufactured in accordance with good manufacturing practice (GMP). FDA has not yet published a final GMP rule or NPRM -- the effective date remains TBD. Companies should follow existing guidance and industry standards in the interim.

Current Guidance

Until FDA finalizes GMP regulations, companies should follow:

• ISO 22716: International standard for cosmetics GMP
• FDA's cosmetics GMP guidelines:Existing voluntary guidelines from FDA
• PCPC guidelines: Industry association guidance on GMP

Key GMP Elements

• Personnel: Training, hygiene, qualifications
• Facilities: Design, maintenance, sanitation
• Equipment: Maintenance, calibration, cleaning
• Raw materials: Supplier qualification, testing, storage
• Production: Batch records, in-process controls, packaging
• Quality control: Testing, specifications, release procedures
• Documentation: Records, procedures, change control

What Is the MoCRA Compliance Timeline?

MoCRA requirements are being phased in over several years. Here's the implementation timeline:

Compliance Checklist

Frequently Asked Questions