MoCRA FDA

Q: What is MoCRA?

The Modernization of the Cosmetics Regulation Act (MoCRA) is the FDA’s first major cosmetics regulatory update in 85 years, focusing on product safety and manufacturing standards. Non-US cosmetic facilities need a US Agent for representation . Cosmeservice offers US Agent services, ensuring compliance and liaising with the FDA.

Q: How do I substantiate the safety of my products under MoCRA?

You must have a documented safety substantiation , based on toxicological data, safety testing or a written assessment by a qualified expert. This documentation must be available in case the FDA requests it

Q: What are the new labeling requirements under MoCRA?

Starting December 2024 , cosmetic labels must include: Direct contact information (address, phone, email or website) so consumers can report adverse events. Clear indication if the product is for professional use only (e.g. in salons or clinics). All existing FDA labeling rules still apply, including ingredient listing, net quantity, function and warnings.

MoCRA modernizes FDA compliance for cosmetics in the US, strengthening product safety and oversight across the industry.

MoCRA FDA: Key Changes in US Cosmetic Regulations

The Modernization of Cosmetics Regulation Act (MoCRA) introduces new obligations for companies selling cosmetic products in the US, including facility registration, product listing, safety substantiation, and adverse event reporting. For the first time, cosmetic manufacturers and distributors are required to meet compliance standards enforced by the FDA. Whether you are already in the US market or planning to expand, understanding MoCRA FDA is essential to ensure full alignment with current US cosmetic regulations.

Ready for MoCRA?

Who is affected by the MoCRA Act?

MoCRA Act predominantly affects cosmetic manufacturers, importers, packers, and distributors. While some small businesses, specifically those with U.S. cosmetic sales under $1M over the past three years, are exempt from certain aspects like GMP and registration, many larger entities must fully engage with MoCRA’s provisions.

Cosmetic products under MoCRA are defined as “formulations with a specific ingredient composition intended for finished product use.”

MoCRA doesn’t govern over-the-counter (OTC), such as sunscreens with cosmetic claims. These fall under OTC compliance, barring new provisions on fragrance allergen disclosure and professional use labeling.

Are you interested in OTC? Click here and find out how to comply with the regulations.

MoCRA FDA Compliance Steps

Safety substantiation

MoCRA mandates that the Responsible Person for a cosmetic product must keep records proving product safety, including tests, studies, and other expert-approved evidence.

Cosmetic product listing

The Responsible Person must annually update cosmetic products with the FDA, focusing on rigorous labeling and setting deadlines for both existing and new products.

Good Manufacturing Practices

MoCRA Act registration highlights the importance of Good Manufacturing Practices (GMP) for cosmetic safety. The FDA is required to propose GMP compliance by December 29, 2024, in line with international standards like ISO 22716.

Labelling requirements

Article 609 of MoCRA regulation introduces new labeling requirements for cosmetics, including contact information for reporting adverse effects and the identification of fragrance allergens.

Facility registration

Cosmetic facilities in the US must register on the FDA platform according to MoCRA and Sec. 607(a), with established deadlines for existing and new facilities. Registration must be renewed every two years.

Adverse event reporting

US companies must retain adverse event records for cosmetics for six years (three for small businesses). For serious events, the Responsible Person must inform the FDA and update medical data for one year following the initial report

Compliance Deadlines Under MoCRA FDA

Facility Registration & Product Listing

To comply with MoCRA FDA, having the FEI number, facility registration, and product listing is crucial. We will verify/obtain your FEI (FDA Establishment Identifier) and handle the facility registration and product listing on your behalf.

Safety Substantiation report

We ensure that your cosmetic products comply with FDA standards and MoCRA Act requirements. We review formulas, labels, and claims justifications.

US Agent & Responsible Person Support

The US Responsible Person is listed on the cosmetic label and holds legal responsibility for its safety, compliance, and labeling. If based outside the US, the company must appoint a US Agent to communicate with the FDA.

Everything is ready!

Your cosmetic products fully comply with MoCRA FDA standards. As your representative in the US, we will oversee your products and provide regulatory updates.

December 29, 2022

Enactment of MoCRA

December 29, 2023

Safety substantiation, serious adverse event reporting, and professional use labeling requirements take effect

June 24, 2024

Proposition of a list of fragrance allergens

July 1, 2024

Mandatory registration of facilities and product listing via the Cosmetic Direct Portal

December 29, 2024

New labeling rules take effect (e.g. responsible person contact)

February, 2025

Final approval of allergen labeling regulation

December 29, 2025

Final rule on Cosmetic GMP expected to take effect. FDA publishes PFAS report

US Agent & Responsible Person Support for MoCRA FDA compliance

Under the MoCRA compliance, all non US cosmetic manufacturers must appoint a US Agent to access the US market. This representative acts as the official point of contact with the FDA for regulatory communications.

At Cosmeservice, we act as your MoCRA US Agent, supporting FDA compliance, managing product listings, and assisting with safety documentation and adverse event reports.

We also provide complete Responsible Person Support for United States, helping you ensure that every product placed on the US market meets MoCRA requirements with accurate information, compliant labelling and proper record keeping.

What our clients say about us

They are always available to clarify doubts and ensure everything runs seamlessly.

A good long relationship

Very polite and helpful in their service.

Long-term experience with a lot of learning and trust

It's a delight to work with Cosmeservice. There is always a response and willingness to help achieve the most professional result.

We appreciate their friendly attitude and quick response, and explains about regulation patiently when we make a inquiry.

We always have answers and high-quality studies.

Reliable service.

FAQS

What is MoCRA?

The Modernization of the Cosmetics Regulation Act (MoCRA) is the FDA’s first major cosmetics regulatory update in 85 years, focusing on product safety and manufacturing standards. Non-US cosmetic facilities need a US Agent for representation. Cosmeservice offers US Agent services, ensuring compliance and liaising with the FDA.

Should I wait for more information from the FDA before working on MoCRA compliance?

It’s recommended to start early. The FDA has outlined many requirements, and starting now ensures you stay ahead and prevent business disruptions due to non-compliance.

What is the deadline for registering products and facilities under MoCRA?

All products and facilities must be registered by December 29, 2023.

What if my contract manufacturer isn't aware of MoCRA?

Every company responsible for a cosmetic product sold in the US must comply. Share your manufacturer’s contact details with experts like us to ensure they’re educated and compliant.

How do I substantiate the safety of my products under MoCRA?

You must have a documented safety substantiation, based on toxicological data, safety testing or a written assessment by a qualified expert. This documentation must be available in case the FDA requests it

What are the new labeling requirements under MoCRA?

Starting December 2024, cosmetic labels must include:

Direct contact information (address, phone, email or website) so consumers can report adverse events.
Clear indication if the product is for professional use only (e.g. in salons or clinics).

All existing FDA labeling rules still apply, including ingredient listing, net quantity, function and warnings.

How often do I need to renew my facility registration?

Facility registrations under Modernization of the Cosmetics Regulation Act (MoCRA) must be renewed every two years.

Who is exempt from MoCRA?

Small US businesses with cosmetic sales under $1M in the last three years are exempt from Good Manufacturing Practices, Facility Registration, and Product Listing. However, exemptions don’t apply to businesses producing cosmetics for eye contact, injectable products, internally consumed products, or products that modify appearance for over 24 hours.

MoCRA FDA

MoCRA FDA: Key Changes in US Cosmetic Regulations