US FDA Cosmetic Regulatory Services
Freyr has a Regulatory team comprising 2300+ members across 120+ countries, and our customers value us for our commitment and expertise. We know how to make you and your product MoCRA-compliant.
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Facility Registration and US Agent Services
Freyr has done 500+ Facility Registrations for various product categories in the last 3 years We can help you become MoCRA Compliant by registering your facility in the US. Freyr can be the US Agent if your facility is outside the USA.
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Product Listing
Freyr registered 5000+ products with USFDA in the last 2 years. Save time, money, and the hassle of doing it yourself as we expedite and simplify product listings for you.
![Safety Substantiation]()
Safety Substantiation
We can help you with Toxicology perspectives for product formulation and ingredient assessment
![Regulatory Labeling]()
Regulatory Labeling
Freyr processes 25,000+ Labels annually for multiple product categories. We can design compliant and harmonized labels for you with QR Codes and smart labels as required.
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Adverse Event Reporting
Collecting data on adverse reactions and evaluating its reportability is a continuous monitoring system. Our experts can guide you in setting up the Cosmetovigilance systems for Adverse Event Reporting.
![Cosmetic Regulatory Intelligence]()
Cosmetic Regulatory Intelligence
Reimagine the regulatory landscape and stay ahead with updates with our state-of-the-art regulatory intelligence tool
Do you want to know
if your Product is MoCRA Compliant?
A One-stop Solution for Global Cosmetic Ingredients Regulatory Compliance
With our centralized cosmetic ingredient repository, search and compare global ingredient regulations on a single platform. Track formulae compliance in real time!
Frequently Asked Questions (FAQs) on MoCRA
We are here to provide you with the information you need quickly and efficiently.
01. What is MoCRA?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law on December 29, 2022. It ushers in heightened regulatory oversight for cosmetic products and facilities.
02. What are the key provisions introduced by MoCRA?
MoCRA introduces provisions related to Facility Registration, Product Listing, Cosmetic GMPs, Labeling, Adverse Event Reporting, Safety Substantiation, Records, Mandatory Recall Authority, Small Businesses, Asbestos Testing in Talc-containing cosmetics and evaluating the Safety of PFAS in Cosmetics.
03. What are the labeling requirements introduced by MoCRA?
MoCRA mandates the inclusion of a domestic address, domestic phone number, or electronic contact information for receiving adverse event reports. It also requires labeling of fragrance allergens.
04. What is the significance of Cosmetic GMPs under MoCRA?
Facilities are required to adhere to Good Manufacturing Practices (GMPs) aligning with national and international standards. This regulation aims to ensure that cosmetic products are not adulterated and protect public health.
05. What is the Small Business exemption under MoCRA?
Any business whose average gross annual sales in the United States (US) of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and which does not engage in the manufacturing or processing of the cosmetic products described below, shall be considered small businesses and they are exempt from GMP, Facility Registration, and Product Listing.
- Cosmetic products that regularly come into contact with the mucus membrane of the eye under conditions of use that are customary or usual.
- Cosmetic products that are injected.
- Cosmetic products that are intended for internal use.
- Cosmetic products that are intended to alter the appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.
06. Who is Considered a responsible person under MoCRA?
The term “responsible person” means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. The “responsible person” will be responsible for:
- Cosmetic product listing
- Adverse events
- Safety substantiation
- Labeling
- Good Manufacturing Practices (GMP)
- Facility Registration
07. How will I list my multiple product categories under MoCRA?
MoCRA allows “flexible listings”. For flexible listings, companies can submit a single listing for cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.
08. What is a "Product Listing" requirement under MoCRA?
A “Responsible Person” (manufacturer, packer, or distributor of a cosmetic product whose name appears on the label) must list each cosmetic product, including its ingredients, with the US FDA not later than July 1,2024. For products marketed after the enactment of MoCRA, an RP must submit the product listing by July 1, 2024. Additionally, the Responsible Person must update product listing information annually.
09. What is the MoCRA recall?
The MoCRA regulation has now been given legal authority to require a mandatory recall of cosmetics if the FDA determines that the cosmetic product may be adulterated or misbranded under the Food and Drug Cosmetics Act (FDCA) and exposure to the product may cause serious adverse health effects.
10. What is the difference between facility registration and product listing under MoCRA?
For facility registration, manufacturers and processors must register their facilities with the FDA and renew their registration every two (02) years. For product listing, a Responsible Person (RP) must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually.
