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List your products with FDA

Designate a U.S. Agent for FDA communication

Adverse Event Contact, Record Keeping, and Reporting

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Many regulations under the Modernization of Cosmetics Regulation Act (MoCRA) are new to cosmetic companies, such as facility registration, product listings, U.S. Agent requirements, and adverse event reporting.

Use the MoCRA Wizard to determine what requirements impact your business:

Discover FDA MoCRA requirements that affect your business.

Registrar Corp, the world’s largest cosmetics compliance firm, created the MoCRA Wizard so you can easily determine which MoCRA requirements apply.

Answer a few short questions and in less than two minutes, you’ll find out how to meet FDA’s new cosmetic compliance standards.

How would you describe your company’s role in the cosmetic industry?*

Brand Owner

Manufacturer

Processor

Contract Manufacturer

Packer

Distributor

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Has your company averaged LESS than USD 1 million/year in cosmetic sales to the U.S. over the last 3 years?*

Yes

Does your company engage in the manufacturing or processing of the cosmetic products described below?

Cosmetic Products that regularly come into contact with 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 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

Does your corporate name and address appear on the label?*

Yes

Does your company have an active drug establishment registration or drug product listings on file with FDA?*

Yes

Is your cosmetic facility located in the United States, outside the United States, or both?*

In the U.S.

Outside the U.S.

Both

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International Office Email

Enter your information:

Complete this form to get your results and see how MoCRA will impact your business.

Your Name*

Company Name*

Country*

Email Address*

Phone Number*

Based on the information you provided, it seems that you may be exempt from MoCRA's Cosmetic Facility Registration and Cosmetic Product Listing requirements. However, if you are a manufacturer, packer, or distributor of a cosmetic product and your name appears on the cosmetic label, you are required to report Report Serious Adverse Events associated with the use of cosmetic products in the United States to FDA within 15 business days.

Additionally, MoCRA will require changes to Cosmetic Labels including disclosure of fragrance allergens to be identified by the FDA and providing a US Address or electronic contact information through which the Responsible Person (or its US Agent) can receive Adverse Event Reports. Please Contact Us for assistance with these requirements or any other US FDA regulations.

Based on the information you provided, you may be exempt from MoCRA's facility registration, product listing, and adverse event reporting requirements.

MoCRA will require changes to cosmetic labels, which include:

Disclosure of fragrance allergens (to be identified by FDA)
Including a U.S. address or electronic contact information that the Responsible Person or U.S. Agent can receive adverse event reports.

Our labeling specialists can assist your company to assure your product labels are compliant when they reach the U.S. market. Contact us to see how we can help you achieve MoCRA compliance the right way.

You’re one step closer to becoming FDA MoCRA compliant.

Based on the answers you provided, your company needs to complete the following to comply with the requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA):

• Register with FDA

• List your products with FDA

• Designate a U.S. Agent for FDA communication

• Adverse Event Contact, Record Keeping, and Reporting

*For more information on each requirement, hold your cursor over the blue 'i' icon next to each requirement.

As your Authorized Agent for FDA Cosmetic Registration and Listings, Registrar Corp will:

As your U.S. Agent for FDA communications, Registrar Corp can:

Existing Novi Connect users, complete your product listings in half the time by leveraging your pre-loaded SKUs.

To comply with adverse event requirements, complete Registrar Corp's simple, two-step form.

To register your facility with FDA, complete the simple, two-step form through Registrar Corp, or click below to return to the Novi Connect platform.

To comply with facility registration and U.S. Agent requirements, complete the simple, two-step form through Registrar Corp.

Existing Novi Connect users, complete your product listings in half the time by leveraging your pre-loaded SKUs.

Return to Novi Connect

To comply with facility registration and adverse event requirements, complete the simple, two-step form through Registrar Corp.

Existing Novi Connect users, complete your product listings in half the time by lever aging your pre-loaded SKUs.

To comply with facility registration, U.S. Agent, and adverse event requirements, complete the simple, two-step form through Registrar Corp.

Assure compliance by fulfilling FDA's mandatory cosmetic facility registration requirements
Issue a Registrar Corp Certificate of Registration to verify your cosmetic facility registration for industry
Properly maintain your cosmetic facility registration and product listings throughout the year, making registration updates as required
Provide detention assistance by communicating with FDA on your behalf to seek the release of detained shipments
Access to patented FDA Compliance Monitor software that proactively alerts you to changes in your company's FDA compliance status

Based on the information you provided, it seems that your Facility(s) and Product(s) are not subject to FDA's New MoCRA requirements. Please Contact Us for more information regarding FDA's MoCRA requirements or any other US FDA regulations.

Based on the information you provided, we need some additional information to determine how you may need to comply with FDA's New MoCRA requirements. Please Contact Us to meet with a Regulatory Advisor.

Based on the information you provided, additional details are needed to confirm which FDA MoCRA requirements your company must comply with. Return to the Novi Connect platform and contact mocra@noviconnect.com to learn more.

Return to Novi Connect

Click below to return to the Novi Connect platform and complete your product listings requirment.

Return to Novi Connect

To comply with facility registration and/or adverse event requirements, complete the simple, two-step form through Registrar Corp.