FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
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U.S. FDA Registration
& Labeling Compliance Assistance
FDA Cosmetic Facility Registration and Product Listing- MoCRA
Click the button below to see the service steps in an easy-to-follow graphic format.
Cosmetic Facility Registration
Under the newly approved Modernization of Cosmetics Regulation Act of 2022-MoCRA, most cosmetic facilities, including contract manufacturers of cosmetic products marketed in the U.S., must register with the FDA. Registered facilities must promptly update and renew any changes to their registration biennially. All facilities outside the U.S. must designate a U.S. Agent with the FDA to complete their facility registration.
Cosmetic Product Listing
The MoCRA further requires cosmetic manufacturers, packers, and distributors whose names are on the product label to submit a cosmetic product listing to the FDA. The listing must include the list of ingredients, including color additives, fragrances, and flavors, the manufacturer facility name and location, the responsible party, and a product label.
Cosmetic product listings must be updated annually. A flexible listing option will enable a unified submission for multiple cosmetic products that share identical formulations or exhibit variances limited to packing size, color additives, fragrances, or flavors.
Cosmetic Labeling Requirement
All cosmetic product labels are subject to the FDA cosmetic labeling regulations, which means the FDA law prohibits false or misleading claims and inaccurate information on a cosmetic label. The differences between a cosmetic claim, either direct or implied, and a drug claim can be very subtle, and failure to recognize the distinction can result in enforcement actions by the FDA. The MoCRA introduces additional labeling requirements, including adverse events contact, declaration of allergens, and a statement for use by an industry professional.
MoCRA Exemptions
Small businesses whose average gross annual U.S. sales for the past three years is less than 1,000,000 USD are exempt from some MoCRA requirements such as GMP, facility registration, and product listing (optional registration will still be available for such small businesses). Certain cosmetic products, such as items that come in contact with the eye or cosmetics for internal use, injectables, and long-lasting cosmetics, are not eligible for the exemption and must comply with MoCRA regardless of their sales volume.
Registration Timeline:
1. Assessment of Responsible Parties….…………..( 1-2 days)
2. Cosmetic Facility Registration ……………………..(2-3 days)
3. Cosmetic Product Listing……………………………..(3-5 days)
4. Cosmetic Label Compliance Review …………….(5-7 days)
Other MoCRA Requirements
Most of the MoCRA requirements, including facility registration and product listing, will become effective before the end of 2023. Below is a synopsis of the main MoCRA requirements:
● Mandatory FDA registration for cosmetics facilities
● Mandatory product listings for products marketed in the U.S.
● Compliance with additional FDA cosmetic labeling requirements
● Compliance with FDA-issued Good Manufacturing Practices -GMP
● Record keeping, recalls, adverse event, and safety substantiation records
Compliance with MoCRA requirements can be challenging, time-consuming, and often requires expert knowledge. FDA Listing Inc. simplifies compliance with MoCRA regulations, helping your firm meet FDA requirements in the following ways.
1) Assistance in registering cosmetic facilities with the FDA.
2) Assistance with cosmetic product listings and proper data submission.
3) Serving as a U.S. Agent for cosmetic facilities outside the U.S.
4) Expert Label review to comply with the FDA cosmetic labeling requirements
Please email or call us if you need assistance evaluating the responsible party for product submissions, U.S. agent designation, or any MoCRA-related matter.
Service Details & Fees
Cosmetic Facility Registration
Cosmetic Product Listing
Time Required
U.S. Agent
Obtaining Facility FEI Number
FDA Registration Certificate
FDA Registration Updates
495 USD
395 USD
3-5 Days
_______ Related Services _______
Frequently Asked Questions (FAQ)
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
Frequently Asked Questions (FAQ)
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
Service Details & Fees
Cosmetic Facility Registration
495 USD
Cosmetic Product Listing
395 USD
Time Required
3-5 Days
U.S. Agent
Obtaining Facility FEI Number
FDA Registration Certificate
FDA Registration Updates
_______ Related Services _______