FDA Cosmetic Facility Registration & Product Listing- MoCRA

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What is Cosmetic Facility Registration ?

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) introduced significant FDA requirements for cosmetic businesses marketing products in the U.S. While cosmetic facility registration and product listing were previously voluntary, MoCRA now requires most covered cosmetic facilities and responsible persons to submit information to the FDA, subject to applicable exemptions. This includes many contract manufacturers and foreign cosmetic facilities that supply cosmetic products to the U.S. market.

The FDA has created a Decision Tool to help companies determine whether they are required to register as Cosmetic Product Facilities. To use the tool, companies can follow the series of questions available on the FDA’s website.

What about Cosmetic Product Listing?

The MoCRA requires the responsible person to submit a cosmetic product listing to the FDA for each cosmetic product marketed in the U.S. The responsible person is the manufacturer, packer, or distributor whose name appears on the product label. Each cosmetic product listing must include the product’s ingredients, including color additives, fragrances, and flavors; the manufacturing facility’s name and location; responsible person information; and a copy of the product label.

In addition, cosmetic product listings must be updated annually. The FDA also allows flexible listings for multiple cosmetic products with identical formulations or variations limited to package size, color additives, fragrances, or flavors. Consequently, this option may reduce duplicate submissions for product lines with closely related product variations.

A cosmetic product listing is not an FDA approval, clearance, or authorization to market the product. Companies remain responsible for ensuring that their cosmetic products and ingredients are safe and properly labeled before U.S. distribution.

What are Cosmetic Labeling Requirements ?

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.

What are 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, cosmetic facility registration, and product listing under MoCRA (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.

Cosmetic 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)

Are there other MoCRA Requirements ?

Most of the MoCRA requirements, including cosmetic facility registration & 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
● Recordkeeping, recalls, adverse events, and safety substantiation records

How can FDA Listing Inc Assist?

Compliance with MoCRA requirements can be challenging and 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 with cosmetic facility registration with the FDA.
2) Assistance with cosmetic product listing 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.

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