Modernization of Cosmetics Regulation Act (MoCRA)
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MOCRA stands for the Modernization of Cosmetics Regulation Act of 2022. It's a law that gives the FDA more authority to regulate cosmetics and protect public health. MoCRA applies to all cosmetics, including ingredients, manufacturing methods, and the companies that make, import, market, or distribute them.
Facility Registration
Manufacturers and processors must register their facilities with the FDA and renew their registration every two years. Non-US cosmetic facilities are required to designate a U.S. Agent for FDA communications.
To determine whether you are required to register your facility, use this link
Required Information:
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the name of the owner and/or operator of the facility;
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the facility’s name, physical address, email address, and telephone number;
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the Facility Establishment Identifier (FEI) #, if previously assigned by FDA;
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all brand names under which cosmetic products manufactured or processed in the facility are sold;
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the product category or categories (Appendix A) and the responsible person for each cosmetic product manufactured or processed at the facility;
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type of submission (initial, amended, biennial renewal, or abbreviated
Product Listing
Companies must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually.
Required Information:
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the facility registration number of each facility where the cosmetic product is manufactured or processed;
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the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;
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the applicable cosmetic category or categories for the cosmetic product (Appendix A);
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a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the scientific or common;
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the product listing number, if any previously assigned; and
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type of submission (initial, update to content (annual), abbreviated renewal).
Adverse Event Reporting
A responsible person is required to report serious adverse events associated with the use of cosmetic products in the U.S. to FDA. The responsible person must include a copy of the label on or within the retail packaging of such cosmetic product. If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, they must submit this new information to FDA within 15 business days. FDA will also have access to adverse event reports during an inspection.
Safety Substantiation of Products
Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products, and to maintain records supporting adequate safety substantiation of their cosmetic products. All data used to support the safety are derived from scientifically robust methods.
Cosmetic Labeling
Additional labeling requirements are required, including an adverse event contact, allergen labeling, and labeling of products for professional use.
Good Manufacturing Practices (GMPs)
Manufacturers and processors must comply with Good Manufacturing Practices (GMPs) for Cosmetics Products ISO 22716.