The Modernization of Cosmetics Regulation Act of 2022, or MoCRA, expanded the U.S. Food and Drug Administration’s authority over cosmetics. A practical review should separate facility registration, product listing, the responsible person, safety substantiation and adverse-event records, then connect each record to the specific product, label and business entity. FDA registration or listing is not FDA approval or certification.
This reference page summarizes FDA’s public MoCRA materials. It is not a legal determination for a particular product, ingredient, intended use or U.S. business arrangement. Imported cosmetics must also meet the U.S. requirements that apply to domestically produced cosmetics.
1. Identify the Product and Responsible Parties
Start with the product’s intended use in the United States, label claims, ingredients and form. Check the boundary between a cosmetic and a drug or another regulated product. FDA describes the responsible person as the manufacturer, packer or distributor whose name appears on the cosmetic label. A facility can include an establishment that manufactures or processes cosmetics distributed in the United States, including relevant importer arrangements.
Build a product-to-party register covering the product, label responsible person, manufacturing or processing facility, U.S. contact, and record version. A brand owner, contract manufacturer, importer and label responsible person may be different entities. A supplier’s record or another SKU’s file should not be treated as automatic evidence for the current product.
2. Check Facility Registration and Product Listing
MoCRA establishes FDA registration requirements for applicable cosmetic manufacturing and processing facilities; facility registrations are generally renewed every two years. A responsible person must also list each marketed cosmetic product and provide information including ingredients, with annual updates as required by FDA. Check the current Cosmetics Direct portal, forms and guidance for the submission fields that apply.
Keep submission receipts, registration or listing identifiers, version dates, product and ingredient information, and the links between the responsible person and facility. Certain small businesses may qualify for exemptions, but exemptions have conditions and exceptions. Do not decide applicability from business size or sales channel alone.
3. Build Traceable Safety Substantiation
MoCRA requires the responsible person to ensure and maintain records supporting adequate safety substantiation. FDA explains that the law and FDA regulations do not prescribe one uniform set of specific tests for every cosmetic product or ingredient. Existing relevant safety data may be used, but the data and reasoning should be scientifically sound and connected to the current formulation, use conditions, exposure context and label claims.
A working file can record the formulation and ingredient version, raw-material specifications, intended use, label and warnings, available safety data, relevant testing or assessment, reviewer and date, open evidence gaps, and change history. More reports do not automatically create stronger substantiation; the subject, method, sample, conclusion and limitations must fit the product under review.
4. Maintain a Serious Adverse Event Process
The responsible person must handle adverse-event records associated with cosmetics sold in the United States. For a serious adverse event within the MoCRA definition, the responsible person must report to FDA within 15 business days after receiving the report and include a copy of the label on or within the retail packaging. Relevant medical or other new information received within one year of the initial report can trigger a supplemental reporting obligation.
The internal process should define the complaint channel, event triage, label and lot information, responsible reviewer, medical or technical assessment, reporting decision, submission evidence and follow-up. A general customer complaint, platform message or isolated test result should not automatically be treated as a statutory serious adverse event; assess the facts against the FDA definition.
5. Review Page Wording and Versions Before Use
Check the product name, ingredients, net quantity, responsible person, manufacturing or processing facility, directions, warnings and language versions. If the wording suggests treatment, disease prevention or a body-function claim, reassess whether the product remains within the cosmetic category. Do not turn “registered” or “listed” into a claim of FDA approval, certification, safety assurance or a sales outcome.
When the formulation, label, responsible person, facility, product name or market wording changes, record the impact review and confirm whether registration, listing, safety substantiation or the adverse-event process needs updating. For uncertain exemptions, product classification or submission fields, return to the current FDA law, guidance and Cosmetics Direct instructions.
Source basis: FDA’s “Modernization of Cosmetics Regulation Act of 2022 (MoCRA),” “Registration & Listing of Cosmetic Product Facilities and Products,” and related industry guidance. Laws, guidance and electronic submission systems can change; check the current FDA version before use.
