[Home](/)/[Resources](/resources)/FDA Cosmetics Regulation USFDA Compliance # FDA Cosmetics Regulation The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly updated US cosmetics regulation, establishing new requirements for facility registration, product listing, adverse event reporting, and safety substantiation. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Ffda-cosmetics-regulation) At a glance MoCRA requirements 4 Labeling rules 4 FAQs 5 ## MoCRA key requirements ### Facility Registration Cosmetics manufacturing and processing facilities must register with FDA. Registration must be renewed every two years. Deadline: Initial registration deadline was December 29, 2023; ongoing biennial renewal Who: Any facility that manufactures or processes cosmetics for US market ### Product Listing Cosmetics companies must list each cosmetic product marketed in the US, including ingredients and labeling information. Deadline: Initial listing deadline was December 29, 2023; annual updates required Who: Responsible persons for cosmetic products marketed in the US ### Serious Adverse Event Reporting Companies must report serious adverse events to FDA within 15 business days of receiving the report. Timeline: 15 business days from receipt of adverse event report What: Serious adverse events including death, life-threatening events, hospitalization, etc. ### Safety Substantiation Companies must maintain records substantiating the safety of their cosmetic products and ingredients. Retention: Records must be maintained and accessible to FDA upon request Standard: Adequate substantiation is required for each product marketed ## Labeling requirements Principal Display Panel Must contain the identity of the product (what it is), net quantity of contents, and appropriate warning statements. Information Panel Must include business name and address, net quantity, directions for safe use, warning statements, ingredients, and distributor information. Ingredient Declaration Ingredients must be listed in descending order of predominance. Use common names established by regulation or INCI names. Warning Statements Required for certain products such as aerosol products, feminine deodorant sprays, and products containing specific ingredients. ## Prohibited practices ### Adulteration Cosmetics are adulterated if they contain harmful or filthy substances, are prepared under insanitary conditions, or contain unsafe color additives. ### Misbranding Cosmetics are misbranded if labeling is false or misleading, fails to contain required information, or does not provide adequate directions for safe use. ### False Claims Cosmetics cannot make false or misleading claims, including claims about treating or preventing disease (which would make them drugs). ## Common compliance mistakes Not registering facilities under MoCRA - mandatory for all cosmetics manufacturers and processors Missing product listing requirements - each cosmetic product must be listed with FDA Inadequate safety substantiation documentation - must maintain records supporting product safety Incorrect ingredient labeling - must use proper ingredient names and order Making drug claims for cosmetics - claims about treating disease make products drugs, not cosmetics Not reporting serious adverse events - 15-day reporting requirement is mandatory ## Frequently asked questions ### What is MoCRA and when did it take effect? The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant update to US cosmetics regulation since 1938. It established new requirements for facility registration, product listing, adverse event reporting, and safety substantiation. Most requirements took effect in late 2023, with ongoing obligations. ### Do I need to register my cosmetics facility with FDA? Yes, if you manufacture or process cosmetics for the US market. This includes both domestic and foreign facilities. Registration is done through FDA's electronic submission system and must be renewed every two years. Small businesses may have different reporting requirements but still must register. ### What is the difference between a cosmetic and a drug? Cosmetics are articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance. Drugs are intended to diagnose, cure, mitigate, treat, or prevent disease. Products that make drug claims are regulated as drugs, which have much stricter requirements. ### What safety substantiation do I need for my cosmetic products? You must have adequate substantiation that your cosmetic products are safe when used as labeled or under customary conditions. This typically includes toxicological assessments, stability testing, and safety data for ingredients. Documentation must be maintained and available to FDA upon request. ### What adverse events must I report to FDA? You must report serious adverse events including death, life-threatening experiences, inpatient hospitalization, persistent or significant disability, congenital anomalies, or serious disfigurement. Reports must be submitted within 15 business days of receiving the information. **Disclaimer:** This guide provides general information about FDA cosmetics regulation. Product-specific determinations require analysis of FDA regulations. Always verify current requirements with FDA resources or qualified regulatory professionals. πŸ‡ΊπŸ‡Έ US roadmap for your product Every standard, document, and test that applies β€” free, no account required. See your free roadmap[ Want an expert to take your product through πŸ‡ΊπŸ‡Έ US compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. 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