Food and Drug Administration (FDA)
The US federal agency within the Department of Health and Human Services responsible for regulating cosmetics, food, drugs, medical devices, and other products. Under MoCRA, the FDA has expanded authority over cosmetics including facility registration, product listing, and mandatory recall power.
The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services. It is responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, medical devices, food, cosmetics, and products that emit radiation.
For cosmetics, the FDA's Center for Food Safety and Applied Nutrition (CFSAN) oversees regulatory compliance. Historically, FDA's authority over cosmetics was limited — it could not require pre-market approval, mandate facility registration, or order recalls. MoCRA fundamentally changed this in 2022.
Under MoCRA, the FDA now requires facility registration and product listing through its Cosmetics Direct portal and the Electronic Submissions Gateway (ESG NextGen), receives mandatory adverse event reports through MedWatch Form 3500A, can order mandatory recalls, can access safety substantiation records during inspections, and is developing GMP requirements.
The FDA also maintains cosmetic ingredient regulations in 21 CFR Parts 700-740 and publishes guidance documents that, while not legally binding, represent the agency's current thinking on cosmetics regulation.
Related Terms
Modernization of Cosmetics Regulation Act (MoCRA)
A US federal law (Public Law 117-328, Title XXXV) signed on December 29, 2022, that gives the FDA new authority over cosmetics including mandatory facility registration, product listing, adverse event reporting, safety substantiation, and recall authority.
RegulationFederal Food, Drug, and Cosmetic Act (FD&C Act)
The foundational US law (21 U.S.C. ch. 9) granting the FDA authority to oversee the safety of food, drugs, medical devices, and cosmetics. MoCRA (2022) amended the FD&C Act to significantly expand FDA's cosmetics oversight.
DocumentCosmetics Direct
The FDA's web-based portal for cosmetic facility registration and product listing submissions under MoCRA. It provides a user-friendly interface as an alternative to the SPL/ESG submission pathway, allowing manual entry of registration and listing data.
DocumentElectronic Submissions Gateway NextGen (ESG NextGen)
The FDA's electronic gateway for receiving regulatory submissions in SPL XML format, including MoCRA cosmetic facility registrations and product listings. ESG NextGen replaced the original ESG and supports automated, API-driven submissions.
Regulation21 CFR Part 700
The section of the US Code of Federal Regulations containing FDA regulations specific to cosmetic products, including prohibited ingredients, required warning statements, and labeling requirements. Parts 700-740 collectively govern cosmetics.
DocumentMedWatch Form 3500A (MedWatch 3500A)
The FDA's mandatory reporting form for serious adverse events associated with cosmetics (and other FDA-regulated products). Under MoCRA, responsible persons must submit Form 3500A within 15 business days of receiving an initial serious adverse event report.
See how Cosmetica automates compliance
Replace manual regulatory work with AI-powered automation — from ingredient screening to submission filing.