Cosmetics in the United States are under the unified regulation of the U.S. Food and Drug Administration (FDA), which works in close collaboration with U.S. Customs and Border Protection (CBP). Its core responsibilities include cosmetic facility registration and product listing administration, entry compliance inspection, post-marketing safety monitoring, adverse event management, and market law enforcement.Official Website of the Regulatory Authority: https://www.fda.gov/cosmetics
Modernization of Cosmetics Regulation Act of 2022 (MoCRA)Title 21 of the Code of Federal Regulations (21 CFR) under the Federal Food, Drug, and Cosmetic ActFair Packaging and Labeling Act
1.Definition of Cosmetics in the U.S.Cosmetics are defined as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance, pursuant to Section 201(i) of the FD&C Act.2.Core Regulatory BoundaryGeneral cosmetics shall not make any drug efficacy claims. If a product bears therapeutic claims that comply with OTC monograph requirements, it will be subject to dual regulation as both a drug and a cosmetic, and must meet all compliance obligations for both product categories.
Complete FDA registration of overseas manufacturing facilities and formalities for corresponding product listingThe manufacturing process shall conform to U.S. cosmetic Good Manufacturing Practice (GMP) quality management specificationsAppoint a U.S.-based liaison person responsible for cosmetic adverse reaction reportingImported cosmetics must appoint a qualified U.S. Agent
English
Facility registration numberProduct nameProduct ingredient listProduct packaging materialsInformation of the responsible person of the U.S. Agent, etc.
Imported cosmetics must appoint a U.S. Agent, which acts as the exclusive communication bridge between the FDA and overseas product owners. The agent shall be an individual or business entity residing in the United States or maintaining a physical business premises within the U.S.
1.Filing Procedure
Standard procedure: FDA account registration → Overseas manufacturing facility registration (system verification) → Product information submission and listing (system verification) → Direct verification approval → Obtainment of product listing number
2.Filing Timeline and Official FeesOfficial fees: The FDA does not charge any official fees for cosmetic facility registration, product listing, or registration formalities.Review timeline: The entire registration process can be completed within 1 to 2 weeks provided that the submitted materials are complete and fully compliant.