Certification and Registration
US. Cosmetics Testing
Category:
U.S. Cosmetics Testing
US Cosmetics Regulatory System
The United States consists of 50 states and the District of Columbia. Therefore, cosmetic regulation in the United States is jointly managed by the U.S. Food and Drug Administration (FDA) and individual state regulatory authorities.
The Modernization of Cosmetics Regulation Act (MoCRA), enacted in 2022, represents the first major update to U.S. cosmetics regulations since 1938. MoCRA introduces a comprehensive regulatory framework covering key requirements such as the Responsible Person system, adverse event reporting, Good Manufacturing Practice (GMP) compliance, mandatory facility registration (effective from July 2024), safety substantiation, and labeling requirements. It also addresses areas including talc-asbestos testing, PFAS risk assessment, and restrictions related to animal testing.
In addition to federal requirements, individual states may impose additional cosmetic regulations, such as California’s California Safe Cosmetics Program (CSCP) requirements, New York State’s restrictions on certain substances such as dioxins, and multi-state restrictions on specific cosmetic ingredients and animal testing practices.
FDA Definition of Cosmetics
According to the Federal Food, Drug, and Cosmetic Act (FD&C Act), cosmetics refer to products intended to be applied to the human body through methods such as rubbing, pouring, sprinkling, or spraying for purposes including cleansing, beautifying, enhancing attractiveness, or altering appearance. Cosmetic products include moisturizing creams, perfumes, lipsticks, nail polishes, shampoos, hair perms, hair dyes, deodorants, and similar products, as well as their constituent ingredients, but exclude soap.
It is important to note that the FD&C Act also defines drugs as products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or products intended to affect the structure or function of the human body (excluding food products). Common examples include sunscreen products and anti-dandruff products.
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Product Categories |
US. Regulatory Category |
Product Categories |
US. Regulatory Category |
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Anti-dandruff shampoo |
Over-the-counter drug |
Cleaning wipes |
Cosmetics |
|
Acne-fighting products |
Medicine |
Tattoo sticker |
Cosmetics |
|
Hair growth products |
Medicine |
Soap |
Cosmetics / General consumer goods (determined based on function) |
|
Sunscreen products |
Over-the-counter drug |
Plastic false nail tips |
Cosmetics |
Accordingly, certain products that are classified as cosmetics in China, such as sunscreens, anti-dandruff products, and acne treatment products, may be regulated as both cosmetics and drugs in the United States and must comply with the applicable requirements for each category.
US Cosmetics Testing Services
(1) Product Testing
Preservative challenge testing (ISO 11930, United States Pharmacopeia USP <51>)
TPCH packaging toxicity testing
Microbial contamination testing (ISO 21148, ISO 21149)
Child-resistant packaging testing for children’s products
Hazardous substance testing (dioxane, PFAs , formaldehyde, phthalates, and other restricted substances )
In vitro testing (alternative methods to animal testing)
(2) Clinical Efficacy Evaluation
Repair, soothing ,anti-wrinkle, firming , nourishing, oil control , moisturizing , exfoliation, long-lasting performance , coverage performance, cleansing efficacy, and other cosmetic efficacy evaluations.
Note: Claims related to preventive effects, such as sun protection, whitening, acne treatment, dandruff control, sweat inhibition, and eye irritation relief, may fall under US. over-the-counter (OTC) drugs regulations.
(3) Human Safety Testing
Human Repeat Insult Patch Test (HRIPT)
Human Patch Test (24/48 hours)
Human Clinical Safety Evaluation
Sensitive skin compatibility assessment
(4) Safety Risk Assessment
US Cosmetic Toxicological Assessment (TRA)
(5) Label and Ingredient Review
California Proposition 65 Ingredient Review
California Safe Cosmetics Program (CSCP) Reportable Ingredient Review
Review of cosmetic ingredients prohibited from intentional addition under U.S. state regulations
US Cosmetic Label Review
US Cosmetic Ingredient Review
Toxic Substances Control Act (TSCA) Review
(6) FDA Registration Services
FDA application for Facility Establishment Identifier (FEI) Number
US Agent Service for Cosmetic Product Facilities
Cosmetic Product Listing
Cosmetic Product Facility Registration
D-U-N-S Number Application
(7) Chemical Safety
(8) Cargo Transportation Safety
Dangerous Goods Transportation Certification (Air, Sea, Road, Rail)
(9) Market claims
Application for the National Eczema Association Seal of Acceptance (NEA Seal of Acceptance)
SATISFY specializes in cosmetic testing, regulatory research, and compliance services. Our expertise covers major global markets, including the United States, Canada, the European Union, Australia, ASEAN countries, and China. We provide customized efficacy assessments, regulatory consulting, safety evaluations, and testing solutions tailored to the requirements of different countries and regions. For more information, please contact SATISFY customer service.
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SATISFY TECH AND SERVICE LLC
SATISFY TECH AND SERVICE LLC delivers full-lifecycle technical solutions for children’s products, hygiene care, protective equipment, furniture, and building materials. Our framework spans compliance pre-assessment, standard upgrading, and risk control. We empower manufacturers and exporters through expert testing, certification, consulting, and standards interpretation.
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