Cosmetic products entering the U.S. market may be subject to both federal and state requirements. Depending on the product’s intended use, claims, formulation, manufacturing activities, the entity named on the label, and where it will be sold, companies may need to address product classification, MoCRA facility registration and product listing, U.S. agent requirements for foreign facilities, formula and labeling compliance, safety substantiation, and post-market obligations. Facility registration and product listing do not constitute FDA product approval or certification.
REACH24H supports cosmetic manufacturers, brand owners, OEM/ODM companies, importers, private-label businesses, and cross-border sellers with U.S. cosmetics regulatory assessment, FEI and facility registration support, cosmetic product listing, U.S. agent support, formula and label review, safety substantiation and toxicological risk assessment (TRA), state-level compliance assessment, and ongoing regulatory maintenance.
How Does the United States Define a Cosmetic?
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a cosmetic generally includes articles intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance, as well as articles intended for use as components of such products. Certain products meeting the statutory definition of soap are treated separately.
Cosmetic vs. Drug: Why Intended Use and Claims Matter
Whether a product is regulated only as a cosmetic, as a drug, or as both depends primarily on intended use. Claims appearing on labels, packaging, websites, e-commerce pages and advertising can affect regulatory status. Sunscreens, acne treatments, antiperspirants, anti-dandruff products and anticaries toothpastes are common examples that may have drug requirements in addition to cosmetic requirements. U.S. law does not recognize “cosmeceutical” as a separate regulatory category.
Related Service: U.S. FDA OTC and Cosmetic Regulatory Support.
What U.S. Cosmetics Compliance Requirements May Apply?
U.S. cosmetics compliance combines federal requirements with state-specific obligations. The applicable scope depends on product classification, company role, manufacturing activities, label ownership, ingredients, claims and sales geography.
Federal Compliance Requirements
Compliance Area | What Companies Need to Assess |
|---|---|
Product classification and regulatory pathway | Determine whether the product is a cosmetic, drug, or both based on intended use and claims. Products with drug uses must follow the applicable drug pathway in addition to any cosmetic requirements. |
FDA facility registration, FEI and U.S. agent | Unless an exemption applies, facilities that manufacture or process cosmetics for U.S. distribution may be subject to MoCRA facility registration. A covered facility needs an FEI for the registration submission. A foreign facility must provide U.S. agent contact information. |
FDA cosmetic product listing and Responsible Person duties | The Responsible Person generally submits or ensures submission of product listings for marketed cosmetics and provides annual updates. Under MoCRA, the Responsible Person is the manufacturer, packer or distributor whose name appears on the product label under the applicable provisions. |
Formula, ingredients and color additives | Review ingredients for applicable federal restrictions and safety considerations. Color additives must be permitted for the intended cosmetic use, and certain color additives must come from FDA-certified batches. |
Review identity, net quantity, business information, ingredient declaration, warnings and the required domestic address, domestic phone number or electronic contact information for receiving adverse event reports. Cosmetic claims should not unintentionally establish a drug intended use. And cosmetics could not affect the structure or any function of the body of man. | |
The Responsible Person must ensure and maintain records supporting adequate safety substantiation. FDA does not prescribe one universal testing package for all cosmetics; evidence should be scientifically robust and appropriate to the product. | |
The Responsible Person must report serious adverse events associated with cosmetic products used in the United States to FDA within 15 business days and maintain the required records and follow-up processes. | |
GMP and quality-system readiness | FDA has not issued a final MoCRA cosmetic GMP regulation. Companies should maintain effective quality controls and can use established cosmetic GMP practices as readiness references while monitoring FDA rulemaking. |
Important distinction: FDA cosmetic facility registration and product listing are not a product approval or certification program. A foreign facility’s U.S. agent is associated with facility registration and FDA contact, while the Responsible Person is the label-based entity with product listing, safety substantiation and post-market responsibilities. The two roles are not interchangeable.
State-Level and Sales-Channel Requirements
Federal MoCRA submissions do not, by themselves, establish compliance for every U.S. state or sales channel. Companies should assess state requirements and commercial documentation requests based on formulation, product type, sales states, import model and distribution channel.
Compliance Layer | Key Requirements |
|---|---|
Federal Requirements | Companies should assess product classification, formula and color additive compliance, labeling and claims, cosmetic facility registration and biennial renewal where applicable, cosmetic product listing and annual updates, safety substantiation, serious adverse event handling, and post-market recordkeeping requirements. |
California Ingredient Restrictions | California imposes additional restrictions on certain ingredients used in cosmetic products. Companies should assess their formulations against applicable state ingredient restrictions before marketing products in California. |
Cosmetic products sold in California that contain ingredients subject to reporting under the California Safe Cosmetics Program (CSCP) are required to be reported to the California Department of Public Health (CDPH) in accordance with applicable program requirements. | |
If a cosmetic product results in consumer exposure to a chemical listed under California Proposition 65 as causing cancer or reproductive toxicity, a warning obligation may apply. Whether a warning is required should be assessed based on the product, exposure level, applicable safe-harbor levels, and any relevant exemptions. | |
The Washington Toxic-Free Cosmetics Act restricts specified toxic chemicals and chemical classes in cosmetics manufactured, distributed, sold, or offered for sale in Washington, including products sold online into the state. | |
New York State Requirements | New York imposes state-specific restrictions on 1,4-dioxane in certain cosmetic and personal care products and restricts the use of mercury in cosmetics and personal care products. Companies should assess applicable concentration limits and product-specific requirements before sale in New York. |
E-commerce and Retail Channels | Amazon, retailers, distributors, importers, or commercial buyers may request additional compliance documentation, such as facility registration or product listing records, test reports, safety documentation, labels, or other supporting materials. These commercial requirements should be distinguished from statutory FDA or state-law obligations. |
U.S. state-level cosmetics compliance may also involve environmental or product-specific requirements beyond those listed above, such as VOC requirements for certain products or labeling requirements for certain wipes. Companies should assess applicable obligations based on product formulation, product category, sales location, company role, and regulatory effective dates rather than treating federal facility registration and product listing as sufficient evidence of overall U.S. market compliance.
For products sold across multiple states or channels, provide the formula, intended claims and planned sales states so federal and state requirements can be assessed together.
Who Needs MoCRA Cosmetic Facility Registration or Product Listing?
Whether a company needs FDA facility registration, product listing or a U.S. agent should be assessed separately based on actual activities, product type, the label entity and any applicable exemptions.
Business Type | Key Questions |
|---|---|
Manufacturer / processor | FEI; facility registration and renewal where required; U.S. agent for a covered foreign facility; manufacturing scope. |
Brand owner | Responsible Person status; product listing; safety substantiation; labels and claims, adverse events records keeping and serious adverse evens reporting. |
OEM / ODM manufacturer | Facility registration where applicable and allocation of submission/maintenance responsibilities with the brand owner. |
Packer or distributor | Actual activities and whether the company is the label-based Responsible Person. |
Importer | Whether its activities make it a facility or Responsible Person; completeness of supplier and product documentation. |
Private-label company | Alignment among brand, label entity, manufacturing facilities and Responsible Person. |
Cross-border e-commerce seller | Product classification, labeling, supplier documentation, federal/state obligations and platform requirements. |
Ingredient supplier | Whether the supplied item is a general ingredient/intermediate or a finished cosmetic product subject to different obligations. |
For MoCRA registration purposes, a “facility” generally includes an establishment that manufactures or processes cosmetic products distributed in the United States. Certain establishments engaged only in specified labeling, relabeling, packaging, repackaging, holding or distribution activities may fall outside the facility definition; filling a cosmetic product into a container is not treated as mere packaging.
See FDA’s final registration and listing guidance.
MoCRA Small Business Exemption
MoCRA provides certain small businesses with exemptions from facility registration, product listing and future GMP requirements. The statutory test considers average gross annual sales in the United States of cosmetic products for the previous three-year period, with the $1 million threshold adjusted for inflation. The exemption does not apply to specified higher-risk product categories, including certain eye-contact, injected, internal-use and long-lasting appearance-altering products.
See FDA’s current MoCRA exemption summary.
MoCRA Implementation Status and Key Compliance Timelines
Companies should plan from current FDA requirements, guidance and system status rather than early post-enactment schedules. As of August 2026, the following items are particularly relevant:
Compliance Item | Current Requirement / Status |
|---|---|
New covered facility — initial registration | Generally within 60 days after first engaging in the covered manufacturing or processing activity. |
Facility information changes | Generally update registration within 60 days of changes to required information. |
Facility registration renewal | Every two years from the initial registration date. |
New marketed cosmetic product — initial listing | Generally within 120 days after the product is first marketed in interstate commerce. |
Product listing maintenance | Provide updates annually, including discontinuation; an abbreviated renewal option is available when there are no changes. |
Safety substantiation | In effect. Responsible Persons must ensure and maintain records supporting adequate safety substantiation. |
Serious adverse event reporting | Report qualifying serious adverse events to FDA within 15 business days. |
February 2026 updates added facility registration status, renewal date and automated renewal reminder features. | |
No final MoCRA cosmetic GMP rule. The 2026 Unified Agenda lists the action as long-term with an NPRM planning target of November 2027. | |
Proposed-rule stage. The 2026 Unified Agenda lists an NPRM planning target of November 2026; this is not a final compliance deadline. | |
FDA withdrew the December 2024 proposed rule in November 2025 for further consideration; that proposal did not become a final rule. | |
FDA published its MoCRA PFAS assessment in December 2025 and reported that available evidence was insufficient for a definitive overall safety conclusion for PFAS use in cosmetics. |
U.S. Cosmetics Compliance Process
Step 1: Collect Company and Product Information
Confirm the company’s role in the supply chain, manufacturing facilities, product category, formulation, labeling, claims, intended sales states, and any existing FDA information.
Step 2: Determine Product Classification and Responsible Entities
Assess whether the product is regulated as a cosmetic, a drug, or both based on its intended use and claims, and identify the relevant facility owner/operator, U.S. agent, and Responsible Person, as applicable.
Step 3: Conduct a Regulatory and Documentation Gap Assessment
Review FEI status, facility registration, cosmetic product listing, formulation and ingredients, color additives, labeling, safety substantiation, and readiness for applicable state-level requirements.
Step 4: Complete Federal Submissions and Technical Reviews
Depending on the agreed project scope, support FEI application, cosmetic facility registration, product listing, formula and label review, safety documentation assessment, and toxicological risk assessment (TRA), as applicable.
Step 5: Maintain Compliance and Support Post-Market Obligations
Depending on the company’s needs, support facility registration renewal, annual product listing updates, information changes, adverse event management, and ongoing regulatory monitoring.
What Information Is Usually Needed?
The following information is commonly requested during an initial U.S. cosmetics compliance assessment.
The exact documentation required depends on the product classification, company role, number of products, manufacturing model, existing FDA status, sales states, and agreed service scope.
Information Category | Typical Inputs |
|---|---|
Company and facility information | Legal/company name; facility address; owner/operator; manufacturing/processing activities; FEI; U.S. agent information. |
Product and formulation information | Product name and category; final formulation which is same as the ingredient list on label; ingredient information; variants; manufacturing facilities; directions and conditions of use. |
Label and claims materials | Product label and artwork; e-commerce page; intended claims; warnings; ingredient declaration; business/contact information. |
Safety and quality information | Ingredient safety data; toxicology information; available product testing; stability and microbiological data; use scenario; target population; existing safety assessment. |
Sales and market information | Planned U.S. sales states; import model; e-commerce platform or retail channel; intended launch timing. |
The exact information and documentation required will depend on the product classification, company role, number of products, manufacturing model, sales markets, and the specific scope of services required.
Project Timeline and Cost Factors
There is no single project timeline or fixed professional-service fee that applies to every U.S. cosmetics compliance project. Timing and cost depend on the actual scope and the readiness of the product and supply chain.
Number of facilities, brands, products and variants;
Complexity of formulas, ingredients, color additives, labels and claims;
Whether an FEI already exists and whether a U.S. agent is needed;
Completeness of safety and quality documentation;
Number of sales states and sales channels to be assessed;
Whether the project involves only federal submissions or also technical review, TRA and ongoing maintenance.
FDA does not charge an official submission fee for MoCRA section 607 cosmetic facility registrations or cosmetic product listings. Professional fees may apply when a company engages a third party for FEI support, U.S. agent service, technical review, submission preparation, safety assessment or ongoing maintenance.
For a meaningful estimate, provide the number of facilities and SKUs, product types, existing FDA status, formulation/label status, target states and required service scope.
REACH24H U.S. FDA Cosmetics Compliance Services
Product classification and regulatory assessment: Assess whether products are cosmetics, drugs or dual-status products and identify company roles, applicable obligations and potential exemptions.
FEI, facility registration and U.S. agent support: Support FEI search/request work, cosmetic facility registration and biennial renewal, and provide U.S. agent support for foreign facilities within the agreed service scope.
Cosmetic product listing and maintenance: Support product listing submissions, annual updates, discontinuation updates and other listing maintenance.
Formula, labeling and claims review: Review ingredients, color additives, labeling elements and claims to identify U.S. cosmetic compliance issues and potential drug-classification risks.
Safety and post-market compliance: Provide safety-data gap analysis, TRA, adverse-event process support, state-level regulatory assessment and ongoing compliance monitoring within project scope.
Why Choose REACH24H for U.S. Cosmetics Compliance?
REACH24H combines U.S. cosmetics regulatory expertise, toxicological assessment capabilities, and global market-access experience to support companies from regulatory pathway assessment through submission, safety substantiation, and ongoing compliance.
Integrated Federal and State Compliance Support
U.S. cosmetics compliance extends beyond MoCRA facility registration and product listing. REACH24H supports product classification, FDA facility registration, cosmetic product listing, formula and labeling review, safety substantiation, and applicable state-level requirements, helping companies assess the full compliance pathway rather than treating individual FDA submissions as sufficient for market access.
Specialized Toxicology and Safety Assessment Expertise
REACH24H’s cosmetic compliance team brings together regulatory specialists, toxicologists, safety assessors, risk assessment experts, and other technical professionals. Its toxicology capabilities support formulation and ingredient review, exposure assessment, evaluation of existing safety and testing data, safety-data gap assessment, and toxicological risk assessment (TRA) for MoCRA safety substantiation.
U.S. Local Presence
REACH24H has maintained a U.S. presence through REACH24H USA Inc. since 2014. Its U.S. operations support market-access services across multiple regulated sectors, including cosmetics, while the local team participates in industry exchanges and engagement with organizations such as the Independent Beauty Association (IBA) and the Personal Care Products Council (PCPC). This local presence complements REACH24H’s broader U.S. regulatory and market-access capabilities.
U.S. Cosmetics Compliance FAQs
1. Do cosmetics need FDA approval or an FDA registration certificate before they are marketed in the United States?
Generally, no. Cosmetic products and ingredients do not require FDA premarket approval, except for color additives, which must be permitted for their intended use and may be subject to FDA batch certification. MoCRA facility registration and cosmetic product listing are not FDA product approval procedures, and FDA does not issue approval certificates for these submissions.
2. Is my product regulated as a cosmetic, an OTC drug, or both in the United States?
Product classification depends primarily on its intended use and claims. Products marketed with claims related to sunscreen protection, acne treatment, antiperspirant effects, dandruff treatment, or anticaries effects may be regulated as drugs or as both cosmetics and drugs. Labels, packaging, websites, e-commerce pages, and advertising can all affect the product’s regulatory status.
3. Does my cosmetic manufacturing or processing facility need to register with FDA under MoCRA?
Not necessarily. The requirement depends on the activities performed at the facility, the type of products involved, and whether an applicable exemption applies. Facilities that manufacture or process cosmetic products for U.S. distribution may be subject to MoCRA facility registration, while certain establishments performing only specified activities may fall outside the facility definition. Qualifying small businesses may also be exempt from certain registration requirements, subject to statutory criteria and product-category exclusions.
4. What is the difference between MoCRA facility registration and cosmetic product listing?
Facility registration applies to covered establishments that manufacture or process cosmetic products for U.S. distribution. Cosmetic product listing applies to marketed cosmetic products and is submitted by, or on behalf of, the Responsible Person. These are separate MoCRA obligations: facility registrations are renewed biennially, while cosmetic product listing information is updated annually.
5. Does a foreign cosmetic facility need a U.S. agent, and how is this different from the Responsible Person?
A foreign facility that is required to complete MoCRA facility registration must provide U.S. agent contact information as part of the registration. The U.S. agent is associated with the foreign facility and FDA communication. The Responsible Person, by contrast, is the manufacturer, packer, or distributor whose name appears on the cosmetic label and is responsible for product-level obligations such as product listing, safety substantiation, and serious adverse event reporting. The Responsible Person does not have to be located in the United States solely because the product is marketed there.
6. What are the deadlines and renewal requirements for facility registration and cosmetic product listing?
A newly covered facility generally must register within 60 days after first engaging in the applicable manufacturing or processing activity. A new cosmetic product generally must be listed within 120 days after it is first marketed in interstate commerce. Facility registrations are renewed every two years, and required facility information changes generally must be updated within 60 days. Cosmetic product listing information is updated annually.
7. What safety evidence is required under MoCRA, and can existing safety data be used?
The Responsible Person must ensure and maintain records supporting adequate substantiation of product safety. FDA does not prescribe one standardized safety dossier or a fixed testing package for every cosmetic product. Relevant existing safety data may be used when scientifically robust and appropriate to the product. Animal testing is not required for marketing a cosmetic. The evidence needed should be assessed based on the formulation, ingredients, intended use, exposure, target population, and available safety information.
8. Can multiple shades, fragrances, flavors, or pack sizes be included in one cosmetic product listing?
In certain cases, yes. FDA allows a single listing submission to include cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents. Whether products can be included in the same listing should be assessed based on the actual formulations, product names, categories, and submission information.
9. Is MoCRA compliance enough to sell cosmetics throughout the United States?
No. MoCRA facility registration and cosmetic product listing address only part of U.S. cosmetics compliance. Companies should also assess applicable state requirements based on product formulation, product category, and sales location. Examples include California ingredient restrictions and California Safe Cosmetics Program reporting, California Proposition 65, the Washington Toxic-Free Cosmetics Act, and New York requirements for certain substances. Retailers, marketplaces, importers, and commercial buyers may also impose additional documentation requirements.
Plan Your U.S. Cosmetics Compliance Project
Whether you are preparing a U.S. market launch, changing manufacturers, taking on Responsible Person responsibilities, renewing a facility registration, or reviewing compliance across multiple states, share your product information, formulation and supply-chain setup with REACH24H. Our regulatory team can help assess the applicable requirements and define the next compliance steps.
Related Services
Key Official References
FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
FDA — Registration & Listing of Cosmetic Product Facilities and Products
FDA — Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
California Department of Public Health — California Safe Cosmetics Program
Washington State Department of Ecology — Toxic-Free Cosmetics Act
