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The United States remains one of the most attractive cosmetic markets in the world. Its large consumer base, strong beauty industry, and growing demand for international brands continue to make the U.S. market an important expansion opportunity for cosmetic companies worldwide.
However, entering the U.S. cosmetic market also involves important regulatory obligations that brands should understand before commercialization. From MoCRA requirements and cosmetic product listings to safety substantiation and state-level regulations, preparing early can help companies reduce compliance risks and avoid delays during market entry.
This guide explains some of the key regulatory aspects cosmetic brands should consider before selling cosmetic products in the United States.
What is MoCRA?
The Modernization of Cosmetics Regulation Act of 2022, commonly known as MoCRA, represents the most significant expansion of FDA authority over cosmetics in decades.
MoCRA introduced a more structured regulatory framework for cosmetic products marketed in the United States and established new obligations for cosmetic companies, manufacturers, processors, and responsible persons.
Among other requirements, MoCRA introduced:
- Mandatory cosmetic facility registration
- Mandatory cosmetic product listing
- Safety substantiation obligations
- Serious adverse event reporting requirements
- Expanded FDA authority over cosmetics
- Future GMP and fragrance allergen requirements
As FDA implementation continues evolving, Cosmeservice helps cosmetic brands entering the U.S. market by closely monitoring regulatory updates and ensuring their compliance strategies remain aligned with current FDA expectations.
Who must comply with MoCRA?
MoCRA may apply to several entities involved in the cosmetic supply chain.
At the facility level, companies involved in manufacturing or processing cosmetic products distributed in the United States should evaluate whether FDA facility registration requirements apply to their operations.
At the product level, the Responsible Person plays a central role under MoCRA. FDA defines the Responsible Person as the manufacturer, packer, or distributor whose name appears on the cosmetic product label.
This means that MoCRA obligations may affect:
- Cosmetic manufacturers
- Brand owners
- Private label companies
- Contract manufacturers
- Import-related operations
- Foreign cosmetic facilities exporting products to the United States
Foreign cosmetic manufacturers should also assess whether they are required to appoint a U.S. Agent during the facility registration process. Since responsibilities may differ depending on the business structure, cosmetic brands should clearly determine which entity is responsible for each regulatory obligation.
Safety substantiation
Under MoCRA, cosmetic companies are responsible for ensuring that their products are safe when used under normal or reasonably foreseeable conditions.
Product safety assessment is mandatory before proceeding with cosmetic product listing and before commercializing products in the U.S. market.
Although the United States does not require a Cosmetic Product Safety Report equivalent to the European CPSR, cosmetic brands should still maintain adequate supporting documentation demonstrating product safety.
This may include:
- Toxicological assessments
- Raw material documentation
- Stability data
- Microbiological quality information
- Compatibility testing
- Claims support documentation
Maintaining organized safety documentation is becoming increasingly important under the evolving FDA regulatory framework.
California proposition 65 & California Safe Cosmetics Program (CSCP):
If cosmetic products are intended to be sold in California, additional regulatory obligations may apply.
California’s Proposition 65 and the California Safe Cosmetics Program (CSCP) may require additional ingredient reviews, safety evaluations, reporting obligations, and labeling considerations depending on the product composition.
Washington state additional requirements:
Washington State has also introduced additional cosmetic regulatory obligations affecting certain substances and product categories.
If cosmetic products are intended to be distributed in Washington State, additional ingredient reviews and compliance evaluations may be necessary.
State-level regulations in the United States are becoming increasingly important for cosmetic brands operating nationally, particularly regarding PFAS, chemical restrictions, reporting obligations, and ingredient safety concerns.
Cosmetic Product Listing
MoCRA requires listing each marketed cosmetic product with the FDA, including product ingredient information.
Cosmetic product listings are submitted electronically through Cosmetics Direct.
Accurate product listing management is becoming an increasingly important part of U.S. cosmetic compliance.
U.S. Agent & Responsible Person
In accordance with the FDA Modernization of Cosmetics Regulation Act (MoCRA), foreign cosmetic manufacturers marketing products in the United States are required to designate a U.S. Agent. The U.S. Agent must be a person or business entity physically located in the United States and serves as the FDA’s primary point of contact for communications related to cosmetic products.
The U.S. Agent is responsible for assisting with FDA communications regarding adverse event reporting, safety questions, public health emergencies, inspections, and regulatory actions. While the designated U.S. Agent must be based in the United States, manufacturers may appoint a qualified third-party service provider to fulfill this role on their behalf.
According to FDA guidance, the U.S. Agent’s contact information must be included as part of the facility registration process for foreign cosmetic facilities under MoCRA requirements.
Based on FDA regulations under MoCRA, the Responsible Person may be the manufacturer, packer, or distributor whose name appears on the cosmetic product label. In most cases, the Responsible Person is the brand owner identified on the product packaging.
Under MoCRA, the Responsible Person holds a central role in ensuring cosmetic compliance, including product listing, adverse event reporting, recordkeeping, labeling compliance, and safety substantiation. The FDA does not automatically recognize a third-party consulting agency as the Responsible Person unless that entity is officially identified on the product label.
Because of the extensive responsibilities associated with this role, many cosmetic brands require ongoing regulatory support to effectively manage their compliance obligations and stay aligned with evolving FDA requirements.
Therefore, Cosmeservice offers dedicated U.S. Responsible Person support services designed to help cosmetic brands remain compliant, informed, and up to date with current FDA cosmetic regulations and MoCRA requirements.
Cosemservice´s goal is to help cosmetic brands maintain a structured and proactive compliance strategy while expanding successfully into the U.S. market.
How can Cosmeservice support your U.S. expansion?
Cosmeservice supports cosmetic brands throughout the U.S. expansion process, including reviewing products according to state-specific requirements and preparing the required safety substantiation documentation.
We can also act as your U.S. Agent for manufacturers and provide Responsible Person support for cosmetic brands in the United States, helping ensure that your cosmetic products comply with U.S. FDA (MoCRA) requirements related to safety, labeling, and regulatory compliance.
- Specializedexpertisein MoCRA and U.S. FDA cosmetic compliance
- Product safety support provided by accredited safety assessment experts
- Established U.S.-based legal entity serving as your FDA contact representative
- Responsive FDA communication support during inspections, audits, and emergencies
- End-to-endassistancefor Responsible Person compliance in the United States
- Trusted regulatory partner for international cosmetic and beauty brands
For tailored support, you can complete the contact form, and our team will get back to you as soon as possible. You may also reach us via info@cosmeservice.com.
FAQs
Is a European cosmetic PIF valid for the U.S. market?
The European PIF (Product Information File) is a strong technical foundation, but it is not sufficient on its own for full U.S. compliance.
Under MoCRA (Modernization of Cosmetics Regulation Act), the FDA requires specific compliance obligations for cosmetic products marketed in the United States.
Some parts of the European PIF can be reused, especially formula, stability, and safety information, but the documentation should still be reviewed and adapted to FDA and MoCRA requirements.
What is the difference between the EU Responsible Person and the U.S. Responsible Person?
The EU Responsible Person (EU RP) is a mandatory role under European Cosmetics Regulation (EC) No 1223/2009 and is responsible for ensuring cosmetic compliance before products are placed on the EU market.
The U.S. Responsible Person, defined under MoCRA, is the person or company whose name appears on the product label in the United States, typically the brand owner, manufacturer, packer, or distributor.
Main differences:
EU Responsible Person
- Mandatory in the EU
- Can be a third party
- Responsible for the PIF
- Manages EU cosmetic compliance
- Manages CPNP notification
- Must beestablishedin the EU
U.S. Responsible Person
- Mandatory underMoCRA
- Linked to the entity named on the label
- Responsible for safety substantiation
- Manages FDA compliance
- Linked to FDA product listing
- Does not necessarily need to be physicallylocatedin the U.S.
What is the difference between a U.S. Agent and the Responsible Person?
These are two separate regulatory roles with different responsibilities.
U.S. Agent:
The U.S. Agent is required for foreign cosmetic manufacturers registering their facilities with the FDA.
The U.S. Agent acts as the official communication contact between the FDA and the foreign manufacturer regarding:
- FDA inspections
- Adverse event communication
- Regulatory communications
- Public health emergencies
- Compliance inquiries
The U.S. Agent must be physically located in the United States.
Responsible Person:
The Responsible Person is the company or individual whose name appears on the product label.
Under MoCRA, the Responsible Person has broader regulatory responsibilities related to cosmetic compliance and product oversight.
In most cases, the brand owner acts as the Responsible Person.
What studies or testing are required for FDA/MoCRA compliance?
The FDA does not provide a fixed list of mandatory tests for every cosmetic product. However, MoCRA requires that all cosmetic products have adequate safety substantiation.
The following documentation or testing is commonly reviewed or required:
- Toxicological assessment of ingredients
- Cosmetic Safety Assessment
- Stability Testing
- Compatibility Testing
- Microbiological Testing
- Preservative Efficacy Test (Challenge Test)
- Heavy metals assessment, when applicable
- Claims substantiation
- FDA-compliant labeling review
Requirements may vary depending on:
- Product type
- Area of application
- Target consumer
- Product claims
- Risk profile
Are cosmetic GMPs required in the U.S.? Does the FDA perform inspections?
Yes. MoCRA gives the FDA authority to establish and enforce Good Manufacturing Practices (GMPs) for cosmetic products.
Although the final GMP regulation is still evolving, the FDA already expects cosmetic products to be manufactured under appropriate quality and safety conditions.
The FDA may conduct:
- Facility inspections
- Documentation reviews
- Record requests
- Adverse event investigations
- Compliance verifications
These inspections may apply to both U.S. and foreign cosmetic facilities registered with the FDA.
