"Pharmaplast began to work with CE.way almost one year ago. CE.way is our cosmetics consultant who look after compilation of PIF, safety assessments and CPNP notifications. Working with CE.way has been a joy so far. Their replies are very swift and Mr Tadej is very cooperative, helpful and with a deep knowledge about the cosmetics regulations."
FDA / MoCRA regulations
USA Cosmetic Regulations
Navigate US cosmetic regulations with confidence — from FDA product listing and facility registration to full MoCRA compliance.
FDAFD&C ActMoCRAFair Packaging and Labelling Act
USA · FDA
CE.way helps cosmetic brands comply with USA cosmetic regulations, including FDA product listing, facility registration requirements, MoCRA safety substantiation, labelling rules, and Responsible Person obligations — under one roof.
15 years
of experience
40+ countries
client base
IE100 Awards Winner 2026
4.8 / 5
Trustpilot rating
Requirements overview
What do you need for the USA?
A summary of the key requirements before placing cosmetic products on the US market under the FDA and MoCRA.
01
FDA Product Listing
All cosmetic products sold in the USA must be listed with the FDA via Cosmetics Direct. New products must be listed within 120 days of entering interstate commerce.
02
Ingredient Compliance
Products must comply with FDA ingredient restrictions, prohibitions, and colour additive approval requirements. Colour additives (except coal tar hair dyes) require FDA approval before use in cosmetics.
03
Safety Substantiation
The Responsible Person must ensure and maintain records of adequate safety substantiation for each cosmetic product, demonstrating it is safe when used as directed or in the customary expected way.
04
Labelling Compliance
Labels must comply with the FD&C Act and FPLA, and must include a US address or electronic contact information for the Responsible Person, fragrance allergen disclosure where present, and a professional-use statement for professional-use products.
Our services
How we can help
A full range of regulatory services tailored for the US cosmetic market.
01
US Agent Service
We act as your US agent for FDA facility registration, providing a US point of contact and managing communications with the FDA on your behalf.
02
US RP Support Service
Support for Responsible Person obligations, including safety substantiation record-keeping, adverse event reporting, and FDA communication.
03
Product Classification & Formula Review
Determine whether your product is classified as a cosmetic, drug, or OTC product under FDA law, and review your formula against US ingredient restrictions.
04
Labelling Review
Full compliance check against the FD&C Act, FPLA, and MoCRA labelling requirements, including allergen disclosure and professional-use statements.
05
Product Listings & Facility Registrations
Preparation and submission of FDA product listings via Cosmetics Direct, and facility registration including FEI number assistance.
06
Safety Evaluation of Products
Toxicological risk assessment and safety substantiation reports prepared by certified experts to meet FDA MoCRA requirements.
Regulatory Expert · USA & Canada
Book a call Tjaša Grum
EU, UK, USA & Canada Regulatory Consultant and Safety Assessor
LinkedInRegulatory framework
Applicable legislation
Regulatory framework
Applicable legislation
The legal authority that regulates cosmetics in the USA is the US Food and Drug Administration (FDA). To sell cosmetics in the USA, you must consider federal cosmetics regulations, which apply to all US States. Two main federal legal frameworks applicable to cosmetic products in the USA are:
- Federal Food, Drug and Cosmetic Act (FD&C Act)
- Fair Packaging and Labelling Act (FPLA)
Additionally, it is important to be aware that there are also many state provisions, which also have to be taken into account, such as California Proposition 65 (Prop 65).
On 29 December 2022, the US President signed into law the Consolidated Appropriations Act 2023, which included the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), a long-awaited reform of the US cosmetics regulation.
MoCRA is the biggest amendment of the Food, Drug and Cosmetics Act since 1938. This new legislation affects all cosmetic companies that manufacture and distribute cosmetics in the USA.
The key changes introduced by MoCRA
- Mandatory FDA registration for cosmetic facilities, both domestic and international.
- Mandatory product listings for cosmetics sold in the USA.
- Compliance with Good Manufacturing Practices (GMPs; will be issued by the FDA).
- Declaration of fragrance allergens on labels
- Labelling requirements for professional-use products.
- Labelling of RP contact information
- Record-keeping, including safety substantiation and adverse events documentation.
- Reporting of adverse events to the FDA.
- Mandatory recall authority for the FDA.
- Phasing out animal testing.
Product scope
What type of products are cosmetics?
Product scope
What type of products are cosmetics?
Cosmetic products are defined by the FD&C Act as: "Articles intended to be rubbed, poured, sprinkled, or sprayed on or introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap" (FD&C Act, sec. 201[i]).
Additionally, MoCRA defines the term cosmetic product as: "a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product." (MoCRA, sec. 604 (2))
It is important to note that products intended for therapeutic use — those used to treat or prevent diseases or that affect the structure or function of the body — are classified as drugs or medical devices, even if they also affect appearance. Certain personal care products are also regulated as food supplements, consumer products, or over-the-counter (OTC) drugs.
Claims made regarding a product can often determine how it will be classified.
Regulatory requirements
Requirements
Regulatory requirements
Requirements
Responsible person and product listing
MoCRA sets out the requirement for a Responsible Person (RP), which has to be designated for each cosmetic product placed on the US market. The RP is defined asthe manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label.
Cosmetic products placed on the market in the USA have to be listed to the FDA. This has to be done by the responsible person via electronic submission portal Cosmetics Direct. New products must be listed within 120 days of marketing such products in interstate commerce.
Facility registration and US agent
Cosmetic facilities that are involved in the manufacturing or processing of cosmetic products distributed in the US have to be registered to the FDA. This has to be done via electronic submission portal Cosmetics Direct. To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration.
Foreign facilities require a US agent, who will handle the facility registration and provide a contact point for the FDA in case of any enquiries. New facilities have to register within 60 days of first manufacturing or processing. Registrations have to be renewed every two years.
Safety substantiation
Cosmetic companies are responsible for selling safe and properly labelled products. Products must be safe when consumers use them according to directions on the labelling, or in the customary or expected way. It is the responsibility of the RP to ensure and maintain records of safety substantiation of their cosmetic products.
Under MoCRA, products require an adequate substantiated of safety, which is further defined as “tests, studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a product is safe.” (MoCRA, Sec. 608(c)(1)). However, the legislation does not provide a specific set of tests or documents to demonstrate the safety of individual products or ingredients. It is up to the cosmetic's manufacturers to determine how they will prove the safety of their products.
Cosmetic products must also comply with the ingredient restrictions, prohibitions, and colour additive requirements. Colour additives, except for coal tar hair dyes, require FDA approval before they can be used in cosmetics. Failure to meet US colour additive requirements can result in a cosmetic to be adulterated. Colour additives may be used only for the intended uses for which they were approved for.
Good Manufacturing Practices (GMP)
Under MoCRA, all cosmetic products placed on the US market must comply with Good Manufacturing Practices (GMP), which will be published by FDA in the near future.
Labelling
Labelling, including cosmetic product claims, is a very important part of ensuring compliance with the relevant legislation. Products that are improperly labelled, deceptively packaged or otherwise misbranded are prohibited and can be removed from the market.
MoCRA sets out some new labelling requirements, which include:
- US address, US phone number or electronic contact information, which is required as a means to contact the Responsible Person in case of any adverse events.
- MoCRA required the FDA to issue a proposed rule by June 29, 2024, but that deadline has passed; the latest available timelines indicate the proposal is now expected in 2026, with finalization still pending.
Additionally, it requires professional-use products to comply with the general labelling requirements for cosmetic products and to include a statement indicating that the product should be used only by professionals.
FDA authority over cosmetics
MOCRA expands the FDA authority over cosmetics. In case of adulterated or misbranded products, or risk of serious adverse health consequences, the FDA can:
- Inspect the product safety dossier;
- Inspect facilities to check compliance with GMP;
- Request cosmetic companies to provide ingredients details of the formulation, fragrances, or flavors;
- Require cosmetic companies to recall the product voluntarily. If the manufacturer does not comply, the FDA can impose a mandatory withdrawal;
- Suspend the facility registration.
It is the responsibility of the RP to record and report adverse events, maintain product safety dossier and communicate with the FDA in case of inspections or any enquiries about the products.
For more information about new requirements under MoCRA, please check our FAQ.
Why CE.way
Why brands choose CE.way for the USA?
From startups to established brands, we help companies navigate the US market with confidence under FDA and MoCRA requirements.
International compliance expertise
Serving clients across 40+ countries with deep FDA and MoCRA regulatory knowledge.
Fast turnaround times
FDA product listings submitted within MoCRA's 120-day window. Safety reports completed efficiently.
In-house laboratory support
Our own lab in Slovenia provides safety testing to support FDA MoCRA requirements.
Experience with USA requirements
Proven track record with MoCRA compliance, US agent services, and FDA product listings and facility registrations.
Support for startups and established brands
Flexible services for first-time US exporters and large multi-SKU portfolios alike.
Getting started
What's the process?
Three steps to launch compliant cosmetics in the USA.
01
Share your product details
Formulas, labels, target market. A short discovery call is enough to scope your project.
02
We review compliance requirements
Ingredient review, label compliance, safety substantiation, and FDA product listing and facility registration — handled end-to-end.
03
Launch your products in the USA
Receive support for compliant market entry, with ongoing US Agent and Responsible Person coverage.
USA cosmetics regulations
FAQ
RESPONSIBLE PERSON & PRODUCT LISTING
Under MoCRA, a responsible person (RP) is defined as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label, in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. The RP has various responsibilities, including:
- Product Listing
- Adverse event reporting
- Safety substantiation
- Disclosure of fragrance allergens
- Fragrance records access
- Labelling
- Contact information on the label
- Record-keeping
- Product recall in case of non-compliance (and upon request by the FDA)
Product listing is applicable to all products introduced into the US market by both US and foreign brands.
The responsible person is responsible for submitting the product listing. The product listing process will be carried out via electronic submission portal Cosmetics Direct.
The following information must be included in the product listing:
- Facility registration number of each facility where the cosmetic product is manufactured.
- Name and contact number of the responsible person
- Name of the cosmetic product
- Cosmetic category of the product
- List of ingredients, including fragrances, flavors, or colors
- Product listing number (if previously assigned)
- Type of submission (initial, update to content (annual), abbreviated renewal)
Each product will be assigned a listing number.
Yes. MoCRA allows flexible listings, which means that multiple cosmetic products with identical formulations, or formulations that differ only in colour, fragrance or flavour, or quantity of contents, may be grouped under the same listing.
Mandatory product listings must be completed by July 1, 2024. These listings must be updated annually.
New products must be registered within 120 days of their introduction into interstate commerce.
US AGENT AND FACILITY REGISTRATION
The mandatory facility registration affects all existing facilities, both domestic and foreign. Foreign facilities require a US agent who will handle the facility registration. It is important to note that a physical address in the US must be provided, and P.O. boxes are not accepted.
The term 'facility' includes any establishment, including importers, involved in the manufacturing or processing of cosmetic products distributed in the United States. Certain establishments such as beauty shops/salons, retailers, pharmacies, hospitals, hotels, etc., are excluded from this term. It does not affect facilities that solely label or re-label, package or repackage or hold or distribute products.
The following information must be included:
- Facility's name, physical address, email address, and telephone number
- The name of the owner and/or operator of the facility
- Contact information of the US agent (for foreign entities)
- Facility registration number (if previously assigned)
- All brand names produced at the facility
- Product category and the RP for each product manufactured at the facility
- Type of submission (initial, amended, biennial renewal, or abbreviated renewal)
To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration.
Mandatory facility registration must be completed by July 1, 2024. Registrations must be renewed every two years.
Following the deadline, new businesses will have 60 days after beginning manufacturing to register with the FDA.
FEI is an FDA Establishment Identifier or Firm Establishment Identifier that is assigned by the FDA to identify a firm. FDA intends to use FEI as the required facility registration number.
To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration. To determine if an entity already has an FEI number, please refer to FEI Search Portal. If your firm doesn't have FEI, you can request it at feiportal@fda.hhs.gov.
EXEMPTIONS UNDER MOCRA
MoCRA exempts certain small businesses from GMP, facility registration and product listing. Small businesses are defined as businesses with average gross annual sales in the USA for the previous 3-year period of less than $1,000,000 (adjusted for inflation). However, this exemption does not apply to facilities producing products that:
- Come into contact with the mucous membrane of the eyes.
- Are injected (e.g., tattoos).
- Are intended for internal use (e.g., mouthwash).
- Alter appearance for more than 24 hours under the usual conditions of use.
Exemptions also apply to certain facilities that are subject to requirements for devices and drugs.
LABELLING REQUIREMENTS
Product labels must include:
- A US address.
- A US phone number or
- Electronic contact information (e.g. a website), which is required as a means to contact the Responsible Person (RP) in case of any adverse events.
- Fragrance allergens, if present in the cosmetic product (the FDA will determine which substances are considered allergens).
Labels for professional-use products must comply with the general labelling requirements for cosmetic products and must include a statement indicating that the product should be used only by professionals.
The labelling for professional-use products must be updated by December 29, 2024.
The responsible contact information and fragrance allergens must be listed on product labels by December 29, 2024.
Client reviews
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"We were looking for a stand-alone service, not too sure what to expect... The professionalism, the assistance and the responsiveness were very much appreciated, amongst the best we have ever experienced."
"We are a small manufacturing company located in the US. We recently used CE.way Regulatory Consultants to help guide us through the Cosmetic regulatory changes that have taken place in the EU. They were instrumental in helping us understand the new laws and streamline the entire process. I would highly recommend their services."
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Speak with our regulatory experts about USA compliance, MoCRA requirements, and FDA product listing and facility registration.
