It is not a low-regulation market in the U.S. any longer. The FDA increased its authority and oversight of cosmetic products, cosmetics manufacturers, and responsible persons under the Modernization of Cosmetics Regulation Act (MoCRA), while new cosmetic compliance requirements added burden to companies selling cosmetics in the U.S.
The problem cosmetic brands and regulatory departments face is creating an import-free, retailer-driven strategy while staying out of the risk of import detentions, rejections, relabelling expenses, and enforcement risk.
Cosmetics Regulatory Authority in the USA
The U.S. Food and Drug Administration regulates cosmetics sold in the USA under the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, and the Modernization of Cosmetics Regulation Act (MoCRA).
US FDA Cosmetics Classification
Products are classified by the FDA according to their intended use, claims, ingredients, and consumer perception.
In the United States, cosmetics are products meant to be used for:
- Cleansing
- Beautifying
- Promoting attractiveness
- Altering appearance
Products designed for the treatment of diseases or for altering the structure or function of the body can be regulated as drugs or as cosmetics.
Do Cosmetics require FDA Approval in the USA?
No, most cosmetics do not need approval from the U.S. Food and Drug Administration before they are sold, except for some color additives.
There are some things to consider:
- If a cosmetic claims to treat acne protect skin from the sun reduce wrinkles help hair grow or repair skin it might be regulated as a drug.
- Some products can be both cosmetics and drugs, like shampoos that prevent dandruff and moisturizers with SPF.
- Imported cosmetics are subject to the same FDA requirements as domestically manufactured cosmetics.
- The FDA can take enforcement steps if misleading “FDA-approved” claims are made.
Misclassification may lead to warning letters, import detention, relabeling expenses, and commercialization delay.
MoCRA Requirements for Cosmetics in the USA
MoCRA introduced FDA regulation of cosmetics in the U.S. and added a number of compliance actions that must be carried out.
Below are the key requirements:
- All facilities are required to be registered and renewed every 2 years.
- All cosmetic products must be listed and updated on an annual basis.
- Safety substantiation records
- Reporting of serious adverse events within 15 business days.
- The label must have mandatory adverse event contact information.
- Authorities to mandate recalls and access to records with FDA.
- The FDA has recently put forth GMP standards for cosmetics manufacturing facilities.
MoCRA changes the paradigm of cosmetics compliance, moving it from registration to regulation.
FDA Guidelines for Cosmetics in the USA
FDA does not approve cosmetics prior to sale, except for some color additives. Cosmetics manufacturers are obliged to make products:
- Safe when used as intended
- Well labelled and not misleading
- Compliant with banned and restricted ingredient standards
- Supported with sufficient safety substantiation records
Imported cosmetics must meet the same FDA standards as domestic cosmetics.
US FDA Step-by-Step Cosmetic Registration Process
To ensure cosmetic product compliance with USA requirements, follow the steps below:
Step 1: Identify the Product
Determine if product is cosmetic, drug, or both.
Step 2: Check Ingredient and Formula Compliance
Check compliance of prohibited ingredients, restricted substances and color additives.
Step 3: Prepare Labeling and Safety Documentation
Keep labels in compliance with FDA requirements and maintain updated safety substantiation records.
Step 4: Get an FDA Establishment Identifier (FEI)
The FEI must be obtained prior to facility registration by manufacturers and processors.
Step 5: Register Cosmetic Facility with FDA
Facility registration is submitted via Cosmetics Direct, ESG NextGen, SPL software or FDA Form 5066.
Step 6: Submit Cosmetic Product Listing
Responsible Persons are required to provide product listings via Cosmetics Direct, ESG NextGen, SPL software or FDA Form 5067.
Step 7: Ensure Continued Compliance
- Update registration within 60 days of changes
- Renew facility registration every 2 years
- Update product listings annually
- Maintain adverse event and safety records
Cosmetic registrations and listings are not approved by FDA.
Documents Required for Cosmetic Registration in the USA
Facility Registration Information
- FDA Establishment Identifier (FEI)
- Name and address of the facility
- Parent company information
- Owner/operator information
- Information regarding agents in the USA (for foreign facilities)
- Authorized individual details
Cosmetic Product Listing Information
- Responsible Person details
- Product category and product name
- Ingredient information
- Product label images
- Manufacturer and processor information
- Contact information for adverse events
Supporting Compliance Documentation
- Safety substantiation records
- Ingredient and formulation records
- Labeling and artwork files
- Complaint and adverse event procedures
Cosmetics Labeling Requirements in the USA
Cosmetic labels must provide required information in English and be truthful and not misleading.
Principal Display Panel Requirements
- Product identity statement
- Net quantity of contents
Information Panel Requirements
- Manufacturer, packer or distributor name and address
- Distributor statement (if applicable)
- Ingredients listed in order of predominance
Additional Requirements
- Required warning and caution statements
- Material facts and safe-use directions (where required)
- Contact information for adverse events as required by MoCRA
Drug claims must also meet OTC drug labeling requirements.
Ingredient Regulations and Safety Requirements in the USA
Cosmetics manufacturers are responsible for ensuring that cosmetics sold in the U.S. are safe and compliant.
Key requirements include:
- Meeting requirements for prohibited and restricted ingredients
- Use of approved color additives for intended use
- FDA certification for certain color additives
- Appropriate safety substantiation records according to MoCRA
FDA does not require specific cosmetic testing procedures, but responsible persons are required to keep records supporting product safety.
Import Requirements for Cosmetics into USA
Imported cosmetics are subject to the same FDA regulations and laws as domestic cosmetics.
Key import requirements include:
- Compliance with FD&C Act, FPLA and MoCRA requirements
- Registration of foreign manufacturers and processors
- Cosmetic product listing by the Responsible Person
- FDA-compliant English language labeling
- Compliance with ingredient and color additive requirements
FDA can refuse entry or detain products that are not compliant with cosmetic regulations.
FDA Cosmetic GMP Requirements
MoCRA mandates FDA to create Good Manufacturing Practice (GMP) rules for cosmetic manufacturing and processing facilities.
Expected GMP focus areas include:
- Personnel and hygiene controls
- Manufacturing and sanitation controls
- Laboratory and testing procedures
- Complaint handling systems
- Documentation and recordkeeping
Currently FDA uses cosmetic GMP guidance and industry best practices, including ISO 22716.
Product Safety & Post-Market Surveillance
Cosmetic companies are responsible for the safety of products marketed in the U.S., adequate labeling, and maintaining safety substantiation records.
Key requirements include:
- Safety substantiation under MoCRA
- Tracking complaints and adverse events
- Reporting serious adverse events within 15 business days
- Meeting color additive requirements
FDA does not require specific cosmetic testing procedures, but responsible persons are required to maintain records supporting product safety.
Timeline for Cosmetic Registration in the USA
Registration timelines vary based on product type, document preparation and submission method.
Typical timelines include:
- ESG NextGen account setup: approximately 1–3 weeks
- Facility registration after FEI acquisition
- Product listing after label finalization
- Facility registration renewal every 2 years
- Product listing updates annually
- Registration updates within 60 days of changes
The FDA highly encourages electronic submissions through Cosmetics Direct or ESG NextGen.
Cosmetic Registration Fees in the USA
At this time, the FDA does not impose official government fees on:
- Cosmetic facility registration
- Cosmetic product listing
- Biennial facility renewals
- Annual product listing updates
Businesses can, however, face expenses for:
- FEI preparation
- U.S. agent support
- Safety substantiation and testing
- Labeling review
- GMP implementation
- Regulatory consulting and submission support
Conclusion
MoCRA greatly broadened FDA’s regulatory authority over cosmetics in the United States, requiring registration of facilities, listing of products, safety substantiation, adverse event reporting, and continuous compliance monitoring.
Cosmetic companies now need a structured approach to U.S. market access that involves product classification, labeling, ingredient compliance, safety documentation and lifecycle compliance management.
The regulatory experts at Artixio can help you with a structured approach for cosmetics product registration in the USA. We can help ensure that your products are compliant with labeling, ingredients, product security, and other regulations in the USA. For more details, you can get in touch with us at info@artixio.com.
