FDA approval certificate issued?
No
FDA does not issue cosmetic approval certificates for MoCRA registration or listing.
United States · Market Entry
USA PRODUCT LISTING
& FDA MoCRA COMPLIANCE
Enter the USA market with the correct regulatory framework in place. NKG supports international manufacturers and beauty brands with product and label compliance, U.S. Agent services, PIF & CPSR preparations, FDA listing, and end-to-end regulatory support.
Regulatory support from documentation to post-market compliance
United States · Cosmetics
U.S. COSMETICS REGULATORY
OVERVIEW
| Primary law | Modernization of Cosmetics Regulation Act of 2022 (MoCRA) |
| Regulatory authority | U.S. Food and Drug Administration (FDA) |
| Facility requirement | Registration for covered manufacturers and processors |
| Facility identifier | Facility Establishment Identifier (FEI) |
| Product requirement | Cosmetic product listing |
| Ongoing maintenance | Biennial facility renewal and annual listing updates |
Important regulatory notice
Registration is not FDA approval.
FDA cosmetic facility registration and product listing under MoCRA do not constitute product approval, and FDA does not issue approval certificates for these submissions. A cosmetic company remains responsible for all applicable U.S. requirements before and after market entry.
MoCRA APPLICABILITY
Who May Need Facility Registration or Product Listing?
Obligations depend on the business role, facility and product. Applicable exemptions should be assessed product by product.
01
Cosmetic manufacturers and processors
Covered facilities that manufacture or process cosmetic products for U.S. distribution may need to register with FDA.
02
Responsible Persons
The manufacturer, packer or distributor named on the label may be responsible for cosmetic product listing.
03
Foreign manufacturers
Foreign facilities subject to registration must provide applicable U.S. Agent information.
04
Beauty brands
Brands should address product listing together with their wider MoCRA, safety and labelling responsibilities.
Certain statutory exemptions may apply, including specific small-business exemptions. These exemptions do not apply to every cosmetic category.
PROUDLY SUPPORTING
TRADE COMMISSIONS
NKG keeps in Close communications with various Trade Commissions,Business Chambers, embassies of many countries on various existing & new Rules & Regulations of government of India
FDA Establishment Identifier
What Is an FEI Number?
The FDA Establishment Identifier is the facility identifier used for cosmetic product facility registration under MoCRA.
Before submitting a required cosmetic facility registration, the owner or operator should determine whether the facility already has an FEI number or request one where necessary.
✓FEI verification and coordination
✓Facility information review
✓Preparation for facility registration
✓Alignment with product listings
FDA facility registration
COSMETIC FACILITY REGISTRATION UNDER MoCRA
Covered cosmetic product manufacturers and processors must register applicable facilities with FDA. Registration information can include the facility name, FEI, address, owner or operator details, relevant brand names, Responsible Person details and U.S. Agent information for foreign facilities.
Facility registrations must be renewed every two years.
Required registration information changes generally must be updated within the applicable statutory timeframe.
Required registration information changes generally must be updated within the applicable statutory timeframe.
FDA product listing
Cosmetic product listing
The brand must list each marketed cosmetic product with FDA, subject to applicable exemptions. Listing information can include product name, category, facility details, ingredient information, fragrance or flavour information and relevant contacts.
Product listings must be updated annually.
Changes, discontinuations and other listing updates may also need to be reflected in FDA submissions.
Beyond the filing
The Wider U.S. Compliance Picture
A successful submission does not replace the need for a compliant product, responsible business structure and defensible safety documentation.
01
Responsible Person
Generally the manufacturer, packer or distributor named on the cosmetic label. Responsibilities may include listing, safety substantiation, adverse-event reporting, records and ongoing updates.
02
U.S. Agent support
Foreign facilities that are required to register must provide U.S. Agent information. NKG can coordinate this requirement where included in the engagement scope.
03
Label compliance
Review of identity, net quantity, ingredient declaration, responsible company details, contacts, warnings, claims and classification risk.
04
Ingredient & claims review
Assessment of composition, restrictions, color additives, fragrance considerations, marketing claims and cosmetic-versus-drug risk.
05
Safety substantiation
Support identifying the regulatory documentation and technical information needed for adequate cosmetic product safety substantiation.
06
Launch readiness
Confirmation of remaining regulatory considerations before inventory, packaging and commercial launch commitments.
Registration is one step. Product compliance is the larger responsibility.
Indicative timelines
How long does the process take?
Timelines depend on the number of products and facilities, FEI availability, documentation readiness, formula and artwork corrections, Responsible Person information and client response time.
Facility renewal required?
Yes
Covered facility registrations are renewed every two years.
Product listing updates required?
Yes
Product listing information is updated annually.
Does compliance end after submission?
No
Ongoing obligations continue after the initial filing.
Ongoing compliance
Post-market compliance support
NKG can remain involved after the initial FDA submissions, supporting renewals, annual listing updates, amendments, facility or Responsible Person changes, label and formula changes, discontinuations, adverse-event compliance and regulatory monitoring.
Safety substantiation
Maintain adequate substantiation of cosmetic product safety.
Serious adverse events
Report qualifying serious adverse events within applicable statutory timelines.
Records
Maintain applicable records supporting regulatory obligations.
Registration maintenance
Keep facility registrations and product listings current.
Who we work with
U.S. Market Entry Support for Cosmetic Businesses
International manufacturersBeauty brandsPrivate-label manufacturersContract manufacturersSkincare companiesHaircare brandsMakeup brandsFragrance companiesPersonal care companiesImporters & distributorsE-commerce brandsRetail brands
Why choose NKG?
Regulatory Support Built Around Market Entry
End-to-end regulatory support
From initial assessment to submission and ongoing compliance.
U.S. market-entry expertise
Support designed for international brands entering the United States.
One coordinated workflow
Formula, label and submission support without fragmented coordination.
Global regulatory team
Experience supporting brands across India, UAE, UK, EU and USA.
Local U.S. presence
NKG Partners Inc. provides a local corporate presence for U.S. market support.
Ongoing compliance support
Regulatory assistance that continues beyond the initial filing.
15,000+Product Registrations & Approvals Delivered
75+Regulatory Professionals
40+Countries Worldwide
100+Global Clients
10+Industries Served
Global offices
NKG’s International Regulatory Network
NKG Advisory
A 18, Outer Ring Rd, A BlockPrashant Vihar, Sector 14, RohiniDelhi 110085, IndiaNKG Partners FZCO
IFZA Property FZCO, Building A1Dubai Digital Park, Dubai Silicon OasisDubai, United Arab EmiratesNKG Partners Ltd
Unit 33 Icon Innovation CentreEastern Way, DaventryEngland, NN11 0QBNKG Partners Inc
5900 Balcones Drive, Ste 100Austin, TexasUSA 78731Supporting clients across 40+ countries through NKG’s global regulatory network.
Frequently asked questions
Clear Answers Before You Start
The exact position depends on the facility, product, business structure and available exemptions.
What is MoCRA?
The Modernization of Cosmetics Regulation Act of 2022 expanded FDA’s authority over cosmetics and established requirements including cosmetic product facility registration and product listing.
Do cosmetic manufacturers need to register with FDA?
Covered cosmetic manufacturing and processing facilities generally must register with FDA unless an applicable exemption applies.
What is an FEI?
The FDA Facility Establishment Identifier is required for cosmetic product facility registration.
Does FDA approve cosmetic products under MoCRA?
No. Facility registration and cosmetic product listing are not FDA approval programs.
Does FDA issue a cosmetic registration certificate?
No. FDA does not issue approval certificates for cosmetic facility registrations or cosmetic product listings.
Who is responsible for cosmetic product listing?
The Responsible Person—generally the manufacturer, packer or distributor whose name appears on the product label.
How often must facility registrations and product listings be maintained?
Required facility registrations are renewed every two years. Cosmetic product listing information must be updated annually.
Do foreign cosmetic facilities need a U.S. Agent?
A foreign facility that is required to register must provide U.S. Agent information for registration purposes.
Does product listing mean the product is fully compliant?
No. Listing does not replace requirements concerning safety, labelling, ingredients, claims and other applicable U.S. cosmetic regulations.
Can NKG handle both facility registration and product listing?
Yes. NKG can support FEI and facility registration, product listing, documentation review and ongoing compliance according to the agreed engagement scope.