What is required for MoCRA registration of peptide cosmetics?

MoCRA requires facility registration, product listing with detailed ingredient declarations, and US Agent appointment for all foreign cosmetic brands. Peptide cosmetics need specific INCI naming compliance and must be registered 60 days before first US shipment.

Do Korean cosmetic brands need a US Agent for peptide products?

Yes, all foreign cosmetic manufacturers must designate a US Agent for FDA regulatory communications under MoCRA requirements. The US Agent serves as your regulatory representative for all compliance matters and FDA correspondence.

How much does FDA registration cost for cosmetic peptide imports?

FDA facility registration is currently free, though this may change. Our complete launch package includes all registration fees, US Agent services, label compliance review, and ongoing support with transparent, upfront pricing.

What labelling requirements apply to peptide skincare in the US?

US labels must include INCI ingredient names, net quantity declarations, responsible person details, and proper peptide ingredient identification. All text must be in English and comply with FDA Title 21 CFR Part 701 requirements.

Can European brands sell peptide cosmetics directly to US consumers?

European brands need proper US regulatory setup including MoCRA registration, US Agent appointment, and FDA-compliant labelling before selling to American consumers. Direct sales require full compliance with US cosmetic regulations.

What customs duties apply to imported peptide cosmetic products?

Import duties depend on HTS classification. Peptide cosmetics typically classify as cosmetic preparations, with the applicable rate determined by formulation and packaging.

US Cosmetic Peptide Launch Package: FDA & MoCRA

How Global Import Agent Can Help

As specialists in cosmetic peptide import services, we understand the unique challenges Korean and European beauty brands face entering the US market.

The Modernization of Cosmetics Regulation Act (MoCRA) introduced mandatory facility registration and product listing requirements, whilst peptide cosmeceuticals face additional scrutiny due to their bioactive ingredient profiles. Our dedicated team manages every aspect of your market entry, from initial MoCRA registration through ongoing compliance obligations.

We serve as your US Agent under FDA Title 21 CFR Part 701 regulations, handling all regulatory communications whilst you focus on building your American customer base.

Complete MoCRA facility registration and product listing submission
US Agent services with dedicated account management
FDA-compliant label review for peptide ingredient declarations

Importer of Record (IOR) services for customs clearance
Ongoing regulatory compliance monitoring and updates

Complete facility registration, product listing, and US Agent appointment under new FDA requirements
Label Compliance – FDA-compliant label review ensuring proper INCI nomenclature and peptide ingredient declarations
Import Operations – IOR services, customs clearance, HTS classification, and prior notice filing for peptide cosmetics

Navigating US Peptide Cosmetics Regulations

Peptide formulations are prominent in the growing US cosmetics market. However, these bioactive ingredients face complex regulatory requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and new MoCRA provisions that came into effect in 2022.

Peptide cosmeceuticals require precise ingredient declarations using correct INCI names, whilst import duties depend on the product’s HTS classification. Foreign brands without US business presence must appoint a responsible person and maintain continuous regulatory compliance, making comprehensive launch packages essential for successful market entry.

MoCRA facility registration with 60-day advance filing requirement
US Agent designation meeting FDA communication protocols
INCI-compliant peptide ingredient labelling under Title 21 CFR Part 701
Prior notice filing compliance under Bioterrorism Act provisions
Customs clearance expertise for HTS codes 3304-3307 classifications

What We Arrange And Manage End-To-End

1) MoCRA Registration & US Agent Setup

We complete your mandatory facility registration and product listing submissions to FDA, appointing Global Import Agent as your designated US Agent for all regulatory communications.

FDA facility registration under new MoCRA requirements
Product listing submission with peptide ingredient declarations
US Agent appointment documentation and protocols
Responsible person designation for ongoing compliance

2) Label Compliance & Documentation Review

Our FDA specialists conduct comprehensive label reviews ensuring full compliance with Title 21 CFR Part 701 requirements, including proper INCI nomenclature for peptide ingredients.

FDA-compliant label design and content review
INCI naming verification for bioactive peptides
Net quantity declarations and responsible person details
Marketing claim compliance assessment

3) Import Classification & Customs Preparation

We determine correct HTS tariff classifications for your peptide formulations and prepare all required import documentation for efficient customs clearance.

4) IOR Services & Prior Notice Filing

As your Importer of Record, we handle all customs obligations including prior notice filing under Bioterrorism Act requirements and FDA import alerts monitoring.

5) Launch Support & Ongoing Compliance

We provide continuous regulatory monitoring, compliance updates, and account management support throughout your US market presence, ensuring ongoing MoCRA obligations are met.

Complete US Market Entry Package

MoCRA Registration

Complete FDA facility registration and product listing submission under new regulatory requirements.

US Agent Services

Dedicated US Agent appointment with ongoing regulatory communication management and compliance monitoring.

Label Compliance Review

Comprehensive FDA-compliant label review ensuring proper peptide ingredient declarations and INCI nomenclature.

Import Documentation

Complete customs documentation preparation including HTS classification and import duty calculations.

IOR Services

Full Importer of Record services with prior notice filing and customs clearance management.

Launch Support

Dedicated account management and ongoing regulatory compliance monitoring throughout your market entry.

What Is MoCRA Compliance for Peptide Cosmetics?

The Modernization of Cosmetics Regulation Act (MoCRA) introduced mandatory registration requirements for all cosmetic manufacturers and brand owners selling in the US market. For peptide cosmetics, this includes facility registration, product listing with detailed ingredient declarations, and ongoing compliance monitoring under FDA oversight.

Foreign brands must designate a US Agent to serve as their regulatory representative, handling all FDA communications and compliance obligations. Peptide ingredients require specific INCI naming conventions and precise labelling under Title 21 CFR Part 701, whilst import operations must comply with Bioterrorism Act prior notice requirements and proper customs classification.

Before-you-ship checklist:

MoCRA facility registration completed 60 days before first shipment
Product listing submitted with complete peptide ingredient declarations
US Agent appointed and FDA notification protocols established
Labels reviewed for FDA compliance and INCI nomenclature accuracy
Import documentation prepared with correct HTS classifications

Our process:

Initial consultation and regulatory assessment
MoCRA registration submission and US Agent appointment
Label compliance review and documentation preparation
Import setup with IOR services and customs protocols
Launch support with ongoing compliance monitoring

Deep expertise in new FDA cosmetic regulations specifically for Korean and European peptide brands. We understand the unique compliance challenges facing international beauty companies entering the US market. Clear, upfront pricing for complete launch packages. Our comprehensive service model eliminates the need to coordinate multiple vendors for your US market entry.

From initial MoCRA registration through ongoing compliance management, we handle every aspect of your peptide cosmetics import operation. Dedicated account managers ensure consistent, reliable service throughout your partnership.

Our specialists provide comprehensive consultation on MoCRA compliance, regulatory requirements, and market entry strategies tailored to Korean and European beauty brands. Get your personalised launch quote today and discover how we simplify US cosmetic import compliance.

US Cosmetic Peptide Launch Package: FDA & MoCRA Experts