Voluntary Cosmetic Registration Program - VCRP Benefits & Process

The FDA's approach to cosmetic registration has undergone a fundamental transformation.

The Voluntary Cosmetic Registration Program (VCRP), which operated for decades as an optional reporting system, was discontinued in March 2023.

It has been replaced by mandatory facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act (MoCRA).

The End of VCRP: What Changed

The FDA stopped accepting VCRP submissions on March 27, 2023, as part of implementing MoCRA's mandatory registration requirements.

This shift represents the most significant expansion of FDA cosmetic regulatory authority since 1938.

Key differences between old VCRP and new MoCRA requirements:

• VCRP was voluntary; MoCRA registration is mandatory

• VCRP had no renewal requirements; MoCRA requires biennial renewal

• VCRP had no enforcement consequences; MoCRA violations can result in facility suspension

• VCRP covered only US-marketed products; MoCRA includes imported products

Current Mandatory Registration Under MoCRA

Facility Registration Requirements

All cosmetic manufacturers and processors must register their facilities with the FDA. This includes domestic facilities and foreign facilities that manufacture or process cosmetics for the US market.

Registration obligations:

• Initial registration by December 29, 2023 (for existing facilities)

• New facilities must register before beginning operations

• Biennial renewal every two years

• Updates within 60 days of any changes to registration information

Covered facilities include:

• Manufacturing facilities that produce finished cosmetic products

• Processing facilities that package, label, or hold cosmetics

• Contract manufacturers and private label producers

• Foreign facilities exporting to the US market

Exemptions:

• Facilities that only store or distribute finished cosmetics without processing

• Retail establishments that don't manufacture cosmetics

• Beauty salons and spas using professional-only products

Product Listing Requirements

The "responsible person" (typically the company whose name appears on the product label) must list each marketed cosmetic product with the FDA.

Listing requirements:

• Complete ingredient identification using INCI nomenclature

• Product category designation and intended use

• Responsible person contact information

• Annual updates for any changes to formulation or labeling

Required information includes:

• Product name and brand

• Product category (moisturizer, cleanser, color cosmetic, etc.)

• Complete ingredient list in descending order of concentration

• Responsible person name and contact information

• Manufacturing facility information

Registration Process and Procedures

Step 1: Determine Registration Requirements

Assess whether your facility requires registration based on your role in cosmetic manufacturing or processing. Facilities that only store or distribute finished products typically don't require registration.

Identify all products requiring listing. Each unique formulation, even different shades of the same product, requires separate listing.

Step 2: Gather Required Information

For facility registration:

• Facility name, address, and contact information

• Parent company information (if applicable)

• Types of cosmetic activities conducted at the facility

• Product categories manufactured or processed

• Emergency contact information

For product listing:

• Complete ingredient lists with INCI names

• Product category codes (available from FDA guidance)

• Manufacturing facility information

• Responsible person details

Step 3: Submit Registration and Listings

Use the FDA's Cosmetics Direct system for electronic submission. This web-based portal replaced the previous VCRP system and provides real-time submission tracking.

Submission process:

• Create account in Cosmetics Direct system

• Complete facility registration forms (FDA Form 5066)

• Submit product listings (FDA Form 5067)

• Receive confirmation numbers for successful submissions

Step 4: Maintain Current Registration

Monitor registration status and ensure timely renewals. The FDA can suspend facility registration for serious safety violations, which prohibits distribution of products from that facility.

Update registrations within 60 days of any changes to facility information, ownership, or operations.

Benefits of Compliance

Regulatory Compliance and Market Access

Proper registration ensures legal market access and avoids enforcement action. Non-compliance can result in:

• Facility registration suspension

• Product seizures and import detention

• Warning letters and enforcement actions

• Criminal prosecution for willful violations

Business Advantages

Enhanced credibility: Registration demonstrates commitment to regulatory compliance and product safety, building trust with retailers, distributors, and consumers.

Supply chain benefits: Many retailers and distributors now require proof of FDA registration before accepting cosmetic products, making compliance essential for market access.

International recognition: FDA registration often facilitates regulatory approval in other countries that recognize US regulatory standards.

Risk management: Proactive FDA compliance reduces the risk of costly enforcement actions, product recalls, and business disruption.

Operational Benefits

Systematic approach: The registration process encourages systematic documentation of ingredients, formulations, and manufacturing processes, improving overall quality management.

Regulatory intelligence: Registered companies receive FDA communications about regulatory changes, safety alerts, and industry guidance.

Professional relationships: Compliance demonstrates professionalism and can improve relationships with suppliers, customers, and regulatory authorities.

Common Registration Challenges

Ingredient Identification

Many companies struggle with proper INCI nomenclature for ingredients. Complex formulations may contain ingredients with multiple acceptable names or proprietary blends requiring careful identification.

Solution: Work with cosmetic chemists or regulatory consultants to ensure accurate ingredient identification and INCI compliance.

Facility Classification

Determining whether a facility requires registration can be complex, particularly for companies with multiple locations or contract manufacturing arrangements.

Solution: Conduct detailed analysis of activities at each facility and consult FDA guidance documents for classification criteria.

International Coordination

Foreign manufacturers must navigate both US registration requirements and their domestic regulatory obligations, which may conflict or create duplicative requirements.

Solution: Engage regulatory experts familiar with both US and international cosmetic regulations to develop coordinated compliance strategies.

Enforcement and Consequences

The FDA has significant enforcement authority under MoCRA, including the power to suspend facility registrations for serious safety violations. Suspended facilities cannot distribute products in the US market until compliance is restored.

Enforcement priorities include:

• Unregistered facilities continuing to manufacture or process cosmetics

• Incomplete or inaccurate registration information

• Failure to update registrations within required timeframes

• Products listed with incorrect or incomplete ingredient information

Penalties for non-compliance:

• Facility registration suspension

• Product seizures and import alerts

• Warning letters and consent decrees

• Criminal prosecution for willful violations

Professional Guidance

The transition from voluntary VCRP to mandatory MoCRA registration has created complex compliance requirements that many companies struggle to navigate independently.

When to seek professional help:

• Multiple facilities with unclear registration requirements

• Complex international supply chains and manufacturing arrangements

• Products with proprietary ingredients or unique formulations

• Previous FDA enforcement actions or compliance issues

Professional services include:

• Registration requirement analysis and facility classification

• INCI ingredient identification and formulation review

• Cosmetics Direct system navigation and submission support

• Ongoing compliance monitoring and renewal management

The Path Forward

VCRP is discontinued: The voluntary program ended March 27, 2023, replaced by mandatory MoCRA requirements.

Registration is now mandatory: All cosmetic manufacturers and processors must register facilities and list products.

Biennial renewal required: Facility registrations must be renewed every two years with updates within 60 days of changes.

Enforcement has teeth: The FDA can suspend facility registrations, prohibiting product distribution for serious violations.

Professional guidance recommended: Complex requirements often require FDA compliance expert assistance for proper compliance and ongoing management.