Regulatory Support for Cosmetic Product Registration in USA

The U.S.cosmetics market is among the world’s largest and most closely monitored.With the introduction of the Modernization of Cosmetics Regulation Act(MoCRA), the U.S.Food and Drug Administration(FDA) has elevated oversight standards to ensure transparency, safety, and accountability across every stage of cosmetic product manufacture and distribution.

At DDReg, we help cosmetic brands, manufacturers, and importers navigate this transformation with strategic precision. Our cosmetic regulatory specialists translate FDA expectations into executable compliance frameworks, supporting cosmetic product registration in USA, market access, operational alignment, and ongoing readiness in one of the world’s most competitive markets.

Key Registration Routes under CDSCO

• + Regulatory Pathway & Compliance Strategy
  • Determining classification under cosmetic, OTC, or hybrid categories.
  • Conducting regulatory gap assessments aligned with MoCRA and state-level cosmetic laws.
  • Developing a clear compliance roadmap with defined timelines, documentation structure, and market launch milestones.
• + Cosmetics Facility Registration & Product Listing Services
  • Managing FDA facility registration (Form 5066) for all U.S. and foreign sites.
  • Submitting product listings (Form 5067 / SPL) with complete ingredient, label, and responsible-person data.
  • Handling annual renewals, updates, and product-line extensions through FDA’s digital submission platforms.
• + Ingredient Review & Labeling Compliance
  • Reviewing ingredients for compliance with MoCRA and state-specific restrictions.
  • Evaluating claims, allergens, and required label disclosures.
  • Ensuring packaging and branding align with FDA cosmetic labeling standards.
• + Safety Substantiation & Toxicological Review
  • Evaluation of artwork and label elements in line with CDSCO rules
  • Claims substantiation (e.g., “organic,” “paraben-free,” “clinically tested”)
  • BIS standard cross-checks and ingredient safety evaluations
  • Mandatory declarations as per Indian labeling norms
• + Adverse Event Reporting & Post-Market Surveillancent
  • Establishing reporting mechanisms for serious adverse events.
  • Monitoring safety signals, trend analysis, and documentation for post-market audits.
  • Supporting FDA inspections and enforcement correspondence management.
• + U.S. Agent & Responsible Person Support
  • Acting as your U.S. regulatory liaison for foreign entities.
  • Managing communications, updates, and submissions on behalf of your organization.
  • Ensuring compliance continuity through all lifecycle stages.
• + Regulatory Intelligence & Continuous Compliance
  • Tracking FDA guidance updates, MoCRA deadlines, and industry advisories.
  • Providing proactive alerts and strategic adjustments to maintain full regulatory alignment.
  • Offering training and ongoing advisory support to integrate U.S. compliance into global operations.

DDReg stands at the forefront of < a href = "/solutions/regulatory-intelligence" > regulatory intelligence and execution in cosmetics compliance.We combine technical mastery with practical understanding, empowering brands to maintain speed, accuracy, and sustainability in their U.S.operations.Our MoCRA experts provide not only procedural support but also strategic insight that strengthens your compliance posture and safeguards your brand reputation.

With extensive experience supporting non-U.S. cosmetic manufacturers, DDReg ensures seamless coordination between your global teams and the FDA’s regulatory systems, helping you achieve fast-track readiness without operational disruption. Connect with DDReg’s MoCRA consultants today for a comprehensive compliance assessment and tailored cosmetics registration strategy.