The United States cosmetics market continues to expand as consumers demand high quality products grounded in safety, transparency, and scientific integrity. With increasing scrutiny from regulatory authorities, cosmetic brands can no longer risk gaps in compliance or safety documentation. Ensuring cosmetics safety in the U.S. requires a comprehensive understanding of regulatory requirements, product testing expectations, documentation standards, and ongoing risk-management practices. The introduction of the Modernization of Cosmetics Regulation Act (MoCRA) has further strengthened the need for robust safety substantiation and proactive regulatory compliance
Regulatory Framework Governing Cosmetics in the United States
Cosmetic products sold in the United States are regulated primarily by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Modernization of Cosmetics Regulation Act (MoCRA) and Fair Packaging and Labeling Act. Together, these laws set the expectations for product safety, labeling accuracy, manufacturing controls, and post-market oversight. Additionally, the Federal Trade Commission (FTC) oversees advertising claims to ensure that all statements are truthful and supported by evidence.
Unlike drugs or medical devices, cosmetics do not require pre-market approval; however, manufacturers and distributors are legally responsible for ensuring their products are safe for consumer use.
Federal Food, Drug, and Cosmetic Act (FD&C Act)
The FD&C Act defines what qualifies as a cosmetic and outlines fundamental requirements:
● Products must be safe for use under normal and foreseeable misuse conditions.
● Labels must not be false or misleading.
● Every claim made on products must be scientifically justified and should not contain therapeutic claims.
Modernization of Cosmetics Regulation Act (MoCRA)
MoCRA introduced the most significant regulatory update in over 80 years, bringing U.S. requirements closer to global standards. Key mandates include:
● Facility Registration and product listing
● Safety Substantiation documentation
● Good Manufacturing Practices (GMP) requirements
● Serious Adverse Event Reporting
● Fragrance allergen disclosure
● Mandatory fragrance allergen disclosure
● Expanded FDA authority to access records and enforce recalls
Labeling Requirements
Accurate labeling is fundamental to U.S. cosmetic compliance. Under the FD&C Act and MoCRA, every cosmetic must be properly labeled, truthfully represented, and supported by adequate safety and claims evidence.
Core Labeling Requirements
Labels must include:
● Statement of Identity
● Net quantity of contents
● Ingredient declaration (INCI Name)
● Required warning statements (including warnings on Principle Display Panel (PDP), when applicable)
● Directions for safe use
● Name and Place of Business of the Responsible Person
Claims and Claim Substantiation
Accurate labeling is fundamental to U.S. cosmetic compliance. Under the FD&C Act and MoCRA, every cosmetic must be properly labeled, truthfully represented, and supported by adequate safety and claims evidence.
The FDA and FTC monitor claims to ensure they are truthful, non-misleading, and evidence-based. Cosmetic claims must not imply treatment, prevention, or modification of bodily functions. Documentation should support:
● Efficacy of the product
● Ingredient related claims including “natural,” “organic,” or “free-from” claims
● Product related claims including “clinically proven,” “non-toxic,” or “dermatologist-tested”
● Safety related statements
● Consumer perception or instrumental test data
Any unverified or misleading statements may result in enforcement actions. A structured claims review helps brands:
● Stay within cosmetic claim boundaries
● Avoid FDA/FTC enforcement
● To ensure marketing claims are fully supported
● To present a compliant and trustworthy product to consumers
Safety Substantiation Requirements
Manufacturers are responsible for ensuring that their products are safe under normal and reasonably foreseeable misuse conditions. Safety substantiation must cover the complete formula and demonstrate that no unreasonable risk under normal and labelled use to consumers.
Safety substantiation typically integrates:
● Toxicological Risk Assessment (TRA): Evaluation of each ingredient’s hazard profile, exposure level, and overall Margin of Safety.
● Formula-Level Safety Assessment: Review of impurities, allergens, and cumulative exposure.
● Product Testing: Stability, microbiological quality, preservative efficacy, and safety studies such as HRIPT, SIU, CIT (as needed).
● Regulatory Compliance Check: Verification against FDA and MoCRA requirements, color additive approvals, and known restrictions (including state-level rules).
Good Manufacturing Practices for Cosmetics
MoCRA has made Good Manufacturing Practices (GMP) a legal requirement for cosmetic manufacturers in the United States. GMP ensures products are produced consistently, hygienically, and with adequate quality controls, reducing risks of contamination, instability, and safety concerns. These practices are aligned with standards ISO 22716.
Key GMP expectations include:
● Controlled Manufacturing Environment: Clean facilities, validated processes, and proper equipment maintenance.
● Quality Management System: Procedures for production, documentation, supplier control, and recordkeeping.
● Raw Material Controls: Verification of identity, purity, COAs, and contamination limits.
● In-Process and Finished Product Testing: Microbial testing, stability checks, and release criteria.
● Batch records, traceability, and recall readiness.
● Personnel Training & Hygiene: Ensuring staff follow safety and sanitation standards.
Strong GMP systems help ensure consistent product quality, reduce contamination risk, and maintain compliance.
Compliance Support Strategies for Safe Product Launches
A proactive, evidence-driven approach is essential for introducing safe and compliant cosmetics in the United States. Integrating regulatory expectations early minimizes risk, strengthens documentation.
Pre Market Due Diligence
Effective compliance begins long before the first batch is produced. Key steps include:
● Early consultation with regulatory experts
● Comprehensive review of ingredient restrictions and watchlists, including California Proposition 65 and international regulatory annexes.
● Verification of supplier documents for quality and compliance.
● Development of structured safety assessment plans.
Safety Documentation and Technical Files
Maintaining comprehensive and organized documentation is essential. brands should maintain:
● Safety Data Sheets and Supplier documentation
● Safety assessments for all ingredients and finished formulations
● Claims substantiation records
● Batch manufacturing and QC records enabling full traceability
Post Market Surveillance
MoCRA has elevated post-market obligations. Brands must maintain systems to:
● Track consumer complaints, adverse reactions, and product performance trends
● Report Serious Adverse Events to the FDA within required timelines
● Conduct continuous regulatory horizon scanning for new rules, MoCRA updates, allergen lists, and enforcement actions
● Support recall readiness, including record access and traceability
Industry Trends Influencing Cosmetics Safety
Several trends affect compliance and safety strategies. Current market forces require brands to continuously adapt:
Growing Use of NAMs (New Approach Methodologies)
Non-animal testing approaches such as in vitro assays, read-across, TTC (Threshold of Toxicological Concern), computational models, and QSAR are increasingly used to support safety substantiation.
Allergen Transparency
There is growing interest in increased disclosure of fragrance allergens, influenced by international standards and consumer expectations for clearer labeling.
Microbial Control
Microbial contamination remains a concern, especially for water based and preservative reduced formulations.
Nanomaterials Oversight
Nano-scale ingredients require enhanced characterization and safety justification. Regulators expect rigorous safety assessment.
Sustainability and Clean Formulations
Environmentally responsible formulations are gaining importance, driving interest in biodegradable materials and lower risk ingredient profiles.
Rapid Innovation
The pace of ingredient development increases the importance of proactive toxicological evaluation to keep products aligned with evolving standards.
Challenges in Compliance and Product Safety
Brands face several challenges, including:
● Fragmented regulatory landscape
● Increased scrutiny of ingredient safety
● Consumer awareness and demand for transparency
● Supply chain complexity and variable raw material quality
● Significant resource needs for testing and compliance documentation
Some small scale organizations may face additional constraints related to testing capacity, regulatory expertise, and documentation systems.
Recommendations for Safe and Compliant Product Launches
To strengthen compliance and reduce risk, brands should:
● Engage regulatory experts early during formulation and claims development
● Conduct comprehensive ingredient vetting with global compliance perspectives
● Maintain detailed batch records and implement traceability systems.
● Ensure documentation readiness for audits, inspections, and claims substantiation.
● Establish strong post market surveillance and rapid response systems.
● Provide continuous training for employees in GMP and regulatory expectations.
These actions help build a resilient regulatory framework that supports growth and consumer trust.
Conclusion
Cosmetics safety in the United States is governed by a robust regulatory framework designed to protect consumers and support scientific standards in product development. With MoCRA now in force and regulatory expectations rising, compliance has become essential to every successful product launch. At SciQra, we support brands with toxicological risk assessment, safety substantiation, and regulatory compliance, helping brands to launch products that are safe, compliant, and ready for the U.S. market.