New MoCRA Adverse Event Reporting Requirements: Impact on the Cosmetic Industry

New MoCRA Adverse Event Reporting Requirements: Impact on the Cosmetic Industry

Product safety and consumer protection are the cornerstones of the cosmetics industry, now reinforced by regulatory milestones like the Modernization of Cosmetics Regulation Act (MoCRA) of 2022 and its 2023 amendment. These legislative advancements underscore the rising importance of cosmetovigilance systems in strengthening oversight and maintaining consumer trust.

A Tighter Grip on Cosmetic Safety

The MoCRA initiative stems from the explosive growth of the cosmetics industry and its pervasive role in everyday life. With a global market value of approximately $571.10 billion and U.S. consumers spending over $89.71 billion annually, the demand for stricter safety oversight and effective adverse event reporting is more urgent than ever. MoCRA addresses these evolving needs by acknowledging the complexities in cosmetic formulations and their potential health implications.

The Gray Area: Cosmetics vs. Pharmaceuticals

One significant challenge in safety regulation lies in product classification. In many cases, a product deemed a cosmetic in one region may be categorized as a pharmaceutical in another. This classification has profound implications—dictating the product’s regulatory pathway, including safety testing, marketing approvals, and adverse event reporting requirements.

While pharmaceuticals are subject to robust pharmacovigilance systems due to their potential therapeutic impact, cosmetics have historically faced less stringent requirements. The rise of cosmeceuticals—hybrid products that straddle both categories—further blurs the lines, demanding a more flexible, comprehensive approach to adverse event reporting and safety monitoring.

Key Factors in Choosing a Cosmetovigilance Solution

Implementing the right cosmetovigilance (CV) solution is essential to ensuring both safety and compliance in today’s beauty landscape. Unlike traditional pharmacovigilance (PV) tools, CV systems are tailored specifically for the needs of the cosmetic industry. A well-rounded CV solution should offer:

• Comprehensive Coverage: Adaptability to global regulations and varying product classifications.

• Regulatory Reporting Integration: Seamless submission of required safety data to global regulatory authorities.

• AI Capabilities: AI-driven features to improve detection, analysis, and reporting of adverse events.

• Flexibility & Scalability: Ability to evolve with regulatory updates and expanding product portfolios.

• Expert Support: Access to regulatory and scientific experts for accurate interpretation and compliance.

Moreover, a combined PV and CV system delivers a unified safety net—ensuring streamlined monitoring and reinforcing a brand’s commitment to consumer safety and regulatory excellence.

Sourcing Excellence in Cosmetovigilance & Pharmacovigilance

ACPL leads the industry with the only combined PV and CV platform currently available on the market. Our AI-powered, unified solution efficiently manages adverse event reporting for both cosmetic and pharmaceutical sectors, drawing from ACPL’s extensive expertise in the life sciences.

Real-World Impact

Our collaboration with a globally renowned luxury brand illustrates how our solution drives real-world success. This high-profile cosmetic leader, dedicated to upholding consumer safety and regulatory compliance, partnered with ACPL to implement a customized CV solution.

Key benefits included:

• Enhanced Data Management and Analytics

• Salesforce Integration for Streamlined Case Creation

• AI-Enabled Monitoring for Proactive Safety Measures

This collaboration not only improved response times and reporting precision but also enabled the brand to meet complex compliance demands across global markets—solidifying ACPL as a go-to partner in product safety and regulatory support.

Explore more: Read our full case study – AI-Driven Cosmetovigilance Solution for the Global Leader in Luxury

Lead With Safety

In a rapidly evolving cosmetic landscape, investing in a comprehensive cosmetovigilance system is not only a regulatory requirement—it’s a strategic business decision. The right platform ensures consumer safety, protects brand reputation, and enhances market credibility.

ACPL’s integrated PV and CV solution is built to meet the industry’s growing needs—bridging compliance, technology, and expert insight into a future-ready framework.

Ready to elevate your safety and compliance strategy?
📩 Contact us today to see how ACPL can transform your approach to product safety and regulatory excellence.