MoCRA in Practice

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most consequential update to U.S. cosmetics regulation since the Federal Food, Drug, and Cosmetic Act was enacted in 1938. In a recent FDA Voices article, the U.S. Food and Drug Administration explains how it is implementing this new authority and why these changes materially affect public health—and regulated companies.

 

Closing Longstanding Gaps in Cosmetics Oversight

Prior to MoCRA, FDA’s regulatory tools for cosmetics lagged well behind those available for other FDA‑regulated products. While cosmetic manufacturers were responsible for ensuring product safety, there were no federal requirements for facility registration, product listing, or serious adverse event reporting. FDA lacked routine visibility into who was manufacturing cosmetics, what products were on the market, and whether emerging safety issues were occurring. MoCRA was enacted specifically to close these gaps.

 

Core Requirements Now in Effect

As FDA describes, MoCRA establishes several foundational compliance obligations for cosmetic companies marketing products in the United States:

• Mandatory facility registration for domestic and foreign manufacturers and processors
• Mandatory cosmetic product listing, including ingredient information
• Serious adverse event reporting, coupled with recordkeeping obligations
• Safety substantiation requirements, requiring responsible persons to maintain records demonstrating that products are adequately safe for intended use

Collectively, these provisions move the U.S. cosmetics framework from an informal, largely voluntary system to a structured federal compliance regime.

 

Expanded Enforcement Authority

MoCRA also significantly strengthens FDA’s enforcement posture. The statute grants FDA mandatory recall authority and records access authority when cosmetics present a reasonable probability of causing serious adverse health consequences. According to FDA, these tools allow the agency to act more quickly and effectively when safety issues arise, rather than relying on voluntary industry cooperation alone.

 

Required Rulemaking on the Horizon

Beyond immediate compliance obligations, MoCRA directs FDA to develop additional regulations that will further define industry expectations. These include rules addressing:

• Fragrance allergen labeling
• Standardized testing methods for detecting asbestos in talc‑containing cosmetics
• Good Manufacturing Practices (GMPs) for cosmetic facilities

FDA characterizes these efforts as necessary infrastructure—bringing cosmetics regulation in line with scientific and regulatory standards long applied to other consumer products.

 

What This Means for Regulated Companies

FDA emphasizes that MoCRA is not intended to impede innovation, but rather to modernize oversight in a market used daily by most Americans. While certain small businesses may qualify for statutory exemptions, the overall message is clear: cosmetics manufacturers and brand owners should expect federal scrutiny grounded in registration, data transparency, and documented safety substantiation.

 

Key Takeaway

MoCRA fundamentally reshapes the FDA–industry relationship in the cosmetics space. As FDA implements this landmark legislation, cosmetic companies should view compliance not as a one‑time filing exercise or a “compliance deadline”, but as an ongoing governance obligation—integrating safety documentation, adverse event tracking, and regulatory readiness into core business operations and systems.

For more information on FDA’s current status of MoCRA implementation, and for compliance with FDA cosmetics regulation or enforcement, please email info@garg-law.com.