A new legal review from Crowell & Moring LLP maps the FDA's expanded enforcement authority under the Modernization of Cosmetics Regulation Act of 2022, signed into law in December 2022 and now rolling through its staggered compliance calendar.

The Washington, D.C.-based law firm published the analysis, titled "Cosmetics Under the Microscope: FDA's Expanding Regulatory Reach Under MoCRA," as the FDA pushes additional draft guidance through the pipeline and state regulators respond in parallel.

What MoCRA changed for U.S. cosmetics

MoCRA, enacted in December 2022 as part of the Consolidated Appropriations Act, ended the cosmetics industry's decades-old regulatory status quo. For the first time, the FDA gained dedicated, written authority over cosmetic products, replacing reliance on the Food, Drug, and Cosmetic Act's general adulteration and misbranding provisions with category-specific tools.

The legal analysis groups the FDA's new powers into operational pillars:

• Facility registration for manufacturers and processors, with biennial renewal
• Ingredient disclosure through mandatory product listing
• Adverse event reporting, with 15-business-day deadlines for serious events
• Safety substantiation documentation producible on FDA demand
• Mandatory recall authority over unsafe cosmetics

Each pillar carries compliance work the prior regime did not require. The review positions this as the core operational shift for any company that formulates, brands, distributes, or imports cosmetics into the U.S. market.

Why the "expanding reach" framing matters

The Crowell & Moring analysis treats MoCRA's implementation as a rolling expansion rather than a single event. Facility registration and product listing deadlines have already passed. Adverse event reporting took effect at the end of 2024. Safety substantiation requirements have rolled out in stages, with full FDA enforcement discretion now active.

The piece frames each successive deadline as widening the agency's visibility into the supply chain — from raw material sourcing through contract manufacturing to finished-product distribution. For multinational brands selling into the U.S., this creates an overlapping compliance footprint where EU Cosmetic Regulation requirements, California's Toxic-Free Cosmetics Act, and federal MoCRA obligations all converge on the same product files.

What compliance teams should track next

The legal review flags two near-term data points worth monitoring: the FDA's next round of cosmetic-specific guidance, expected as the agency finalizes safety substantiation standards, and parallel state-level responses to MoCRA — particularly California's cosmetics framework, which creates a dual-filing burden for products sold in the state.

For formulation chemists, the practical implication is straightforward: ingredient choices that previously triggered no federal documentation requirement now generate safety substantiation files that must be retained and produced on demand. For procurement teams, the supplier-vetting paper trail expands — third-party safety data, certificates of analysis, and GMP documentation move from best practice to documented obligation.

For treatment-menu operators and professional buyers, the analysis underscores that product safety claims backed by marketing copy now sit within FDA's labeling authority, raising the cost of unsubstantiated language in retail or professional channels.

The bottom line

Crowell & Moring's review treats MoCRA as a regulatory expansion whose full operational footprint is still being defined. Compliance teams should expect continued FDA activity through 2025 and 2026 as the agency finalizes guidance and as state-level responses add parallel requirements. The legal review's central message for industry: the era of voluntary cosmetic compliance in the U.S. has ended, and the documentation work is now structural rather than discretionary.