MoCRA: What the Push for Full Implementation Means for Your Skincare

The Modernization of Cosmetics Regulation Act, commonly called MoCRA, is one of the biggest changes to U.S. cosmetic regulation since 1938.

Signed into law in December 2022, it gives the FDA broader authority to oversee cosmetic manufacturing, safety reporting, and product information.

What Does MoCRA Require?

MoCRA introduced requirements including:

Reporting serious adverse events
Registering cosmetic manufacturing facilities
Listing cosmetic products with the FDA
Maintaining safety records
Updating certain product labels
Developing federal manufacturing standards

Facility registration and product listing requirements began in 2024. Companies must now provide information about where products are made, what they contain, and who is responsible for them.

Why Is Implementation Still Ongoing?

Several major rules have not yet been finalized, including those involving:

Fragrance allergen labeling
Good Manufacturing Practices
Testing methods for talc-containing cosmetics
Additional safety and compliance procedures

Some rulemaking was delayed during the change in presidential administration, as new administrations may review regulations developed under their predecessors.

What Are Good Manufacturing Practices?

Good Manufacturing Practices, or GMPs, establish standards for how cosmetics are manufactured, tested, stored, and quality controlled.

These rules may cover:

Facility cleanliness
Employee training
Raw material testing
Contamination prevention
Equipment maintenance
Batch documentation
Product storage and distribution

The goal is to reduce contamination, labeling mistakes, inconsistent formulas, and other manufacturing problems.

The State Regulation Problem

MoCRA does not prevent states from passing their own cosmetic laws. As a result, companies may face different ingredient restrictions, reporting requirements, and compliance deadlines across the country.

Industry groups argue that a consistent federal system may be more effective than a patchwork of state rules.

One example involves trace amounts of lead. Lead is generally not intentionally added to cosmetics, but very small amounts may occur naturally in minerals, pigments, or raw materials. The debate centers on how these unavoidable impurities should be measured and regulated.

Why MoCRA Matters to Consumers

MoCRA gives the FDA more information about:

Where cosmetics are manufactured
Which products are being sold
What ingredients they contain
Whether serious reactions have been reported
Whether manufacturers are following safety standards

This may help regulators identify problems and respond more quickly.

However, MoCRA does not require the FDA to individually test or approve every cosmetic before it reaches the market. Cosmetics remain regulated differently from prescription and over-the-counter drugs.

The law instead strengthens company obligations related to reporting, registration, recordkeeping, labeling, and manufacturing.

Reference

Albrizio L. “PCPC To Push for MoCRA Implementation.” Happi. November 3, 2025.

Dr. Jane Yoo Board-Certified Dermatologist and Mohs Surgeon

Jane Yoo, MD, MPP, is a Korean American board-certified dermatologist and fellowship-trained Mohs surgeon based in Midtown Manhattan. She is a Clinical Assistant Professor at the Icahn School of Medicine at Mount Sinai and the founder of Jane Yoo MD, PLLC and the Clinical Research Center of New York. Dr. Yoo holds an undergraduate degree from MIT and a Masters of Public Policy from Harvard's Kennedy School of Government. She completed her Mohs micrographic surgery fellowship at Yale. Her clinical and research focus spans aesthetic clinical trials including injectables and laser technology, skincare formulation and sunscreen science, K-Beauty and skin of color, ultrasound guided filler dissolution, artificial intelligence and beauty tech. Dr. Yoo's research is indexed under ORCID 0000-0002-7112-8963.

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