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.
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