CUSTOM PRODUCT REQUEST

About MoCRA

What is MoCRA?

MoCRA is the Modernization of Cosmetic Regulations Act of 2022. It was passed by Congress and signed into law by the President on December 29, 2022, as part of the huge spending bill for the year. It is the first major update to the cosmetics laws since the Food, Drug, and Cosmetic Act was first approved in 1938.

Ensuring the safety of cosmetic products sold in the United States is the key concern of MoCRA. It also gives the FDA some additional authority that was overlooked when the law was written in 1938.

The sections of MoCRA each address different cosmetic safety issues which will go into effect over the next 1 – 4 years. As a result of our work over the last ten years, small businesses are exempt from several of the requirements of MoCRA.

IMPORTANT NOTE: The FDA has missed all the deadlines for issuing proposed rules. The dates below are ESTIMATED based on FDA statements, but could very easily change.
What When
Serious adverse events must be reported. In effect now
Labels must include information to report a serious adverse event. In effect now
Safety substantiation required for all cosmetic products and their ingredients. In effect now
Products for professional use require ingredient declaration In effect now
FDA has the right to inspect cosmetic manufacturing records. In effect now
FDA has the authority to require a recall of an unsafe cosmetic product. In effect now
Cosmetic manufacturing facilities must be registered with the FDA In effect now
Small Businesses are exempt
Cosmetic products must be listed with the FDA. (not approved, just listed) In effect now
Small Businesses are exempt
Fragrance Allergens must be identified on the product label. January 2025 – proposed rule
June 2025 – final rule
Effective date sometime after that.
FDA must issue good manufacturing practices regulations, and cosmetic manufacturers must follow them. October 2025 – proposed rule
October 2026 – final rule
Effective date sometime after that.
FDA to issue rules for standardized testing of talc products to detect and identify asbestos December 2024 – proposed rule
June 2025 – final rule
Effective date sometime after that.
MoCRA does not change or remove any existing regulations covering the labeling of cosmetic products.

Additional Resources

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