Cosmetic Products

Modernization of Cosmetics Regulation Act (MoCRA)

Navigate MoCRA with Confidence

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant update to cosmetic law since 1938—expanding FDA oversight across product safety, labeling, recordkeeping, and adverse event reporting.

At [Your Company Name], we provide expert guidance and regulatory support to help your cosmetic business comply with MoCRA’s new requirements.

Our Mocra Compliance Servcies: 

  • FDA Facility Registration & Product Listing

  • Safety Substantiation & Ingredient Review

  • Labeling Compliance (Including Fragrance Allergens)

  • Adverse Event Reporting Systems

  • Responsible Person Designation & Recordkeeping

Some of the new requirements of MoCRA include: 

Mandatory recall authority

The FDA can order a mandatory recall if a cosmetic is adulterated or misbranded. 

Facility registration

Cosmetic facilities must register with the FDA by July 1, 2024. 

Product listing

Cosmetic companies must list each marketed cosmetic product, including ingredients.

Adverse event reporting

Companies must provide a way for consumers to report adverse effects on packaging.

Safety substantiation records

Companies must develop and maintain safety substantiation records

Good manufacturing practice (GMP) regulations

 Companies must follow GMP regulations

Some of the new requirements of MoCRA include: 

  • Cosmetics Direct: An electronic submission portal for registering and listing cosmetic products and facilities
  • Xforms: An SPL authoring tool for registering and listing cosmetic products and facilities
  • Form FDA 5066 and Form FDA 5067: Paper forms for registering and listing cosmetic products and facilities