MoCRA Compliance Services (USA Cosmetic Regulation)

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant update to U.S. cosmetics law since 1938. Enforced by the FDA, MoCRA enhances safety standards and introduces mandatory requirements for cosmetics marketed in the U.S.

All companies that manufacture, package, or distribute cosmetics for the U.S. market—including foreign entities—must comply with MoCRA. This includes:

• U.S. and overseas manufacturers
• Brand owners and private labelers
• Distributors importing into the U.S.

• Facility Registration & Renewal (biennial)
  All U.S. and foreign facilities must register with the FDA and renew every two years.
• Product Listing
  Each marketed cosmetic product must be listed with the FDA, including its ingredients and intended use.
• Responsible Person Designation
  A U.S.-based contact is required to handle product safety documentation and FDA communications.
• Safety Substantiation
  Evidence must demonstrate that products are safe under labeled conditions.
• Adverse Event Reporting
  Serious adverse events must be reported to the FDA within 15 business days.
• Fragrance Allergen Labeling (Upcoming)
  Disclosure of certain allergens will be required in ingredient labeling.

At EZFDA Consulting, we simplify the regulatory burden with tailored services:

✅ Facility Registration & Renewal
✅ Product Listing Support
✅ U.S. Agent / Responsible Person Service
✅ MoCRA Compliance Strategy Planning
✅ Safety Substantiation & Documentation Review
✅ Adverse Event Reporting System Setup
✅ Label Compliance & Allergen Disclosure
✅ Ongoing Compliance Monitoring

Whether you're launching in the U.S. or ensuring legacy compliance, we provide turnkey solutions aligned with MoCRA's evolving framework.

📨 Contact us today to schedule a compliance consultation.