MoCRA Cosmetics: Requirements, Deadlines, and How to Comply

The Modernization of Cosmetics Regulation Act (MoCRA) is the most significant change to U.S. cosmetic law since 1938. Signed into law on December 29, 2022, MoCRA replaces decades of voluntary self-regulation with mandatory federal requirements for cosmetic facility registration, product listing, safety substantiation, adverse event reporting, and Good Manufacturing Practices. Whether you are a domestic manufacturer, a foreign exporter, or a private-label brand, MoCRA compliance is now required to sell cosmetics in the United States.

 

✅ Facility registration and 2026 biennial renewal support

✅ Product listing via Cosmetics Direct

✅ Safety substantiation and adverse event systems

✅ US Agent designation for foreign facilities

Start Your MoCRA Compliance

What Is MoCRA?

MoCRA was enacted as part of the Consolidated Appropriations Act of 2023 and amends the Federal Food, Drug, and Cosmetic Act (FD&C Act).

It gives the FDA new mandatory authority over the cosmetics industry — including the power to mandate recalls, suspend facility registrations, and require safety substantiation for marketed products.

MoCRA applies to any cosmetic product manufactured, distributed, or sold in the United States.

 

Key Objectives:

  • Improve product safety transparency
  • Enforce standardized manufacturing practices
  • Enable FDA recalls of dangerous cosmetic products
  • Ensure accurate ingredient and facility disclosures

Who Must Comply With MoCRA Cosmetics?

MoCRA applies to all cosmetic products marketed in the United States, including:

U.S.-based manufacturers and private labelers

Foreign manufacturers exporting to the U.S.

Amazon and eCommerce sellers

Importers and distributors of cosmetic goods

MoCRA Cosmetics Compliance Checklist

Here’s what your company must do to stay compliant:

Facility Registration

Every domestic and foreign facility that manufactures or processes cosmetics distributed in the U.S. must register with the FDA. Registration is submitted electronically through the Cosmetics Direct portal using Form FDA 5066. Each facility must have an FDA Establishment Identifier (FEI) before submitting registration.

Cosmetic Product Listing

Every Responsible Person (typically the brand owner) must list each cosmetic product with the FDA using Form FDA 5067 via Cosmetics Direct. Product listings must include the product name and brand, a full ingredient list (including fragrances and flavors), the facility or facilities where the product is manufactured, and product category codes.

Product listings must be updated annually or whenever significant changes occur, such as reformulation or a new manufacturing facility. Unlike facility registration, product listing does not need to be renewed biennially — but it must remain current.

  • Each product must be listed with the FDA
  • Required details include:
  • Product name
  • Category (e.g., shampoo, skin cream)
  • Ingredient list
  • Must be updated annually or after formula changes
  • Deadline: July 1, 2024

Serious Adverse Event Reporting

Under MoCRA, the Responsible Person must submit a serious adverse event report to the FDA within 15 business days of receiving the report. A serious adverse event is any health-related event associated with the use of a cosmetic product that results in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability, a congenital anomaly or birth defect, or any event requiring medical or surgical intervention to prevent one of these outcomes.

Companies must maintain adverse event records for a minimum of 6 years. If new medical information arises within one year of the initial report, a follow-up report must be submitted.

  • Any serious adverse events (e.g., hospitalization, infection, disfigurement) must be reported to the FDA within 15 business days
  • Requires clear procedures for post-market surveillance

Biennial Renewal — Due by July 1, 2026

Facility registration must be renewed every two years. The first biennial renewals are now underway. Facilities that registered by the initial July 1, 2024 deadline must renew by their two-year anniversary — many of which fall in early-to-mid 2026. In February 2026, the FDA updated Cosmetics Direct with new “Registration Status” and “Renewal Date” fields and began sending automated email reminders to registered facilities. 

Two renewal options are available: a full biennial renewal (for registrations with changes) and an abbreviated renewal (for registrations with no changes since the last submission). The FDA recommends initiating the renewal process at least two weeks before the due date to account for possible portal delays. Failure to maintain active registration is a prohibited act under Section 301(hhh) of the FD&C Act and may result in FDA enforcement action, including import holds for foreign facilities.

Safety Substantiation

MoCRA requires the Responsible Person to ensure and maintain records supporting the safety of each cosmetic product marketed in the United States. While the FDA has not yet issued specific testing requirements, the law states that a product is deemed unsafe — and therefore adulterated — if there is inadequate evidence of safety.

In practice, this means companies should maintain toxicological assessments, ingredient safety data, and clinical testing results (such as HRIPT or patch testing) as part of their safety substantiation files.

  • You must maintain scientific evidence showing that each cosmetic product is safe for its intended use
  • This includes toxicological assessments and/or documented product safety reports

Good Manufacturing Practices (GMP)

MoCRA mandates Good Manufacturing Practices for cosmetic manufacturing, though the FDA’s formal GMP rule is still in development (the statutory NPRM deadline of December 2024 has passed). In the interim, the FDA has indicated that ISO 22716 — the international standard for cosmetics GMP — serves as a recognized benchmark. Companies should align their manufacturing, quality control, documentation, and personnel practices with ISO 22716 now rather than waiting for the final rule.

  • The FDA will enforce GMP rules specific to cosmetics
  • Expect inspections, documentation checks, and hygiene controls
  • Final GMP rule expected by end of 2025

Upcoming MoCRA Requirements

Several MoCRA provisions are still in the rulemaking phase. Fragrance allergen labeling is expected to require disclosure of specific allergens on cosmetic labels (NPRM anticipated May 2026). Standardized asbestos testing for talc-containing cosmetics has a final rule expected March 2026. A proposed ban on formaldehyde and formaldehyde-releasing chemicals in hair-straightening products has an NPRM expected December 2025. Cosmereg tracks all MoCRA rulemaking developments and proactively advises clients on preparation.

Who Is the Responsible Person Under MoCRA?

The Responsible Person is the manufacturer, packer, or distributor whose name appears on the cosmetic product label. This entity bears primary responsibility for facility registration, product listing, safety substantiation, adverse event reporting, and labeling compliance. For foreign companies, the U.S. importer may serve as the Responsible Person.

MoCRA Small Business Exemption

Companies with average annual gross sales below $1 million over the past three years are exempt from facility registration and product listing requirements. However, they are NOT exempt from safety substantiation, adverse event reporting, label compliance, or GMP standards. Cosmereg recommends that even exempt businesses voluntarily comply to demonstrate good faith and preparedness.

REGISTER YOUR COSMETIC FACILITY

What’s the Role of a US Agent Under MoCRA?

Foreign facilities must designate a US Agent, who will:

Serve as the official contact with the FDA

Assist with facility registration and product listings

Communicate adverse event reports

Respond to FDA inquiries during inspections or alerts

Learn more about our US Agent services

How Cosmereg Supports MoCRA Compliance

Cosmereg provides complete MoCRA compliance services including facility registration and biennial renewal via Cosmetics Direct, product listing with ingredient review and category coding, safety substantiation file preparation and review, adverse event reporting system setup and management, GMP gap analysis aligned with ISO 22716, US Agent designation for foreign facilities, and ongoing regulatory monitoring for upcoming MoCRA rules.preparation

Frequently Asked Questions About MoCRA

MoCRA was signed into law on December 29, 2022. Facility registration and product listing became enforceable on July 1, 2024. Biennial renewal of registrations is now underway in 2026.

Cosmetics Direct is the FDA’s electronic submission portal for cosmetic facility registration (Form FDA 5066) and product listing (Form FDA 5067). It was launched in December 2023 and updated in February 2026 with biennial renewal features.

Failure to register is a prohibited act under the FD&C Act. Products from unregistered facilities may be considered adulterated or misbranded, leading to FDA enforcement actions including import holds, seizures, and potential facility suspension.

 

Yes. Any foreign facility that manufactures or processes cosmetics for distribution in the United States must register with the FDA and designate a US Agent under MoCRA.

Each facility’s renewal deadline is two years from its initial registration date. Facilities that registered by the July 1, 2024 deadline are due for renewal by mid-2026. The FDA recommends starting the process at least two weeks early.

 

MoCRA mandates GMP for cosmetics, but the FDA’s formal rule is still in development. In the interim, ISO 22716 is recognized as the benchmark standard. Companies should begin aligning their operations now.

 

No. Companies under $1 million in average annual sales are exempt from facility registration and product listing, but NOT from safety substantiation, adverse event reporting, or labeling requirements.

 

Yes. The Voluntary Cosmetic Registration Program (VCRP) has been replaced by MoCRA’s mandatory facility registration and product listing system via Cosmetics Direct.

 

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