MoCRA Compliance Guide

1. What Is MoCRA?

The Modernization of Cosmetics Regulation Act (MoCRA) is the most significant update to US federal cosmetic regulation since the original Federal Food, Drug, and Cosmetic Act of 1938. MoCRA was enacted on December 29, 2022, as Title III, Subtitle E of the Consolidated Appropriations Act, 2023 (P.L. 117-328).

MoCRA amends the FD&C Act by adding new Sections 604 through 614, which establish mandatory FDA oversight of cosmetic products for the first time in modern US history. Before MoCRA, the FDA had no authority to require cosmetic facility registration, no power to mandate adverse event reporting, and no ability to order mandatory recalls of unsafe cosmetics.

Why MoCRA Matters

• Gives FDA mandatory recall authority over cosmetics for the first time.
• Requires cosmetic facility registration and product listing with FDA.
• Creates a federal framework for adverse event reporting.
• Mandates safety substantiation for all cosmetic products.
• Directs FDA to establish Good Manufacturing Practice (GMP) regulations.
• Requires future rulemaking on fragrance allergen disclosure.

MoCRA applies to all cosmetic products distributed in the United States, regardless of whether they are manufactured domestically or imported. Both domestic and foreign manufacturers, processors, and distributors are subject to its requirements.

2. What MoCRA Requires

MoCRA introduces six core regulatory requirements for cosmetics. Some are already in effect; others await FDA rulemaking.

Each of these requirements is discussed in detail in the sections that follow. Businesses should note that the three active requirements are already enforceable, meaning non-compliance carries regulatory risk today.

3. Facility Registration

Under FD&C Act Section 607, every facility that manufactures or processes cosmetic products for distribution in the United States must register with the FDA. Enforcement of this requirement began on July 1, 2024.

Who Must Register

• Domestic facilities that manufacture or process cosmetics distributed in the US.
• Foreign facilities that manufacture or process cosmetics exported to the US.
• Contract manufacturers that produce cosmetics on behalf of brand owners.

Facilities that only label, relabel, package, or repackage cosmetics are generally exempt from registration, provided they are not also manufacturing or processing the product.

What to Submit

• Facility name and physical address.
• FDA Establishment Identifier (FEI number).
• Contact person information.
• Product categories manufactured or processed at the facility.
• For foreign facilities: the name and contact information of a designated US Agent.

How to Register

Registration is submitted electronically through FDA's Cosmetics Direct system, which is the agency's dedicated portal for cosmetic facility registration and product listing. Paper submissions are also accepted in limited circumstances.

Renewal Requirements

Facility registration must be renewed biennially (every two years). The renewal window runs from October 1 through December 31 of even-numbered years. The first renewal window was October through December 2024. The next renewal window will be October through December 2026. Failure to renew renders the registration inactive.

Foreign Facility Requirements

Foreign facilities must designate a US Agent — a person or entity physically located in the United States who serves as the point of contact between the foreign facility and FDA. The US Agent must be available during normal business hours to respond to FDA inquiries.

4. Product Listing

In addition to facility registration, FD&C Act Section 607 requires that each cosmetic product distributed in the United States be listed with FDA. Product listing enforcement also began on July 1, 2024.

What to Include in a Product Listing

• Product name (as it appears on the label).
• Product category (using FDA's cosmetic product categories).
• Complete list of ingredients, including fragrances and flavors listed as general categories.
• Responsible person name and contact information.

When to Update

Product listings must be updated annually and whenever there is a change to the product formulation. New products must be listed within 120 days of marketing in the US. Discontinued products should be removed from the listing.

How to File

Product listings are submitted through the same Cosmetics Direct electronic system used for facility registration. The system allows responsible persons to manage all of their product listings in a single account.

Note that the "responsible person" for product listing purposes is typically the manufacturer, packer, or distributor whose name appears on the product label.

5. Small Business Exemption

FD&C Act Section 612 provides a critical exemption for qualifying small businesses. This exemption relieves eligible businesses from the facility registration and product listing requirements — but it does not exempt them from all MoCRA obligations.

Qualification Criteria

A business qualifies for the small business exemption if its average gross annual sales of cosmetic products over the previous 3-year period are less than $1,000,000.

What the Exemption Covers

• Facility registration with FDA (exempt).
• Product listing with FDA (exempt).

What the Exemption Does NOT Cover

• Serious adverse event reporting — required regardless of business size.
• Safety substantiation — required regardless of business size.
• Labeling requirements — required regardless of business size.
• FDA's mandatory recall authority — applies regardless of business size.

When the Exemption Is Forfeited

The small business exemption is forfeited entirely if the business manufactures ANY of the following product types:

• Products intended for use in the area of the eye.
• Injectable cosmetic products.
• Products intended for internal use.
• Products that alter appearance for more than 24 hours under customary use and whose alteration requires removal by the consumer.

This forfeiture applies to the entire business, not just the specific product. If a qualifying small business manufactures even one product in any of the categories above, the exemption is lost for all of its products. The business must then register its facilities and list all of its cosmetic products with FDA.

6. Adverse Event Reporting

FD&C Act Section 605 requires responsible persons to report serious adverse events associated with cosmetic products to the FDA. This requirement has been in effect since December 29, 2023, one year after MoCRA's enactment.

What Qualifies as a "Serious" Adverse Event

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.
• A persistent or significant disability or incapacity.
• A congenital anomaly or birth defect.
• An infection, or
• A condition that requires medical or surgical intervention to prevent one of the outcomes listed above.

Reporting Timeline

The responsible person must submit a serious adverse event report to FDA within 15 business days of the date the responsible person receives the report — not the date the event occurred. This distinction is important: the clock starts when the company becomes aware of the event, not when the consumer experienced it.

Follow-Up and Recordkeeping

Any new medical information received within one year of the initial report must be submitted to FDA as a follow-up within 15 business days of receipt. The responsible person must maintain records of all adverse events (both serious and non-serious) for a minimum of 6 years. These records must be made available to FDA upon request.

Who Is the "Responsible Person"?

The responsible person is the manufacturer, packer, or distributor whose name appears on the cosmetic product label, as defined in FD&C Act Section 604. This is typically the brand owner or the company selling the finished product.

7. Good Manufacturing Practice (GMP)

FD&C Act Section 606 directs FDA to issue regulations establishing Good Manufacturing Practice requirements for cosmetic facilities. As of March 2026, these GMP regulations have not been finalized.

What FDA Has Indicated

FDA has stated that its forthcoming GMP regulations will likely align with ISO 22716:2007 (Cosmetics — Good Manufacturing Practices: Guidelines on Good Manufacturing Practices). ISO 22716 is already the recognized GMP standard for cosmetics in the European Union and many other jurisdictions worldwide.

What ISO 22716 Covers

• Personnel — training, hygiene, and health requirements.
• Premises — facility design, maintenance, and cleaning.
• Equipment — qualification, calibration, and maintenance.
• Raw materials and packaging — supplier qualification, incoming inspection, and storage.
• Production — documented procedures, in-process controls, and batch records.
• Quality control — testing, specifications, and release procedures.
• Documentation and records — standard operating procedures, batch records, and deviation handling.
• Internal audits — periodic self-assessment of GMP compliance.

What Businesses Should Do Now

Although GMP regulations are not yet finalized, FDA strongly recommends that cosmetic manufacturers begin aligning their operations with ISO 22716. Businesses that proactively adopt ISO 22716 practices will be well-positioned when FDA's regulations take effect. Companies already exporting to the EU are likely already in compliance, as ISO 22716 adherence is mandatory under EU Cosmetics Regulation 1223/2009.

Small Business Considerations

MoCRA provides that FDA's GMP regulations may include limited exemptions or modifications for small businesses. The details of any such exemptions will not be known until the final rule is published.

8. Fragrance Allergen Disclosure

FD&C Act Section 610 requires FDA to issue regulations on the disclosure of individual fragrance allergens on cosmetic product labels. As of March 2026, these rules have not been finalized.

What Will Change

When the rules are issued, cosmetic labels will be required to name specific fragrance allergens individually rather than listing "fragrance" or "parfum" as a single catch-all ingredient. This will represent a major shift in US labeling practice. Currently, US cosmetic labeling regulations allow manufacturers to list "fragrance" as a single INCI ingredient without disclosing the individual allergens within the fragrance compound.

Alignment with EU Practice

The EU has required individual fragrance allergen disclosure on cosmetic labels since 2005 under EU Cosmetics Regulation (EC) No 1223/2009, Annex III. Originally 24 allergens, the list was expanded to 80 allergens by Regulation (EU) 2023/1545 (adding 56 new substances), with compliance required for new products by July 31, 2026. The EU requires disclosure when allergens exceed specified concentration thresholds (0.001% in leave-on products, 0.01% in rinse-off products). MoCRA's allergen disclosure rules are expected to move US practice closer to this EU framework.

Current Obligations

Until FDA finalizes its fragrance allergen disclosure rules, the current INCI labeling practice — listing "fragrance" as a single ingredient — remains acceptable and compliant with US federal law. Businesses that already disclose individual allergens (for example, to comply with EU requirements) may continue to do so.

9. How MoCRA Compares to EU Cosmetics Regulation

MoCRA brings US cosmetic regulation closer to the EU framework, but significant differences remain. The following table summarizes key points of comparison.

The most notable gap remains ingredient restrictions: the EU bans or restricts over 1,700 substances, while the US restricts only about 30 at the federal level. MoCRA did not expand FDA's authority to ban specific cosmetic ingredients, though FDA retains the ability to take action against adulterated or misbranded cosmetics.

10. Compliance Checklist

Registration & Listing

• Determine whether your business qualifies for the small business exemption (under $1M average gross annual cosmetic sales over 3 years).
• Confirm you do not manufacture any exemption-forfeiting product types (eye-area, injectable, internal use, or >24-hour alteration).
• Register each manufacturing/processing facility through Cosmetics Direct.
• Obtain or confirm your FDA Establishment Identifier (FEI) for each facility.
• Designate a US Agent if your facility is located outside the United States.
• List each cosmetic product through Cosmetics Direct, including ingredients and responsible person info.
• Set a calendar reminder for biennial registration renewal (Oct-Dec of even-numbered years).
• Update product listings annually and whenever formulations change.

Adverse Event Reporting

• Establish a system to receive and document consumer adverse event reports.
• Train customer-facing staff to identify and escalate serious adverse event reports.
• Create a process for submitting serious adverse event reports to FDA within 15 business days of receipt.
• Maintain records of all adverse events (serious and non-serious) for a minimum of 6 years.
• Establish a follow-up process for new medical information received within one year of the initial report.

Ongoing Compliance

• Ensure adequate safety substantiation exists for every cosmetic product you market.
• Begin aligning manufacturing operations with ISO 22716:2007 in anticipation of FDA GMP regulations.
• Monitor FDA announcements for finalization of GMP and fragrance allergen disclosure rules.
• Review labeling for compliance with current INCI and FD&C Act requirements.
• If exporting to the EU, ensure dual compliance with EU Cosmetics Regulation 1223/2009.

11. Common Mistakes

The following are the most frequent compliance errors businesses make with MoCRA:

Assuming Small Businesses Are Exempt from Everything

The small business exemption under FD&C Act Section 612 only applies to facility registration and product listing. It does not exempt businesses from adverse event reporting, safety substantiation, labeling requirements, or FDA's recall authority. A small business that fails to report a serious adverse event is in violation of MoCRA regardless of its revenue.

Not Renewing Registration Biennially

Facility registration is not a one-time filing. It must be renewed every two years during the October through December window of even-numbered years. A registration that is not renewed becomes inactive, and the facility is considered unregistered.

Filing Through the Wrong FDA System

Cosmetic facility registration and product listing must be filed through Cosmetics Direct, FDA's dedicated cosmetic portal. Some businesses mistakenly attempt to register through FDA's food facility registration system (FURLS) or the drug establishment registration system. These are separate systems for separate product categories.

Confusing Cosmetic Registration with Drug Registration

Products that make therapeutic or drug claims (such as anti-acne, sunscreen, or anti-dandruff products) are regulated as over-the-counter drugs, not cosmetics, even if they are marketed alongside cosmetics. Drug products require separate drug establishment registration, drug listing, and compliance with drug GMP regulations under 21 CFR Parts 210-211. MoCRA's cosmetic registration does not satisfy drug registration requirements, and vice versa.

Not Designating a US Agent for Foreign Facilities

Every foreign facility that manufactures or processes cosmetics for the US market must designate a US Agent — a person or entity physically located in the United States. Submitting a facility registration without a valid US Agent will result in an incomplete registration. The US Agent must be reachable during US business hours and is authorized to act on behalf of the foreign facility in communications with FDA.