MoCRA Requirements for Cosmetics Importers: 2026 Guide

Understanding MoCRA requirements is now part of importing and selling cosmetics in the U.S. The Modernization of Cosmetics Regulation Act of 2022 gave FDA its biggest expansion of cosmetics authority in more than 80 years. Some requirements have been enforced since 2024, while others, including fragrance allergen labeling and good manufacturing practice rules, are still waiting on FDA. This guide covers where each requirement stands in September 2026 and what importers and beauty brands need to do.

MoCRA Requirements at a Glance

Who Is the Responsible Person Under MoCRA?

The responsible person is the manufacturer, packer or distributor whose name appears on the product label. For imported cosmetics this is often the U.S. brand owner or importer. The responsible person handles product listing, adverse event reporting, safety substantiation and labeling compliance, so it is the first thing to settle before a product ships.

Facility Registration and Product Listing

Facilities that manufacture or process cosmetics for U.S. distribution must register with FDA and renew every two years. Foreign facilities must name a U.S. agent. Products are listed by the responsible person, with listings updated each year. New facilities register within 60 days of starting operations, and new products are listed within 120 days of going on the market. FDA’s preferred filing tool is Cosmetics Direct.

MoCRA Labeling Requirements

Since December 29, 2024, cosmetic labels must include a domestic U.S. address, phone number or electronic contact where consumers can report adverse events. This is on top of existing FDA cosmetic labeling rules for identity, net contents, ingredients and warnings. Fragrance allergen labeling is required by the law, but FDA has not yet issued the rule; its regulatory agenda lists a proposed rule for November 2026. Watch for it, because label changes take time to work through packaging inventory.

Adverse Event Reporting and Safety Substantiation

Serious adverse events must be reported to FDA within 15 business days of the responsible person receiving the report, and new medical information received within a year must also be reported within 15 business days. The responsible person must also keep records that support each product’s safety.

What Is Still Pending

• Good manufacturing practice: The law required a final GMP rule by December 29, 2025. FDA has not proposed one and lists it as a long-term action. FDA’s older draft GMP guidance still applies as a reference.
• Fragrance allergens: Proposed rule listed for November 2026.
• Talc: FDA withdrew its proposed asbestos testing rule for talc-containing cosmetics on November 28, 2025 and plans to reissue it.

Small Business Exemptions

Qualifying small businesses, generally those averaging less than $1 million a year in U.S. cosmetic sales over the prior three years (adjusted for inflation), are exempt from facility registration, product listing and GMP. The exemption does not apply to products that contact the mucous membranes of the eye, are injected, are intended for internal use, or alter appearance for more than 24 hours. Small businesses still have to report adverse events, keep safety records and meet labeling rules.

What Cosmetics Importers Should Do Now

1. Confirm who the responsible person is for every product you import.
2. Check that each foreign manufacturing facility is registered and has named a U.S. agent.
3. Confirm each product is listed, and diary the annual listing update.
4. Audit labels for the U.S. adverse event contact.
5. Set up an adverse event intake and 15-business-day reporting process.
6. Keep safety substantiation files current, and watch for the fragrance allergen and GMP rules.

How Argents Supports Beauty and Cosmetics Brands

Argents is a licensed U.S. customs broker, freight forwarder and 3PL with FDA-registered facilities in Elgin, IL and Ladson, SC. We clear imported cosmetics with FDA data at entry, store and fulfill beauty products, and build gift sets through our kitting and assembly services. See our customs clearance services, or contact us to talk through your products.

Frequently Asked Questions

What are the main MoCRA requirements?

Facility registration, product listing, serious adverse event reporting, safety substantiation and a U.S. adverse event contact on labels. Fragrance allergen labeling and GMP rules are required by the law but not yet issued by FDA.

What are the MoCRA labeling requirements?

Since December 29, 2024, labels must include a domestic address, phone number or electronic contact for adverse event reports. Fragrance allergen labeling will be added once FDA issues its rule.

Do foreign cosmetics manufacturers have to register with FDA?

Yes. Foreign facilities that manufacture or process cosmetics for the U.S. must register with FDA and name a U.S. agent.

Are there MoCRA exemptions for small businesses?

Yes. Qualifying small businesses are exempt from registration, listing and GMP, but not from adverse event reporting, safety substantiation or labeling. Certain higher-risk products are not eligible.

Has FDA issued the MoCRA GMP rule?

Not as of September 2026. The statutory deadline passed on December 29, 2025, and FDA lists the rule as a long-term action.

Sources: FDA MoCRA overview; FDA registration and listing. Updated September 2026. General information, not legal or regulatory advice.