MoCRA for Canadian Cosmetic Exporters: Registration, Listing and the Coming GMP Rule

For most of the last century, the United States regulated cosmetics with a light touch. That changed with the Modernization of Cosmetics Regulation Act of 2022, known as MoCRA, the largest expansion of the U.S. Food and Drug Administration's authority over cosmetics in decades. If your company makes or sells cosmetics in the United States from a Canadian base, MoCRA now sets obligations you cannot meet with a Health Canada Cosmetic Notification Form alone.

The good news for Canadian exporters is that much of the work overlaps with what you already do for Health Canada, and a single, well organized compliance file can serve both markets. This article explains what MoCRA requires, who is responsible, what is already in force, and what is still coming, so you can prepare your facilities, listings, and safety records before your next shipment crosses the border.

Executive Summary

MoCRA gives the FDA new authority over cosmetics sold in the United States, including mandatory facility registration, product listing, safety substantiation, serious adverse event reporting, and recall powers. Canadian companies that export cosmetics to the United States are affected. Foreign facilities must register and name a U.S. agent, the responsible person must list each product, and more rules on good manufacturing practice and fragrance allergen labelling are still to come.

What Is MoCRA, and Why It Matters

What is it? MoCRA is the Modernization of Cosmetics Regulation Act of 2022, which amended the U.S. Federal Food, Drug, and Cosmetic Act. It replaced a largely voluntary system with mandatory requirements: facility registration, product listing, safety substantiation, adverse event reporting, recordkeeping, and, for the first time, FDA authority to order a mandatory recall of a cosmetic.

Why it matters for Canadian exporters. A Canadian brand that sells into the United States, or a Canadian contract manufacturer that makes cosmetics shipped to the United States, now sits inside the FDA's oversight. Meeting Health Canada's Cosmetic Regulations does not satisfy MoCRA, because the two systems ask for different things. Treating MoCRA as a separate, parallel file is the safest approach.

Who Is the Responsible Person

Definition. The responsible person is the manufacturer, packer, or distributor whose name appears on the label of a cosmetic product. That company carries most MoCRA duties: product listing, safety substantiation, labelling, and serious adverse event reporting. For a Canadian brand whose name is on the label, the Canadian company is usually the responsible person, even though the product is sold in the United States.

Clarifying who the responsible person is should be the first step, because the answer decides who registers, who lists, and who keeps the safety file. A contract manufacturer and a brand owner can each have duties, and assuming the other party will handle everything is a common and costly error.

Facility Registration: What Canadian Exporters Must Do

What to do. Every facility that manufactures or processes cosmetics for distribution in the United States must register with the FDA. This includes foreign facilities, so a Canadian manufacturing site that makes product for the U.S. market must register. Registration must be renewed every two years, and each foreign facility must designate a U.S. agent who serves as a domestic contact for the FDA. The FDA can suspend a facility's registration where a product is likely to cause serious harm, which stops distribution from that site.

Registration is submitted electronically through the FDA's Cosmetics Direct portal. Practical points for Canadian exporters: confirm which legal entity owns or operates the site, appoint a U.S. agent and keep the contact current, and calendar the two year renewal so the registration never lapses. A missing or expired U.S. agent is one of the most common reasons a registration stalls.

Product Listing

What to do. The responsible person must submit a cosmetic product listing for each marketed product, including its ingredients, and update that listing every year. Listing is separate from facility registration. One facility can make many listed products, and one responsible person can be behind products made at several facilities. Keep a master list that ties each product to its facility, its ingredients, and its listing number so annual updates are routine rather than a scramble.

Deadlines and the Enforcement Timeline

Where things stand. The registration and listing requirements took effect under the statute in late 2023. The FDA then exercised enforcement discretion and did not enforce those requirements until 1 July 2024. They are now in effect, so a new facility or product should be registered and listed without waiting. Other duties, such as safety substantiation and adverse event reporting, also apply now. The good manufacturing practice rule and the fragrance allergen labelling rule are still being developed.

Safety Substantiation, Adverse Events, and Records

What to do. The responsible person must maintain records that adequately substantiate the safety of each cosmetic product. MoCRA does not require specific tests and does not require animal testing, but the evidence must be scientifically sound. The responsible person must also report serious adverse events that occur in the United States to the FDA within 15 business days, with a copy of the label, and must submit new information received within one year of that report within a further 15 business days. These records must be available to the FDA during an inspection.

For a Canadian exporter, the practical takeaway is that a safety file cannot be an afterthought. Assemble the formulation, the safety assessment, the stability data, and the supporting literature into a single, retrievable record for each product. The absence of a written safety substantiation is one of the clearest gaps an FDA review would flag.

Labelling and the Coming Fragrance Allergen Rule

What to do. MoCRA requires the responsible person contact information to appear on the label so consumers can report adverse events. MoCRA also directs the FDA to establish fragrance allergen labelling requirements, similar in spirit to disclosure rules in other markets. A proposed rule has been expected, but the fragrance allergen requirement is not yet in force. Canadian exporters should track the rule and plan for label changes once it is final, rather than waiting for a short compliance window.

Canadian brands already working through Canadian fragrance allergen disclosure requirements have a head start, because much of the ingredient analysis carries over. The same is true for brands that have mapped their formulas against the Health Canada Cosmetic Ingredient Hotlist. Build one allergen dataset and reuse it for both markets.

The Cosmetic GMP Rule That Is Coming

What to do. MoCRA directs the FDA to establish good manufacturing practice regulations for cosmetic facilities. The rule is still in development and is not yet in force, so there is no fixed compliance date to plan against yet. The smart move is not to wait. Building a documented quality system now, aligned with the international cosmetics GMP standard ISO 22716, means your site will already meet most of what a U.S. rule is likely to require.

Our cosmetics GMP and ISO 22716 guide sets out the quality system elements that apply across Canada, the European Union, and the United States: documented procedures, trained personnel, controlled production and batch records, supplier controls, and complaint and recall handling. A site built to ISO 22716 is in a strong position whenever the FDA GMP rule lands.

What MoCRA Looks Like in Practice

Consider a Canadian skincare brand that manufactures at its own site near Toronto and ships to U.S. retailers. In a readiness assessment, three gaps surface. First, the facility is not registered, because the team assumed the U.S. retailer would handle it. Second, there is no U.S. agent on file, which would stall the registration. Third, the safety substantiation exists as scattered supplier documents rather than a single assessment per product.

The fixes are straightforward once identified: register the facility through Cosmetics Direct, appoint a U.S. agent and record the contact in the quality system, and compile a safety substantiation file for each listed product. The brand then sets a corrective and preventive action to calendar the two year registration renewal and the annual listing update, so the gaps do not reopen. None of this duplicates the Health Canada notification already on file, but all of it is required to sell lawfully in the United States.

How MoCRA Fits With Health Canada's Rules

The overlap. Canada and the United States regulate cosmetics differently, but the underlying evidence often overlaps. In Canada, a company files a Cosmetic Notification Form within ten days of first sale and must keep its ingredients off the Cosmetic Ingredient Hotlist. In the United States, the company registers its facility, lists its products, and keeps a safety substantiation file. Building one organized dataset of formulas, ingredients, and safety evidence lets you feed both systems from a single source.

Where a product sits on the line between a cosmetic and a drug, the classification question matters in both countries. Our note on how Health Canada drew that line for exosome skincare, cosmetic or drug, shows why claims decide the regulatory path, a theme that applies equally to U.S. market entry.

Compliance Checklist: MoCRA for Canadian Cosmetic Exporters

• Confirm whether your company is the responsible person for each product sold in the United States.
• Register every foreign facility that manufactures or processes your cosmetics for the U.S. market, and renew every two years.
• Designate a U.S. agent for each foreign facility and keep the contact details current.
• List each marketed cosmetic product and its ingredients with the FDA, and update the listing every year.
• Build and keep records that adequately substantiate the safety of each product.
• Put the responsible person contact details on the label so consumers can report adverse events.
• Set up a procedure to report serious adverse events to the FDA within 15 business days, with a copy of the label.
• Keep adverse event records for the required period and make them available during an inspection.
• Review labels for U.S. requirements and plan for the coming fragrance allergen rule.
• Prepare for the GMP rule by building a documented quality system now, aligned with ISO 22716.
• Confirm whether a small business exemption applies, and remember it does not cover certain higher risk products.
• Map your Canadian notifications and Hotlist work against U.S. requirements so one file supports both markets.

Common Mistakes to Avoid

• Assuming a Canadian Cosmetic Notification Form covers U.S. obligations. It does not. Registration and listing are separate.
• Forgetting to appoint a U.S. agent for a foreign facility, which stalls the registration.
• Letting a facility registration lapse. It must be renewed every two years.
• Treating product listing as a one time task. It must be updated every year.
• Believing there are no rules yet because the GMP and allergen rules are not final. Registration, listing, safety substantiation, and adverse event reporting already apply.
• Relying on a supplier or retailer to register when your company is the responsible person.
• Keeping no written safety substantiation, which is one of the clearest gaps an FDA review would find.
• Assuming the small business exemption applies to every product, including eye area, injected, or internal use products, which are excluded.

Frequently Asked Questions

Do Canadian cosmetic companies need to register with the FDA under MoCRA?

If your company manufactures or processes cosmetics outside the United States for sale in the United States, the facility generally must register with the FDA and renew every two years, and you must designate a U.S. agent. The responsible person must also list the products and keep a safety file.

Who is the responsible person under MoCRA?

The responsible person is the manufacturer, packer, or distributor whose name appears on the label of the cosmetic product. That company is responsible for product listing, safety substantiation, adverse event reporting, and labelling.

What is the deadline to register and list?

The statutory requirement took effect in late 2023, and the FDA exercised enforcement discretion until 1 July 2024. Registration and listing are now in effect, so new facilities and products should be registered and listed without waiting.

Is there a cosmetic GMP rule yet?

Not yet. MoCRA directs the FDA to establish good manufacturing practice regulations for cosmetics, but the rule is still in development. Building a documented quality system aligned with ISO 22716 now is the best way to prepare.

What about fragrance allergen labelling?

MoCRA directs the FDA to establish fragrance allergen labelling requirements. A proposed rule has been expected, but the requirement is not yet in force. Track the rule and plan for label updates once it is final.

Does a small business exemption apply to us?

Certain small businesses are exempt from the GMP, registration, and product listing requirements based on average gross annual cosmetic sales. The exemption does not apply to products that contact the mucous membrane of the eye, are injected, are intended for internal use, or alter appearance for more than 24 hours. Confirm your status before relying on it.

How MFLRC Can Help

MFLRC helps Canadian cosmetic brands and contract manufacturers meet MoCRA without duplicating the work they have already done for Health Canada. We run U.S. readiness gap assessments, confirm who the responsible person is, support FDA facility registration and product listing, help appoint and brief a U.S. agent, build safety substantiation files, and set up adverse event reporting procedures. Because the GMP rule is coming, we build quality systems aligned with ISO 22716 so your site is ready for inspection, and we support cosmetic market entry and compliance across Canada, the United States, and the European Union. We also map your Hotlist and fragrance allergen work to U.S. requirements so a single, well organized file supports every market you sell into.

Exporting cosmetics to the United States? Book an MFLRC MoCRA readiness assessment to confirm your registration, listing, and safety files before your next shipment.

Conclusion

MoCRA turned U.S. cosmetic oversight from a light touch system into one with registration, listing, safety substantiation, and recall authority, and more rules are still coming. For Canadian exporters, the work is manageable and often overlaps with what Health Canada already expects. Register your facilities, appoint a U.S. agent, list your products, keep safety and adverse event records, and build a quality system ready for the GMP rule. A single, organized compliance file can carry your brand confidently in both markets.

Sources and References

• U.S. FDA, Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
• U.S. FDA, Registration and Listing of Cosmetic Product Facilities and Products
• U.S. FDA, Cosmetics Direct electronic submissions portal
• Health Canada, Cosmetics