For decades, the US cosmetic market operated under a regulatory framework that dated back to 1938. The FDA had limited authority, manufacturers largely self-regulated, and foreign exporters could enter the market with minimal federal oversight. That era ended with the Modernization of Cosmetics Regulation Act, commonly known as MoCRA, signed into law in December 2022. MoCRA fundamentally changes the compliance landscape for every company that manufactures, packages, or distributes cosmetic products in the United States — including foreign manufacturers who export to the US market.
Facility Registration Is Now Mandatory
Under MoCRA, every facility that manufactures or processes cosmetic products for the US market must register with the FDA. This is not a voluntary program. If your facility is not registered, your products cannot legally enter US commerce. Registration must be completed through the FDA's electronic system and renewed every two years. Foreign facilities must also designate a US Agent — a person or entity physically located in the United States who serves as the FDA's point of contact. The registration requirement applies to contract manufacturers as well. If you produce cosmetics on behalf of a brand, your facility must be registered independently.
Product Listing: Every SKU on Record
Beyond facility registration, MoCRA requires that every cosmetic product distributed in the United States be listed with the FDA. Product listings must include the product name, category, a list of ingredients, and the name of the Responsible Person. This creates a searchable federal database of all cosmetic products on the US market. For foreign manufacturers with extensive product lines, the listing process demands careful internal cataloging. Each formulation variant, each product name, and each intended use must be documented accurately. Errors or omissions in product listings can trigger FDA enforcement actions.
Adverse Event Reporting: The 15-Business-Day Clock
One of MoCRA's most operationally significant requirements is mandatory adverse event reporting. When a Responsible Person receives a serious adverse event report associated with a cosmetic product, they must report it to the FDA within 15 business days. A serious adverse event includes any health outcome that results in death, a life-threatening condition, hospitalization, persistent disability, or a congenital anomaly. The Responsible Person must also submit any follow-up information received within one year of the initial report. This means foreign manufacturers must establish clear adverse event intake procedures, train customer-facing staff, and maintain records that can withstand FDA scrutiny.
What Counts as a Serious Adverse Event
The FDA defines serious adverse events broadly. Skin reactions requiring medical treatment, allergic responses leading to emergency room visits, and infections caused by contaminated products all qualify. Minor complaints — temporary redness, mild irritation that resolves without treatment — generally do not trigger the reporting requirement. However, the Responsible Person must document all complaints and make a determination for each one. Failing to report a qualifying event is a federal violation.
Safety Substantiation: Prove Your Product Is Safe
MoCRA codifies the expectation that cosmetic products must have adequate safety substantiation. This means manufacturers must maintain records demonstrating that their products are safe under labeled or customary conditions of use. The FDA has not prescribed a single testing methodology, but the substantiation must be based on sound scientific principles. For most manufacturers, this involves a combination of ingredient-level toxicology reviews, stability testing, microbiological testing, and finished product safety assessments. Foreign manufacturers should be aware that the FDA can request access to these records, and an inability to produce them may result in the product being deemed adulterated.
Fragrance Allergen Disclosure
MoCRA introduces new labeling requirements for fragrance allergens. The FDA is developing a list of allergens that must be individually disclosed on product labels, rather than being hidden behind the generic term 'fragrance.' While the final allergen list has not yet been published, manufacturers should begin reviewing their formulations and preparing label artwork that can accommodate individual allergen declarations. The EU has enforced similar requirements for years under the Cosmetics Regulation, so manufacturers already exporting to Europe may have a head start on compliance.
GMP Requirements on the Horizon
MoCRA directs the FDA to establish Good Manufacturing Practice regulations for cosmetic facilities. While the final GMP rule has not yet been issued, the FDA is expected to align its requirements with ISO 22716, the international standard for cosmetic GMP. Manufacturers who already operate under ISO 22716 or similar quality management systems will likely find the transition manageable. Those without formal GMP programs should begin implementing documented procedures for production, quality control, storage, and distribution now — before the rule is finalized and enforcement begins.
Small Business Exemptions and Limitations
MoCRA provides limited exemptions for small businesses with average annual gross sales of less than one million dollars over the previous three-year period. Qualifying small businesses are exempt from certain requirements, including facility registration and product listing. However, they are not exempt from adverse event reporting, safety substantiation, or the prohibition on adulterated and misbranded products. The exemption also does not apply to businesses that manufacture products containing certain categories of ingredients that the FDA designates as requiring additional oversight. Foreign manufacturers should not assume the small business exemption applies to them without careful analysis of their US revenue.
The Responsible Person: Who Bears the Legal Burden
MoCRA introduces the concept of the Responsible Person, defined as the manufacturer, packer, or distributor whose name appears on the product label. For foreign manufacturers, the Responsible Person is typically the US-based importer or distributor. The Responsible Person bears primary responsibility for adverse event reporting, product listing, and maintaining safety records. This means your US partner is legally accountable for your products. If your US distributor is not prepared to fulfill these obligations, your market access is at risk. FDABridge recommends that foreign manufacturers establish clear contractual agreements with their US partners defining who handles each MoCRA obligation.
FDA Enforcement Powers Under MoCRA
MoCRA grants the FDA significantly expanded enforcement authority over cosmetics. The agency now has the power to issue mandatory recalls — previously, all cosmetic recalls were voluntary. The FDA can also suspend the registration of facilities that pose a reasonable probability of serious adverse health consequences. Additionally, MoCRA includes federal preemption provisions that prevent states from establishing their own cosmetic registration or adverse event reporting requirements, creating a single national standard. For foreign manufacturers, this means the FDA is no longer a passive regulator. Inspections, warning letters, import alerts, and mandatory recalls are all tools the agency can deploy against non-compliant products.
Key Compliance Dates
Facility registration and product listing requirements took effect on July 1, 2024. Adverse event reporting requirements are already in effect. GMP regulations and fragrance allergen labeling requirements will be phased in over the coming years as the FDA finalizes the relevant rules. Foreign manufacturers who have not yet completed their facility registration and product listings are already operating outside federal law.
FDABridge provides end-to-end MoCRA compliance services for foreign cosmetic manufacturers, including FDA facility registration, product listing preparation, Responsible Person designation support, adverse event reporting systems, and safety substantiation reviews. Visit fdabridge.com/cosmetics to learn how we can prepare your brand for the US market, or contact us directly at fdabridge.com/contact.
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