Cosmetic Product Compliance in the US Under MoCRA: What Foreign Brands Must Know

MoCRA has introduced several requirements for Cosmetic companies selling products in the United States. These include facility registration, product listing, safety documentation, recordkeeping, serious adverse event reporting, labelling, and post-market responsibilities. Meeting these requirements is important for companies to maintain MoCRA compliance and follow applicable US regulatory requirements when marketing Cosmetic products in the United States.

What Foreign Brands Must Know About MoCRA

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was introduced to strengthen the regulation of Cosmetics in the United States and update the regulatory framework established under the Federal Food, Drug, and Cosmetic Act since 1938. This law introduced new requirements to help improve the safety of Cosmetic products used by consumers in the United States. 

MoCRA also introduced requirements for product listing, safety substantiation, serious adverse event reporting, Good Manufacturing Practices, records access, and mandatory recall authority under US Cosmetic regulations.¹ 

Registration and Listing Requirements for Selling Cosmetics in the US

Under MoCRA, foreign manufacturers and processors whose Cosmetic products are marketed in the United States must register their facilities with the FDA. This requirement forms an important part of Cosmetic facility registration US requirements for companies marketing Cosmetics in the country.

The table below summarises the main registration and product listing requirements for foreign Cosmetic brands selling Cosmetics in the United States.² 

Table 1

Meeting Product Safety and Recordkeeping Requirements

MoCRA also requires companies to maintain evidence that their Cosmetic products are safe before they are marketed in the United States.¹ 

These are some of the main product safety and recordkeeping requirements for MoCRA compliance:

• Companies should maintain records that support the safety of their Cosmetic products using appropriate tests, studies, research, analyses, or other scientific evidence. 
• The available safety information should be based on scientifically robust methods, and animal testing is not mandatory to market Cosmetic products in the United States. 
• If the FDA has reason to believe that a Cosmetic product may present a serious health risk, it can request access to safety records and other relevant documents needed for its evaluation.¹ 
• Responsible persons should keep records of adverse events associated with their Cosmetic products for six years, while eligible small businesses are required to maintain these records for three years.³ 

Reporting Serious Adverse Events Under MoCRA

Foreign Cosmetic brands should report serious adverse events as part of their post-market compliance responsibilities under MoCRA. 

These are the important requirements for reporting serious adverse events of Cosmetic products are marketed in the United States.

• If any information is received regarding a serious adverse event when taking a Cosmetic product, the responsible person needs to submit the report to FDA within 15 days.
• A copy of the Cosmetic product label on or within the retail packaging should be included with the serious adverse event report submitted to the FDA. 
• If additional medical information related to the reported adverse event is received within one year of the initial report, it should also be submitted to the FDA within 15 business days. 
• Serious adverse event reports may be submitted electronically or through paper forms using the reporting methods provided by the FDA. 

FDA Actions for Non-Compliance

MoCRA authorises the FDA to take regulatory action when Cosmetic products or facilities do not comply with the applicable FDA Cosmetic registration and other regulatory requirements.

The following enforcement actions may apply under specific circumstances:

• The FDA may suspend a facility’s registration if a Cosmetic product manufactured or processed at that facility has a reasonable probability of causing serious adverse health consequences or death, and other products from the same facility may also be affected.² 
• Before suspending a facility registration, the FDA provides notice to the registrant and an opportunity to submit a plan to address the identified issues.³ 
• If a Cosmetic product is adulterated or misbranded and may cause serious adverse health consequences or death, the FDA may ask the responsible person to voluntarily stop distribution and recall the product.
• If the responsible person does not voluntarily recall the product, the FDA may order a mandatory recall and require the product to be removed from distribution in the United States.

Regulatory Support for MoCRA Compliance

Foreign Cosmetic brands need to manage registration, product information, safety documentation, labelling, and post-market requirements when entering the US market.

The key regulatory activities involved in supporting Cosmetic product compliance are presented in the flowchart below:

Figure description: A six-step workflow showing the main regulatory activities involved in supporting Cosmetic product compliance under MoCRA.

Figure 1

These activities require careful coordination to ensure that regulatory requirements are addressed throughout the product lifecycle. CliniExperts provides regulatory consulting and compliance support across multiple regulated product areas, including Cosmetics, with experience supporting regulatory requirements and US FDA-related work.⁴

Conclusion

MoCRA has introduced several important requirements for Cosmetic brands selling products in the United States. Companies need to meet requirements for facility registration, product listing, safety documentation, labelling, adverse event reporting, and post-market compliance. Following US Cosmetic regulations can help companies maintain compliance and reduce regulatory risks. Proper regulatory planning and ongoing monitoring are also important for supporting continued compliance in the US market over time.

References 

1. Commissioner O of the. Modernization of Cosmetics Regulation Act of 2022 (MoCRA). FDA. March 13, 2026. Accessed August 11, 2026. https://www.fda.gov/Cosmetics/Cosmetics-laws-regulations/modernization-Cosmetics-regulation-act-2022-mocra

2. Commissioner O of the. Registration & Listing of Cosmetic Product Facilities and Products. FDA. July 2, 2026. Accessed August 11, 2026. https://www.fda.gov/Cosmetics/registration-listing-Cosmetic-product-facilities-and-products

3. Consolidated Appropriations Act, 2023. 2022. https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf

4. Regulatory Outsourcing -CliniExperts. Accessed August 12, 2026. https://cliniexperts.com/strategic-regulatory-outsourcing-for-life-sciences/