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Responsible Person and US Agent — Key roles for compliance under MoCRA

In the United States, the Responsible Person and US Agent are essential in the compliance of cosmetic products. Below is an overview of their role and responsibilities under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the new federal law on cosmetic products.

Responsible Person: Definition and Responsibilities

The law defines the Responsible Person as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label. Hence, the Responsible Person is the brand owner and is accountable for compliance.

The Responsible Person is responsible for the following activities:

  • Products and facilities registration with the FDA
  • Adverse events recording and evaluation
  • Serious adverse events reporting
  • Holding of safety substantiation dossier
  • Compliance with Good Manufacturing Practices (GMP) and labelling requirements
  • Communication with the FDA, including fragrance disclosure

Responsible Person: Differences with the EU

According to European Union law, cosmetic and personal care brands based outside the EU must appoint an EU-based entity as their Responsible Person (RP). Additionally, EU companies can designate another entity as RP by written mandate to take over their responsibilities.

Conversely, in the United States, the brand owner remains the Responsible Person, even if located outside the US. However, the brand owner can delegate another entity to carry out its duties, but it always remains accountable for such activities.

Here is where Obelis steps in! If you are a beauty brand selling cosmetic products in the United States, you can appoint Obelis USA as your regulatory consultant or US Agent. Our team of regulatory professionals will ensure you are compliant with the law. But why should a brand owner outsource its obligations to another entity if it remains accountable? Precisely because the brand owner is liable, we recommend that it engages a professional regulatory company with the expertise and capabilities to perform these activities smoothly.

US Agent: A new role

MoCRA introduces a new role, the US Agent. Foreign facilities manufacturing or processing cosmetic products must appoint a US Agent. MoCRA does not clearly define the responsibilities of the US Agent; however, they will likely resemble those of the US Agent for medical devices. Therefore, its main role will be representing non-US facilities with the FDA, facilitating communication, and replying to authorities’ queries.

Moreover, MoCRA requires that all labels include a domestic address or electronic contact information in the United States by December 29, 2024. Consumers will use these details to report adverse events. Considering this, beauty brands outside the United States can appoint a US Agent and use its address on the labels.

Besides that, as mentioned above, the US Agent can support the manufacturer on several aspects related to regulatory compliance.

How can Obelis help you?

If you appoint Obelis as your US Agent or regulatory consultant, we will list your products and register your facilities. And we will do much more! Our team of regulatory professionals will support you to ensure your products meet MoCRA requirements and can be lawfully sold in the United States. We will make the compliance path as easy as possible.

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Francesca Santacatterina

Publications Department



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