The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the new law for cosmetic products in the United States. It establishes new requirements for brand owners and contract manufacturers. It requires stronger cooperation between entities; therefore, existing agreements must be updated.
Brand owners, contract manufacturers and facilities: definitions and responsibilities
Under MoCRA, a brand owner is the Responsible Person, and it must carry out the following activities:
- Product listing with the FDA
- Preparation and holding of a safety substantiation dossier
- Adverse events recording and serious adverse events reporting
- Comply with Good Manufacturing Practices (GMP) when they are finalized in 2025 if they manufacture the products in their own facility, and labeling requirements
MoCRA also addresses contract manufacturers. MoCRA defines a facility as an establishment manufacturing or processing cosmetic products distributed in the United States, excluding entities that solely perform the following activities: (re)labeling, (re)packaging, holding, and distributing. A contract manufacturer is a facility that manufactures or processes a cosmetic product on behalf of another company.
Facilities are responsible for the following activities:
- Facility registration with the FDA — The Facility Establishment Identifier (FEI) is necessary for brand owners to list their products and needs to be provided to them so that they can list their products with the FDA
Note that a contract manufacturer only needs one FEI number which will be given to each of the brand owners they supply.
- Appointment of a US Agent for non-US facilities
- Compliance with GMP once established by the FDA
Furthermore, considering brand owners’ tasks, contract manufacturers should do the following:
- Provide the brand owner relevant information about ingredients, allergens, etc.
- Remain available for investigation of the causes of adverse events and serious adverse events.
How to regulate the relationship between brand owners and contract manufacturers
MoCRA tightens the link between brand owners and contract manufacturers by setting new requirements for both parties. Therefore, brand owners and contract manufacturers should revise their existing quality agreements in light of MoCRA to ensure they address all novelties. An agreement that clearly defines roles and responsibilities is the best way to avoid issues in the future.
One of the biggest problems between brand owners and contract manufacturers is protecting the latter’s confidential information (such as the formula) while ensuring the owner has access to the data necessary for regulatory compliance. As a contract manufacturer, you must have in place non-disclosure agreements to define this aspect.
With decades of experience in global regulatory affairs, Obelis can help both brand owners and facilities comply with MoCRA.
If you appoint Obelis USA as your US Agent, we will assist you with the above and ensure you meet all regulatory requirements for selling cosmetic products in the United States.
Francesca Santacatterina
Publications department
02.10.2023
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