MoCRA & the US Agent: A New Era for Cosmetics in the USA

The US cosmetics industry has entered a new era of regulation with the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This landmark legislation, the first major update to federal cosmetic regulations since 1938, introduces significant changes impacting both domestic and international cosmetic companies. Central to these changes are the concepts of the "Responsible Person" and the "US Agent."

Understanding the Responsible Person

MoCRA establishes the "Responsible Person" as the manufacturer, packer, or distributor whose name appears on a cosmetic product's label. This individual or entity bears the primary responsibility for ensuring the product's safety and compliance with MoCRA requirements. Their duties include:

• Ensuring product safety: Substantiating product safety through adequate testing and record keeping.

• Registering facilities: Registering manufacturing facilities with the FDA.

• Listing products: Submitting product listings to the FDA, including ingredient information.

• Reporting adverse events: Reporting serious adverse events to the FDA.

• Maintaining records: Maintaining records supporting product safety and compliance.

The Role of the US Agent

For international companies marketing cosmetics in the US, MoCRA introduces a critical requirement: the designation of a US Agent. This agent must reside in the United States and serve as the domestic point of contact for the FDA.

Key Responsibilities of the US Agent:

• Communication with the FDA: Acting as the primary point of contact for the FDA on behalf of the foreign Responsible Person.

• Assisting with compliance: Assisting the Responsible Person in fulfilling MoCRA requirements, such as facilitating communication and providing information to the FDA.

• Receiving official correspondence: Receiving and forwarding official communications from the FDA to the Responsible Person.

Why is a US Agent Necessary?

The US Agent requirement ensures that the FDA has a readily accessible point of contact within the US for addressing any compliance issues or safety concerns related to imported cosmetic products. This strengthens the FDA's oversight and enhances consumer protection.

Choosing a US Agent:

Selecting a reliable and experienced US Agent is crucial for international cosmetic companies. Key considerations include:

• Regulatory expertise: A strong understanding of US cosmetic regulations, including MoCRA.

• Communication and responsiveness: Effective communication skills and prompt responsiveness to FDA inquiries.

• Reliability and trustworthiness: A proven track record of reliability and adherence to ethical standards.

Kompass Europe and US Agent Services:

While Kompass Europe specializes in EU and UK cosmetics regulations, we recognize the importance of supporting our clients in their global expansion efforts. We can connect you with trusted partners and resources to fulfill your US Agent requirements under MoCRA.

MoCRA represents a significant shift in the US cosmetics landscape. By understanding the roles of the Responsible Person and the US Agent, and by partnering with knowledgeable experts, international companies can confidently navigate these new regulations and successfully access the US market.