Why You Need a US Agent?
Legal background
Navigating the US cosmetics regulatory landscape without a trusted partner can expose you to unnecessary risks and delays. Appointing a US Agent is not just a legal requirement under MoCRA, it is a strategic move to protect your brand and streamline compliance. With Obelis as your US Agent, you benefit from trusted expertise and a direct line of communication with the FDA.
Failing to designate a US Agent can lead to:
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- Refusal of facility and product registrations
- Regulatory action or product holds at US borders
- Missed updates on compliance obligations
- Delays in market entry or costly enforcement measures
Our services
Your Trusted US Agent for Cosmetic Compliance
Obelis serves as your professional US Agent, handling everything from facility and product registrations to adverse event reporting and FDA representation. We ensure your formulas, labels, and technical documentation comply with MoCRA, and we maintain your records up to date. As your single point of contact, we manage regulatory correspondence, support during inspections and recalls, and advise on safety substantiation. You will also benefit from a dedicated consultant, tailored regulatory training, and access to our COSlaw platform, empowering you with real-time insights into US, EU, and UK cosmetic regulations.
FAQ
Frequently Asked Questions
A US Agent for cosmetics, as required by the Modernization of Cosmetics Regulation Act (MoCRA), is an in-country representative who communicates with the US Food and Drug Administration (FDA) on behalf of foreign cosmetic manufacturers and facility operators. This role ensures compliance with US cosmetic regulations and supports smooth market entry.
A MoCRA US Agent for cosmetics manages FDA facility and product registrations, oversees adverse event reporting, and ensures your product labels and documentation meet regulatory standards. They also act as your official point of contact during inspections and recalls, keeping you informed about any regulatory updates.
Failing to appoint a US Agent for cosmetics under MoCRA can lead to rejected facility registrations, delayed market entry, and potential product holds at US borders. You may also miss critical updates from the FDA, increasing the risk of non-compliance and costly enforcement measures.
To appoint a US Agent for cosmetics, you need to officially designate a qualified representative with the FDA. Obelis can handle the entire process, ensuring your facility and products are registered correctly and your business remains inspection-ready.
Yes. Obelis serves as a professional US Agent for cosmetics, offering comprehensive compliance services, including FDA representation, safety substantiation, and regulatory training. We also provide access to our COSlaw platform for real-time insights into US, EU, and UK cosmetic regulations.
