Tag: fda-agent
Responsible Person vs. U.S. Agent: What Every Cosmetics Company Needs to Know
If you’re bringing a cosmetic product into the United States, you’ve probably run into two terms that sound like they mean the same thing: Responsible Person and U.S. Agent. Mixing them up is one of the most common compliance mistakes we see from international cosmetics brands, and it can leave a gap in your FDA…
FSVP vs. U.S. Agent: What’s the Difference?
FSVP and U.S. Agent are not the same FDA role. Learn the legal difference, who needs each one, and how FDA Entry can help as your U.S. Agent.
Importing Cosmetics into the United States: A Beginner’s Guide for International Brands
This guide walks through the basics: what counts as a cosmetic under U.S. law, what doesn’t need FDA oversight at all, what MoCRA actually requires of you, and how a shipment moves through customs. It’s written for someone doing this for the first time, not for a regulatory specialist.
What Is FDA Prior Notice and Why Does It Matter for Your U.S. Shipment?
If you’re exporting food, beverages, or animal feed to the United States, you’ve likely encountered the term Prior Notice. Missing this requirement, or getting it wrong, can stop your shipment at the border, leading to costly delays and product destruction. Here is what you need to know to keep your cargo moving. What Is Prior Notice?…
Top 10 Questions About FDA Registered Agents — Answered
Use this 8-step FDA compliance checklist to avoid costly shipment delays and ensure your products enter the U.S. smoothly.
Navigating FDA Requirements: Establishment Registration Explained
If your company is based outside of the United States, the FDA has one more requirement during that registration process: you need to name a U.S. Agent.