Category: FDA Regulations & Updates
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.
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?…
Step-by-Step Guide for Importers Needing to Register a Food Facility with the FDA
If your company manufactures, processes, packs, or holds food intended for U.S. consumers, FDA food facility registration is not optional. Under the Food Safety Modernization Act (FSMA), food from unregistered foreign facilities can be held at the U.S. port of entry, a costly disruption no importer wants to face. Here’s exactly what you need to…
The FDA Just Launched a New Import Resource Hub: Here’s What Every Importer Needs to Know
If you import (or plan to import) products into the United States, the FDA just made your life a little easier. On May 18, 2026, the agency launched a new centralized page: FDA Import Educational Resources. It’s a one-stop hub of videos, quick guides, and organized links covering every stage of the import process. It’s a…
How to Choose the Right FDA Registered Agent in 2026: A Practical Guide for International Companies
If you manufacture or export FDA-regulated products to the United States, choosing the right FDA Registered Agent is no longer a box-checking exercise. In 2026, FDA enforcement, data transparency, and cross-border communication expectations are higher than ever. For international companies, the right U.S. agent can mean the difference between smooth market access and costly delays,…
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.