Tag: fda
FDA Food Facility Registration Renewal 2026: The Window Is Now Open
The FDA food facility registration renewal window opened October 1, 2026 and closes December 31, 2026. Every food facility that is required to register must renew in this window. The FDA will consider the registration of any facility that does not renew by December 31, 2026 to be expired. Registration renewal happens every two years,…
When Does a Cosmetic Become a Drug?
If you sell a cream, serum, or shampoo into the U.S. market, the ingredients aren’t what decide whether FDA treats your product as a cosmetic or a drug. The claims you make about it do. This is a very important factor to consider. You could be looking at an unapproved drug on the market, a…
How to Import Food Into the US: A Step-by-Step Guide
Importing food into the United States is not a single filing. It is a chain of separate requirements, run by two different federal agencies, that all have to be satisfied before your shipment reaches a store shelf. Miss one link and FDA can hold your product at the port, no matter how good the product…
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?…
Why Every International Manufacturer Needs a U.S. FDA Registered Agent (and How to Choose the Right One)
Your Complete Guide to FDA Registration, U.S. Agent Requirements, and Smooth Importing If your company is located outside the United States and you want to sell food, cosmetics, medical devices, supplements, or pharmaceuticals in the U.S. market, the U.S. Food and Drug Administration (FDA) requires you to appoint a U.S. FDA Registered Agent. This role is not optional—it’s…
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.