In this short video, FDA compliance attorney Lisa Capote covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa, an FDA compliance attorney. Dietary supplement facility registration — let’s cover exactly what you need to know.
If your facility manufactures, processes, packs, or holds dietary supplements intended for sale in the United States, you are required to register with the FDA under 21 CFR Part 1. This applies to both domestic and foreign facilities.
Registration is done through the FDA’s Unified Registration and Listing System — FURLS — online. The application asks for information about your facility’s name and address, the types of activities you perform, and the types of products you handle.
Here’s an important deadline: registration must be renewed every two years, and the renewal window is October 1 through December 31. If you miss the renewal window, your registration lapses, and distributing supplements from an unregistered facility is a prohibited act under federal law.
When you renew, you’ll also need to verify that all information is current and accurate. If your facility has moved, your ownership has changed, or the types of products you make have changed, those updates need to be reflected in your registration.
New facilities must register before they begin manufacturing. You can’t manufacture and then register after the fact.
Registration is foundational — it’s one of the first things an FDA investigator checks during an inspection, and it’s one of the first things buyers and retailers ask about when evaluating suppliers. Get it right and keep it current. If you need help with registration or have questions about whether your facility requires registration, reach out. We can help.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.