Frequently Asked Questions

Who needs to register?

Any food facility manufacturing, packing, importing, or distributing food intended for consumption in the US must register with the FDA. Whether such food products are sold directly or indirectly, as long as said food products are intended for consumption in the United States, the facility is required to maintain an FDA registration, regardless of sale volume.

How does the registration process work?

1. Open a free account on our website — no payment required to start!
2. Obtain a DUNS number from D&B (Need help?).
3. Fill out the short registration form, choose a plan (1, 2, or 3 years) and submit your application.
4. Our specialists verify the information and reach out if clarifications are needed.
5. We prepare the information and submit it to the FDA.
6. We wait for an approved registration and send you a certificate.
7. Congratulations — you are now registered with the FDA!

How long does the registration process take?

From submission of application to final certificate it may take 48–72 hours, though the majority of businesses see shorter waiting times. Faster than you thought, right?

What are the specific documents and information we need to provide in order to register?

While the FDA may request certain documents, in the vast majority of cases, no documents are necessary. The FDA uses your DUNS number to verify the location of your business, and if any documents are required, we will let you know.

What does the US Agent service provide?

We not only register your business with the FDA — we also provide our expert US Agent services. As part of our obligation to you, and to ensure full compliance with the FDA (21 U.S.C. section 350d), our experts maintain an open line of communication ready to receive any requests and notices, however rare, from the FDA. In the extremely rare event that a notice or request is received from the FDA, we will notify you of such request and forward any notices to you.

Does our specific food product need any FDA approval?

The FDA does not approve food products. While there are several regulations related to food safety, labeling, and ingredients, food products do not require prior approval as long as they are compliant with FDA standards and regulations.

How much does it cost?

Our guarantee is to offer the lowest price possible — globally. We are able to offer such low prices by relying heavily on strong professional automation and leading-edge technology that almost no other agencies provide.

How often do we need to renew the registration?

We are registered with a different agent — how can we transfer over to FDA Express?

Very simply. All you have to do is create an account with us and click “Switch agent” within your account. You will find a short form to fill out, and we will take care of it from there.

Are there any risks associated with registration?

Absolutely none for registering with us. However, not having an active registration with the FDA brings unnecessary risks, which may include being barred from importing to the US, plus penalties and fines.

We have only now learned about the FDA requirements. We were previously unaware — what should we do?

To avoid having your business barred or facing severe fines and penalties, you should register as soon as possible. It is imperative that you take this seriously and not wait until it is too late. Take action today. Regardless of whatever process you had in place previously, you must maintain a registration.

What happens if there are changes to our business address or other company information?

Please inform us as soon as any changes to your address or contact information occur. You can do so through your account or by contacting us directly via email: help@fdaexpress.us.

Are there other requirements as far as importing our food to the US?

How do we contact you?

How do we get started?