Frequently Asked Questions

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.

The registration process is simple and straightforward:

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 info and submit to the FDA
6. We wait for an approved registration, and send you a certificate
7. Congratulations, you are now registered with the FDA!

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?

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.

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. § 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.

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

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

Very simply! All you have to do is create an account with us and click on "switch agent" within your account - you will find a short form to fill out, and we will take care of it from there.

Absolutely none! However, not having an active registration with the FDA brings businesses unnecessary risks which may include a full ban from importing to the US, penalties and fines.

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

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.