The U.S. Food and Drug Administration (FDA) is amping up registration cancellation enforcement for facilities that failed to renew their 2023 FDA registration and for food facilities that didn’t provide a DUNS number in their registration renewal.
FDA is actively removing facilities with invalid registrations from its databases, effectively cancelling their registrations. FDA-regulated products shipped to the U.S. without a valid registration will be detained at the port of entry.
It’s important that companies renew their registrations as soon as possible to avoid costly detentions and delays. The sooner you act, the sooner you can continue selling your products in the U.S.
For food facilities needing a DUNS number, Registrar can help.
When Was the Renewal Deadline?
The 2023 deadline to renew FDA registrations for all regulated products was December 31, 2022.
Drug and medical device establishments must renew between October 1 and December 31 of every year. Food facilities must renew their registration between October 1 and December 31 every two years on even-numbered years.
In 2016, FDA updated the Food, Drug, and Cosmetic (FD&C) Act to state that food facilities must obtain a Unique Facility Identifier (UFI) (21 CFR 1). The DUNS number is currently the only UFI FDA recognizes.
After multiple extensions, FDA announced in 2021 that it would begin enforcing the UFI requirement during the registration renewal period in December 2022.
At the beginning of each year, FDA begins purging its database of companies that did not renew their registrations, rendering those registrations invalid.
How to Renew Your FDA Registration
You must submit your registration renewal properly, with all required information or face possible registration cancellation. Keep in mind that renewal requirements vary depending on how your products are regulated:
- Food facilities were required to include their DUNS number in their 2023 renewal. Each company must have a separate DUNS number for each food facility. Food facility registrations submitted without a valid DUNS number are incomplete and are subject to cancellation.
- Drug establishments must list all products, specify a Registrant Contact, and submit a “Blanket No Change Notification” for all product listings that have not been updated during the current year. Drug registration and listing data must be submitted electronically using structured product labeling (SPL) format (section 510 of the Federal Food, Drug, and Cosmetic Act).
- Medical device establishments must list their devices and specify the activities performed on those devices. Additionally, companies must designate an Official Correspondent responsible for registration. If a device requires a premarket submission, the submitter should include the premarket submission number (510(k), De Novo, PMA, PDP, HDE) (21 CFR Part 807).
For all industries, companies located outside the United States must designate a U.S. Agent for FDA communications.
What Happens If You Don’t Renew?
If your registration was not renewed, you can’t legally market your products in the U.S.
If you ship products to the U.S. without a valid registration, they are subject to detention, and will likely be stopped by the U.S. Customs Border Protection (CBP). CBP will continue to detain your shipment until you provide a valid registration number, resulting in costly delays.
Not only will you incur fees every day CBP holds your shipment, but you’ll also lose potential revenue. Because detentions are public information, your brand’s reputation could also suffer, as importers prefer to purchase from suppliers that do not have detentions on record.
Act Quickly to Avoid FDA Enforcement Actions
Avoid unnecessary penalties by assuring your FDA registration is up to date. If your registration is currently invalid, renew as soon as possible and take steps to prevent your registration from becoming invalid in the future.
Don’t know if your registration is valid? Click your industry to verify that your registration was successfully renewed for 2023 at no cost: