Introduction
Any manufacturer or packaging facility exporting food, cosmetics, supplements or medical products to the US must be registered with the FDA.
This registration is renewed every 2 years - i.e. it must be reconfirmed in December of every even year (such as 2022, 2024, 2026).
So by example:
- If you registered in 2023,
- You need to renew in December 2024.
- If you cannot be renewed, your registration becomes "inactive" in the FDA system.
In this case, your products are stopped (detention) at US customs and cannot be imported.
FDA Renewal 2025: Has the Two-Year Renewal Process Begun?
The FDA Renewal process must be repeated every two years for all companies exporting food, food supplements, cosmetics or medical products to the US. For 2025, the renewal period runs as usual from October 1 to December 31. This period is known as the "FDA biennial renewal window" and only during this time period can registrations be updated.
If the renewal process is not completed, your company's FDA registration automatically becomes inactive (expired). In this case, you may face serious consequences such as your products being stopped, detained or refused importation at US customs.
What is the Renewal Process?
Renewal is not just about pressing the "confirm" button.
By 2025, the FDA system asks you to re-verify updated company information, address, type of activity, U.S. Agent information and facility data.
Renewal steps:
- Updating facility information (address, ownership structure, contact information)
- Control of the type of production activity
- Update or confirmation of U.S. Agent information
- Verification with current D-U-N-S Number
- Receiving Renewal Submission Confirmation through the system
What if I can't be beaten?
The FDA deletes all unrenewed registrations at the end of the renewal period (as of January 1).
In this case:
- Your FDA registration will be canceled.
- Your products will be blocked from entering the US.
- Imports cannot be made without re-registration.
- Sales may be suspended on platforms such as Amazon and Walmart.
Renewal Service with Export Partners Turkey
As Export Partners Turkey, through our official representatives in the US:
- We complete the FDA Renewal process on time.
- We are following the U.S. Agent approval process.
- We are verifying the current D-U-N-S.
- After registration, we forward the confirmation mail from the FDA to the company.
Delays or incorrect entries in the renewal process can lead to both deregistration in the FDA system and commercial disruptions. It is therefore important that the process is carried out by an expert team.
Keywords:
FDA Renewal 2025, FDA registration renewal, biennial renewal, FDA registration renewal process, FDA biennial renewal, FDA inactive registration, Food Facility Registration renewal, FDA consultation 2025, food exports to the US, FDA U.S. Agent
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