FDA kaydı, ABD’ye ürün gönderen tesisin FDA’ya kendini bildirmesidir. Onay değildir. Gıda, takviye ve kozmetikte FDA hiçbir ürünü onaylamaz; sadece tesisi kayda alır ve kayıt ücretsizdir. Onay yalnızca ilaç, biyolojik ürün, orta ve yüksek riskli tıbbi cihaz ile gıda ve renk katkılarında söz konusudur. Bu ayrım önemli, çünkü gıda ürününde “FDA onaylı” ifadesi kullanmak ABD’de yanıltıcı beyan sayılır.
There is also a renewal requirement for food facility registrations: registrations must be renewed between October 1 and December 31 of even-numbered years. Since 2026 is an even-numbered year, the renewal window for this year opens on October 1, 2026. The FDA considers any registration that is not renewed to have expired and revokes it.
What is the difference between FDA registration, approval, and certification?
Three terms are constantly used interchangeably in Turkey, causing problems in contracts, product labels, and correspondence with customers. The distinction varies depending on the product category:
| Product group | Facility Registration | Product Approval | Requirements for market entry |
|---|---|---|---|
| Food and Beverages | Mandatory, free, renewed every two years | No | Facility Registration + U.S. Representative + Prior Notice per Shipment |
| Dietary supplement | Required | No | Facility registration + NDI notification if there are new components |
| Cosmetics | Required (included with MoCRA) | No, except for color additives | Facility Registration + Product Listing |
| Food and color additives | – | There is | Premarket approval or GRAS notification |
| Medical device, Class I-II | Required | Most of them have 510(k) clearance | Establishment Registration + Device Listing + 510(k) |
| Medical device, Class III | Required | Available (PMA) | PMA approval |
| Drugs and biological products | Required | Exists (NDA, ANDA, BLA) | Clinical file and approval |
As can be seen in the table, the vast majority of products exported from Turkey to the U.S.—namely, food and cosmetics—are subject to registration rather than approval.
Is there such a thing as an FDA certificate?
The FDA does not issue a fancy certificate upon registration. When you complete the food facility registration, what you receive is an 11-digit registration number (FFR number). The FDA’s own system generates this number; it does not send a PDF document.
The colorful documents titled “FDA Registration Certificate” sold on the market are not documents issued by the FDA. They are service documents printed on the letterhead of intermediary firms that handle the registration process on your behalf. Your buyer may accept this document, but its official validity lies in the registration number being valid in the FDA system—not in the document itself.
Another document that is often confused is the Certificate of Free Sale. This document is issued for U.S. manufacturers exporting goods outside the United States. A manufacturer exporting from Turkey to the United States does not need such a document.
How do I obtain FDA registration?
The sequence for a food facility is as follows:
- Select a product category. The processes for food, dietary supplements, cosmetics, and medical devices differ. If the product contains animal-derived ingredients, the USDA may also be involved.
- Appoint a U.S. Agent. This is required for every food facility located outside the United States. Communication between the facility and the FDA takes place through this person. The agent’s responsibilities and the process for replacing the agent are explained in detail in our article on U.S. Agents.
- Register your facility through FDA Industry Systems. Registration is free.
- Obtain the registration number and keep it on file. This number is used on shipping documents and in the Prior Notice submission.
- Submit a Prior Notice for each shipment. Registration is a one-time process; the Prior Notice is required for each shipment. These are two separate obligations.
In addition to facility registration, FCE and SID registrations are also required for acid and low-acid canned products. For a complete list of cost items, please refer to our article on the cost of exporting food to the U.S.
When is the 2026 renewal period?
Food facility registrations are renewed in even-numbered years, between October 1 and December 31. The 2026 registration period opens on October 1, 2026, and closes on December 31, 2026.
If the registration is not renewed, the FDA will consider it expired and revoke it. Shipments sent under a revoked registration will be held at U.S. Customs. Failure to register is considered a violation under U.S. law. Expiration, revocation, and suspension are distinct situations; we have outlined the differences between them in this article.
Renewal is free, just like registration. It is common during this period to receive high bills from brokerage firms labeled as a “renewal fee”; before paying, have the registration number verified to ensure the transaction was actually processed.
How do you check an FDA registration?
The FDA does not publish a list of registered food facilities on a publicly accessible search interface; food facility registrations are confidential. The categories that are publicly searchable include drugs, medical devices, and certain product groups:
- Drugs@FDA – Approved Drugs
- NDC Directory – National Drug Code List
- 510(k) Premarket Notification – Device Clearances
- PMA – Class III Device Approvals
- Establishment Registration – Device Establishment Registrations
You can check the status of your own food facility registration through your FDA Industry Systems account. If you want to verify a supplier’s registration, simply ask them for their registration number and the last renewal date.
Are a food registration certificate and FDA registration the same thing?
No. The food registration certificate is a business registration certificate issued by the Ministry of Agriculture and Forestry in Turkey and is valid within Turkey. FDA registration, on the other hand, is a separate notification submitted to U.S. authorities for shipments to the United States. One does not replace the other; a producer exporting to the United States must have both.
What is the FDA, and in which areas does it have authority?
FDA stands for the Food and Drug Administration; it is known in Turkish as the Food and Drug Directorate. In the United States, it regulates the safety of food, drugs, medical devices, cosmetics, dietary supplements, veterinary products, tobacco products, and certain electronic devices that emit radiation.
Some products that fall outside the scope of these agencies’ authority are causing confusion: the regulation of meat, poultry, and egg products falls under the USDA; most alcoholic beverages fall under the TTB; and pesticides fall under the EPA. If you’re shipping animal products, the process doesn’t end with the FDA.
