FDA Detention and Red List Process
For exports of food, cosmetics and medical products to the United States,
detention during FDA (Food and Drug Administration) inspection is one of the most critical risks for exporters.
The FDA's purpose is to ensure that imported products comply with US public health protection standards.
What happens if your product is stopped by the FDA at US customs?
For what reasons does this happen and how can it be resolved?
1. What is FDA Detention
FDA "detention" means that an imported product is held at customs on suspicion that it does not meet FDA standards.
The product has not yet been rejected, but an inspection or document verification is carried out before the import process is completed.
The most common causes:
- The facility is not FDA registered or has expired
- Inconsistency in product labeling information (Nutrition Facts, Supplement Facts errors)
- Incomplete Prior Notice notification in the FDA system
- The product was manufactured by a company that has been found to be non-compliant in the past
- Suspicion of microbiological or chemical residues (e.g. aflatoxin, heavy metal, bacterial contamination)
In this case, the product moves to the physical examination or document request phase by the FDA.
3. What happens if the product is stopped?
When the product is stopped, the FDA follows these steps:
- Notice of Action is sent (with product or batch details).
- Clarification and corrective documents are requested from the manufacturer or importer.
- If necessary, the product sample is sent for laboratory analysis.
- If the FDA approves, the product is released(Release Notice).
- Product if not found suitable:
- Returned to the exporter (exported),
- Or destroyed.
- Returned to the exporter (exported),
This process usually takes between 15-45 days.
4. Reasons for Suspension and Remedies
| Why? | Description | |
| No FDA Registration | The manufacturer or facility is not registered in the FDA system | |
| Inappropriate Label | Nutrition Facts/Supplement Facts incorrect | ı |
| Lack of Prior Notice | Product notification was not made on time | |
| Red List Registration | The company has experienced non-compliance in the past | |
| Residue/Analysis Problem | Detection of microbiological or chemical residues in the product |
5. Removal from Red List
Removal from Red List
Exit from the Red List is possible, but involves a technical and rigorous application process.
At this point, Export Partners Turkey manages the process on your behalf by coordinating directly with the FDA.
This application, called a "Petition for Removal", requires an official dossier to be submitted to the FDA, certifying that your company has made the necessary corrections and now meets the eligibility criteria.
We are in this process:
- We will check your current FDA registration and renew it if it is missing,
- We organize the production process and formula revisions according to FDA standards,
- We provide the necessary laboratory test reports,
- We redraft label and packaging revisions according to FDA labeling rules,
- We submit the Petition for Removal file to the FDA system and actively follow the process.
Once this process is complete, your company will be removed from the FDA Red List and your products will be reopened for US imports.
The average duration of the procedure varies between 30-90 days.
As Export Partners Turkey, we prepare the application file and handle all correspondence with the FDA on your behalf.
In this way, your products become available for resale and import without waiting at customs.
6. The Role of Export Partners Turkey
As Export Partners Turkey, we work as a solution partner in all import issues that require coordination with the FDA withour *FDAconsultancy service.
*https://www.exportpartners.com.tr/fda-kayit-belgelendirme/
The support we offer:
- FDA Food Facility Registration & Renewal
- FDA Red List inquiry and Petition for Removal
- Prior Notice arrangement
- Label & Ingredient Review
- U.S. Agent representation support
- *U.S. Customs (CBP) coordination
*https://www.usa.gov/agencies/u-s-customs-and-border-protection
In this way, it is ensured that your products do not wait at customs, are protected from the risk of Red List
and proceed safely in the FDA system.
Frequently Asked Questions
What does it mean to be on the FDA Red List?
If the company has experienced non-compliance in the past, its products are automatically stopped.
Is it possible to get off the Red List?
Yes, it is. The list is updated as a result of applications made with the correct documents.
What is Prior Notice?
Every food product shipped to the US must be notified to the FDA in advance. Without notification, the product is automatically stopped.
Does FDA registration prevent Red Listing?
Yes, up-to-date registration and correct labeling greatly reduce the risk of Red List.
