U.S. FDA Registration Services in Turkey
FDA Registration Assistance provides U.S. FDA registration and regulatory consulting for companies across Turkey (Türkiye) that export dietary supplements, hazelnuts, dried figs and apricots, other foods, cosmetics, pharmaceuticals, and medical devices to the United States. As a U.S.-based firm, we help Turkish manufacturers, processors, and trading companies register foreign facilities, appoint a U.S. Agent where required, coordinate FSVP and Prior Notice with U.S. importers, review labeling and claims, and complete drug, device, and cosmetic requirements before products reach the U.S. market.
Confirm which FDA programs apply before your first U.S. shipment. Tell us what your Turkish company produces or exports, where each product is made or packed, and who will import it. We can identify the registrations, U.S. Agent, label and claim, Prior Notice, and importer questions to address, handled remotely from the United States.
Request My Turkey FDA AssessmentFDA Registration for Turkish Exporters Entering the U.S. Market
A National Service Area
Turkey's exporters span Istanbul, the Aegean and Mediterranean ports of Izmir and Mersin, the Black Sea hazelnut belt, and the dried fig and apricot regions. Wherever a Turkish company is based, FDA requirements apply the same way when its products are sold into the United States, and we support businesses nationwide from our U.S. office.
FDA-Regulated Products
FDA requirements may apply to foods, including nuts, dried fruit, and olive oil, as well as dietary supplements, cosmetics, OTC and prescription drugs, and medical devices, depending on intended use, labeling, ingredients, claims, manufacturing, and how products are exported and imported into the United States.
Foreign-Facility Support
FDA Registration Assistance is based in Miami, Florida and supports Turkish exporters remotely with foreign facility registration, U.S. Agent service where FDA requires one, FSVP coordination, labeling, drug and device listing, and import compliance, with particular depth in dietary supplement, nut, dried fruit, and packaged food exports.
Turkey's FDA Equivalents: TİTCK and the Ministry of Agriculture vs the U.S. FDA
One of the most common points of confusion for Turkish exporters is the relationship between the country's own regulator and the U.S. Food and Drug Administration. Turkey has no single "Turkish FDA." Medicines, medical devices, and cosmetics are regulated by the Turkish Medicines and Medical Devices Agency (Türkiye İlaç ve Tıbbi Cihaz Kurumu, or TİTCK), part of the Ministry of Health, while food and food supplements (takviye edici gıdalar) are regulated and approved by the Ministry of Agriculture and Forestry. These bodies operate under Turkish law. The U.S. FDA is a separate agency that governs products entering the United States.
These are two different systems, and clearing one does not clear the other. A TİTCK license, a Ministry of Agriculture supplement approval, or a CE mark is not recognized by the U.S. FDA, so a medicine, device, food, supplement, or cosmetic that is fully compliant in Turkey still needs its own U.S. FDA registration, listing, labeling, and, where relevant, U.S. Agent representation before it can be exported to the United States. In the same way, completing FDA requirements does not replace any Turkish obligation. You can review the FDA's own overview of importing FDA-regulated products for context. Our role is to handle the U.S. FDA side so that a company already meeting its home requirements can add U.S. market access cleanly.
How FDA Requirements Apply Across Turkey's Export Sectors
Turkey exports across several FDA-regulated categories, and each follows a different pathway. This overview shows how the main requirements map to the sectors Turkish companies most often ship to the United States.
| Export Sector | Primary FDA Pathway | Key Point for Turkish Exporters |
|---|---|---|
| Food & Agricultural Products | Foreign food facility registration, U.S. Agent, Prior Notice, FSVP | Facilities that make, pack, or hold food generally register; the U.S. importer generally needs an FSVP, and each shipment needs Prior Notice. |
| Hazelnuts & Dried Fruit | Food facility registration, Prior Notice, importer FSVP | Turkey is the world's largest hazelnut producer and exporter. Processing and packing facilities register, and nuts and dried figs can be detained for aflatoxins; dried apricots must declare sulfites. |
| Dietary Supplements | Food facility registration, Part 111 CGMP readiness, label and claim review | There is no FDA product registration for supplements. The facility registers, manufacturing follows 21 CFR Part 111, and Supplement Facts and claims must meet U.S. rules. |
| Cosmetics & Personal Care | MoCRA facility registration, product listing, Responsible Person | MoCRA added facility registration, product listing, adverse event reporting, and safety substantiation; the Responsible Person is the firm named on the label. |
| Pharmaceuticals | Drug establishment registration, listing, NDC, U.S. Agent | Foreign drug establishments register and list before their drugs are imported, separate from TİTCK licensing. |
| Medical Devices | Establishment registration, device listing, classification review, U.S. Agent | Requirements depend on FDA classification; many Class II devices need 510(k) clearance, and a CE mark does not substitute for it. |
FDA Planning Points for Turkish Exporters
The United States imported about $16.4 billion in goods from Turkey in 2025 (U.S. Census Bureau). Only part of that is FDA-regulated, but every food, supplement, cosmetic, drug, and device shipment is screened by FDA at entry, and FDA's import alert list for Turkey covers mycotoxins, Salmonella, pesticides, undeclared allergens and sulfites, and supplements containing drug ingredients (FDA import alerts for Turkey). Three questions come up most often:
Dietary Supplements From Turkey
FDA has no product registration or approval for supplements. The Turkish facility that manufactures, packs, or holds the product registers as a food facility, follows the 21 CFR Part 111 CGMP rule, and uses a U.S. Agent. A structure/function claim needs the FDA disclaimer, and FDA must be notified within 30 days of first marketing (FDA). A Ministry of Agriculture supplement approval does not carry over. See our dietary supplement FDA page.
Hazelnuts, Figs, and Apricots
Turkey supplies about 60 to 70 percent of the world's hazelnuts (USDA FAS). FDA's mycotoxin Import Alert 23-14 names Turkish dried fig and fig paste shippers for aflatoxins (Import Alert 23-14), and undeclared sulfites, common in dried apricots, can also lead to detention. Lot testing, sulfite declarations, and supplier records for the U.S. importer's FSVP matter as much as registration.
CE Marks and TİTCK Do Not Transfer
Turkey's EU-aligned device and cosmetic rules help in Europe, not in the U.S. FDA's mutual recognition agreements cover the EU, Switzerland, and the United Kingdom, not Turkey (FDA), and the United States has no free trade agreement with Turkey (USTR). A Turkish device maker still registers, lists, and may need 510(k) clearance; a drug maker still registers, lists, and obtains NDCs.
The 2026 biennial food facility renewal window runs from October 1 to December 31, 2026; existing Turkish food and supplement facility registrations must be renewed in that period to stay valid (renewal help). For city-level detail, see the Turkey city guides below.
FDA Consulting by City in Turkey
We publish dedicated FDA service area pages for Turkey's commercial and manufacturing centers. Explore the city guides below for local detail, or contact us directly if your city is not yet listed — we support exporters across the whole country.
FDA Consulting in Istanbul, Turkey
Turkey's largest city and commercial heart — supplement, food, cosmetic, pharmaceutical, and device exporters and brand owners.
FDA Consulting in Izmir, Turkey
A major Aegean port and export center — dried fruit, olive oil, food, and agricultural exporters.
FDA Consulting in Mersin, Turkey
A leading Mediterranean container port — food, citrus, and agricultural shippers reaching the U.S. market.
FDA Consulting in Bursa, Turkey
A key manufacturing and food-processing hub — packaged food, confectionery, fruit and vegetable, and consumer product exporters.
FDA Consulting in Ankara, Turkey
The capital, home to TİTCK, and an industrial center — pharmaceutical, medical device, supplement, and food exporters.
FDA Consulting in Adana, Turkey
An agricultural and food-processing center in the south — food, citrus, and agricultural exporters.
FDA Consulting in Sakarya, Turkey
An industrial and manufacturing region near the Marmara Sea — food, hazelnut, and consumer product exporters.
FDA Consulting in Tekirdağ, Turkey
A Marmara port and industrial zone — food, agricultural, and manufactured product exporters.
How FDA Registration Works for a Turkish Company
1. Product and Facility Review
We review your products, facilities, and target U.S. market to determine which FDA categories and registrations apply across food, supplement, cosmetic, drug, and device lines.
2. Pathway and U.S. Agent Setup
We identify the required registrations and listings, obtain a DUNS number where needed, and put U.S. Agent representation in place where FDA requires a U.S. contact.
3. Filing and Labeling
We prepare and submit the registrations and listings, review labels and claims against U.S. rules, and coordinate FSVP and Prior Notice with your U.S. importer.
4. Ongoing Compliance
We manage renewals, keep registrations and listings current, and support FDA communications, so your Turkish company stays compliant as it grows in the U.S. market.
Need U.S. FDA Registration Services in Turkey?
Whether you export dietary supplements, hazelnuts, dried fruit, other foods, cosmetics, pharmaceuticals, or medical devices, FDA Registration Assistance can map your pathway and handle the U.S. FDA side from start to finish.
- Identify which FDA programs apply to each product and each manufacturing or packing site in Turkey.
- Confirm U.S. Agent, Prior Notice, FSVP, labeling, and claim responsibilities with your U.S. importer.
- Agree the scope, required documents, and pricing before any paid work begins.
Contact our specialists to get started. View registration pricing, learn about FDA Registration Assistance, or see all service areas.
Request My Turkey FDA AssessmentFDA Registration Assistance is a private consulting firm, not FDA. Professional assistance is not government approval or a guarantee of a regulatory outcome.
Frequently Asked Questions About FDA Registration in Turkey
1. Do companies in Turkey need FDA registration to sell products in the United States?
Most do. Any Turkish business that manufactures, processes, packs, holds, labels, or exports FDA-regulated food, dietary supplements, cosmetics, drugs, or medical devices to the United States is treated as a foreign facility or foreign establishment and must meet the applicable FDA registration, listing, and U.S. Agent requirements before products enter the U.S. market.
2. Is U.S. FDA registration the same as registering with TİTCK, the Turkish Medicines and Medical Devices Agency?
No. TİTCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu) is Turkey's own regulator for medicines, medical devices, and cosmetics, and the Ministry of Agriculture and Forestry approves food supplements and regulates food; their approvals govern the Turkish market. U.S. FDA registration is a separate, U.S. requirement that applies when products are exported to the United States. A product licensed by TİTCK or approved by the Ministry still needs its own FDA compliance to enter the U.S., and clearing FDA does not replace any Turkish requirement.
3. Does the U.S. FDA have an office in Turkey?
No. FDA's European office is in Brussels, Belgium, and FDA has no office in Turkey that registers or approves companies (FDA foreign offices). Foreign facilities interact with the U.S. FDA through its online registration systems, and food facilities and drug and device establishments do so through a U.S. Agent based in the United States.
4. Which FDA-regulated products does Turkey most commonly export?
Turkish exporters commonly deal with hazelnuts, dried figs and apricots, pistachios, olive oil, packaged and processed foods, confectionery, dietary supplements and nutraceuticals, cosmetics and personal care products, and, in some cases, pharmaceuticals and medical devices. Each category has its own FDA pathway, and the right one depends on the product, its intended use, and its labeling.
5. Do Turkish exporters need a U.S. Agent?
Yes, in every FDA program that registers foreign facilities. Foreign food and dietary supplement facilities and foreign drug and medical device establishments must designate a U.S. Agent located in the United States, who serves as FDA's contact for communications, inspection scheduling, and emergencies. Foreign cosmetic facilities registering under MoCRA must name one too. FDA Registration Assistance can serve as the U.S. Agent for eligible Turkish food, supplement, drug, device and cosmetic establishments.
6. Does FDA registration mean the FDA has approved a Turkish product?
No. For most foods, supplements, and cosmetics, registration and listing are compliance steps, not an approval or endorsement. The FDA does not pre-approve these products, and it is misleading to describe registration as FDA approval. Drugs and certain devices involve additional review pathways that are separate from basic establishment registration.
7. Can one FDA registration cover a company's whole operation in Turkey?
Not always. Registration is generally facility and product-category specific, so a company that operates more than one facility, or that ships across food, drug, device, or cosmetic categories, may need several registrations and listings. We map which registrations apply across a Turkish company's sites and product lines.
8. How long does FDA registration take for a Turkish company?
Many foreign food and supplement facility registrations can be completed within a few business days once the facility details, product information, DUNS number, and U.S. Agent are in place. Drug, device, and cosmetic pathways can take longer because of listing, classification, and labeling steps, so timelines depend on the product category.
9. Which Turkish cities does FDA Registration Assistance support?
We support businesses across Turkey, working remotely from our U.S. base. We have dedicated service area pages for Istanbul, Izmir, Mersin, Bursa, Ankara, Adana, Sakarya, and Tekirdağ, covering the country's main commercial centers and ports, and we assist exporters in other regions as well.
10. Does Turkish or EU approval count toward U.S. FDA requirements?
No. A product approved or certified in Turkey, or carrying a CE mark under EU-aligned rules, still needs its own U.S. FDA registration, listing, and labeling before it can be sold in the United States. TİTCK registration and CE marking do not transfer to the FDA, which applies its own standards to products entering the U.S. market. We handle the U.S. FDA side so a Turkish company can add U.S. access alongside its existing approvals.
11. Do Turkish food and supplement exporters need FSVP?
The Foreign Supplier Verification Program is generally the U.S. importer's responsibility, but it directly affects Turkish suppliers because the importer must verify that the foreign supplier meets U.S. food safety standards, including hazards such as aflatoxins in nuts and dried figs. Some importers and products follow modified requirements, including finished dietary supplements, which still require the importer to verify the supplier and its compliance with the supplement CGMP rule (FDA FSVP rule summary). We coordinate FSVP between Turkish exporters and their U.S. importers so the verification records are in place.
12. How do I start FDA registration for a Turkish company?
The simplest first step is a short review of your products, facilities, and target U.S. market. From there we identify which FDA registrations, listings, U.S. Agent service, and labeling steps apply, and we handle the filings. You can contact FDA Registration Assistance by email, phone, or the form at the bottom of this page to begin.
13. Does Turkey have a free trade or mutual recognition agreement that removes FDA requirements?
No. The United States has no free trade agreement with Turkey (USTR), and FDA's mutual recognition agreements cover the EU, Switzerland, and the United Kingdom, not Turkey (FDA). No arrangement lets a Turkish company skip U.S. FDA registration. Trade preferences and market-access programs can affect tariffs and customs treatment, but they do not change FDA's product safety, registration, listing, or labeling requirements, which apply based on the product and its use in the United States.
14. Are FDA fees different for companies in Turkey?
FDA's fee structure is based on the product category and activity, not the exporter's country. Medical device establishments pay an annual FDA registration user fee, and some drug programs carry user fees, while food, supplement, and cosmetic facility registration have no FDA registration fee. We outline any applicable government fees and our service fees up front for each Turkish pathway.
15. Can a Turkish company register with the FDA on its own?
A company can attempt registration itself, but foreign facilities must appoint a U.S. Agent, obtain a DUNS number, and navigate category-specific listing and labeling rules, which is where errors commonly cause border problems. Using an experienced firm reduces the risk of rejected filings, misclassification, and shipments held at entry.
16. What is a DUNS number and do Turkish facilities need one?
A DUNS number is a unique business identifier that FDA uses to verify a facility's identity for food facility registration and drug establishment registration. Foreign facilities in Turkey generally need a valid DUNS number that matches the facility's legal name and address before registration can be completed, and we help obtain or correct it where needed.
17. How often must a Turkish company renew its FDA registration?
It depends on the category. Food and supplement facility registrations renew every two years between October 1 and December 31 of each even-numbered year, so the current window runs to December 31, 2026. Cosmetic facility registrations renew every two years and MoCRA product listings are updated annually, while drug and device establishment registrations renew annually, with an annual user fee for devices. We track renewal windows so a Turkish company's registrations do not lapse.
18. Does FDA inspect facilities located in Turkey?
The FDA can inspect foreign facilities, and it also relies on import screening, records, and importer verification. Whether or not an inspection happens, a Turkish facility is expected to meet the applicable U.S. standards, keep records, and respond to FDA, through its U.S. Agent where one is required, so readiness matters regardless of inspection frequency.
19. What happens to a Turkish shipment that arrives without proper FDA registration?
The FDA can detain or refuse the shipment at the U.S. port, which usually means storage costs, delays, and possible return or destruction of the goods. Getting registration, labeling, product coding, Prior Notice, and importer verification right before the goods ship is the way to avoid these outcomes.
20. Can FDA Registration Assistance help Turkish exporters with U.S. labeling?
Yes. We review labels against U.S. requirements, including required statements, Nutrition Facts or Supplement Facts formatting, ingredient and allergen declarations, claims, net quantity, and the responsible firm's U.S. contact details, so products are labeled correctly before printing and export.
21. Do Turkish cosmetics need FDA registration under MoCRA?
Generally yes. Under MoCRA, facilities that manufacture or process cosmetics for the U.S. market register with FDA, and the Responsible Person, the manufacturer, packer, or distributor named on the label, lists each product. Small businesses may be exempt from some requirements. Turkish cosmetic and personal care brands should confirm facility registration, product listing, labeling, and safety substantiation before entering the U.S. market.
22. Are dietary supplements from Turkey treated as food or as drugs by the FDA?
The FDA regulates dietary supplements as a category of food, not as drugs, so there is no FDA product registration for a supplement. The Turkish facility generally needs food facility registration and must follow supplement labeling rules and the dietary supplement CGMP rule in 21 CFR Part 111; a product with a new dietary ingredient may need a premarket notification. Claims are important: structure/function claims need the FDA disclaimer and a notification to FDA within 30 days of first marketing, and a supplement that makes disease claims can be treated as an unapproved drug.
23. Can FDA Registration Assistance act as the U.S. Agent for a Turkish exporter long term?
Yes. We provide ongoing U.S. Agent representation for eligible Turkish food and supplement facilities and drug and device establishments, serving as FDA's required U.S. contact for communications, inspection scheduling, and emergencies for as long as the registration is active.
24. Does FDA registration expire if a Turkish company stops exporting for a while?
Registrations must be kept current and renewed on schedule, and a lapse can require re-registration before shipping resumes. If a Turkish company pauses exports, it is usually better to keep the registration active and renewed than to let it expire and rebuild it later, and we can advise on the best approach.
25. Why should a Turkish company choose FDA Registration Assistance?
We are a U.S.-based firm focused on foreign facility and foreign exporter FDA compliance, so we understand both the FDA's requirements and the practical realities Turkish exporters face. We map the pathway across food, supplement, cosmetic, drug, and device categories, handle the filings, serve as U.S. Agent where one is required, and support renewals and FDA communications end to end.
Request FDA Support for Your Turkish Business
Tell us what your company makes, sells, or distributes, where each product is manufactured or packed, your U.S. importer or buyer arrangement, label readiness, and target shipment date.
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