Beverage Exports to the U.S.: FDA Registration, DUNS, and Label Review—From Start to Finish
Most Turkish manufacturers planning to export beverages to the U.S. approach the process from three main angles: FDA food facility registration, a DUNS number, and labeling compliance. No matter how high the product quality may be, if these three elements are not properly established from the outset, the product cannot clear U.S. customs, is held up at customs, or proceeds only after costly revisions.
Bu yazıda, danışmanlığını yürüttüğümüz bir Türk içecek üreticisinin FDA giriş sürecinden yola çıkarak; kayıt, DUNS ve etiket inceleme adımlarını uygulamada nasıl yönettiğimizi anlatıyoruz. Amaç, hem süreci ilk kez öğrenen üretici için net bir yol haritası çıkarmak, hem de aynı yolu düşünen firmaların baştan doğru karar verebilmesini sağlamak.
3. Tag and Content Compliance Review
FDA registration ensures that a product can “enter” the U.S.; however, for it to clear customs without issues and remain on the shelf, the label must also comply with FDA regulations. In the beverage category, label review is more complex than for standard foods because additional rules specific to fruit juice apply.
What Does a Label Review Cover?
- Statement of Identity: Product name and description; correct use of terms such as “juice,” “nectar,” and “juice drink.”
- Net quantity declaration: Both metric and U.S. units (fl oz); location, font size, and format specified.
- Nutrition Facts: Current U.S. format; for beverages, the “added sugars” line and the calculation of serving size are particularly important.
- Ingredients and allergens: Listed in order of weight ; allergens such as sulfites are declared.
- Percentage of fruit juice declaration (21 CFR 101.30): Required for all beverages containing fruit juice; calculated based on Brix.
- Pasteurization warning (21 CFR 101.17(g)): Mandatory warning statement for unprocessed fruit juices; the format is specified.
- Manufacturer information and country of origin: “Product of Türkiye” statement; manufacturer’s/distributor’s name and address.
- Language: The entire label must be in English.
The Most Common Revisions We Encounter During Reviews
In the multi-product review of our case, the most frequently discussed corrections centered on these three points:
- Incorrect percentage declaration: In products made from concentrate , the actual percentage calculated using the Brix scale often differs from the percentage stated on the label.
- Product name category mismatch: A product sold as “nectar” in Turkish falls into a different category in the U.S. based on its actual fruit juice content; the product name is revised accordingly.
- Old Nutrition Facts format: The current U.S. format includes a line for “added sugars”; the old format is no longer accepted.
The review is conducted on a SKU-by-SKU basis; a separate compliance report is prepared for each product, and the necessary revision recommendations are provided to the customer. This report subsequently becomes a document that is reused time and again at customs, during meetings with buyers, and on marketplaces, including Amazon. Our FDA Labeling and Customs Advisory Guide will serve as a reference for all labeling-related matters.
After Registration and Labeling Are Complete
Once these three items are completed, the manufacturer is officially “ready” to export to the U.S.; however, the entire process does not consist solely of these three steps. Additional items that come into play in the next phase are as follows:
- Prior Notice: Electronic prior notice to the FDA and CBP before each shipment.
- Importer registration and customs bond: The operational infrastructure required for a shipment to clear customs.
- FSVP: For U .S. food imports, the importer is expected to have a supplier verification plan; this obligation falls on the importer, not the producer.
- Trademark Registration and Brand Registry: These are critical for brand awareness if you plan to sell on Amazon or in retail.
- Amazon and e-commerce setup: Once the regulatory framework is in place, building the sales side of the business moves much faster.
Roadmap, At a Glance
| Stage | What's Happening | Why It Matters |
| 1. DUNS | D&B Application and Obtaining a Number | Technical prerequisite for FDA registration |
| 2. FDA registration | Foreign Facility Registration + U.S. Agent | A prerequisite for entry into the U.S. |
| 3. Label Review | Compliance analysis and reporting by SKU | A Common Language Between Customs and Retailers |
| 4. Shipping | Prior Notice + customs bond + customs | A recurring operation in every shipment |
| 5. Sales Infrastructure | Brand, Amazon, distributor channels | Built on regulation |
Frequently Asked Questions (FAQ)
Do I need to get a DUNS number before registering with the FDA?
Yes. To register as a foreign food facility in the FDA system, you must first obtain a DUNS number through D&B. If the sequence is incorrect, the registration will be rejected by the system.
Can the manufacturer choose the US Agent themselves?
Yes. It is sufficient for the U.S. Agent to be based in the United States; the service provider can be an organization or an individual. A corporate U.S. Agent offers advantages in terms of continuity of service and tracking correspondence. We have explained in detail how the confirmation process and change notifications work in our FDA U.S. Agent guide.
How long does it take to complete an FDA registration?
If the documents are complete and US Agent approval is obtained quickly, the process can be completed within a few days. Incomplete or inconsistent information is the main reason the process takes longer.
Is the FDA registration number displayed on the product packaging?
No. An FDA registration number is not an approval or a quality certification; it is not printed on the product. The phrase “FDA-registered” may be used in marketing communications, but the phrase “FDA-approved” is misleading.
Can we make changes to the tags later?
It is possible, but it will incur printing and packaging costs. Our experience shows that completing the label review before printing is the most cost-effective approach.
Is FDA registration renewed every two years?
Yes. Registrations are renewed between October and December of even-numbered years; expired registrations are automatically canceled, and the product cannot enter the U.S.
Three Pens, One Unity
The success of beverage exports to the U.S. is often determined by whether these three elements are addressed together in practice. When viewed separately, DUNS, FDA registration, and label review may seem like minor operational steps; however, when addressed together in the correct order, they form a solid and predictable foundation for entering the U.S. market.
We provide end-to-end management of FDA registration, DUNS number, and labeling compliance processes for food and beverage exports from Turkey to the U.S. In addition, we coordinate customs and import operations, U.S. tax and accounting, and trademark registration—all under one roof. Upon request, we can also build your Amazon and e-commerce setups on top of this regulatory infrastructure.
Related guides: FDA Registration and Certification · FDA Labeling and Customs Advisory Guide · Trademark Registration in theU.S. · Amazon Brand Registry
Other guides in this series
This guide is part of a series explaining FDA processes for exporting to the U.S. Other related guides:
- FDA Registration and Labeling for Fruit Juice Exports to the U.S.
- FDA Registration, GMP, and Customs for Vegetable Oil Exports
- The FDA and Labeling Process for the Sale of Collagen and Protein Powder
- For support with registration and certification, please see our FDA registration and certification services.
