FDA registration (Food and Drug Administration) is a critical step for any manufacturer wishing to export food, cosmetics or medical products to the United States. Incorrect or incomplete registrations can result in products being detained at customs, being returned or facing high penalties. In this article, we have summarized the current FDA registration processes, FCE & SID number requirements and the advantages of our consultancy services as of 2025.
What is FDA Registration?
- Manufacturers or packaging facilities wishing to export to the US must be registered with the FDA.
- Food Facility Registration → Required registration for all food production facilities.
- U.S. Agent → There is an obligation to have an official representative in the USA. This representative company is involved in FDA correspondence and inspections.
- Annual renewal → FDA registrations must be renewed every two years and kept up to date.
FCE & SID Number : For Canned and Low Acid Foods
If you export canned food, low acid foods (LACF) or acidified foods to the US, you must obtain FCE (Food Canning Establishment) and SID numbers (Submission Identifier number) in addition to FDA registration.
FCE Number → This is the registration of your factory, i.e. your production facility, as a "canned food production facility" in the FDA system.
SIDNumber → This is the unique identification number given after the formula and heat treatment (cooking, sterilization) parameters submitted to the FDA for each product are approved.
If we explain the SID Number more simply:
Let's say you produce canned peas.
- You send the FDA the recipe (formulation) of this product and how it is cooked/sterilized.
- When the FDA reviews this information and deems it appropriate, it assigns a special SID number to that product.
- So FCE → identifies your factory, SID → identifies the product.
Without an SID, the product will get stuck at US customs because the FDA wants to know that the product has been processed safely.
This process is particularly relevant for canned vegetables, ready meals, milk-based drinks, sauces and canned fruit.
What is Low-Acid Canned Food (LACF)?
Low-Acid Canned Food (LACF), or "low-acid canned food", is food with a pH greater than 4.6 and a water activity (aw) greater than 0.85.
- Alcohol-containing drinks do not fall into this category.
- However, tomatoes and tomato products are not included in the LACF as long as the pH is below 4.7.
Example LACF products: canned vegetables (such as corn, peas), non-carbonated bottled drinks.
What is Acidified Food (AF)?
Acidified Food (AF), i.e. "acidified food", is actually a low-acid food, but then acid or an acidic food is added to reduce the pH below 4.6. The water activity must still be above 0.85.
Example AF products: pickles, sauces, some bottled sour products.
Labeling and Content Compliance Check
The FDA is not only concerned with facility registration, the product's labeling and ingredient declaration must also comply with the regulations.
Labeling requirements:
- Nutrition Facts Panel (US-specific nutrition facts table)
- Ingredients list & allergen declaration
- Net quantity (in both metric and American units)
- Manufacturer name, address, FDA registration number
In this regard, Export Partners' team of specialists will make your product labels compliant with US standards through a preliminary review and revision.
Customs Processes and Compliance
FDA registration alone is not enough. In order for your products to enter the US customs(CBP) without any problems:
- Importer customs registration
- Customs Bond supply
- Choosing the right HS Code
- FDA & CBP integration
We also manage their services.
For Nuts, Dried Fruits and Cosmetics Exporters
In 2025, the most demanded product groups in the US include nuts (hazelnuts, pistachios, almonds), dried fruits (apricots, figs, grapes), olive oil and cosmetics.
Both FDA registration and label compliance are critical for these products. In particular, FDA registration documents are mandatory in order to sell on platforms such as Amazon.
Why Export Partners Turkey?
As Export Partners Turkey, through our solution partners in the US:
- FDA facility registration and renewal
- FCE & SID applications
- Label and content alignment
- U.S. Agent service
- Customs Bond and customs registration
- Supply of D-U-N-S number
services from a single source.
Contact
If you are planning to export to the US, it is critical that you set up the FDA and customs processes of your products correctly from the very beginning.
Visit our contact page to get in touch with us
