Do You Need FDA Approval to Import Food?

One of the most common questions international food suppliers ask is whether they need FDA approval before importing food into the United States.

The short answer is:

➡️ No, FDA does not pre-approve food before it enters the U.S.A
But…
➡️ You must follow FDA compliance rules to legally import.

So while there is no approval certificate, there are clear regulations that must be met.

Does FDA Approve Food Before Entry?

No. FDA does not review or “approve” individual food products before they leave the exporting country.

Instead, FDA checks two main things:

Labeling and ingredients must meet U.S.A rules.
The producing facilities must be registered with FDA.

If these are not correct, your shipment may face delays or rejection at customs.

What Happens When Food Arrives at the Port?

Every food shipment entering the U.S.A is monitored by both:

U.S. Customs and Border Protection (CBP)
FDA (Food and Drug Administration)

If documentation, labeling, or registration is missing or incorrect:

The shipment can be held
You may need to submit corrections
In some cases, products can be refused entry

This is why compliance is essential before shipping.

So What Is Actually Required by FDA?

1. Facility Registration

Any facility that manufactures, stores, or packs food must be registered with FDA.

This includes:

Turkish manufacturers
Consolidation warehouses
U.S. storage facilities

Registration must be renewed every 2 years.

2. Prior Notice

FDA must be notified electronically before food arrives at the port.

Shipments without Prior Notice may be held.

3. Correct Labeling

Labels must follow FDA rules:

English text
Nutrition panel
Ingredient list
Allergen information
Net quantity
Manufacturer details

4. Ingredient Compliance

Ingredients must be allowed under U.S. regulations (21 CFR).

Some additives:

Are restricted
Require specific limits
Are not approved for U.S. use

Incorrect formulas can result in shipment refusal.

5. FSVP (Foreign Supplier Verification Program)

The U.S. importer must verify:

Where food comes from
That it meets safety standards
Any potential hazards

If the importer cannot prove compliance, FDA may block future shipments.

Why This Matters

The U.S. imports over $170 billion in food products each year, including:

Chocolate
Sweets
Snacks
Beverages
Consumer packaged goods

Demand is strong, but compliance is often the reason shipments get delayed.